Index 
Texts adopted
Thursday, 10 March 2016 - StrasbourgFinal edition
Freedom of expression in Kazakhstan
 Egypt, notably the case of Giulio Regeni
 Democratic Republic of the Congo
 Introduction of emergency autonomous trade measures for Tunisia ***I
 Veterinary medicinal products ***I
 Authorisation and supervision of veterinary medicinal products ***I
 Towards a thriving data-driven economy
 Situation in Eritrea
 2015 Report on the former Yugoslav Republic of Macedonia
 2015 Report on Montenegro
 Banking Union – Annual report 2015

Freedom of expression in Kazakhstan
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European Parliament resolution of 10 March 2016 on freedom of expression in Kazakhstan (2016/2607(RSP))
P8_TA(2016)0083RC-B8-0337/2016

The European Parliament,

–  having regard to its previous resolutions on Kazakhstan, including those of 18 April 2013(1), of 15 March 2012(2), of 22 November 2012 containing the European Parliament’s recommendations to the Council, the Commission and the European External Action Service on the negotiations for an EU-Kazakhstan Enhanced Partnership and Cooperation Agreement(3), of 15 December 2011 on the state of implementation of the EU Strategy for Central Asia(4), and of 17 September 2009 on the case of Yevgeny Zhovtis in Kazakhstan(5),

–  having regard to remarks made by the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, Federica Mogherini, following the signing of the EU-Kazakhstan Enhanced Partnership and Cooperation Agreement (EPCA) on 21 December 2015,

–  having regard to the seventh round of the annual EU-Kazakhstan Human Rights Dialogue in Astana on 26 November 2015,

–  having regard to the Council conclusions of 22 June 2015 on the EU Strategy for Central Asia,

–  having regard to the fourth progress report of 13 January 2015 on the implementation of the EU Strategy for Central Asia adopted in 2007,

–  having regard to the report of the Special Rapporteur on the rights to freedom of peaceful assembly and of association, Maina Kiai, following his mission to Kazakhstan and presented on 16 June 2015,

–  having regard to the Enhanced Partnership and Cooperation Agreement signed on 21 December 2015,

–  having regard to Article 19 of the International Covenant on Civil and Political Rights,

–  having regard to the 1948 Universal Declaration of Human Rights,

–  having regard to Article 20 of the Constitution of Kazakhstan,

–  having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

A.  whereas on 21 December 2015 the European Union and Kazakhstan signed an Enhanced Partnership and Cooperation Agreement (EPCA) aimed at providing a broad framework for reinforced political dialogue and cooperation in justice and home affairs and many other areas; whereas this agreement puts a strong emphasis on democracy and the rule of law, human rights and fundamental freedoms, and sustainable development, and on civil society cooperation;

B.  whereas Kazakhstan is an important international actor and plays an important role in the political and socio-economic development, and in the security situation, of the whole region; whereas Kazakhstan has played a positive role in Central Asia, making efforts to develop good neighbourly relations with bordering countries, to resume regional cooperation and to resolve all bilateral issues by peaceful means; whereas the EU has a vital interest in stepping up political, economic and security cooperation with the Central Asia region via a strong, open and strategic EU-Kazakhstan relationship;

C.  whereas the EPCA will need to be ratified by the parliaments of all 28 EU Member States and by the European Parliament; whereas this agreement will not only strengthen political dialogue between the EU and Kazakhstan and serve to promote mutual trade and investment, but also puts a strong emphasis on international obligations; whereas it can be acknowledged that during the course of the EPCA negotiations improvements were made in terms of civil society engagement through measures taken to involve civil society in public policymaking;

D.  whereas the general situation with regard to freedom of expression has deteriorated in recent years; whereas in December 2015 the Kazakh authorities detained Guzal Baidalinova, a journalist and the owner of the Nakanune.kz online news site, in connection with a criminal case on charges of ‘deliberately publishing false information’; whereas concerns were expressed after the arrest of Guzal Baidalinova about the harassment of independent media in Kazakhstan; whereas on 29 February 2016 a court acquitted journalist Yulia Kozlova, who writes for Nakanune.kz;

E.  whereas there is an ongoing criminal investigation against Seytkazy Matayev, the head of the National Press Club and journalists’ union, who is accused of embezzling millions of Kazakh tenge in public funds; whereas on 22 February 2016 Seytkazy Matayev, who denies the charges, and his son Aset Matayev, who is the director of the KazTag independent news agency, were detained; whereas Aset Matayev was released after questioning;

F.  whereas on 22 January 2016 a court convicted Ermek Narymbaev and Serikzhan Mambetalin – bloggers who had been arrested in October 2015 on charges of ‘inciting national discord’– and sentenced them to three years and two years in prison respectively; whereas blogger Bolatbek Blyalov was put under limited house arrest;

G.  whereas the Kazakh authorities have closed down independent and opposition media outlets, including the Assandi Times, Pravdivaya and the ADAM bol and ADAM journals; whereas in late 2012 the Kazakh authorities sued independent and opposition media outlets, in particular the Golos Respubliki and Vzglyad newspapers, as well as their affiliate newspapers and websites, and the K+ and Stan.TV online television portals;

H.  whereas in October 2014 a court in Almaty imposed a fine of KZT 34 million on Havas Worldwide Kazakhstan;

I.  whereas the European Instrument for Democracy and Human Rights (EIDHR) is an important financing tool that aims to support civil society organisations and democratisation in both the country and the region;

J.  whereas according to ILGA (the International Lesbian, Gay, Bisexual, Trans and Intersex Association), LGBTI persons in Kazakhstan face legal challenges and discrimination not experienced by non-LGBTI residents; whereas both male and female same-sex sexual activity is legal in Kazakhstan, but same-sex couples and households headed by same-sex couples are not eligible for the same legal protections available to opposite-sex married couples;

K.  whereas on 20 March 2016 Kazakhstan will hold early parliamentary elections which should be preceded by guarantees regarding freedom of expression in society and the easy and transparent registration of political parties that are considered free and fair; whereas, according to the Organisation for Security and Cooperation in Europe (OSCE) Election Observation Mission Final Report of 3 April 2012, the 2012 elections were marred by ‘significant irregularities’(6);

L.  whereas a new Criminal Code, a new Code of Administrative Offences and a new Criminal Procedure Code came into force on 1 January 2015;

M.  whereas Kazakhstan is ranked 160th out of 180 countries in the 2015 Reporters Without Borders press freedom index;

N.  whereas the EU has consistently worked with Kazakhstan on its WTO accession path, which has now resulted in the completion of negotiations to join the WTO; whereas it is important that Kazakhstan follow the rule of law, uphold its international obligations and guarantee legal certainty for international companies operating in the country, together with the protection of their investments;

O.  whereas development cooperation with Kazakhstan focuses on strengthening the capacity of regional and local government, supporting the reform of the justice sector and improving the capacity of the public sector to introduce social and economic reforms;

1.  Stresses the importance of relations between the EU and Kazakhstan and of strengthening economic and political cooperation in all areas; highlights the great interest the EU has in a sustainable relationship with Kazakhstan in terms of political and economic cooperation;

2.  Expresses its concerns about the climate for media and free speech in Kazakhstan; is very concerned about the pressure on independent media outlets and the possible negative implications of new draft legislation on the funding of civil society organisations; points out that freedom of speech for independent media, bloggers and individual citizens is a universal value that cannot be bargained away;

3.  Regrets the indiscriminate blocking of news, social media and other websites on the grounds that they feature unlawful content, and calls on the Kazakh authorities to ensure that any measure to restrict access to internet resources is based on law; is concerned about the amendments to the Communications Law adopted in 2014;

4.  Is deeply worried about the disrespect and violation of prisoners’ rights in Kazakhstan’s prison system; is concerned about the physical and mental well-being of prisoners Vladimir Kozlov, Vadim Kuramshin (who won the Ludovic Trarieux International Human Rights Prize 2013) and Aron Atabek, who have been convicted on political grounds, and demands that they receive immediate access to necessary medical treatment and are allowed regular visits, including by family members, legal representatives and representatives of human rights and prisoners’ rights organisations;

5.  Recognises the ‘100-step programme’ as an attempt to address urgent reforms in Kazakhstan; calls on Kazakhstan to implement the National Torture Prevention Mechanism and to open a debate on the new Penal and Criminal Codes;

6.  Stresses that deeper political and economic relations with the EU as envisaged by the recently signed Enhanced Partnership and Cooperation Agreement must be based on shared values and correspond to an active and concrete engagement by Kazakhstan to conduct political and democratic reforms stemming from its international obligations and commitments;

7.  Welcomes the release, since the last Human Rights Dialogue, of a number of imprisoned human rights and labour activists;

8.  Emphasises that the legitimate fight against terrorism and extremism should not be used as an excuse to ban opposition activity, hinder the freedom of expression or hamper the independence of the judiciary;

9.  Calls for a review of the articles of the Criminal Code that can be used to criminalise lawful behaviour protected by human rights law, in particular Article 174 on ‘inciting social, national, clan, racial, class or religious discord’;

10.  Calls on the Kazakh authorities to quash the convictions of bloggers, including Ermek Narymbaev, Serikzhan Mambetalin and Bolatbek Blyalov; calls for the release of Guzal Baidalinova; calls for an end to the harassment of Seytkazy and Aset Matayev; points out, in this connection, that cases involving journalists should be public and that there should be no harassment during the proceedings;

11.  Calls for the release of the opposition leader Vladimir Kozlov, who is currently being held under strict prison conditions, pending an independent and impartial review of his case;

12.  Expresses its deep concerns regarding the Law on NGOs, which undermines the existence and independence of NGOs in Kazakhstan; urges the Kazakh authorities to guarantee in all circumstances that all human rights activists and NGOs in Kazakhstan are able to carry out their legitimate human rights activities without fear of reprisals, and free of all restrictions;

13.  Welcomes Kazakhstan’s ambition to engage actively as a mediator/facilitator in international security issues concerning the wider region; urges the Kazakh authorities to honour the international commitments they have signed up to, including those relating to the rule of law and the independence of the judiciary;

14.  Welcomes the regular EU-Kazakhstan Human Rights Dialogues; underlines the importance of human rights dialogues between the EU and the Kazakh authorities; calls for the dialogues to be strengthened to make them conducive to the establishment of a forum in which issues can be openly addressed; stresses that these dialogues should be effective and results-oriented;

15.  Calls on the EU, and in particular on the European External Action Service, to monitor closely developments in Kazakhstan, to raise concerns with the Kazakh authorities where necessary, to offer assistance, and to report regularly to Parliament; calls on the EU Delegation in Astana to continue to play an active role in monitoring the situation and to raise the issue of freedom of expression in all relevant bilateral meetings with Kazakhstan;

16.  Urges the Kazakh authorities to implement fully the recommendations of the OSCE/Office for Democratic Institutions and Human Rights before the next parliamentary elections, and to take concrete steps to implement the recommendations made by the UN Special Rapporteur on freedom of peaceful assembly and of association; reminds Kazakhstan of its ambition to be a candidate for a non-permanent seat on the UN Security Council in 2017-2018;

17.  Calls on the Kazakh authorities to commit to the achievements of the Sustainable Development Goals recently adopted at international level;

18.  Instructs its President to forward this resolution to the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, the Council, the Commission, the EU Special Representative for Human Rights, the governments and parliaments of the Member States, the Organisation for Security and Cooperation in Europe, the UN Human Rights Council and the Government and Parliament of Kazakhstan.

(1) OJ C 45, 5.2.2016, p. 85.
(2) OJ C 251 E, 31.8.2013, p. 93.
(3) OJ C 419, 16.12.2015, p. 159.
(4) OJ C 168 E, 14.6.2013, p. 91.
(5) OJ C 224 E, 19.8.2010, p. 30.
(6) http://www.osce.org/odihr/elections/89401?download=true


Egypt, notably the case of Giulio Regeni
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European Parliament resolution of 10 March 2016 on Egypt, notably the case of Giulio Regeni (2016/2608(RSP))
P8_TA(2016)0084RC-B8-0338/2016

The European Parliament,

–  having regard to its previous resolutions on Egypt, in particular those of 17 December 2015(1) and 15 January 2015(2),

–  having regard to the EU Foreign Affairs Council (FAC) conclusions on Egypt of 21 August 2013 and of 10 February 2014,

–  having regard to the EU-Egypt Association Agreement,

–  having regard to the EU Guidelines on the Death Penalty, on Torture, on Freedom of Expression and on Human Rights Defenders,

–  having regard to the response of 27 October 2015 by the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy (VP/HR) to Written Question E‑010476/2015 on EU and Member State military support to Egypt,

–  having regard to the Egyptian Constitution, in particular Articles 52 (on torture) and 93 (on the binding nature of international human rights law),

–  having regard to the International Covenant on Civil and Political Rights and the UN Convention against Torture, to which Egypt is a party,

–  having regard to the statement by the Egyptian Commission for Rights and Freedoms, which reported the disappearance of 1 700 people at the hands of the state security forces in 2015,

–  having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

A.  whereas, according to information available, Giulio Regeni, a 28-year-old Italian doctoral student at Cambridge University, disappeared on 25 January 2016 after leaving his home in Cairo; whereas his body was found on 3 February 2016 next to a road on the outskirts of Cairo;

B.  whereas the Egyptian authorities ordered a post-mortem examination before repatriating his body to Italy, where Italian investigators performed their own post-mortem; whereas the results have yet to be made public; whereas the Egyptian authorities have affirmed that they have nothing to hide regarding this murder, that they are equally interested in finding the truth and that they are ready to cooperate fully with their Italian counterparts in the ongoing investigation;

C.  whereas, according to media reports and to the Italian ambassador to Cairo, Mr Regeni’s body was found to have been subjected to severe beating and multiple forms of torture; whereas the Italian Interior Minister said that the body showed signs of ‘something inhuman, animal-like, an unacceptable violence’;

D.  whereas Mr Regeni was conducting research in Cairo on the development of independent trade unions in post-Mubarak and post-Morsi Egypt, and had contact with opponents of the government;

E.  whereas the case of Giulio Regeni follows a long list of enforced disappearances that have occurred in Egypt since July 2013; whereas these disappearances are met with impunity;

F.  whereas the current Egyptian Government has conducted a large-scale campaign of arbitrary detention of critics of the government, including journalists, human rights defenders and members of political and social movements; whereas, since July 2013, more than 22 000 people have been detained, according to the Egyptian authorities;

G.  whereas the El Nadeem Center for the Management and Rehabilitation of Victims of Violence is under threat of closure by the authorities as a result of false accusations pertaining to health violations; whereas the centre’s role has been critical in treating victims of violence and torture, and has been crucial to the provision of information on torture, killings and the worst abuses in detention;

H.  whereas Egypt is a long-standing strategic partner of the European Union; whereas the EU’s level of engagement with Egypt should be incentive-based, in line with the ‘more for more’ principle of the European Neighbourhood Policy, and depend on progress in reforming democratic institutions and in relation to the rule of law and human rights; whereas on 21 August 2013 the EU Foreign Affairs Council (FAC) tasked the VP/HR with reviewing EU assistance to Egypt; whereas the FAC decided that the EU’s cooperation with Egypt would be readjusted in line with developments on the ground;

I.  whereas the FAC conclusions of 21 August 2013 stated that, ‘Member States also agreed to suspend export licences to Egypt of any equipment which might be used for internal repression and to reassess export licences of equipment covered by Common Position 2008/944/CFSP and review their security assistance with Egypt’; whereas these conclusions were reiterated by the FAC in February 2014; whereas the VP/HR confirmed in her response of 27 October 2015 to Written Question E‑010476/2015 that these conclusions constituted ‘a political commitment against any military support to Egypt’;

J.  whereas the Egyptian Constitution adopted in 2014 enshrines fundamental rights and freedoms;

K.  whereas Egypt faces terrorism from various jihadi organisations which are active in Egypt, in particular in Sinai, and which have links to Islamic State and other terrorist organisations active in the Libyan crisis; whereas the ongoing conflict in Libya has a direct influence on Egypt’s security; whereas the ongoing crisis is of serious concern to the European Union, and Italy in particular;

1.  Strongly condemns the torture and assassination under suspicious circumstances of EU citizen Giulio Regeni, and expresses its deep sympathy and condolences to the family;

2.  Calls on the Egyptian authorities to provide the Italian authorities with all the documents and information necessary to enable a swift, transparent and impartial joint investigation into the case of Mr Regeni in accordance with international obligations, and for every effort to be made to bring the perpetrators of the crime to justice as soon as possible;

3.  Underlines with grave concern that the case of Giulio Regeni is not an isolated incident, but that it occurred within a context of torture, death in custody and enforced disappearances across Egypt in recent years, in clear violation of Article 2 of the EU‑Egypt Association Agreement, which states that the relations between the EU and Egypt are to be based on respect for democratic principles and fundamental human rights as set out in the Universal Declaration on Human Rights, which is an essential element of the agreement; calls, therefore, on the European External Action Service (EEAS) and the Member States to raise with the Egyptian authorities the routine practice of enforced disappearances and torture and to press for effective reform of Egypt’s security apparatus and judiciary;

4.  Is deeply concerned about the imminent threat of forced closure of the El Nadeem Center for the Management and Rehabilitation of Victims of Violence and Torture; calls for the swift withdrawal of the order for its administrative closure;

5.  Expresses concern at the continuous harassment of the Egyptian Commission for Rights and Freedoms for its apparent role in the ‘Stop Enforced Disappearance’ campaign in Egypt;

6.  Reminds the Egyptian authorities of their national and international legal obligations, and calls on them to prioritise the protection and promotion of human rights and to ensure accountability for violations of such rights; calls, once again, for the immediate and unconditional release of all individuals detained and sentenced solely for exercising their right to freedom of expression and peaceful assembly, including human rights defenders, media professionals and bloggers; calls on the Egyptian authorities to ensure the right to a fair trial in accordance with international standards;

7.  Calls on the Government of Egypt to guarantee that domestic and international civil society organisations and independent trade unions can operate freely without government interference or intimidation in the country; calls on the Egyptian authorities to withdraw the travel bans imposed on a number of Egypt’s leading human rights defenders;

8.  Expects the new Constitution, approved on 14 and 15 January 2014, in particular Articles 52, 73 and 93 thereof, to constitute an important step forward in the country’s transition to democracy;

9.  Takes note of the formation of the new People’s Assembly, and calls on it to review as a matter of urgency the repressive Protest Law of November 2013, which has been used to clamp down on all forms of peaceful dissent, as well as the Assembly Law of 1914; calls also for the review of all other repressive legislation adopted in violation of Egypt’s Constitution, including the Law on Terrorist Acts and the Law on Terrorist Entities, which could be misused for internal repression rather than to improve collective security; stresses its readiness, in partnership with the country’s authorities, to study the possibility of developing a capacity-building programme for the Egyptian parliament;

10.  Insists that only by building a truly pluralistic society, respectful of the diversity of views and lifestyles, can long-term stability and security in Egypt be ensured, and calls on the Egyptian authorities to commit to a reconciliation dialogue bringing together all non‑violent forces, including non-violent Islamists, in order to rebuild trust in politics and the economy in an inclusive political process;

11.  Underlines the importance that the European Union attaches to cooperation with Egypt as an important neighbour and partner, and Egypt’s role in ensuring stability in the region; shares the concerns of the Egyptian people about the economic, political and security challenges facing their country and the region; condemns the terrorists’ attacks on Egyptian civilians and military;

12.  Calls for the EU, in particular the VP/HR and the EU Delegation in Cairo, to ensure regular exchanges with human rights defenders and other voices of dissent, to support those at risk or in detention and to monitor their trials in a comprehensive manner;

13.  Urges the Member States to adhere fully to the FAC conclusions of August 2013 concerning the export of military technology and equipment and security cooperation; calls for exports of surveillance equipment to be suspended when there is evidence that such equipment would be used for human rights violations; calls on the VP/HR to report on the current state of military and security cooperation by EU Member States with Egypt, and to develop a roadmap in close consultation with the European Parliament outlining concrete steps to be taken by the Egyptian authorities to improve significantly the human rights situation and achieve comprehensive judicial reform before a reassessment of the FAC conclusions of August 2013 can be considered;

14.  Instructs its President to forward this resolution to the Council, the Commission, the Vice‑President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, the parliaments and governments of the Member States, the President and Government of the Arab Republic of Egypt and the African Commission on Human and Peoples’ Rights.

(1) Texts adopted, P8_TA(2015)0463.
(2) Texts adopted, P8_TA(2015)0012.


Democratic Republic of the Congo
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European Parliament resolution of 10 March 2016 on the Democratic Republic of the Congo (2016/2609(RSP))
P8_TA(2016)0085RC-B8-0342/2016

The European Parliament,

–  having regard to its previous resolutions on the Democratic Republic of the Congo (DRC), in particular those of 9 July 2015(1) and of 17 December 2015(2),

–  having regard to the joint press release of 16 February 2016 by the African Union, the United Nations, the European Union and the International Organisation of La Francophonie on the necessity of an inclusive political dialogue in the DRC and their commitment to supporting Congolese actors in their efforts towards the consolidation of democracy in the country,

–  having regard to the EU’s local statement of 19 November 2015 following the launch of the national dialogue in the DRC,

–  having regard to the statement of 9 November 2015 by the President of the UN Security Council on the situation concerning the DRC,

–  having regard to the EU’s local statement of 21 October 2015 on the human rights situation in the DRC,

–  having regard to the statement of 12 October 2015 by the Spokesperson for the European External Action Service on the resignation of the head of the Electoral Commission in the DRC,

–  having regard to the UN Security Council resolutions on the DRC, in particular resolutions 2198 (2015) on renewing the DRC sanctions regime and the mandate of the Group of Experts and 2211 (2013), which renewed the mandate of the UN Stabilisation Mission in the DRC (MONUSCO),

–  having regard to the joint press statement of 2 September 2015 by the Team of International Envoys and Representatives for the Great Lakes region of Africa on Elections in the DRC,

–  having regard to the annual report of the UN High Commissioner for Human Rights of 27 July 2015 on the situation of human rights and the activities of the UN Joint Human Rights Office in the DRC (UNJHRO),

–  having regard to the statement of 25 January 2015 by the Vice-President of the Union/High Representative for Foreign Affairs and Security Policy (VP/HR), Federica Mogherini, following the adoption of the new electoral law in the DRC,

–  having regard to the report of 12 January 2015 of the UN Group of Experts on the DRC,

–  having regard to the Nairobi Declarations of December 2013,

–  having regard to the Peace, Security and Cooperation Framework Agreement for the DRC and the Region signed in Addis Ababa in February 2013,

–  having regard to the African Charter of Human and Peoples’ Rights of June 1981,

–  having regard to the African Charter on Democracy, Elections and Governance,

–  having regard to the Congolese Constitution of 18 February 2006,

–  having regard to the Cotonou Agreement,

–  having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

A.  whereas the next presidential and legislative elections, which are scheduled to be held in November 2016, could represent a further opportunity for a democratic transition of power;

B.  whereas the mandate of the President of the DRC is constitutionally limited to two terms;

C.  whereas President Joseph Kabila, in power since 2001, has been accused by his opponents of using administrative and technical means to try to delay the election and remain in power beyond the end of his mandate, and has yet to declare publicly that he will step down at the end of his term; whereas this has caused growing political tension, unrest and violence across the country;

D.  whereas doubts have been expressed as to the independence and impartiality of the Independent National Electoral Commission (CENI);

E.  whereas since January 2015 Congolese security and intelligence officials have clamped down on peaceful activists, political leaders and others who oppose attempts to allow President Kabila to modify the constitution in order to stay in power past his constitutionally mandated two-term limit; whereas human rights groups continually report on the worsening of the situation with regard to human rights and freedom of expression and assembly in the DRC, including the use of excessive force against peaceful demonstrators and an increase in the number of politically motivated trials; whereas MONUSCO has registered more than 260 election-related human rights violations, mainly against political opponents, civil society and journalists, during the past year; whereas the UNJHRO in the DRC has stated that it has documented more than 400 cases of human rights violations, including 52 arrests, since the beginning of 2016;

F.  whereas in June 2015 President Kabila announced the launch of a national dialogue; whereas formal preparations for such a dialogue have not yet begun, as two major opposition groups decided not to participate because they consider this to be a delaying tactic;

G.  whereas in September 2015 seven senior political figures were expelled from the DRC’s ruling coalition for signing a letter urging President Kabila to comply with the constitution and not to cling to power after his term expires; whereas violent clashes broke out the same month in Kinshasa, where a rally opposing any bid for an unconstitutional third term was violently attacked;

H.  whereas those arbitrarily detained include Fred Bauma and Yves Makwambala, human rights activists from the Filimbi (‘Whistle’) movement, both of whom were arrested for participating in a workshop intended to encourage Congolese young people to perform their civic duties peacefully and responsibly, and who have now been jailed for 11 months, their release having already been demanded by the European Parliament in its aforementioned resolution of 9 July 2015;

I.  whereas leaders of Congo’s main opposition parties, non-governmental organisations and pro-democracy youth movements called on Congolese citizens to stay home from work and school on 16 February 2016 for ‘Ville Morte’ (‘Dead City Day’) in commemoration of those killed during a pro-democracy march on 16 February 1992, and to protest against the delays in organising presidential elections and the government’s alleged failure to comply with the constitution;

J.  whereas eight youth activists and at least 30 political opposition supporters were detained on or around 16 February 2016 in connection with this national strike, while other activists received text message threats from unknown phone numbers and Employment Minister Willy Makiashi prohibited public employees from participating in the strike; whereas six members of the LUCHA movement were sentenced to six months in prison; whereas traders and officials who had observed ‘Dead City Day’ saw their shops sealed or were the subject of disciplinary sanctions;

K.  whereas the African Union, the UN, the EU and the International Organisation of La Francophonie have jointly underscored the importance of dialogue and the search for an agreement between political actors that respects democracy and the rule of law, and have urged all Congolese political actors to extend their full cooperation to the mediators designated by the international community;

L.  whereas the situation is worsened by the persistence and consolidation of impunity in the DRC; whereas the security situation in the DRC continues to deteriorate, in particular in the eastern part of the country, owing to violence caused by more than 30 foreign and domestic armed groups, with constant reports of abuses of human rights and international law, including targeted attacks against civilians, widespread sexual and gender-based violence, systematic recruitment and abuse of children by armed groups, and extrajudicial executions;

M.  whereas there has recently been a deterioration in the freedom of the media in the DRC; whereas government officials have blocked free speech by shutting down media outlets (specifically targeting those that aired messages about the protests), text messaging services and the internet; whereas in February 2016 the government closed two private TV channels in Lubumbashi; whereas in its last annual report, released in November 2015, Journalists in Danger, the partner organisation of Reporters Without Borders, listed 72 cases of attacks against journalists and media in the DRC and revealed that 60 % of violations of press freedom are perpetrated by military or security service agents, the National Intelligence Agency (ANR) or the police; whereas transmission of Radio France International broadcasts was suspended to coincide with the ‘Dead City Day’ protest;

N.  whereas the 2014-2020 National Indicative Programme for the DRC, with EUR 620 million in funding under the 11th European Development Fund, prioritises strengthening governance and the rule of law, including reforms of the judiciary, police and army;

1.  Calls on the authorities of the DRC to expressly undertake to comply with the constitution and to ensure the timely holding of elections by the end of 2016, in full accordance with the African Charter on Democracy, Elections and Governance, and to guarantee an environment conducive to transparent, credible and inclusive elections; stresses that the successful holding of elections will be crucial to the long-term stability and development of the country;

2.  Expresses deep concern about the deteriorating security and human rights situation in the DRC, and in particular about the continual reports of increasing political violence and the severe restrictions and intimidation faced by human rights defenders, political opponents and journalists ahead of the upcoming electoral cycle; insists on the government’s responsibility to prevent any deepening of the current political crisis or escalation of violence and to respect, protect and promote the civil and political rights of its citizens;

3.  Strongly condemns any use of force against peaceful, unarmed demonstrators; recalls that freedom of expression, association and assembly is the basis of a dynamic political and democratic life; strongly condemns the increasing restrictions of the democratic space and the targeted repression of members of the opposition, civil society and the media; calls for the immediate and unconditional release of all political prisoners, including Yves Makwambala, Fred Bauma and other Filimbi and LUCHA activists and supporters, and the human rights defender Christopher Ngoyi;

4.  Considers the fight against impunity to be a prerequisite for re-establishing peace in the DRC; asks for a full, thorough and transparent investigation to be launched by the DRC Government, together with international partners, into the human rights violations that took place during the election-related protests, with the aim of identifying any illegal actions or denial of rights or freedoms; urges that measures be taken to ensure that perpetrators of human rights violations, war crimes, crimes against humanity and sexual violence against women, together with those responsible for recruiting child soldiers, are reported, identified, prosecuted and punished in accordance with national and international criminal law;

5.  Calls on the VP/HR and the Member States to make full use of all policy instruments, including the recommendations issued in the final report of the 2011 EU Electoral Observation Mission and in the report of the follow-up mission of 2014, and to exert political pressure at the highest level, in order to prevent the spread of electoral violence in the DRC and any further destabilisation of the Great Lakes region;

6.  Takes note of the willingness of the EU and the international community to support the Congolese electoral process, provided that a valid electoral calendar is published and that constitutional provisions are complied with; considers that this support should concentrate on voter registration, training and election securitisation; insists that the nature and amount of EU support to the electoral process in the DRC must depend on the progress made in implementing the recommendations of the Electoral Observation Missions of 2011 and 2014, in particular as regards guarantees of the CENI’s independence, the revision of the electoral roll, budgetary requirements and compliance with the constitutional timeframe;

7.  Calls on the Congolese authorities to ratify the African Charter on Democracy, Elections and Governance at the earliest

8.  Highlights the crucial role of the African Union (AU) in preventing a political crisis in Central Africa and invites the AU member states, in particular South Africa, to engage in favour of compliance with the constitution of the DRC; urges the EU to use all its diplomatic and economic tools, including the forthcoming signing of the Economic Partnership Agreements, to reach this goal;

9.  Recalls that full participation of the opposition, independent civil society and electoral experts in the CENI is an important factor in legitimising the electoral process; recalls that the CENI should be an impartial institution; stresses that the authorities should make available to the CENI the necessary financial resources to allow a comprehensive and transparent process;

10.  Calls on the VP/HR to intensify the dialogue with the DCR authorities under Article 8 of the Cotonou Agreement, with the objective of obtaining definitive clarification concerning the electoral process; recalls the commitment made by the DRC under the Cotonou Agreement to respecting democracy, the rule of law and human rights principles, which include freedom of expression and of the media, good governance and transparency in political office; urges the Government of the DRC to uphold these provisions in accordance with Articles 11b, 96 and 97 of the Cotonou Agreement, and, failing that, asks the Commission to launch the relevant procedure in accordance with Articles 8, 9 and 96 of the Cotonou Agreement;

11.  Calls for the EU to consider imposing targeted sanctions on those responsible for the violent crackdown in the DRC, including travel bans and asset freezes, so as to help prevent further violence;

12.  Urges the EU Delegation to monitor developments and to use all appropriate tools and instruments, including the European Instrument for Democracy and Human Rights, to support human rights defenders and pro-democracy movements;

13.  Calls for the reinstatement of a UN rapporteur on human rights in the DRC;

14.  Recalls that peace and security are preconditions for a successful election; notes, in this connection, the renewal of MONUSCO’s mandate, and calls for the reinforcement of its competences in the field of civilian protection in the electoral context;

15.  Reiterates its deep concern regarding the alarming humanitarian situation in the DRC, caused in particular by the violent armed conflicts in the country’s eastern provinces; calls for the EU and its Member States to continue their assistance to the people of the DRC with a view to improving the living conditions of the most vulnerable populations and tackling the consequences of displacement, food insecurity, epidemics and natural disasters;

16.  Condemns the ongoing acts of sexual violence in the eastern Congo; notes that the Congolese authorities have held 20 trials in recent months in respect of sexual violence in the eastern Congo, convicting 19 army officers, and that much more needs to be done; strongly encourages the Congolese authorities to continue their fight against impunity by investigating cases of sexual violence and prosecuting the perpetrators;

17.  Welcomes the decision of the Congolese authorities to review the adoption cases blocked since 25 September 2013; takes note of the work of the Congolese Interministerial Committee on the sporadic issuance of exit permits for adopted children; calls on the Interministerial Committee to continue its work diligently and coherently in a serene atmosphere; calls on the EU delegation and the Member States to monitor the situation closely;

18.  Calls on the African Union and the EU to ensure a permanent political dialogue among the countries of the Great Lakes region in order to prevent any further destabilisation;

19.  Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, the African Union, the President, Prime Minister and Parliament of the DRC, the Secretary-General of the United Nations, the UN Human Rights Council, and the ACP-EU Joint Parliamentary Assembly.

(1) Texts adopted, P8_TA(2015)0278.
(2) Texts adopted, P8_TA(2015)0475.


Introduction of emergency autonomous trade measures for Tunisia ***I
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Resolution
Text
European Parliament legislative resolution of 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council on the introduction of emergency autonomous trade measures for the Republic of Tunisia (COM(2015)0460 – C8-0273/2015 – 2015/0218(COD))
P8_TA(2016)0086A8-0013/2016

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2015)0460),

–  having regard to Article 294(2) and Article 207(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0273/2015),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the undertaking given by the Council representative by letter of 9 March 2016 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on International Trade and the opinion of the Committee on Agriculture and Rural Development (A8-0013/2016),

1.  Adopts its position at first reading hereinafter set out(1);

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 10 March 2016 with a view to the adoption of Regulation (EU) 2016/... of the European Parliament and of the Council on the introduction of emergency autonomous trade measures for the Republic of Tunisia

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2016/580.)

(1) This position corresponds to the amendments adopted on 25 February 2016. (Texts adopted P8_TA(2016)0056).


Veterinary medicinal products ***I
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Amendments adopted by the European Parliament on 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014)0558 – C8-0164/2014 – 2014/0257(COD))(1)
P8_TA(2016)0087A8-0046/2016

(Ordinary legislative procedure: first reading)

Text proposed by the Commission   Amendment
Amendment 1
Proposal for a regulation
Recital 2
(2)  In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality.
(2)  In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality, with respect to animals, nature and their interaction with man.
Amendment 2
Proposal for a regulation
Recital 6
(6)  Animals may suffer from a broad range of diseases which can be prevented or treated. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors.
(6)  Despite the measures that farmers take on good hygiene, feed, management and biosecurity, animals may suffer from a broad range of diseases which need to be prevented or treated by veterinary medicinal products for both animal health and welfare reasons. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors. To that end, good husbandry and management practices should be put in place in order to improve animal welfare, limit the spread of diseases, prevent antimicrobial resistance and ensure proper nutrition of livestock.
Amendment 3
Proposal for a regulation
Recital 7
(7)  This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health. At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.
(7)  This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health and the environment. At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.
Amendment 4
Proposal for a regulation
Recital 7 a (new)
(7a)  This Regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. Therefore, the precautionary principle should be applied. This Regulation should ensure that industry demonstrates that pharmaceutical substances or veterinary medicinal products produced or placed on the market have no harmful effects on human or animal health nor have any unacceptable effects on the environment.
Amendment 5
Proposal for a regulation
Recital 9
(9)  The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells. At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products.
(9)  The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells. At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products. The use of the centralised procedure should be encouraged in every way, in particular by facilitating access for small and medium-sized enterprises (SMEs).
Amendment 6
Proposal for a regulation
Recital 14
(14)  Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment.
(14)  Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the Member States concerned, being taken on the basis of an overall benefit-risk assessment. The authorisation procedure for veterinary medicinal products should be adjusted so as to eliminate other administrative procedures that might hamper the development of research and innovation for the purpose of identifying new medicines.
Amendment 7
Proposal for a regulation
Recital 17
(17)  However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.
(17)  However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In such cases, antimicrobial medicinal products for human use could be employed only subject to the issuing of a prescription by a veterinarian and the granting of authorisation by the veterinary authority responsible for monitoring the work of the veterinarian in question. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain, and particular care should therefore be taken when administering antibiotics to food-producing animals.
Amendment 8
Proposal for a regulation
Recital 18
(18)  Member States should be able to allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases and where the health situation in a Member State so requires.
(18)  Member States should be able to allow temporary exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases or new diseases and where the health situation in a Member State so requires.
Amendment 9
Proposal for a regulation
Recital 20
(20)  Directive 2010/63/EU of the European Parliament and of the Council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be such as to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be the least likely to cause pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU.
(20)  Directive 2010/63/EU of the European Parliament and of the Council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be designed to avoid causing pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU.
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15 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
15 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Amendment 10
Proposal for a regulation
Recital 23
(23)  Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in some cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas.
(23)  Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in exceptional cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted, on the basis of a benefit-risk assessment of the situation and, where necessary, subject to specific obligations. In particular, this should be possible in the case of veterinary medicinal products for use in minor species or for the treatment or prevention of diseases that occur infrequently or in limited geographical areas. Such products should only be used on the basis of a prescription.
Amendment 11
Proposal for a regulation
Recital 25
(25)  Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation, so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition.
(25)  Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation, in particular on veterinary medicinal products for minor species and antimicrobials, so that it is ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be protected against use by other applicants. That protection should, however, be limited in time in order to allow competition.
Amendment 311
Proposal for a regulation
Recital 25 a (new)
(25a)  Research should be incentivised, not only through the commercial protection of innovative active substances, but also through the protection of significant investments in data generated to improve or maintain on the market an existing veterinary medicinal product. In such cases, only the new data package would benefit from the period of protection and not the active substance or any associated products.
Amendment 13
Proposal for a regulation
Recital 27
(27)  It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals.
(27)  It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals. The current impact assessment system results in repetitive and potentially divergent assessments of substances' environmental properties. That can lead to divergent decisions being taken on products with similar effects on the environment, especially in the case of products authorised before the environmental impact assessment was carried out. The establishment of a single centralised assessment of the environmental properties of active substances for veterinary use by means of a monograph system could be a potential alternative. The Commission should therefore submit a report to the European Parliament and the Council examining the feasibility of monographs and potential alternative options as soon as possible.
Amendment 14
Proposal for a regulation
Recital 27 a (new)
(27a)  In accordance with Directive 2010/63/EU, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should therefore be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of products, wherever possible.
Amendment 15
Proposal for a regulation
Recital 31
(31)  It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls.
(31)  It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should also be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls.
Amendment 16
Proposal for a regulation
Recital 32
(32)  In certain circumstances where a significant animal or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle17. In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time.
(32)  In certain circumstances where a significant animal, environmental or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in the Communication from the Commission on the precautionary principle17. In such circumstances, Member States or the Commission should seek to obtain additional information necessary for a more objective assessment of the particular concern and should review the measure accordingly within a reasonable period of time.
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17 Communication from the Commission on the precautionary principle, COM(2000)0001 (final).
17 Communication from the Commission on the precautionary principle, COM(2000)0001 (final).
Amendment 17
Proposal for a regulation
Recital 33
(33)  Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials. Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.
(33)  Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide, thus involving a common responsibility of all actors concerned. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are highly critical for preventing or treating life-threatening infections in humans and their use on animals, whether or not covered by the terms of a marketing authorisation, should be prohibited. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that measures are proportionally applied in both the human and animal sectors and that appropriate warnings and guidance are included on the labels of human and veterinary antimicrobials. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.
Amendment 18
Proposal for a regulation
Recital 34 a (new)
(34a)  The routine prophylactic and metaphylactic use of antimicrobials on groups of food-producing animals should be brought to an end. Disease should be prevented not by routine recourse to antimicrobials but by good hygiene, husbandry and housing, and sound management practices.
Amendment 19
Proposal for a regulation
Recital 35
(35)  The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised where evidence is provided that the benefit-risk balance of the combination is favourable.
(35)  The combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Combinations of antimicrobial substances should therefore only be authorised exceptionally where evidence is provided that the long-term benefit-risk balance of the combination is favourable.
Amendment 20
Proposal for a regulation
Recital 36
(36)  The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in veterinary medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore the misuse of antimicrobials should not be allowed.
(36)  The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore, the misuse of antimicrobials should not be allowed. Preventive treatments using antimicrobials should be regulated more strictly and recommended only in certain specific, well-defined cases, in compliance with animal health, biosecurity and nutritional requirements.
Amendment 21
Proposal for a regulation
Recital 37
(37)  In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it may be necessary to reserve those antimicrobials for humans only. Therefore it should be possible to decide that certain antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.
(37)  In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it is necessary to reserve those antimicrobials for humans only. As a baseline, that should apply for the highest priority critically important antimicrobials identified by the World Health Organisation (WHO). Moreover, it should be possible to decide that other critically important antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector.
Amendment 22
Proposal for a regulation
Recital 37 a (new)
(37a)  As antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide, action also needs to be taken in the field of human medicine, for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this Regulation.
Amendment 23
Proposal for a regulation
Recital 38
(38)  If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care.
(38)  If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials. Veterinarians have a legal obligation, which is part of their professional code of conduct, to ensure responsible use of veterinary medicinal products. They should not be influenced, directly or indirectly, by economic incentives when prescribing those products. The animal health industry and veterinarians should together promote responsible use. Therefore the supply of veterinary antimicrobials by veterinarians or other persons authorised under national law should be restricted to the amount required for treatment of the animals under their care, and only once a veterinary diagnosis has been established following a clinical examination of the animal, or, in exceptional cases, in the light of continuous health checks on the animal.
Amendment 24
Proposal for a regulation
Recital 38 a (new)
(38a)  Prudent use of antimicrobials is a cornerstone in addressing antimicrobial resistance. The Guidelines for the prudent use of antimicrobials in veterinary medicine, elaborated by the Commission, need to be considered by Member States.
Amendment 25
Proposal for a regulation
Recital 38 b (new)
(38b)  In order to facilitate responsible use of antimicrobials, there is an imperative need for rapid, reliable and efficacious veterinary diagnostics both to identify the cause of disease and to perform antibiotic sensitivity testing. That would facilitate correct diagnosis, allow for a targeted use of antimicrobials, support using as little as possible critically important antimicrobials and therefore, inhibit the development of antimicrobial resistance. There is clear need for future innovation specifically for pen-site diagnosis, and a need to consider carefully whether there is a case for more harmonisation and regulation in this sector.
Amendment 26
Proposal for a regulation
Recital 39
(39)  It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the Union. Moreover, antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, measures restricting the use of veterinary antimicrobials in the Union should be based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressing antimicrobial resistance in order the ensure consistency with their activities and policies.
(39)  It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, the Union should be active in advocating the creation of an international strategy to combat antimicrobial resistance, in line with the recent Global Action Plan adopted by the WHO.
Amendment 27
Proposal for a regulation
Recital 40
(40)  There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.
(40)  There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. Better data are needed on how, when, where and why antimicrobials are being used. Therefore, the data collected should be broken down by type of antimicrobial, species, disease or infection treated. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.
Amendment 28
Proposal for a regulation
Recital 40 a (new)
(40a)  Commercial sensitivity should not be used as an excuse to deny citizens access to information about chemicals affecting their bodies or those of other non-target species in the wider environment. Maximum transparency should be ensured while protecting the most commercially sensitive information.
Amendment 29
Proposal for a regulation
Recital 49
(49)  It is necessary, in specific cases, or from a public health and animal health perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.
(49)  In specific cases it is necessary, from a public health, animal health or environmental perspective, to complement the safety and efficacy data available at the time of authorisation with additional information following the placing of the product on the market. Therefore the obligation to conduct post-authorisation studies should be imposed on the marketing authorisation holder.
Amendment 30
Proposal for a regulation
Recital 50
(50)  A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities.
(50)  A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work-sharing between the competent authorities and other concerned authorities, including environmental protection agencies and food safety authorities both at national and Union level.
Amendment 314
Proposal for a regulation
Recital 52 a (new)
(52a)  In order to ensure that the imports from third countries of veterinary medicinal products, active substances, intermediate products and excipients used as starting materials have been manufactured in accordance with the animal welfare standards established in the Union, unlike for instance the current production method utilised in third countries for "pregnant mare serum gonadotropin" (PMSG), the Commission should revise Directive 91/412/EEC and include animal welfare standards in the good manufacturing practice for veterinary medicinal products.
Amendment 31
Proposal for a regulation
Recital 56
(56)  The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products via the Internet to buyers in other Member States.
(56)  The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by veterinarians or other persons authorised to do so by the Member State where they are established. However, Member States which do not allow prescriptions to be issued by persons other than veterinarians could refuse to recognise prescriptions issued by persons other than veterinarians in other Member States in accordance with their national laws. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products, except for antimicrobials, via the Internet to buyers in their own or other Member States. In order to minimise the risk to animal and human health, online sales of antimicrobials should be prohibited.
Amendment 32
Proposal for a regulation
Recital 56 a (new)
(56a)  In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, the professionally qualified animal medicines advisors should continue to prescribe and supply certain veterinary medicines.
Amendment 33
Proposal for a regulation
Recital 56 b (new)
(56b)  Any ban on veterinarians supplying medicines could make it impossible for some Member States to maintain a network of veterinarians covering all of their territory. Such territorial coverage is of key importance in ensuring high-quality epidemiological monitoring of existing and emerging diseases.
Amendment 34
Proposal for a regulation
Recital 57
(57)  The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. It is necessary to address this threat. Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level and, therefore, Member States may impose conditions for supplying medicinal products to the public within the limits of the Treaty.
(57)  The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. A system should be introduced to ensure that such products are properly sold and that controls are placed on the distribution and falsification of substances that are potentially dangerous for human use. Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level. To minimise the risks to animal and human health, the online sale of antimicrobials should be prohibited. Member States might impose conditions for supplying medicinal products to the public within the limits of the Treaty.
Amendment 35
Proposal for a regulation
Recital 58 a (new)
(58a)  Member States should, after informing the Commission, be able to subject the supply of veterinary medicinal products offered for sale to stricter conditions justified by the protection of public health, animal health and the environment, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.
Amendment 36
Proposal for a regulation
Recital 62
(62)  Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a member of a regulated animal health profession for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.
(62)  Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a veterinarian or other persons authorised to do so under national law for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State, provided that the other Member State authorises persons with similar qualifications to issue prescriptions. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.
Amendment 295
Proposal for a regulation
Recital 65
(65)  The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products. In order to preserve the effectiveness of the inspections, authorities should have the possibility to perform unannounced inspections.
(65)  The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products and should publish annual inspection reports. In order to preserve the effectiveness of the inspections, all inspections should be unannounced inspections.
Amendment 38
Proposal for a regulation
Recital 67
(67)  In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment. To ensure a harmonised approach to inspections throughout the Union, the Commission should be able to carry out audits in the Member States to verify the functioning of national control systems.
(67)  In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment. The Commission should ensure a harmonised approach to inspections throughout the Union, and should be able to carry out audits in the Member States to verify the functioning of national control systems.
Amendment 39
Proposal for a regulation
Recital 71
(71)  Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules.
(71)  Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules. Furthermore, it is desirable to generally allow, under specific conditions, the use of homeopathic medicinal products designed for human use, including immunological homeopathic products that have a potency starting from D4, on all animals, including food producing animals.
Amendment 40
Proposal for a regulation
Recital 71 a (new)
(71a)  The usual rules governing the authorisation to market veterinary medicinal products should be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which might present risks which should be balanced against the desired therapeutic effect. Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products for pet animals and exotic species, provided that they notify these rules to the Commission.
Amendment 41
Proposal for a regulation
Recital 73
(73)   In order to protect public health, animal health and the environment, the activities and tasks attributed to the Agency in this Regulation should be adequately funded. Those activities, services and tasks should be funded through fees charged to enterprises. Those fees, however, should not affect the right of Member States to charge fees for activities and tasks at national level.
(73)   In order to protect public health, animal health and the environment, the activities and tasks attributed to the Agency in this Regulation should be adequately funded. Those activities, services and tasks, including the establishment of new information technology services with the aim of reducing bureaucracy, should be funded through fees charged to enterprises and through an increased financial contribution from the Commission. Those fees, however, should not affect the right of Member States to charge fees for activities and tasks at national level.
Amendment 42
Proposal for a regulation
Article 1
This Regulation lays down rules for the placing on the market, manufacture, import, export, supply, pharmacovigilance, control and use of veterinary medicinal products.
This Regulation lays down rules for the placing on the market, development, manufacture, import, export, wholesale distribution, retail supply, pharmacovigilance, control and use of veterinary medicinal products.
Amendment 43
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Member States may impose stricter conditions, justified on grounds of public health, animal health and environmental protection, for the use and retail of veterinary medicinal products on their territory, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.
Amendment 44
Proposal for a regulation
Article 1 – paragraph 1 b (new)
The Member States shall notify the measures referred to in paragraph 1a to the Commission.
Amendment 45
Proposal for a regulation
Article 2 – paragraph 4 – point e a (new)
(ea)  substances or preparations which are intended exclusively for external use in animals, to clean or groom them or to alter their appearance or body odour, provided that no substances or preparations subject to veterinary prescription have been added to them;
Amendment 46
Proposal for a regulation
Article 2 – paragraph 4 – point e b (new)
(eb)  medicated feed and intermediate products as defined, respectively, in points (a) and (b) of Article 2(2) of Regulation (EÚ) .../... of the European Parliament and of the Council 1a;
_________________
1a Regulation (EÚ) .../... of the European Parliament and the Council of ... on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC (OJ L ...) [2014/0255(COD)].
Amendment 47
Proposal for a regulation
Article 2 – paragraph 4 – point e c (new)
(ec)  feedingstuffs as defined in Regulation (EC) No 767/2009 of the European Parliament and of the Council.
Amendment 48
Proposal for a regulation
Article 3 – paragraph 1 a (new)
1a.  In cases of doubt, taking into account all its characteristics, as to whether a product may fall within the definition of a veterinary medicinal product within the meaning of Article 4(1), or within the definition of a product covered by other Union legislation, the provisions of this Regulation shall prevail.
Amendment 49
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
(b)  its purpose is to be used in or administered to animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;
(b)  it may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;
Amendment 50
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point c
(c)  its purpose is to be used for euthanasia of animals;
(c)  it may be used for euthanasia in animals;
Amendment 51
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – introductory part
(2)  ‘substance' means any matter of the following origin:
(2)  ‘substance' means any matter irrespective of its origin which may be:
Amendment 52
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point a
(a)  human,
(a)  human, for example human blood and human blood products;
Amendment 53
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point b
(b)  animal,
(b)  animal, for example micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;
Amendment 54
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point c
(c)  vegetable,
(c)  vegetable, for example micro-organisms, plants, parts of plants, vegetable secretions, extracts;
Amendment 55
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point c a (new)
(ca)  fungal;
Amendment 56
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point c b (new)
(cb)  microbial;
Amendment 57
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point d
(d)  chemical;
(d)  chemical, for example elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis;
Amendment 58
Proposal for a regulation
Article 4 – paragraph 1 – point 2 – point d a (new)
(da)  mineral.
Amendment 59
Proposal for a regulation
Article 4 – paragraph 1 – point 2 a (new)
(2a)  ‘active substance‘ means a substance with a pharmacological activity;
Amendment 60
Proposal for a regulation
Article 4 – paragraph 1 – point 3
(3)   ‘immunological veterinary medicinal product’ means a veterinary medicinal product consisting of vaccines, toxins, sera or allergen products and intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity;
(3)   ‘immunological veterinary medicinal product’ means a veterinary medicinal product, such as vaccines, toxins, sera or allergen products intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity;
Amendment 61
Proposal for a regulation
Article 4 – paragraph 1 – point 7
(7)  ‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;
(7)  ‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States; a homeopathic veterinary medicinal product may contain a number of active ingredients;
Amendment 62
Proposal for a regulation
Article 4 – paragraph 1 – point 7 a (new)
(7a)  ‘herbal medicinal product’ means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations;
Amendment 63
Proposal for a regulation
Article 4 – paragraph 1 – point 8
(8)  ‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill microorganisms of the same species;
(8)  ‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to halt the growth of or kill microorganisms of the same species;
Amendment 64
Proposal for a regulation
Article 4 – paragraph 1 – point 8 a (new)
(8a)  ʻantimicrobialʼ means any compound with a direct action on micro-organisms used for treatment or prevention of infections; antimicrobials include anti-bacterials, anti-virals, anti-fungals and anti-protozoals; in the context of this Regulation, an antimicrobial substance refers to an antibacterial;
Amendment 65
Proposal for a regulation
Article 4 – paragraph 1 – point 8 b (new)
(8b)  'antiparasitic' means a medicinal product or substance used in the treatment of parasitic diseases attributable to various causes;
Amendment 66
Proposal for a regulation
Article 4 – paragraph 1 – point 8 c (new)
(8c)  ʻantibacterialʼ means a compound with a direct action on bacteria used for treatment or prevention of infections;
Amendment 67
Proposal for a regulation
Article 4 – paragraph 1 – point 9
(9)  ‘clinical trial' means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof;
(9)  ‘clinical trial' means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice;
Amendment 68
Proposal for a regulation
Article 4 – paragraph 1 – point 10
(10)  'pre-clinical study' means a study not covered by the definition of clinical trial which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change thereof;
(10)  'pre-clinical study' means a study not covered by the definition of clinical trial;
Amendment 69
Proposal for a regulation
Article 4 – paragraph 1 – point 11 – introductory part
(11)  benefit-risk balance' means an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:
(11)  'benefit-risk balance' means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:
Amendment 70
Proposal for a regulation
Article 4 – paragraph 1 – point 12
(12)  common name' means the international non-proprietary name recommended by the World Health Organisation for a veterinary medicinal product, or, if one does not exist, the name generally used;
(12)  'common name' means the international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name;
Amendment 71
Proposal for a regulation
Article 4 – paragraph 1 – point 18
(18)  package leaflet' means a documentation leaflet on a veterinary medicinal product which contains information to ensure its safe and efficacious use;
(18)  'package leaflet' means an information leaflet attached to a veterinary medicinal product which is intended for a user of the veterinary medicinal product and which contains information to ensure its safe and efficacious use which are compliant with the information provided for in the summary of product characteristics of the veterinary medicinal product;
Amendment 72
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point b
(b)   veterinary medicinal products for animal species other than cattle, sheep, pigs, chickens, dogs and cats;
(b)   veterinary medicinal products for animal species other than cattle, pigs, chickens, dogs, cats, salmon and sheep reared for their meat;
Amendment 73
Proposal for a regulation
Article 4 – paragraph 1 – point 21
(21)  pharmacovigilance' means the process of monitoring and investigating adverse events;
(21)  'pharmacovigilance' means scientific, control and administrative activities relating to detection, reporting, assessment, understanding, prevention and communication of adverse events which include continuous evaluation of the risk-benefit balance of veterinary medicinal products;
Amendment 74
Proposal for a regulation
Article 4 – paragraph 1 – point 24
(24)  'veterinary prescription‘ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law;
(24)  'veterinary prescription‘ means any prescription for a veterinary medicinal product issued by a veterinarian or another professional person qualified to do so in accordance with applicable national law once a veterinary diagnosis has been established following a clinical examination of the animal;
Amendment 75
Proposal for a regulation
Article 4 – paragraph 1 – point 25
(25)   ‘withdrawal period’ means the minimum period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health;
(25)   ‘withdrawal period’ means the period necessary between the last administration of a veterinary medicinal product to an animal under normal conditions of use, and the production of foodstuffs from that animal, for the purpose of ensuring that such foodstuffs do not contain residues in quantities greater than the maximum limits established under Regulation (EC) No 470/2009 of the European Parliament and of the Council1a;
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1a Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Amendment 76
Proposal for a regulation
Article 4 – paragraph 1 – point 26
(26)  ‘making available on the market' means any supply of a veterinary medicinal product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(26)  ‘making available on the market' means any supply of a veterinary medicinal product for distribution, consumption or use on the market of a Member State in the course of a commercial activity, whether in return for payment or free of charge;
Amendment 77
Proposal for a regulation
Article 4 – paragraph 1 – point 27 a (new)
(27a)  ‘essentially similar product means a generic product that satisfies the criteria of having the same qualitative and quantitative composition in terms of active substances, of having the same pharmaceutical form, and of being bioequivalent to the original product, unless it is apparent in the light of scientific knowledge that it differs from the original product as regards safety and efficacy;
Amendment 78
Proposal for a regulation
Article 4 – paragraph 1 – point 27 b (new)
(27b)  ʻmarketing authorisation holderʻ means the holder of a marketing authorisation granted in accordance with this Regulation;
Amendment 79
Proposal for a regulation
Article 4 – paragraph 1 – point 27 c (new)
(27c)  ʻgood animal husbandryʼ means the management and care of farm animals by humans for profit whilst ensuring the health and welfare of these animals by respecting and safeguarding the specific needs of each species and by minimising as much as possible the need to use veterinary pharmaceutical products;
Amendment 80
Proposal for a regulation
Article 4 – paragraph 1 – point 27 d (new)
(27d)  ʻresponsible use of veterinary medicinal productsʼ means ensuring good husbandry and management practices such as biosecurity measures aiming to keep groups of animals healthy or to limit the spread of disease within an animal population, as well as asking veterinary advice, following vaccination programmes and prescription instructions, and ensuring good hygiene, appropriate nutrition and regular monitoring of health and welfare;
Amendment 81
Proposal for a regulation
Article 4 – paragraph 1 – point 27 e (new)
(27e)  ʻadverse eventsʻ means any of the undesirable events set out in Article 73(2);
Amendment 82
Proposal for a regulation
Article 4 – paragraph 1 – point 27 f (new)
(27f)  ʻserious adverse eventsʻ means any adverse event which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly or birth defect, or which results in permanent or prolonged signs in the animals treated;
Amendment 83
Proposal for a regulation
Article 4 – paragraph 1 – point 27 g (new)
(27g)  'curative (therapeutic) treatment' means the treatment of an ill animal or group of animals, when the diagnosis of disease or infection has been made;
Amendment 84
Proposal for a regulation
Article 4 – paragraph 1 – point 27 h (new)
(27h)  ʻcontrol treatment (metaphylaxis)ʼ means the treatment of a group of animals after the diagnosis of clinical disease in part of the group, with the aim of treating the clinically sick animals and controlling the spread of the disease to animals in close contact and at risk which may already be subclinically infected; the presence of such a disease in the group shall be established before the product is used;
Amendment 85
Proposal for a regulation
Article 4 – paragraph 1 – point 27 i (new)
(27i)  'preventive treatment (prophylaxis)' means the treatment of an animal or a group of animals before clinical signs of disease emerge, in order to prevent the occurrence of disease or infection;
Amendment 86
Proposal for a regulation
Article 4 – paragraph 1 – point 27 j (new)
(27j)  ‘parallel importation’ means the importation into a Member State of a veterinary medicinal product authorised in another Member State in accordance with this Regulation and having the same characteristics as the veterinary medicinal product authorised in the Member State of import, in particular with:
(a)  the same qualitative and quantitative composition in terms of active substances and excipients and the same pharmaceutical form;
(b)  the same therapeutic indications and target species.
The medicinal product authorised in the Member State and the product imported in parallel shall have been either harmonised under Article 69 or 70 or authorised in accordance with Articles 46 and 48;
Amendment 87
Proposal for a regulation
Article 4 – paragraph 1 – point 27 k (new)
(27k)  ‘parallel distribution’ means distribution from one Member State to another Member State of a veterinary medicinal product authorised under a centralised procedure by an establishment authorised as referred to in Article 105 which is independent of the holder of the marketing authorisation;
Amendment 88
Proposal for a regulation
Article 4 – paragraph 1 – point 27 l (new)
(27l)  'wholesale distribution' means all activities consisting of procuring, holding, supplying or exporting veterinary medicinal products, whether in return for payment or free of charge, apart from retail supply; such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorised or entitled to supply medicinal products to the public in accordance with applicable national law;
Amendment 89
Proposal for a regulation
Article 4 – paragraph 1 – point 27 m (new)
(27m)  'name of veterinary medicinal product' means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder;
Amendment 90
Proposal for a regulation
Article 4 – paragraph 1 – point 27 n (new)
(27n)  'pre-mix for medicated feedingstuffs' means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feeding stuffs in accordance with Regulation (EU) .../... of the European Parliament and of the Council+.
_________________
+ 2014/0255(COD).
Amendment 91
Proposal for a regulation
Article 5 – paragraph 1
1.  A veterinary medicinal product shall be placed on the market only when a marketing authorisation has been granted in respect of the product by a competent authority in accordance with Articles 44, 46 or 48 or by the Commission in accordance with Article 40.
1.  Without prejudice to other provisions of this Regulation, a veterinary medicinal product shall be placed on the market of a Member State only when a marketing authorisation has been granted in respect of the product by a competent authority of that Member State or by the Commission in accordance with this Regulation.
Amendment 92
Proposal for a regulation
Article 5 – paragraph 2
2.  A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time.
2.  A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time, unless risks to public health, animal health and the environment are detected or new scientific knowledge gives grounds for re-examination of the benefit risk balance. In such situations Member States or the Commission shall refer the matter to the Agency in accordance with the procedure described in Article 84.
When a previously authorised veterinary medicinal product has not been present on the market in any Member State for a period of five consecutive years, the authorisation granted for that veterinary medicinal product shall cease to be valid.
The competent authority may, in exceptional circumstances, and on human or animal health grounds, grant an exemption from the termination of validity referred to in the second subparagraph. Such exemptions shall be duly justified.
The marketing authorisation holder shall be responsible for marketing the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of its legal responsibility.
Amendment 93
Proposal for a regulation
Article 6 – paragraph 1 – point c
(c)  the mutual recognition procedure laid down in Articles 47 and 48.
(c)  the mutual recognition procedure laid down in Articles 47, 48 and 57.
Amendment 94
Proposal for a regulation
Article 6 – paragraph 3
3.  Applications shall be submitted electronically. For applications submitted in accordance with the centralised marketing authorisation procedure, the formats made available by the Agency shall be used.
3.  Applications shall be submitted electronically or saved in exceptional circumstances and following agreement with a competent authority or in the case of centralised application, with the Agency. The Commission, in collaboration with the Member States and with the Agency shall adopt detailed guidelines on the format of electronic applications.
Amendment 95
Proposal for a regulation
Article 6 – paragraph 5
5.  Within 15 days of receipt of the application, the competent authority or the Agency shall notify the applicant of whether all data required in accordance with Article 7 have been presented.
5.  Without prejudice to specific provisions related to the mutual recognition procedure or the decentralised procedure, the competent authority or the Agency shall, within 15 days of receipt of the application, notify the applicant whether the formal requirements laid down in this Regulation for the application concerned have been met and whether the application can be subject to scientific assessment.
Amendment 96
Proposal for a regulation
Article 7 – paragraph 2 – point a
(a)  documentation on the direct or indirect risks to public or animal health of use of the antimicrobial veterinary medicinal product in animals,
(a)  documentation on the direct or indirect risks to public or animal health or the environment of use of the antimicrobial veterinary medicinal product in animals,
Amendment 97
Proposal for a regulation
Article 7 – paragraph 2 – point b
(b)  information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product.
(b)  information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product, including specifications that the product is not to be used as a routine prophylactic or metaphylactic measure in food-producing animals, and is not to be used in prophylactic group treatments where there has been no diagnosis of disease.
Amendment 98
Proposal for a regulation
Article 7 – paragraph 3
3.  Where the application concerns a veterinary medicinal product intended for food-producing target species and containing pharmacologically active substances that are not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in question, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council22 shall be submitted in addition to the information listed in paragraph 1.
3.  Where the application concerns a veterinary medicinal product intended for food-producing target species and containing pharmacologically active substances that are not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in question, a document shall be submitted in addition to the information listed in paragraph 1 of this Article certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council22 and that at least six months has elapsed from submission of such application.
__________________
__________________
22 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
22 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Amendment 100
Proposal for a regulation
Article 8 – paragraph 2
2.   Approvals of clinical trials shall be granted on condition that food-producing animals used in the clinical trials or their produce do not enter the human food chain unless:
2.   Member States shall not permit test animals to be used as a source of foodstuffs for human consumption unless the competent authorities have established an appropriate withdrawal period. Such period shall either:
(a)   the tested product is a veterinary medicinal product authorised for the food-producing species used in the clinical trial, and the withdrawal period set out in the summary of the product characteristics is respected, or
(a)   be at least as long as the withdrawal period laid down in Article 117, including, where appropriate, a safety factor reflecting the nature of the substance being tested; or
(b)   the tested product is an authorised veterinary medicinal product for target species other than the food-producing species used in the clinical trial and the withdrawal period set out in accordance with Article 117 is respected.
(b)   if maximum residue limits have been established by the Union in accordance with Regulation (EC) No 470/2009, the period shall be such as to ensure that those residue limits will not be exceeded in foodstuffs.
Amendment 101
Proposal for a regulation
Article 8 – paragraph 4 a (new)
4a.  The principles of replacement, reduction and refinement concerning the care and use of live animals for scientific purposes shall be taken into account during the design and performance of clinical trials.
Amendment 102
Proposal for a regulation
Article 8 – paragraph 6 a (new)
6a.  The holder of the clinical trial authorisation shall notify the competent authority of every serious adverse event and all human adverse reactions shall be notified promptly and in any case not later than 15 days following receipt of the information.
Amendment 103
Proposal for a regulation
Article 9
Labelling of the immediate packaging of veterinary medicinal products
Labelling of the immediate packaging of veterinary medicinal products
1.  The immediate packaging of a veterinary medicinal product shall contain only the following information:
1.  The immediate packaging of a veterinary medicinal product shall contain only the following information:
(a)  the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;
(a)  the name of the veterinary medicinal product, followed by its strength and pharmaceutical form;
(b)  a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;
(b)  a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names;
(c)  the batch number, preceded by the word "Lot";
(c)  the batch number, preceded by the word "Lot";
(d)  the name or corporate name or logo name of the marketing authorisation holder;
(d)  the name or corporate name or logo name of the marketing authorisation holder;
(e)  the target species;
(e)  the target species;
(f)  the expiry date, in the format: "mm/yyyy", preceded by the abbreviation "Exp.";
(f)  the expiry date, in the format: "mm/yyyy", preceded by the abbreviation "Exp.";
(g)  special storage precautions, if any.
(g)  special storage precautions, if any.
1a.  In exceptional cases, additional information in accordance with Article 30 may be included, on request of the applicant or the competent authority when it is absolutely necessary to ensure the safe and correct administration of the product.
2.  The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union.
2.  The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union.
2a.  In addition, all the information listed in points (a) to (g) of paragraph 1 shall also appear in a format that is electronically readable, such as a barcode. Data shall be made available for other documentation systems through standards interface.
Amendment 104
Proposal for a regulation
Article 10
Labelling of the outer packaging of veterinary medicinal products
Labelling of the outer packaging of veterinary medicinal products
1.  The outer packaging of a veterinary medicinal product shall contain only the following information:
1.  The outer packaging of a veterinary medicinal product shall contain only the following information:
(a)  the information listed in Article 9(1);
(a)  the information listed in Article 9(1);
(b)  the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product;
(b)  the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product;
(c)  warning that the veterinary medicinal product must be kept out of the sight and reach of children;
(c)  warning that the veterinary medicinal product must be kept out of the sight and reach of children;
(d)  warning that the veterinary medicinal product is for animal treatment only;
(d)  a common pictogram warning that the veterinary medicinal product is for animal treatment only;
(e)  recommendation to read the package leaflet;
(e)  recommendation to read the package leaflet;
(f)  requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;
(f)  requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products in accordance with the applicable law;
(g)  in case of homeopathic veterinary medicinal products, the statement "homeopathic veterinary medicinal product".
(g)  in case of homeopathic veterinary medicinal products, the statement "homeopathic veterinary medicinal product".
1a.  In exceptional cases, additional information in accordance with Article 30 may be included, on request of the applicant or the competent authority when it is absolutely necessary to ensure safe and correct administration of the product.
2.  The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union.
2.  The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, as well as in machine-readable format, or, where appropriate, abbreviations or pictograms common throughout the Union.
3.  Where there is no outer packaging, all the particulars listed in paragraph 1 shall appear on the immediate packaging.
3.  Where there is no outer packaging, all the particulars listed in paragraph 1 shall appear on the immediate packaging.
Amendment 105
Proposal for a regulation
Article 11
Labelling of small immediate packaging units of veterinary medicinal products
Labelling of small immediate packaging units of veterinary medicinal products
By way of derogation from Article 9, small immediate packaging units shall contain only the following information:
By way of derogation from Article 9, small immediate packaging units shall contain only the following information:
(a)  the name of veterinary medicinal product;
(a)  the name of veterinary medicinal product;
(b)  the quantitative particulars of the active substances;
(b)  the quantitative particulars of the active substances, unless the product exists in only one concentration or the concentration is reflected in the name;
(c)  the batch number, preceded by the word "Lot";
(c)  the batch number, preceded by the word "Lot";
(d)  the expiry date, in the format: "mm/yyyy", preceded by the abbreviation "Exp."
(d)  the expiry date, in the format: "mm/yyyy", preceded by the abbreviation "Exp.".
In exceptional cases, additional information in accordance with Article 30 may be included, on request of the applicant or the competent authority when it is absolutely necessary to ensure safe and correct administration of the product.
Amendment 106
Proposal for a regulation
Article 12
Package leaflet of veterinary medicinal products
Package leaflet of veterinary medicinal products
1.  The package leaflet shall be available for each veterinary medicinal product and shall contain at least the following information:
1.  The package leaflet shall be directly available with each veterinary medicinal product and shall contain at least the following information:
(a)  the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder;
(a)  the name or corporate name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder;
(b)  the name of the veterinary medicinal product or, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;
(b)  the name of the veterinary medicinal product or, where applicable, a list of the names of the veterinary medicinal product, as authorised in different Member States;
(c)  the strength and pharmaceutical form of the veterinary medicinal product;
(c)  the strength and pharmaceutical form of the veterinary medicinal product;
(d)  the target species, the dosage for each species, the method and route of administration and advice on correct administration, if necessary;
(d)  the target species, the dosage for each species, the method and route of administration and, if necessary, advice on correct administration;
(e)  the therapeutic indications;
(e)  the therapeutic indications;
(f)  the contra-indications and adverse events in so far as this information is necessary for the use of the veterinary medicinal product;
(f)  the contra-indications and adverse events in so far as this information is necessary for the use of the veterinary medicinal product;
(g)  the withdrawal period, even if this is nil, in the event that the target species are food-producing animals;
(g)  the withdrawal period, even if this is nil, in the event that the target species are food-producing animals;
(h)  special storage precautions, if any;
(h)  special storage precautions, if any;
(i)  information essential for safety or health protection, including any special precautions relating to use and any other warnings;
(i)  information essential for safety or health protection, including any special precautions relating to use and any other warnings;
(j)  requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;
(j)  requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products in accordance with the applicable law;
(k)  the marketing authorisation number;
(l)  in case of generic veterinary medicinal products, the statement ‘generic veterinary medicinal product’;
(l)  in case of generic veterinary medicinal products, the statement ‘generic veterinary medicinal product’;
(m)  in case of homeopathic veterinary medicinal products, the statement "homeopathic veterinary medicinal product".
(m)  in case of homeopathic veterinary medicinal products, the statement "homeopathic veterinary medicinal product";
(ma)  qualitative and quantitative composition.
2.  The package leaflet may bear additional information concerning distribution, possession or any necessary precaution in conformity with the marketing authorisation, provided that the information is not promotional. This additional information shall appear in the package leaflet clearly separated from the information referred to in paragraph 1.
2.  The package leaflet may bear additional information concerning distribution, possession or any necessary precaution in conformity with the marketing authorisation, provided that the information is not promotional. This additional information shall appear in the package leaflet clearly separated from the information referred to in paragraph 1.
3.  The package leaflet shall be written and designed to be clear and understandable, in terms that are comprehensible to the general public.
3.  The package leaflet shall be written and designed to be clear, readable and understandable, in terms that are comprehensible to the general public.
Amendment 107
Proposal for a regulation
Article 13
Package leaflet of homeopathic veterinary medicinal products
Package leaflet of homeopathic veterinary medicinal products
By way of derogation from Article 12(1), the package leaflet for homeopathic veterinary medicinal products registered in accordance with Articles 89 to 90 shall contain only the following information:
By way of derogation from Article 12(1), the package leaflet for homeopathic veterinary medicinal products registered in accordance with Articles 89 to 90 shall contain only the following information:
(a)  the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States;
(a)  the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States; if the homeopathic veterinary medicinal product is composed of more than one stock, the scientific names of the stocks may be supplemented by a brand name in the label;
(b)  name and address of the marketing authorisation holder and, where appropriate, of the manufacturer;
(b)  name and address of the marketing authorisation holder and, where appropriate, of the manufacturer;
(c)  method of administration and, if necessary, route;
(c)  method of administration and, if necessary, route;
(d)  the expiry date, in the format "mm/yyyy", preceded by the abbreviation "Exp.";
(e)  pharmaceutical form;
(e)  pharmaceutical form;
(f)  special storage precautions, if any;
(f)  special storage precautions, if any;
(g)  target species;
(g)  target species, as well as dosage levels for the different target species;
(h)  a special warning if necessary for the medicinal product;
(h)  a special warning if necessary for the medicinal product;
(i)  the batch number, preceded by the word "Lot";
(j)  registration number;
(j)  registration number;
(k)  withdrawal period, if applicable.
(k)  withdrawal period, if applicable;
(l)  the statement "homeopathic veterinary medicinal product".
(l)  the statement "homeopathic veterinary medicinal product".
Amendment 108
Proposal for a regulation
Article 16 – paragraph 2
2.  For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety or efficacy. Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety and/or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product.
2.  For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety, efficacy and behaviour of residues. Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety and/or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product.
Amendment 109
Proposal for a regulation
Article 16 – paragraph 6
6.  A competent authority or the Agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 July 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product.
6.  The applicant shall submit to the competent authority or the Agency, on their request, safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment if there are well founded reasons to believe that authorisation can result in an increased risk to the environment from the generic product as compared to the reference product.
Amendment 110
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products, but have not hitherto been authorised in that combination (‘combination veterinary medicinal product') shall satisfy the following criteria:
By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products shall satisfy the following criteria:
Amendment 111
Proposal for a regulation
Article 21
Reduced data requirements for applications for limited markets
Reduced data requirements for applications for limited markets
1.  By way of derogation from Article 7(1)(b), a marketing authorisation for a veterinary medicinal product intended for a limited market shall be granted although the quality and/or efficacy documentation required in accordance with Annex II has not been provided, if all the following conditions are met:
1.  By way of derogation from Article 7(1)(b), a marketing authorisation for a veterinary medicinal product intended for a limited market shall be granted even when, for objective, verifiable reasons, the applicant is unable to provide the quality and/or efficacy documentation required in accordance with Annex II, subject to the following conditions:
(a)  the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;
(a)  the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided;
(b)  the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.
(b)  the applicant provides the evidence that the veterinary medicinal product is intended for a limited market.
2.  By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be granted for a period of 3 years.
2.  By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be granted for a period of five years. At the end of that period, the holder may request, in the light of scientific data and on grounds of pharmacovigilance and efficiency, that this authorisation be converted into an open-ended authorisation.
3.  Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality and/or efficacy has been conducted due to the lack of comprehensive efficacy and/or quality data.
3.  Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only limited information on its quality and efficacy has been submitted. The packaging shall bear a warning with the same information.
3a.  A veterinary medicinal product that has been granted marketing authorisation in accordance with this Article may only be issued on the basis of a prescription.
Amendment 113
Proposal for a regulation
Article 22
Data requirements for applications in exceptional circumstances
Data requirements for applications in exceptional circumstances
1.  By way of derogation from Article 7(1)(b), in exceptional circumstances related to animal or public health, where the applicant has demonstrated that for objective, verifiable reasons he is unable to provide the quality, safety and/or efficacy documentation required in accordance with Part 1, Part 2 and Part 3 of Annex II, a marketing authorisation may be granted subject to any of the following:
1.  By way of derogation from Article 7(1)(b), in exceptional circumstances related to animal or public health, including unmet needs with respect to animal health, where the applicant has demonstrated that for objective, verifiable reasons he is unable to provide the quality, safety and/or efficacy documentation required in accordance with Part 1, Part 2 and Part 3 of Annex II, a marketing authorisation may be granted subject to any of the following:
(a)  a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;
(a)  a requirement to introduce conditions or restrictions, in particular concerning the safety of the veterinary medicinal product;
(b)  a requirement to notify the competent authorities of any incident relating to the use of the veterinary medicinal product;
(b)  a requirement to notify the competent authorities of any adverse event relating to the use of the veterinary medicinal product;
(c)  a requirement to conduct post-authorisation studies.
(c)  a requirement to provide further data based on either post-authorisation studies or on data collected on the performance of the product in the field, where data from the field is identified as more appropriate based on a risk-benefit assessment.
2.  By way of derogation from Article 5(2), a marketing authorisation in exceptional circumstances shall be granted for a period of 1 year.
2.  The continuation of a marketing authorisation granted in accordance with paragraph 1 shall be tied to an annual review of the conditions set out in that paragraph, until all those conditions are fulfilled.
3.  Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety and/or efficacy has been conducted due to the lack of comprehensive quality, safety and/or efficacy data.
3.  Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety and/or efficacy has been conducted due to the lack of comprehensive quality, safety and/or efficacy data. The packaging shall bear a warning with the same information.
3a.  The competent authority or the Commission may at any time grant a valid marketing authorisation for an unlimited period of time, provided that no safety or efficacy problems have been reported with the product in use and the marketing authorisation holder has supplied the missing quality, safety and efficacy information set out in paragraph 1.
3b.  A veterinary medicinal product that has been granted marketing authorisation in accordance with this Article may only be issued on the basis of a prescription.
Amendment 114
Proposal for a regulation
Article 25 – paragraph 1
The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 7(1).
The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries comply with applicable Union law, are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 7(1) and that they minimise environmental pollution.
Amendment 115
Proposal for a regulation
Article 28 – paragraph 3
3.  Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission may require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance.
3.  Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission shall require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance.
Amendments 116 and 298
Proposal for a regulation
Article 29
Requirement for a veterinary prescription
Requirement for a veterinary prescription
1.   A competent authority or the Commission shall classify the following veterinary medicinal products as subject to veterinary prescription:
1.   The following veterinary medicinal products shall be subject to mandatory veterinary prescription:
(a)  veterinary medicinal products which contain psychotropic drugs or narcotics, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and the United Nations Convention on Psychotropic Substances of 1971;
(a)  veterinary medicinal products which contain psychotropic drugs or narcotics, including those covered by the United Nations Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and the United Nations Convention on Psychotropic Substances of 1971;
(b)  veterinary medicinal products for food-producing animals;
(b)  veterinary medicinal products for food-producing animals;
(c)  antimicrobial veterinary medicinal products;
(c)  antimicrobial veterinary medicinal products;
(d)  products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;
(d)  products intended for treatments of pathological processes which require a precise prior diagnosis or the use of which may have effects which impede or interfere with subsequent diagnostic or therapeutic measures;
(e)  officinal formulae intended for food-producing animals;
(e)  officinal formulae intended for food-producing animals;
(f)  veterinary medicinal products containing an active substance that has been authorised for less than 5 years in the Union.
(f)  veterinary medicinal products containing an active substance that has been authorised for less than 5 years in the Union;
(fa)  veterinary medicinal products for which marketing authorisations have been granted in accordance with Article 21 and/or 22.
1a.  Member States may on their territories provide for additional legal subcategories in accordance with the respective national law.
2.   A competent authority or the Commission may classify a veterinary medicinal product as subject to veterinary prescription where special precautions are contained in the summary of product characteristics referred to in Article 30, and in particular potential risks to:
2.  A veterinary medicinal product may be classified as subject to mandatory veterinary prescription where special precautions are contained in the summary of product characteristics referred to in Article 30, and in particular potential risks to:
(a)  the target species,
(a)  the target species,
(b)  the person administering the products to the animal,
(b)  the person administering the products to the animal,
(c)  the environment
(c)  the environment.
3.  By the way of derogation from paragraph 1, a competent authority or the Agency may not classify a veterinary medicinal product as subject to veterinary prescription if all of the following conditions are fulfilled:
3.  By the way of derogation from paragraph 1, a competent authority or the Commission may exempt a veterinary medicinal product from a mandatory veterinary prescription if all of the following conditions are fulfilled:
(a)  the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;
(a)  the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products;
(b)  the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal(s) treated, to the person administering the product or to the environment;
(b)  the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal(s) treated, to the person administering the product or to the environment;
(c)  the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious side effects deriving from its correct use;
(c)  the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious adverse events deriving from its correct use;
(d)  neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;
(d)  neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent adverse event reporting;
(e)  the summary of the product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription;
(e)  the summary of the product characteristics does not refer to contraindications related to other veterinary medicinal products commonly used without prescription;
(f)  the veterinary medicinal product is not subject to special storage conditions;
(g)  there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;
(g)  there is no risk for public health as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;
(h)  there is no risk to public or animal health as regards the development of resistance to anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly.
(h)  there is no risk to public or animal health as regards the development of antiparasitic resistance even where the veterinary medicinal products containing those substances are used incorrectly.
Amendment 117
Proposal for a regulation
Article 29 – paragraph 3 a (new)
3a.  Notwithstanding paragraph 1, medicinal products for veterinary use may be used without prescription if:
(a)  they are registered as single homeopathic products and released for sale in pharmacies, have a dilution of not less than D4 (1:10 000) and are not produced using alcohol;
(b)  they are registered as complex homeopathic products, contain no individual components below a dilution of D4, are released for sale in pharmacies and are not produced using alcohol.
Amendment 118
Proposal for a regulation
Article 30 – paragraph 1 – point b
(b)  qualitative and quantitative composition of the active substances or other constituents stating the common name or the chemical description of the substances or other constituents;
(b)  qualitative and quantitative composition of the active substances and all the essential constituents, stating the common name or the chemical description of the substances or other constituents;
Amendment 119
Proposal for a regulation
Article 30 – paragraph 1 – point c – point vi
(vi)  frequency and seriousness of adverse events,
(vi)  frequency and seriousness of adverse reactions,
Amendment 120
Proposal for a regulation
Article 30 – paragraph 1 – point c – point xiii
(xiii)  special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance,
(xiii)  special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance, and specifying that the product is not allowed to be used as a routine preventive measure,
Amendment 121
Proposal for a regulation
Article 30 – paragraph 1 – point e – point iii a (new)
(iiia)  list of excipients,
Amendment 122
Proposal for a regulation
Article 30 – paragraph 1 – point e a (new)
(ea)  information from the environmental risk assessment of the product, in particular environmental endpoints and risk characterisation data, including ecotoxicological information on effects on non-target species and persistence of active substances and active metabolites in soil and water;
Amendment 123
Proposal for a regulation
Article 30 – paragraph 1 – point j a (new)
(ja)  when the veterinary medical product is authorised to be administered via medicated feed, information on the possibility to have interaction between the veterinary medicinal products and the feed impairing the safety or the efficacy of the medicated feed shall be provided through a list of incompatibilities.
Amendment 124
Proposal for a regulation
Article 31 – paragraph 2 a (new)
2a.  Where two products have the same therapeutic effect, comparative assessments may be carried out. In such a case, the products that are hazardous to the environment or to the treated animals shall be substituted by the less hazardous products having the same therapeutic effects.
Amendment 125
Proposal for a regulation
Article 32 – paragraph 1 – point d
(d)  the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals;
(d)  the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals, or to increase yields from treated animals, or as a routine prophylactic in food producing animals, or to be added to feed or water for mass medication when no disease has been diagnosed in any of the animals;
Amendment 126
Proposal for a regulation
Article 32 – paragraph 1 – point e
(e)  the withdrawal period is not long enough to ensure food safety;
(e)  the proposed withdrawal period to ensure food safety is not well justified, or the proposed withdrawal period by the Agency or by the competent authorities is not taken into account;
Amendment 127
Proposal for a regulation
Article 32 – paragraph 1 – point g a (new)
(ga)  the product is a substance of high concern;
Amendment 128
Proposal for a regulation
Article 32 – paragraph 1 – point g b (new)
(gb)  active substances within the product which meet the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to EMA guidelines, or are considered as having endocrine-disrupting properties that risk causing adverse effects in the environment;
Amendment 129
Proposal for a regulation
Article 32 – paragraph 1 – point h a (new)
(ha)  the product poses significantly higher risks to the treated animal, public health or the environment compared to the standard reference treatment;
Amendment 130
Proposal for a regulation
Article 32 – paragraph 1 – point h b (new)
(hb)  unacceptable side effects or secondary effects on the treated animal;
Amendment 132
Proposal for a regulation
Article 32 – paragraph 2
2.  A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans.
2.  A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans within the meaning of paragraph 4.
Amendment 133
Proposal for a regulation
Article 32 – paragraph 3
3.  The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans.
3.  The Commission shall be empowered to adopt delegated acts in accordance with Article 146 and taking into consideration the scientific advice of the Agency in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of certain active substances in humans.
The Agency, in its advice, shall consider appropriate designations at the class, substance or even the indication level and shall consider also the route of administration.
Member States which implement or wish to implement stricter rules shall be allowed to do so.
Amendment 134
Proposal for a regulation
Article 32 – paragraph 4
4.  The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
4.  The Commission shall, by means of implementing acts and taking into consideration the scientific advice of the Agency as well as the work already carried out by the WHO, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Such designations, where relevant, shall be done at the class, substance or even the indication level and shall consider also the route of administration.
Amendment 301
Proposal for a regulation
Article 33 – paragraph 3 a (new)
3a.  Safety information with regard to the environmental effects of veterinary medicinal products shall not be protected.
Amendment 136
Proposal for a regulation
Article 34
Periods of the protection of technical documentation
Periods of the protection of technical documentation
1.  The period of the protection of technical documentation shall be:
1.  The period of the protection of technical documentation shall be:
(a)  10 years for the veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats;
(a)  10 years for the veterinary medicinal products for cattle, sheep (reared for meat), pigs, chickens, salmon, dogs and cats;
(b)  14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;
(b)  14 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, salmon, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;
(c)  18 years for veterinary medicinal products for bees;
(c)  20 years for veterinary medicinal products for bees;
(d)  14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).
(d)  14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).
2.  The protection shall apply from the day when the marketing authorisation for the veterinary medicinal product was granted in accordance with Article 7.
2.  The protection shall apply from the day when the marketing authorisation for the veterinary medicinal product was granted in accordance with Article 7.
2a.  Where the veterinary medicinal product has been authorised for more than one species, the period shall be extended in accordance with the prolongation periods provided for in Article 35.
Amendment 312
Proposal for a regulation
Article 34 a (new)
Article 34a
Period of protection of new data packages related to existing veterinary medicinal products
1.  Any new studies and trials, submitted by the applicant for a marketing authorisation to the competent authorities for an existing veterinary medicinal product no longer covered by any protection period shall benefit from a stand-alone period of protection of four years, provided that they are:
(a)  needed to extend a marketing authorisation in respect of dosages, pharmaceutical forms or routes of administration;
(b)  needed for a reevaluation requested by the Agency or the competent authorities post-authorisation, unless they have been requested by competent authorities as a follow-up to post authorisation pharmacovigilance concerns, or requested as a condition of authorisation or as a post-authorisation commitment at the time of authorisation. Each period of protection shall operate independent from any other that may operate concurrently and shall therefore not be cumulated.
2.  No other applicant may use the results of these trials or studies for commercial purposes during that four year period without the written consent of the holder of the marketing authorisation in the form of a letter of access to those trials or studies.
Amendment 138
Proposal for a regulation
Article 35
Prolongation of the periods of the protection of technical documentation
Prolongation of the periods of the protection of technical documentation
1.  Where a variation is approved in accordance with Article 65 extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that Article shall be prolonged by 1 year for each additional target species, provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a).
1.  Where the first marketing authorisation is granted for more than one species or a variation is approved in accordance with Article 65, extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that Article 34 shall be prolonged by two years for each additional target species in the original dossiers, provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in Article 34(1)(a). The information on the submission for extension of the marketing authorisation shall be made publicly available.
2.  Where a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 4 years.
2.  Where the first marketing authorisation is granted for more than one species or a variation is approved in accordance with Article 65, extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 4 years, provided that the variation has been submitted at least three years before the expiration of the protection period laid down in Article 34. The information on the submission for extension of the marketing authorisation shall be made publicly available.
3.  The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ('overall period of the protection of technical documentation') shall not exceed 18 years.
3.  The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ('overall period of the protection of technical documentation') shall not exceed 14 years for products referred to in Article 34(1)(a). For products referred to in Article 34(1)(b) and (d), this period shall not exceed 18 years.
4.  Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of the marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with clinical trials during the application procedure, other applicants shall not use those trials for a period of 5 years from the granting of the marketing authorisation for which they were carried out, unless the other applicant has obtained written agreement in the form of a letter of access with regard to those trials.
4.  Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of the marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with clinical trials during the application procedure, other applicants shall not use the results of these trials for commercial purposes for a period of 5 years from the granting of the marketing authorisation for which they were carried out, unless the other applicant has obtained written agreement in the form of a letter of access with regard to those trials.
Amendment 139
Proposal for a regulation
Article 38 – paragraph 1
1.  Centralised marketing authorisations shall be granted by the Commission in accordance with this Section. They shall be valid throughout the Union.
1.  Centralised marketing authorisations shall be granted by the Commission in accordance with this Section. They shall be valid throughout the Union and considered the priority procedure. The Commission and the Agency shall develop and encourage use of the centralised procedure, particularly by facilitating access for SMEs.
Amendment 141
Proposal for a regulation
Article 38 – paragraph 2 – point c
(c)  veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application;
(c)  veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application, with the exception of veterinary medicinal products subject to authorisation under Articles 21 and 22;
Amendment 142
Proposal for a regulation
Article 38 – paragraph 2 – point e
(e)  generic veterinary medicinal products of reference veterinary medicinal products authorised under the centralised authorisation procedure.
deleted
Amendment 143
Proposal for a regulation
Article 38 – paragraph 3
3.  For veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union.
3.  For veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may also be granted.
Amendment 144
Proposal for a regulation
Article 38 – paragraph 4
4.  The Commission, taking into account the state of animal and public health in the Union, shall be empowered to adopt delegated acts in accordance with Article 146 in order to amend the list set out in paragraph 2.
deleted
Amendment 145
Proposal for a regulation
Article 46 – paragraph 1
1.  Applications for decentralised marketing authorisation shall be submitted to the Member State chosen by the applicant (‘reference Member State').
1.  Applications and the dossier for decentralised marketing authorisation shall be submitted to all the Member States. The Member State chosen by the applicant shall be the reference Member State.
Amendment 146
Proposal for a regulation
Article 46 – paragraph 2
2.  The application shall list Member States where the applicant seeks to obtain a marketing authorisation (Member States concerned').
2.  The application shall list Member States where the applicant seeks to obtain a marketing authorisation ('Member States concerned'). The applicant shall send to all Member States concerned an application identical to that submitted to the reference Member State, including an identical dossier as provided under Article 7.
Amendment 147
Proposal for a regulation
Article 48 – paragraph 1
1.  Applications for mutual recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation (‘reference Member State').
1.  Applications and the dossier for mutual recognition of marketing authorisations shall be submitted to all the Member States. The Member State that granted the first national marketing authorisation shall be the reference Member State.
Amendment 148
Proposal for a regulation
Article 48 – paragraph 2
2.  A minimum of 6 months shall elapse between the decision granting the first national marketing authorisation and the submission of the application for mutual recognition of the national marketing authorisation.
Deleted
Amendment 149
Proposal for a regulation
Article 48 – paragraph 3 – point c
(c)  an information about the Member States in which an application for a marketing authorisation submitted by the applicant for the same veterinary medicinal product is under examination;
deleted
Amendment 150
Proposal for a regulation
Article 48 – paragraph 4
4.  Within 90 days of receipt of a valid application, the reference Member State shall prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all Member States and the applicant, together with the list of Member States where the applicant seeks to obtain recognition of the marketing authorisation (‘concerned Member States').
4.  Within 45 days of receipt of a valid application, the reference Member State shall prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all concerned Member States and the applicant.
Amendment 151
Proposal for a regulation
Article 49 – paragraph 1
1.  If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by Article 142(‘the coordination group') by the reference Member State.
1.  If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet, on grounds of a potential serious risk to human or animal health or to the environment, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The points of disagreement shall be referred without delay to the coordination group for mutual recognition and decentralised procedures set up by Article 142 (‘the coordination group’) by the reference Member State.
Amendment 152
Proposal for a regulation
Article 49 – paragraph 2
2.  Within the coordination group, a rapporteur shall be appointed in order to prepare a second assessment report for the veterinary medicinal product.
deleted
Amendment 153
Proposal for a regulation
Article 49 – paragraph 4
4.  In the event of an opinion in favour of granting a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly.
4.  In the event of an opinion in favour of granting or amending a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly.
Amendment 154
Proposal for a regulation
Article 50 – paragraph 1
1.  Within 15 days after receipt of the assessment report referred to in Article 46(3) or in Article 48(4) the applicant may provide written notice to the Agency requesting a re-examination of the assessment report. In that case the applicant shall forward to the Agency detailed grounds for the request within 60 days of receipt of the assessment report. The application shall be accompanied by proof of payment of the fee payable to the Agency for the re-examination.
1.  Within 15 days after receipt of the assessment report referred to in Article 46(3) or in Article 48(4) the applicant may provide written notice to the Coordination group requesting a re-examination of the assessment report. In that case the applicant shall forward to the Agency detailed grounds for the request within 60 days of receipt of the assessment report. The application shall be accompanied by proof of payment of the fee payable to the Agency for the re-examination.
Amendment 155
Proposal for a regulation
Article 50 – paragraph 3
3.   The re-examination procedure shall deal only with the points of the assessment report identified by the applicant in the written notice.
3.   The Committee shall define the scope of the examination, taking into account the information supplied by the applicant.
Amendment 156
Proposal for a regulation
Article 50 – paragraph 4
4.  Within 15 days of its adoption, the Agency shall forward the opinion of the Committee to the coordination group, together with a report describing the assessment of the veterinary medicinal product by the Committee and stating the reasons for its conclusions. Those documents shall be forwarded to the Commission, to Member States and to the applicant for information purposes.
4.  Within 15 days of its adoption, the Agency shall forward the opinion of the Committee to the Commission, together with a report describing the assessment of the veterinary medicinal product by the Committee and stating the reasons for its conclusions. Those documents shall be forwarded to Member States and to the applicant for information purposes.
Amendment 157
Proposal for a regulation
Article 50 – paragraph 5
5.   Upon presentation of the Agency ' s opinion, the coordination group shall act by the majority of the votes cast by its members represented at the meeting. The reference Member State shall record the agreement, close the procedure and inform the applicant. Article 49 shall apply accordingly. Where the decision is not in accordance with the opinion of the Agency, the coordination group shall annex a detailed explanation of the reasons for the differences.
5.  Within 15 days of receipt of the opinion, the Commission shall prepare a draft of the decision associated with the procedure.
If the draft decision proposes that a marketing authorisation be granted, the draft shall include or refer to the documents listed in Article 28.
Where the draft decision proposes that a marketing authorisation be refused, the grounds for refusal shall be stated in accordance with Article 32.
Where the draft decision does not concur with the Committee’s opinion, the Commission shall attach detailed explanations of the grounds for these differences.
The Commission may, by means of implementing acts, take a final decision on the granting of a marketing authorisation under the decentralised or mutual recognition procedure. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
The Agency shall forward to the applicant the documents provided for by Article 28.
The Agency shall make the opinion publicly available, after deleting any commercially confidential information.
Amendment 158
Proposal for a regulation
Article 51 – paragraph 1
1.  A Union database on veterinary medicinal products (‘product database') shall be set up and maintained by the Agency.
1.  A Union-wide database on veterinary medicinal products (‘product database') shall be set up and maintained by the Agency.
Amendment 159
Proposal for a regulation
Article 51 – paragraph 2 – point a
(a)  veterinary medicinal products authorised within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets and lists of sites where each product is manufactured;
(a)  veterinary medicinal products authorised within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets, and lists of sites where each product is manufactured and reference numbers to the pharmacovigilance system master file;
Amendment 160
Proposal for a regulation
Article 52 – paragraph 2
2.  Marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations.
2.  Marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations and limited access to other products.
Amendment 161
Proposal for a regulation
Article 52 – paragraph 3
3.  The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics and package leaflets.
3.  The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics, package leaflets and their environmental data, and all safety information.
Amendment 162
Proposal for a regulation
Article 54 – paragraph 1
1.  Member States shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products.
1.  Member States shall collect relevant comparable and sufficiently detailed data, at per-farm level, on the volume of sales in terms of weight and cost for each antimicrobial type and the use of veterinary antimicrobial medicinal products including the species treated, the disease diagnosed and the route of administration.
Amendment 163
Proposal for a regulation
Article 54 – paragraph 2
2.  Member States shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agency. The Agency shall analyse the data and publish an annual report.
2.  Member States shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the Agency. The Agency shall cooperate with other European agencies to analyse the data and publish an annual report which shall also include the corresponding data for human use of antimicrobials as well as the current situation on antimicrobial resistance in the Union and, where appropriate, issue guidelines and recommendations.
Amendment 164
Proposal for a regulation
Article 54 – paragraph 3 a (new)
3a.  Member States shall collect relevant and comparable data on the volume of sales and the use of anti-parasitic and hormonal veterinary medicinal products, and make these available to the Agency.
Amendment 165
Proposal for a regulation
Article 54 – paragraph 4 a (new)
4a.  Data requirements for adopting those implementing acts shall include animal species, the dose, the duration and type of treatment, the number of animals treated and the administration route or routes. In addition, any off-label use of antimicrobials shall be mandatorily reported to national authorities.
Amendment 166
Proposal for a regulation
Article 54 – paragraph 4 b (new)
4b.  The use of antibiotics in drinking water shall be restricted to cases where most of the animals or the whole herd are sick. Five years after the entry into force of this Regulation, the Commission shall publish a report examining the different routes used to administer antibiotics to food-producing animals, and in particular the oral routes used through feed and water, and their subsequent impact on antimicrobial resistance.
Amendment 167
Proposal for a regulation
Section 2 a (new)
Section 2a
Imports, parallel imports and parallel distribution
Amendment 168
Proposal for a regulation
Article 56 a (new)
Article 56a
Import authorisations
1.  An import authorisation shall be required for the following actions:
(a)  the importation of veterinary medicinal products used in the context of Article 8, point (a)(ii) of Article 115(1), point (b) of Article 116(1), point (b) of Article 116(2) and point (a) of Article 116(3) by a veterinarian or by any person authorised to deliver veterinary medicinal products in the Member States;
(b)  the parallel importation of veterinary medicinal products by a manufacturer or distributor authorised in a Member State that is independent of the holder of the marketing authorisation. The imported veterinary medicinal product and the national reference medicinal product shall have:
(i)  the same qualitative and quantitative composition in terms of active substances and excipients, and the same pharmaceutical form;
(ii)  the same therapeutic effects and the same target species.
The national reference medicinal product and the veterinary medicinal product imported in parallel are required to have been harmonised under Article 69 or 70, or authorised in accordance with Articles 46 and 48;
(c)  the parallel distribution of veterinary medicinal products by a distributor independently of the holder of the marketing authorisation.
2.  Applications for authorisation for these activities shall be submitted to the national authorities responsible for authorisation as referred to in points (a) and (b) of paragraph 1, and to the Authorisations Agency referred to in point (c) of paragraph 1.
The competent authorities and the Agency shall register the authorisation of parallel importation or parallel distribution that they have granted in the database on veterinary medicinal products established under Article 51.
3.  The veterinary medicinal product imported in parallel or distributed in parallel shall be marketed in the packaging and with labelling in the language(s) stipulated by each Member State of importation or distribution.
4.  By way of derogation from paragraph 1 of this Article, the authorisation shall not be required for:
(a)  the importation of veterinary medicinal products by a veterinarian service-provider in accordance with Article 114;
(b)  the transportation by a holder of a pet animal of veterinary medicinal products required for its treatment other than immunological medicines and within the limit of three months of treatment.
Amendment 169
Proposal for a regulation
Article 56 b (new)
Article 56b
Import authorisation applications
1.  An import authorisation application as referred to in point (a) of Article 56a(1) shall be submitted to the competent authority of the Member State of the importer.
These authorisations shall be granted for a single operation.
Any change in the information submitted in order to obtain authorisation shall be notified to the competent authority, which shall accordingly alter the initial authorisation if necessary.
An import authorisation application shall contain at least the following information:
(a)  the name of the veterinary medicinal product, its strength, its pharmaceutical form and its therapeutic indications;
(b)  the Member State of origin and details of the marketing authorisation;
(c)  details of the distributor responsible for the sale of the product;
(d)  the quantities imported.
2.  An import authorisation application as referred to in point (b) of Article 56a(1) shall be submitted to the competent authority of the Member State of the importer.
These authorisations shall be granted for a period of five years.
Any change in the information submitted in order to obtain authorisation shall be notified to the competent authority, which shall accordingly alter the initial authorisation if necessary.
A parallel import authorisation application shall contain at least the following information:
(a)  the name of the veterinary medicinal product, its strength and its pharmaceutical form;
(b)  details of the imported veterinary medicinal product and of the medicinal product authorised in the Member State of importation, and details of the nature of the relabelling;
(c)  the name or company name of the applicant;
(d)  the name or company name or logo of the holder of the marketing authorisation or the number of the marketing authorisation of the reference product and of the imported product;
(e)  details of the manufacturing site where the veterinary medicinal products are to be relabelled;
(f)  the name of the qualified person responsible for pharmacovigilance;
(g)  a declaration that the applicant is independent of the holder of the marketing authorisation.
3.  An import authorisation application as referred to in point (c) of Article 56a(1) shall be submitted to the Agency.
These authorisations shall be granted for a period of five years.
Any change in the information submitted in order to obtain authorisation shall be notified to the Agency, which shall accordingly alter the initial authorisation if necessary.
The application shall contain information concerning:
(a)  the name or company name of the applicant, of the manufacturer involved in relabelling, and the parallel distributor;
(b)  the name of the qualified person responsible for pharmacovigilance;
(c)  the Member State of origin and destination.
4.  The competent authority or the Agency may suspend or withdraw parallel import or parallel distribution authorisations if Article 56a and paragraphs 1, 2 and 3 of this Article are no longer complied with or if the product presents a risk to human or animal health or to the environment.
Amendment 170
Proposal for a regulation
Article 57 a (new)
Article 57a
Subsequent conversion into centralised marketing authorisation
1.  After completion of a decentralised procedure laid down in Article 46, a mutual recognition procedure laid down in Article 48, or a marketing authorisation harmonisation procedure laid down in Article 69, the marketing authorisation holder may submit an application to convert the existing marketing authorisations for the veterinary medicinal product into a centralised marketing authorisation granted by the Commission which shall be valid throughout the Union.
2.  The application for the conversion into a centralised marketing authorisation shall be submitted to the Agency and shall include the following:
(a)  a list of all decisions granting marketing authorisations concerning this veterinary medicinal product;
(b)  a list of variations introduced since the first marketing authorisation in the Union was granted;
(c)  a summary report on pharmacovigilance data.
3.  Within 30 days of receipt of the documents listed in paragraph 2, the Commission shall prepare a draft of the decision granting the Union marketing authorisation in conformity with the assessment report referred to in Articles 46(3), 48(4) and 69(3) or, where appropriate, an updated assessment report, a summary of the product characteristics, and a labelling and package leaflet.
4.  The Commission shall, by means of implementing acts, take a final decision on the granting of the centralised marketing authorisation.
This Article shall only apply to veterinary medicinal products that have been authorised through a mutual recognition procedure, a decentralised procedure or a marketing authorisation harmonisation procedure after the date of the application of this Regulation.
Amendment 171
Proposal for a regulation
Article 64 – paragraph 1
1.  If a variation application fulfils the requirements laid down in Article 61, the competent authority or the Agency, or a competent authority assigned in accordance with Article 63(3) shall acknowledge receipt of a complete application.
1.  If a variation application fulfils the requirements laid down in Article 61, the competent authority or the Agency, or a competent authority assigned in accordance with Article 63(3) shall acknowledge receipt of a complete application in 15 days.
Amendment 172
Proposal for a regulation
Article 68
Preparatory phase of the harmonisation exercise
Preparatory phase of the harmonisation exercise
-1a.  A single marketing authorisation holder or a group of marketing authorisation holders may, in accordance with Article 69, request a harmonisation of different national marketing authorisations that have been granted for a particular veterinary medicinal product.
-1b.  A harmonised summary of product characteristics shall be prepared for the particular veterinary medicinal product, for which national marketing authorisations have been granted in different Member States. The coordination group shall draw up detailed rules of procedure for harmonisation.
-1c.  National marketing authorisations may be harmonised with decentralised and/or mutual recognition marketing authorisations if they are for the same product or for essentially similar products
1.  A harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in Article 69 for veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different Member States before 1 January 2004 (‘similar products’).
1.   Harmonised conditions of use as set out in Article 69(4) shall be prepared in accordance with the procedure laid down in Article 69 for groups of essentially similar veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and have been shown to be bio-equivalent ('essentially similar' products) and for which national marketing authorisations have been granted in different Member States before the entry into force of this Regulation.
2.  For the purposes of determining qualitative and quantitative composition of the active substances, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy.
2.  For the purposes of determining qualitative and quantitative composition of the active substances, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety or efficacy.
Amendment 173
Proposal for a regulation
Article 69
Procedure for harmonisation of summaries of products characteristics
Procedure for harmonisation of summaries of products characteristics
1.  By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted before 1 January 2004.
1.  By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted.
2.  The coordination group shall establish groups of similar products. For each of the groups of similar products, the coordination group shall appoint one member to act as a rapporteur.
2.  The coordination group shall establish groups of essentially similar products as identified in point (b) of Article 68(4). For each of these groups of essentially similar products, the coordination group shall appoint one member to act as a rapporteur.
3.  Within 120 days of his appointment, the rapporteur shall present the coordination group a report regarding possible harmonisation of summaries of product characteristics for the similar veterinary medicinal products in the group and propose a harmonised summary of products characteristics.
3.  Within 120 days of his appointment, the rapporteur shall present to the coordination group a report proposing harmonisation of the conditions of use for the group of essentially similar veterinary medicinal products or of the marketing authorisation of a particular veterinary medicinal product.
4.  Harmonised summaries of product characteristics for veterinary medicinal products shall contain all of the following information:
4.  Harmonised conditions of use shall contain at least the following information:
(a)  all species mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group;
(a)  all species mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group;
(b)  all therapeutic indications mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group;
(b)  all therapeutic indications and posology mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group;
(c)  the shortest withdrawal period of those stated in the summaries of the product characteristics.
(c)  a withdrawal period which ensures that consumers are adequately protected;
(ca)  special precautions regarding impact on the environment.
4a.  Further than the conditions of use, other elements of the summary of product characteristics and data quality set, may be harmonised.
5.  Upon presentation of a report, the coordination group shall act by a majority of the votes cast by the members of the coordination group represented at the meeting. The rapporteur shall record the agreement, close the procedure and inform Member States and the marketing authorisation holders accordingly.
5.  Upon presentation of a report, the coordination group shall act by a majority of the votes cast by the members of the coordination group represented at the meeting. The rapporteur shall record the agreement, close the procedure and inform Member States and the marketing authorisation holders accordingly.
6.  In the event of an opinion in favour of adopting a harmonised summary of the product characteristics, each Member State shall vary a marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur.
6.  In the event of an opinion in favour of adopting harmonised conditions of use, each Member State shall vary the marketing authorisation or authorisations of the products in their territory so that the elements listed in paragraph 4, where they are already included in the summaries of characteristics for a product belonging to that group, are in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur. Once an opinion in favour of adopting harmonised conditions of use has been issued, marketing authorisations for a particular product shall be eligible to be considered to be mutual recognition marketing authorisations granted under this Regulation.
7.  In the event of an unfavourable opinion, the procedure referred to in Article 49 shall apply.
7.  In the event of an unfavourable opinion, the procedure referred to in Article 49 shall apply.
Amendment 174
Proposal for a regulation
Article 70
Harmonisation of summary of products characteristics following reassessment
Harmonisation of summary of products characteristics following reassessment
1.  By way of derogation from Article 69, the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before a harmonised summary of the product characteristics is prepared.
1.  By way of derogation from Article 69, and where harmonisation of the conditions of use of a group of products is in the interests of public or animal health at Union level, the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before harmonised conditions of use are prepared.
1a.  For the purpose of harmonisation under this Article similar veterinary medicinal products shall refer to products, not all of which are bioequivalent, and other than homeopathic veterinary medicinal products, that have the same active substance or active substances and the same pharmaceutical form or a range of veterinary medicinal products belonging to the same therapeutic class.
2.  The Commission shall, by means of implementing acts, adopt decisions on groups of product for which a reassessment is necessary. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
2.  The Commission shall, by means of implementing acts, adopt decisions on groups of similar products for which a reassessment is necessary. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
3.  By way of derogation from Article 69, veterinary medicinal products authorised before 20 July 2000 as well as veterinary medicinal products authorised after that date but which were identified as potentially harmful to the environment in the course of the environmental risk assessment shall be reassessed before a harmonised summary of the product characteristics is prepared.
3.  By way of derogation from Article 69, veterinary medicinal products which have not been subject to an environmental risk assessment in the Union shall be assessed in accordance with Annex II before harmonised conditions of use are prepared. For that purpose, marketing authorisation holders shall update accordingly the documentation mentioned in point (b) of Article 7(1).
3a.  By way of derogation from Article 69, antimicrobial veterinary medicinal products shall be reassessed within five years of the entry into force of this Regulation.
4.  For the purposes of paragraphs 1 and 3, the procedure for a Union interest referral in accordance with Articles 84 to 87 shall apply accordingly.
4.  For the purposes of paragraphs 1, 3 and 3a the procedure for a Union interest referral in accordance with Articles 84 to 87 shall apply accordingly.
Amendment 175
Proposal for a regulation
Article 71
Position of marketing authorisation holder
Position of marketing authorisation holder
Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of similar products identified for a harmonisation of the summaries of the product characteristics shall submit information concerning their products.
Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of products identified for a harmonisation of the summaries of the product characteristics or the holders of a particular product identified for harmonisation of marketing authorisations shall submit information concerning their products
Amendment 176
Proposal for a regulation
Article 72 – paragraph 1
1.  Marketing authorisation holders shall elaborate and maintain a system for collecting information on the risks of veterinary medicinal products as regards animal health, public health and the environment enabling them to fulfil their pharmacovigilance responsibilities listed in Articles 73, 76 and 77 (‘pharmacovigilance system').
1.  Marketing authorisation holders shall ensure that risk-benefit balance of authorised veterinary medicinal products is evaluated on a continuous basis and that appropriate measure are taken by the marketing authorisation holders in order to ensure that this balance remains positive for the authorised veterinary medicinal products. To this end, the marketing authorisation holders shall elaborate and maintain a system for collecting, investigating, assessment and communicating of information on the adverse events of veterinary medicinal products as regards animal health, public health and the environment. The system shall serve to coordinate the necessary measures to fulfil the pharmacovigilance responsibilities listed in Articles 73, 76 and 77 (‘pharmacovigilance system').
Amendment 177
Proposal for a regulation
Article 72 – paragraph 2
2.  Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders.
2.  Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders and shall not have any conflict of interest with regard to the marketing authorisation holder.
Amendment 178
Proposal for a regulation
Article 73 – paragraph 1
1.  Member States, the Commission, the Agency and marketing authorisation holders shall collaborate in setting up and maintaining a system to monitor the safety of authorised veterinary medicinal products, enabling them to fulfil their responsibilities as listed in Articles 77 and 79 (‘Union pharmacovigilance system’).
1.  Member States, the Commission and the Agency shall collaborate in setting up, interconnecting and further developing their systems to monitor the safety, effectiveness and quality of authorised veterinary medicinal products in order to fulfil their responsibilities as listed in Article 79. Marketing authorisation holders shall set up and maintain a system to monitor the safety, effectiveness and quality of their products, enabling them to fulfil their responsibilities as listed in Articles 77 and 78.
Amendment 179
Proposal for a regulation
Article 73 – paragraph 2
2.  Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals and animal holders different means of reporting to them the following events whether or not the event is considered to be product-related (‘adverse events’):
2.  Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals, animal holders, environmental authorities of the Member States and other interested parties different means of reporting to them the following events (‘adverse events’) whether or not the event is considered to be product-related:
(a)  any response in an animal to a veterinary or human medicinal product, that is noxious and unintended;
(a)  any response in an animal to a veterinary or human medicinal product, that is noxious and unintended, regardless of whether or not the event is considered to be product-related and whether or not the product was administered in accordance with the summary of product characteristics;
(b)  any observation of a lack of efficacy of a veterinary medicinal product following administration to an animal in accordance with the summary of product characteristics;
(b)  any observation of a lack of efficacy of a veterinary medicinal product, including potential signs of antimicrobial resistance, following its use on an animal;
(c)  any environmental incidents observed following administration of a veterinary medicinal product to an animal;
(c)  any adverse, unforeseen, or unintended impact in the environment (including ground and surface water) following administration of a veterinary medicinal product to an animal;
(d)   any infringements of withdrawal period following administration to an animal of a veterinary or human medicinal product;
(d)  any infringements of withdrawal period following administration to an animal of a veterinary medicinal product;
(e)   any noxious response in humans to a veterinary medicinal product;
(e)   any noxious reaction in humans to a veterinary medicinal product;
(f)   any finding of an active substance in a produce of a food-producing animal exceeding the levels of residues established in accordance with Regulation (EC) No 470/2009.
(f)  any finding of an active substance in a produce of a food-producing animal exceeding the levels of residues established in accordance with Regulation (EC) No 470/2009;
(fa)  any suspected unintended transmission via a veterinary medicinal product of any infectious agent.
Amendment 180
Proposal for a regulation
Article 73 – paragraph 2 a (new)
2a.  Competent authorities and the Agency shall, in addition to the events provided under paragraph 2, make available to healthcare professionals and animal holders different means of reporting to them any response in an animal to a human medicinal product.
Amendment 181
Proposal for a regulation
Article 73 a (new)
Article 73a
No later than six months before the date of application of this Regulation, the Commission shall present a report to the European Parliament and the Council on a feasibility study of a substance-based review system ('monographs') and other potential alternatives for the environmental risk assessment of veterinary medicinal products, to be accompanied, if appropriate, by a legislative proposal.
Amendment 182
Proposal for a regulation
Article 74 – paragraph 1
1.  The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the " pharmacovigilance database ").
1.  The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the "pharmacovigilance database"), linked to the database on veterinary medicinal products. The Union database on veterinary medicinal products shall be the only data entry point for adverse events reported by the holders of marketing authorisations. Maintaining the database shall include electronic archiving of the original reports, related subsequent reports and continuous quality control of the data.
Amendment 183
Proposal for a regulation
Article 74 – paragraph 2
2.  The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the pharmacovigilance database.
2.  The Agency shall, in consultation with the Member States, the Commission and interested parties, draw up the functional specifications for the pharmacovigilance database. These shall include environmental monitoring data which would report undesirable effects on non-target species in the ecosystem, and extend sources of inputs to the pharmacovigilance system to include observation and monitoring by specialists who are not necessarily veterinarians.
Amendment 184
Proposal for a regulation
Article 74 – paragraph 3
3.  The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made accessible in accordance with Article 75.
3.  The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made publicly accessible in accordance with Article 75.
Amendment 185
Proposal for a regulation
Article 74 – paragraph 3 a (new)
3a.  The Agency shall ensure that the transfer of information between its pharmacovigilance database and the national pharmacovigilance databases of the individual Member States is safeguarded.
Amendment 186
Proposal for a regulation
Article 75 – paragraph 3 – point a
(a)  the number of adverse events reported each year, broken down by product, animal species and type of adverse event;
(a)  the number of adverse events reported each year, broken down by type of product and active substance, animal species and type of adverse event;
Amendment 187
Proposal for a regulation
Article 75 – paragraph 3 – point b a (new)
(ba)  information about incidence of adverse events.
Amendment 188
Proposal for a regulation
Article 75 – paragraph 3 a (new)
3a.  Health professionals shall have access to the pharmacovigilance database as regards the following information:
(a)  the number of adverse events reported each year, broken down by product, animal species and type of adverse event;
(b)  previous declarations made concerning the same product and the number of cases per species in the previous six months;
(c)  information on the results of the signal detection system for veterinary medicinal products and groups of products.
Amendment 189
Proposal for a regulation
Article 76 – paragraph 1
1.  Competent authorities shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their Member State, within 30 days following the receipt of the adverse event report.
1.  Competent authorities shall record and assess all adverse events of which they learn under Article 73 and which occur in the territory of their Member State and shall enter them immediately, but no later than 15 days following the receipt of the information, in the pharmacovigilance database. Competent authorities shall record any serious adverse event in animals, noxious response in humans to a veterinary medicinal product or environmental incident observed following administration of a veterinary medicinal product to an animal within 15 days following the receipt of such an adverse event report.
Amendment 190
Proposal for a regulation
Article 76 – paragraph 2
2.  Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, within 30 days following the receipt of the adverse event report.
2.  Marketing authorisation holders shall record in the pharmacovigilance database and evaluate all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products. Serious adverse event in animals, noxious response in humans to a veterinary medicinal product and environmental incidents observed following administration of a veterinary medicinal product to an animal shall be reported within 15 days following the receipt of such adverse event report. Less serious adverse events relating to the use of veterinary medicinal products shall be reported no later than 42 days following receipt of the information. Different requirements shall apply for adverse events observed in clinical trials, as specified in the Good Clinical Practice guidelines for clinical trials.
Amendment 191
Proposal for a regulation
Article 76 – paragraph 3
3.  Competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to collect specific pharmacovigilance data, in particular regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, and the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.
3.   Competent authorities may, on their own initiative or on a request from the Agency, request the marketing authorisation holder to provide specific pharmacovigilance data, such as, information relating to ongoing risk-benefit balance evaluations regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, or the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.
Marketing authorisation holders shall be required to comply with such a request within an appropriate deadline set by the competent authority.
Amendment 192
Proposal for a regulation
Article 77 – paragraph 1
1.  The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation.
1.  The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation and shall take all appropriate steps to encourage members of the health professions and animal holders to report adverse events.
Amendment 193
Proposal for a regulation
Article 77 – paragraph 2
2.  Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party, those arrangements shall be set out in details in the pharmacovigilance system master file.
2.  Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party (contractor), the responsibilities of both parties shall be set out explicitly in a contract and in the pharmacovigilance system master file.
Amendment 194
Proposal for a regulation
Article 77 – paragraph 2 a (new)
2a.  The marketing authorisation holder shall be required to check regularly that the contractor is carrying out the work in accordance with the requirements of the contract.
Amendment 195
Proposal for a regulation
Article 77 – paragraph 3
3.  The marketing authorisation holder shall permanently have at his disposal one or more appropriately qualified persons responsible for pharmacovigilance. Those persons shall reside and operate in the Union. Only one qualified person shall be designated by the marketing authorisation holder per pharmacovigilance system master file.
3.  The marketing authorisation holder shall permanently have at his disposal an appropriately qualified person responsible for pharmacovigilance. That person shall reside and operate in the Union. The qualified person responsible for pharmacovigilance may delegate specific areas of work to appropriately trained staff but shall remain responsible for the marketing authorisation holder’s pharmacovigilance system and for the safety profile of his veterinary medicinal products.
Amendment 196
Proposal for a regulation
Article 77 – paragraph 4
4.  Where the tasks of the qualified person responsible for pharmacovigilance listed in Article 78 have been contracted out to a third party, those arrangements shall be detailed in the contract.
4.  Where the tasks of the qualified person responsible for pharmacovigilance listed in Article 78 have been contracted out to a third party, the relevant arrangements shall be set out explicitly in a contract.
Amendment 197
Proposal for a regulation
Article 77 – paragraph 6
6.  The marketing authorisation holder shall not communicate information regarding adverse events to the general public in relation to the veterinary medicinal product without giving prior notification of his intention to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure.
6.  The marketing authorisation holder shall not communicate information regarding adverse events and potential pharmacovigilance concerns to the general public in relation to the veterinary medicinal product without sending in advance a copy of that communication to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure.
Amendment 198
Proposal for a regulation
Article 77 a (new)
Article 77a
Single master file
The organisation of the pharmacovigilance operations conducted by marketing authorisation holders shall be described in a single master file, which shall be subject to authorisation by the Member States. The single evaluation procedures for these authorisations shall be defined by the Member States and the resulting decisions shall be recognised throughout the Union.
The competent authority shall issue a decision on this authorisation within 90 days of the receipt of a complete application.
The single master file shall be addressed to the competent authority of the Member State in which the qualified person designated by the authorisation holder conducts the operations described in this file. The competent authority concerned shall notify its decision to the authorisation holder and shall record it in the Union database on veterinary medicinal products together with a copy of the relevant single master file.
The authorisation holder shall also submit to the competent authority any substantive changes to his single master file.
Amendment 199
Proposal for a regulation
Article 78
Qualified person responsible for pharmacovigilance
Qualified person responsible for pharmacovigilance
Qualified persons responsible for pharmacovigilance as referred to in Article 77(3) shall carry out the following tasks:
Qualified persons responsible for pharmacovigilance as referred to in Article 77(3) shall ensure that the following tasks are carried out :
(a)  elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to the veterinary medicinal product for which the authorisation has been granted (‘pharmacovigilance system master file’) for all products under their responsibility;
(a)  elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder (‘pharmacovigilance system master file’) for all products under their responsibility;
(b)  allocating reference numbers to the pharmacovigilance system master file and communicating the reference number of the pharmacovigilance master file of each product to the product database;
(b)  allocating reference numbers to the pharmacovigilance system master file and communicating the relevant reference number of the pharmacovigilance master file to the product database for each product;
(c)  notifying the competent authorities and the Agency of the place where the qualified person operates and where the pharmacovigilance system master file is accessible in the Union;
(c)  notifying the competent authorities and the Agency of the place where the qualified person operates and where the pharmacovigilance system master file is accessible in the Union;
(d)  establishing and maintaining a system which ensures that all adverse events which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;
(d)  establishing and maintaining a system which ensures that all adverse events, including on non-target species and the environment, which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;
(e)  preparing the adverse event reports referred to in Article 76;
(e)  preparing the adverse event reports referred to in Article 76;
(f)  ensuring that collected adverse event reports are recorded in the pharmacovigilance database;
(f)  ensuring that collected adverse event reports are recorded in the pharmacovigilance database;
(g)  ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly, including providing information about the volume of sales or prescriptions of the veterinary medicinal product concerned;
(g)  ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly, including providing information about the volume of sales or prescriptions of the veterinary medicinal product concerned;
(h)  providing competent authorities or the Agency with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies;
(h)  providing competent authorities or the Agency with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies;
(i)  evaluating by means of the pharmacovigilance system all information, considering options for risk minimisation and prevention and taking appropriate measures if necessary;
(i)  evaluating by means of the pharmacovigilance system all information, considering options for risk minimisation and prevention and taking appropriate measures if necessary;
(j)  monitoring the pharmacovigilance system and ensuring that if needed, an appropriate corrective action plan is prepared and implemented;
(j)  monitoring the pharmacovigilance system and ensuring that if needed, an appropriate corrective action plan is prepared and implemented;
(k)  ensuring that all personnel involved in the performance of pharmacovigilance activities receives continued training;
(k)  ensuring that all personnel involved in the performance of pharmacovigilance activities receives continued training tailored to their duties, on an ongoing basis; training courses are documented and their effectiveness reviewed;
(l)  communicating any regulatory measure that is taken in a third country and is based on pharmacovigilance data to the competent authorities and the Agency within 15 days of receipt of such information.
(l)  communicating any regulatory measure that is taken in another Member State or a third country and is based on pharmacovigilance data to the competent authorities and the Agency within 15 days of receipt of such information;
(la)  conducting for each product an annual risk-benefit review taking into account all pharmacovigilance surveillance data available on the product concerned, including pharmacovigilance signal monitoring. This review shall be documented by the marketing authorisation holder and the outcome recorded in the pharmacovigilance database. The marketing authorisation holder shall provide the documentation supporting the outcome of the review on request from the national competent authority or during the conduct of an inspection carried out in accordance with Article 128;
(lb)   the authorisation holder shall be required to ensure that the qualified person responsible for pharmacovigilance is authorised to maintain and further develop the pharmacovigilance system and to ensure compliance with requirements.
Amendment 200
Proposal for a regulation
Article 79 – paragraph 1
1.  Competent authorities shall evaluate all adverse events reported to them by healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary.
1.  Competent authorities shall evaluate all adverse events reported to them by marketing authorisation holders, healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary.
Amendment 201
Proposal for a regulation
Article 79 – paragraph 4
4.  Competent authorities and the Agency shall provide the general public, veterinarians and other healthcare professionals with all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication.
4.  Competent authorities and the Agency shall make public all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication. Competent authorities and the Agency shall ensure that veterinarians receive feedback on adverse events reported and regular feedback on all adverse reactions reported.
Amendment 203
Proposal for a regulation
Article 80 – paragraph 1
1.  A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent authority in another Member State subject to the written agreement of the latter.
1.  A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent public authority in another Member State subject to the written agreement of the latter.
Amendment 204
Proposal for a regulation
Article 81
Signal management process
Signal management process
1.  Competent authorities and the Agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit-risk balance of veterinary medicinal products with a view to detecting risks to animal health, public health and protection of the environment (‘signal management process’).
1.   Marketing authorisation holders, competent authorities, other concerned authorities and the Agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit-risk balance of veterinary medicinal products with a view to detecting risks to animal health, public health and protection of the environment (‘signal management process’).
2.  Competent authorities and the Agency shall establish groups of veterinary medicinal products for which signal management process can be combined with a view of detecting risks to animal health, public health and protection of the environment.
2.  Competent authorities and the Agency shall establish groups of veterinary medicinal products for which signal management process can be combined with a view of detecting risks to animal health, public health and protection of the environment.
3.  The Agency and the coordination group shall agree on sharing of the monitoring of data on groups of veterinary medicinal products recorded in the pharmacovigilance database. For each group of veterinary medicinal products a competent authority or the Agency shall be appointed as responsible for the monitoring thereof (‘lead authority’).
3.  The Agency and the veterinary pharmacovigilance group shall agree on sharing of the monitoring of data on groups of veterinary medicinal products recorded in the pharmacovigilance database. For each group of veterinary medicinal products a competent authority or the Agency shall be appointed as responsible for the monitoring thereof (‘lead authority’).
4.  The results of the signal management process shall be agreed upon by the competent authorities and, where appropriate, the Agency. The lead authority shall record the results in the pharmacovigilance database.
4.  Given that marketing authorisation holders are the primary source of expertise and information concerning the products under their responsibility, the lead authority may where necessary consult them during the signal management process. The results of the signal management process shall be agreed upon by the competent authorities and, where appropriate, the Agency. The lead authority shall record the results in the pharmacovigilance database.
5.  Where necessary, based on the results of the signal management process referred to in paragraph 4 the competent authorities or the Commission shall take appropriate measures as referred to in Articles 130 to 135.
5.  Where necessary, based on the results of the signal management process referred to in paragraph 4 the competent authorities or the Commission shall take appropriate measures as referred to in Articles 130 to 135.
Amendment 205
Proposal for a regulation
Article 82 – paragraph 1
Before the expiry of the period of validity of 3 years, marketing authorisations for a limited market granted in accordance with Article 21 shall be re-examined on application from the marketing authorisation holder. After the initial re-examination, it shall be re-examined every 5 years.
Before the expiry of the period of validity of five years, marketing authorisations for a limited market granted in accordance with Article 21 shall be re-examined on application from the marketing authorisation holder. After the initial re-examination, it shall be re-examined, if necessary, every five years.
Amendment 206
Proposal for a regulation
Article 83
Article 83
deleted
Procedure for re-examination of a marketing authorisation in exceptional circumstances
1.  Before the expiry of the period of validity of 1 year, marketing authorisations granted in accordance with Article 22 shall be re-examined on application from the marketing authorisation holder.
2.  The application for re-examination shall be submitted to the competent authority that granted the authorisation or the Agency at least 3 months before the expiry of the marketing authorisation.
3.  When an application for re-examination has been submitted, the marketing authorisation shall remain valid until a decision on the application has been adopted by the competent authority or the Commission.
4.  The competent authority or the Commission may at any time grant a marketing authorisation valid for an unlimited period of time, provided that the marketing authorisation holder submits the missing comprehensive safety and efficacy data referred to in Article 22(1).
Amendment 207
Proposal for a regulation
Article 88 – paragraph 1
1.  By way of derogation from Article 5, homeopathic veterinary medicinal products that satisfy the requirements set out in Article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with Article 90.
1.  By way of derogation from Article 5, homeopathic veterinary medicinal products that satisfy the requirements set out in Article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with Article 90. Veterinary medicinal products registered or approved in accordance with national rules before 31 December 1993 shall not be affected by this Article.
Amendment 208
Proposal for a regulation
Article 88 – paragraph 2 a (new)
2a.  The veterinary homeopathic medicinal products not subject to Article 89(1) shall be authorised in accordance with the general regulations. Where the safety tests, preclinical and clinical trials of veterinary homeopathic medicinal products are not subject to Article 89(1), a Member State may introduce or retain on its territory specific rules in accordance with the principles and characteristics as practised in that Member State.
Amendment 209
Proposal for a regulation
Article 89 – paragraph 1 – point b
(b)  there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product shall not contain more than one part per 10 000 of the mother tincture;
(b)  there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product shall not contain more than one part per 10 000 of the mother tincture, unless the ingredients of the medicinal product are included in Table 1 of Regulation (EU) No 37/2010 with the comment "No maximum residue level (MRL) required";
Amendment 210
Proposal for a regulation
Article 90 – paragraph 1 – point a
(a)  scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered;
(a)  scientific name or other name given in a pharmacopoeia or documented in a monograph of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered;
Amendment 211
Proposal for a regulation
Article 91 – paragraph 1 – point b a (new)
(ba)  in addition to a manufacturing authorisation, the manufacturers in question shall be required to have proof and confirmation of compliance with good manufacturing practices ('GMP');
Amendment 212
Proposal for a regulation
Article 91 – paragraph 2 – subparagraph 1 a (new)
A manufacturing authorisation shall also not be required for preparation, filling or changes in packaging or presentation where these processes are carried out solely for dispensing by pharmacists in a pharmacy or by veterinarians in a veterinary practice.
Amendment 302
Proposal for a regulation
Article 92 – paragraph 2 – point c
(c)  details about the manufacturing site where the veterinary medicinal products are to be manufactured or tested;
(c)  details about the manufacturing site where the veterinary medicinal products are to be manufactured or tested, including data about emissions, discharges and losses of the active substance and its precursors to the environment;
Amendment 213
Proposal for a regulation
Article 93 – paragraph 5
5.  A manufacturing authorisation may be granted conditionally, subject to a requirement for the applicant to undertake actions or introduce specific procedures within a given time period. The manufacturing authorisation may be suspended if these requirements are not complied with.
5.  A manufacturing authorisation may be granted conditionally where minor shortcomings are identified, subject to a requirement for the applicant to rectify the shortcomings within a given time period. The manufacturing authorisation may be suspended if these requirements are not complied with. The manufacturing authorisation shall be refused if manufacturing causes unacceptable risks to the environment.
Amendment 214
Proposal for a regulation
Article 98 – paragraph 1 – point c a (new)
(ca)  comply with the rules on good manufacturing practice for medicinal products established in the Union and use as starting materials only active substances which have been manufactured in accordance with the rules on good manufacturing practice for starting materials established in the Union;
Amendment 215
Proposal for a regulation
Article 104 – paragraph 3
3.   Supplies of small quantities of veterinary medicinal products from one retailer to another shall not be regarded as wholesale distribution.
3.  The purchase, sale, import or export of veterinary medicinal products or any other kind of commercial transaction concerning these medicinal products, whether for profit or not for profit, shall be subject to the possession of a wholesale distribution authorisation for veterinary medicinal products. Such an authorisation shall not apply to the supply, by a manufacturer, of veterinary medicinal products which it has itself manufactured, nor to the retail sale of veterinary medicinal products by persons entitled to conduct such sales in accordance with Article 107.
Amendment 216
Proposal for a regulation
Article 104 – paragraph 4 a (new)
4a.  On the basis of the best practices model that already exists for medicinal products for human use, the Commission shall adopt, within 24 months of the entry into force of this Regulation, principles and guidelines, to which wholesalers shall be obliged to adhere, for best practices in the wholesale distribution of veterinary medicinal products.
Amendment 217
Proposal for a regulation
Article 104 – paragraph 4 b (new)
4b.  Wholesalers shall obtain their supplies of medicinal products only from the manufacturer, a person designated by the holder of the marketing authorisation or from persons who themselves hold a wholesale distribution authorisation.
Amendment 218
Proposal for a regulation
Article 104 – paragraph 5 a (new)
5a.  Wholesalers shall comply with the obligations laid down in points (ca) and (cc) of Article 105(3) with regard to supply of medicinal products.
Amendment 219
Proposal for a regulation
Article 105 – paragraph 3 – point a
(a)  has at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down by the Member State concerned as regards the storage and handling of veterinary medicinal products;
(a)  has at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down by the Member State concerned as regards the storage and handling of veterinary medicinal products, and which premises representatives of the competent authority may enter at any time;
Amendment 220
Proposal for a regulation
Article 105 – paragraph 3 – point c a (new)
(ca)  concerning the supply of medicinal products to persons permitted to carry out retail activities in the Member State in accordance with Article 107(1), is able to guarantee permanently an adequate range of medicinal products to meet the requirements of the territory being supplied and to deliver the supplies requested within a very short time over the whole of the territory in question;
Amendment 221
Proposal for a regulation
Article 105 – paragraph 3 – point c b (new)
(cb)  within the limits of his responsibility, ensure appropriate and continued supplies of medicinal products to persons authorised to carry out retail activities in the Member State in accordance with Article 107(1) so that animal health needs in the Member State in question are covered;
Amendment 222
Proposal for a regulation
Article 105 – paragraph 3 – point c c (new)
(cc)  is able to notify the competent authority of any shortage of stock likely to be detrimental to animal health needs in the Member State in question.
Amendment 223
Proposal for a regulation
Article 106 a (new)
Article 106a
Qualified persons
1.  The holder of a wholesale distribution authorisation shall make permanent and continuous use of the services of at least one qualified person satisfying the conditions set out in this Article, who shall be responsible, in particular, for performing the task specified in Article 104.
2.  Qualified persons shall hold a diploma, certificate, or any other form of proof serving to demonstrate that they are properly qualified and have acquired sufficient experience of wholesale distribution. The holder of the authorisation may assume the responsibility referred to in paragraph 1, if that person personally fulfils those conditions as specified above.
3.  The competent authority shall ensure that the obligations of qualified persons referred to in this Article are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct. The competent authority may temporarily suspend such persons upon the commencement of administrative or disciplinary proceedings against them for failure to fulfil their obligations.
Amendment 224
Proposal for a regulation
Article 107 – paragraph 2
2.  Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care, and only in the amount required for the treatment concerned.
2.  Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their immediate care, subject to an appropriate veterinary diagnosis and examination of the animal(s) concerned, and only in the amount required for the treatment concerned. In the case of food-producing animals, the continuation of the treatment with antimicrobial products shall be decided based on a renewed clinical examination by a veterinarian.
Amendment 225
Proposal for a regulation
Article 107 – paragraph 2 a (new)
2a.  Member States may impose stricter conditions, justified on grounds of public health, animal health and environment protection, for the retail of veterinary medicinal products on their territory, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market.
Amendment 226
Proposal for a regulation
Article 107 – paragraph 2 b (new)
2b.   Any commercial participation in companies which trade in, manufacture or import veterinary medicinal products shall be prohibited.
Amendment 227
Proposal for a regulation
Article 107 – paragraph 2 c (new)
2c.  Given the risks associated with antimicrobial resistance, no economic incentives may be provided in any form, directly or indirectly, by pharmaceutical companies to persons who prescribe veterinary medicinal products.
Amendment 228
Proposal for a regulation
Article 107 – paragraph 3 – introductory part
3.  Retailers of veterinary medicinal products shall keep detailed records of the following information in respect of each purchase and sale of veterinary medicinal products:
3.  Retailers of veterinary medicinal products shall keep detailed records of the following information in respect of each purchase and sale of veterinary medicinal products obtainable only on prescription:
Amendment 229
Proposal for a regulation
Article 107 – paragraph 3 – subparagraph 1 a (new)
Where they consider it necessary, Member States may require that the obligation to keep the above records likewise apply to the purchase and sale of non-prescription veterinary medicinal products.
Amendment 230
Proposal for a regulation
Article 108
Retail of veterinary medicinal products at a distance
Retail of veterinary medicinal products at a distance
1.  Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products by means of information society services in the meaning of Directive 98/34/EC of the European Parliament and of the Council28 to natural or legal persons established in the Union under the condition that those medicinal products comply with the legislation of the destination Member State.
1.  Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products, with the exception of antimicrobials, psychotropic and biological or immunological veterinary medicinal products, on the internet to natural or legal persons established in the Union under the condition that:
(a)  the veterinary medicinal products and the prescriptions comply with the law of the destination Member State;
(b)  the natural or legal person offering veterinary medicinal products is permitted or qualified to supply prescription and non-prescription veterinary medicinal products to the public, including at a distance, in accordance with the national law of the Member State in which that person is established;
(c)  the person referred to in point (a) has notified at least the following information to the Member State of establishment:
(i)  the name or corporate name and the permanent address of the place of business from where the veterinary medicinal products are supplied;
(ii)  the date on which veterinary medicinal products were first offered for sale at a distance to the public on the internet;
(iii)  the address of the website used for that purpose and all information necessary to identify that website.
1a.  On grounds of public or animal health, animal welfare or environmental protection, Members States shall be able to limit or condition, or both, the sale at a distance on the internet to the public on their territory of veterinary medicinal products or of other prescription veterinary medicinal products for food producing animals.
2.  In addition to the information requirements set out in Article 6 of the Directive 2000/31/EC of the European Parliament and of the Council29, websites offering veterinary medicinal products shall contain at least:
2.  In addition to the information requirements set out in Article 6 of the Directive 2000/31/EC of the European Parliament and of the Council29 and Article 6 of Directive 2011/83/EU of the European Parliament and of the Council29a, websites offering veterinary medicinal products shall contain at least:
(a)  the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established;
(a)  the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established;
(b)  a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5;
(b)  a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5;
(c)  the common logo established in accordance with paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of veterinary medicinal products and containing a hyperlink to the entry of the retailer in the list of authorised retailers referred to in point (c) of paragraph 5.
(c)  the common logo established in accordance with paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of veterinary medicinal products and containing a hyperlink to the entry of the retailer in the list of authorised retailers referred to in point (c) of paragraph 5.
3.  A common logo shall be established that is recognisable throughout the Union, while enabling the identification of the Member State where the person offering veterinary medicinal products for sale at a distance to the public is established. The logo shall be clearly displayed on websites offering veterinary medicinal products for sale at a distance.
3.  A common logo shall be established that is recognisable throughout the Union, while enabling the identification of the Member State where the person offering veterinary medicinal products for sale at a distance to the public is established. The logo shall be clearly displayed on websites offering veterinary medicinal products for sale at a distance.
4.  The Commission shall adopt the design of the common logo by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
4.  The Commission shall adopt the design of the common logo by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
5.  Each Member State shall set up a website regarding sale of veterinary medicinal products at a distance, providing at least the following information:
5.  Each Member State shall set up a website regarding sale of veterinary medicinal products at a distance, providing at least the following information:
(a)  information on its national legislation applicable to the offering of veterinary medicinal products for sale at a distance to the public by means of information society services, including information on the fact that there may be differences between Member States regarding the classification of the supply of the veterinary medicinal products;
(a)  information on its national legislation applicable to the offering of veterinary medicinal products for sale at a distance on the internet, including information on the fact that there may be differences between Member States regarding the classification of the supply of the veterinary medicinal products;
(b)  information on the common logo;
(b)  information on the common logo;
(c)  a list of retailers established in the Member State authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in accordance with paragraph 1 as well as the website addresses of those retailers.
(c)  a list of retailers established in the Member State authorised to offer veterinary medicinal products for sale at a distance to the public on the internet in accordance with paragraph 1 as well as the website addresses of those retailers; and also a hyperlink to the website of the Agency set up in accordance with paragraph 6;
(ca)  information on applicable procedures for the safe disposal of medicinal products, specifying the public or private body responsible at national or local level for the disposal of veterinary medicine residues and the collection points for disposal free of charge;
(cb)  hyperlinks to the web pages of the bodies responsible in Member States for listing authorised national retailers.
The websites set up by Member States shall contain a hyperlink to the website of the Agency set up in accordance with paragraph 6.
6.  The Agency shall set up a website providing information on the common logo. The Agency’s website shall explicitly mention that the websites of Member States contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in the Member State concerned.
6.  The Agency shall set up a website providing information on the common logo. The Agency’s website shall explicitly mention that the websites of Member States contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public on the internet in the Member State concerned. The Agency’s website shall be linked to the web pages of the appropriate Member State bodies which list authorised retailers in Member States.
7.  Members States may impose conditions, justified on grounds of public health protection, for the retail on their territory of medicinal products offered for sale at a distance to the public by means of information society services.
7a.  Member States shall take the measures necessary to ensure that persons other than those referred to in paragraph 1 offering veterinary medicinal products for sale at a distance to the public on the internet and operating on their territory are subject to effective, proportionate, and dissuasive penalties in case of abuse or illegal practice, or the failure to act according to their professional code of conduct.
7b.  No later than (six) months after the date of application of this Regulation, the Commission shall adopt guidelines supporting the Member States in the development of a harmonized system of digital prescription across the Union, including measures for controlling cross-border veterinary prescriptions.
7c.  On the basis of the guidelines referred to in paragraph 7b, Member States shall be encouraged to develop a system of digital prescription at national level, to include measures for the delivery and control of prescriptions. Member States shall also be encouraged to set up a system to facilitate the e-submission of prescriptions by means of a national database, directly linked to all pharmacies (both shop and internet ones), national competent authorities and veterinarians.
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28 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).
29 Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce') (OJ L 178, 17.7.2000, p. 1).
29 Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce') (OJ L 178, 17.7.2000, p. 1).
29a Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).
Amendment 231
Proposal for a regulation
Article 109 – title
Retail of anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic veterinary medicinal products
Retail only of medicinal products which are subject to prescription, or active substances, with anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal, immunological or psychotropic properties
Amendment 232
Proposal for a regulation
Article 109 – paragraph 1
1.  Only manufacturers, wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties.
1.  Only manufacturers, wholesale distributors and retailers authorised to do so in accordance with applicable national law shall be allowed to supply and purchase prescription only veterinary medicinal products which have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal, immunological or psychotropic properties or substances which may be used as veterinary medicinal products having those properties. In the case of non-food producing animals (i.e. companion and small animals) all retailers, ranging from supermarkets, pet stores, to traditional and online (veterinary) pharmacies,shall be allowed to sell anti-parasitic and anti-inflammatory products, without the need to be specifically authorised to do so.
Amendment 233
Proposal for a regulation
Article 109 – paragraph 3 – subparagraph 1 – introductory part
3.  Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction:
3.  Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction of prescription for veterinary medicinal products:
Amendment 234
Proposal for a regulation
Article 109 – paragraph 3 – subparagraph 1 – point d
(d)  name and address of the supplier in the event of purchase, or of the recipient in the event of sale.
(d)  name and address of the supplier in the event of purchase.
Amendment 235
Proposal for a regulation
Article 110
Veterinary prescriptions
Veterinary prescriptions
1.  A veterinary prescription shall contain at least the following elements (‘minimum requirements’):
1.  A veterinary prescription shall contain at least the following elements (‘minimum requirements’):
(a)  identification of the animal under treatment;
(a)  identification of the animal or class of animal under treatment and the condition which is being treated;
(b)  full name and contact details of the animal owner or keeper;
(b)  full name and contact details of the animal owner or keeper;
(c)  issue date;
(c)  issue date;
(d)  full name and contact details, qualifications and professional membership number of the person writing the prescription;
(d)  full name and contact details, qualifications and professional membership number of the person writing the prescription;
(e)  signature or an equivalent electronic form of identification of the person writing the prescription;
(e)  signature or an equivalent electronic form of identification of the person issuing the prescription;
(f)  name of the prescribed product;
(f)  name of the prescribed product and the active substance(s);
(g)  pharmaceutical form (tablet, solution, etc.);
(g)  pharmaceutical form (tablet, solution, etc.);
(h)  quantity;
(h)  quantity and in cases where the treatment has to be repeated, it shall also contain the number of times it can be repeated;
(i)  strength;
(i)  strength;
(j)  dosage regimen;
(j)  dosage regimen;
(k)  withdrawal period if relevant;
(k)  withdrawal period if relevant;
(l)  any necessary warnings;
(l)  any necessary warnings and restrictions, including, where relevant, the risks entailed by imprudent use of antimicrobials;
(m)  if a product is prescribed for a condition not mentioned in the marketing authorisation for that product, a statement to that effect.
(m)  if a product is prescribed for a condition not mentioned in the marketing authorisation for that product, a statement to that effect;
(ma)  period of validity of prescription.
2.  A veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law.
2.  A veterinary prescription shall only be issued by a veterinarian or other person qualified to do so in accordance with applicable national law, following a proper assessment of the health status of the animal concerned.
2a.  A veterinary prescription of a veterinary medicinal product which has anabolic, anti-inflammatory, anti-infectious (other than anthelmintic), anti-cancer, hormonal or psychotropic properties or substances shall only be issued by a veterinarian after a clinical examination and diagnosis.
3.  Where a veterinary medicinal product is supplied on prescription, the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned.
3.  Where a veterinary medicinal product is supplied on prescription, the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned. The maximum quantity of veterinary medicinal products supplied at one time shall not, however, exceed one month's treatment. For chronic diseases and for periodic treatments the maximum quantity shall not exceed three month's treatment.
4.  Veterinary prescriptions shall be recognised throughout the Union. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.
4.   Veterinary prescriptions issued by a veterinarian shall be recognised throughout the Union. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.
Those provisions shall not apply to prescriptions issued under the exceptional circumstances set out in Articles 115 and 116. Those Member States that recognise prescriptions in their national systems issued by any person other than a veterinarian shall immediately notify the Commission, which shall forward such information to all Member States.
Amendment 236
Proposal for a regulation
Article 110 – paragraph 4 a (new)
4a.   The removal of regulatory and administrative barriers to such recognition shall not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription.
Amendment 237
Proposal for a regulation
Article 111 – paragraph 1
1.  Veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation.
1.  Veterinary medicinal products shall be used responsibly in accordance with the principle of good animal husbandry and with the terms of the marketing authorisation or registration when no marketing authorisation is required.
Amendment 238
Proposal for a regulation
Article 111 – paragraph 2 a (new)
2a.  Antimicrobial veterinary medicines shall not under any circumstances serve to improve performance or compensate for poor animal husbandry. Routine prophylactic use of antimicrobials is therefore prohibited. Prophylactic use of antimicrobial veterinary medicines shall only be permitted on single animals and when fully justified by a veterinarian in exceptional indications, of which a list shall be drafted by the Agency.
Metaphylactic use of antimicrobial veterinary medicines shall be restricted to use in clinicall-ill animals and to those single animals that are identified as being at a high risk of contamination, to prevent further spread of the disease in the group. Where such products are to be used for non-routine metaphylaxis, owners and keepers of food-producing animals shall ensure that they have a health plan specifying appropriate non-medical measures to reduce the need to resort to metaphylactic use in the future. Moreover, they shall be required to comply with the following measures:
(i)  using good healthy breeding stock with suitable genetic diversity;
(ii)  conditions that respect the behavioural needs of the species, including social interactions/hierarchies;
(iii)  stocking densities that do not increase risk of disease transmission;
(iv)  isolation of sick animals away from the rest of the group;
(v)  for chickens and smaller animals, subdivision of flocks into smaller, physically separated groups;
(vi)  implementation of existing animal welfare rules already in cross compliance under the Common Agricultural Policy's horizontal Regulation (EU) nr. 1306/2013, Annex II, SMRs 11, 12, 13.
(Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23) Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs (OJ L 340, 11.12.1991, p. 33), Council Directive 91/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves (OJ L 340, 11.12.1991, p. 28))
Amendment 239
Proposal for a regulation
Article 111 a (new)
Article 111a
Supply and use of antimicrobials
1.  Member States may restrict or prohibit the supply or use, or both, of certain antimicrobials in animals on their territory if either of the following conditions is fulfilled:
(a)  the antimicrobials are critically important for use in humans; or
(b)  the administration of antimicrobials to animals is contradictory to the implementation of a national policy on prudent use of antimicrobials and that the policy is in line with the precautionary principle.
2.  Before adopting measures referred to in paragraph 1, the Member State shall ensure that relevant stakeholders have been consulted.
3.  Measures adopted by Member States on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of protection of animal and public health.
4.  A Member State adopting a measure on the basis of paragraph 1 shall inform the Commission thereof.
Amendment 240
Proposal for a regulation
Article 112 – paragraph 1
1.  Owners or, where the animals are not kept by the owners, keepers of food-producing animals shall keep records of the veterinary medicinal products they use and, if applicable, a copy of the veterinary prescription.
1.  Owners or, where the animals are not kept by the owners, keepers of food-producing animals shall keep records of the veterinarian-prescribed veterinary medicinal products and veterinary medicinal products with a withdrawal period higher than nil they use and, if applicable, a copy of the veterinary prescription.
Amendment 241
Proposal for a regulation
Article 112 – paragraph 2 – point a
(a)  date of administering the veterinary medicinal product to the animal;
(a)  date of administering the veterinary medicinal product to the animal and the disease treated;
Amendment 242
Proposal for a regulation
Article 112 – paragraph 2 – point d
(d)  name and address of the supplier;
(d)  name and address of the supplier and, if applicable, a copy of the delivery note;
Amendment 243
Proposal for a regulation
Article 112 – paragraph 2 – point e
(e)  identification of the animals treated;
(e)  identification of the animals treated and the diagnosis of the disease treated;
Amendment 244
Proposal for a regulation
Article 112 – paragraph 2 a (new)
2a.  Particulars already contained in the prescription or in a delivery note shall not need to be recorded again if a clear reference can be made to the corresponding prescription and delivery note.
Amendment 245
Proposal for a regulation
Article 112 a (new)
Article 112a
Examination of therapy frequency
1.  The national competent authority shall identify on the basis of the numbers determined under Article 112, for each half year, the average number of treatments with antibacterial effective substances and the treatment frequency following a standard European key, based on the particular business and the particular type of animals kept, taking into account the type of use.
2.  The competent national authority shall inform the farmer in accordance with paragraph 1 about the biannual therapy frequency for the particular species of animals held by him in consideration of their type of use.
3.  The information collected under paragraph 1 by the national competent authority are evaluated by the Commission and compared throughout the Union.
4.  Member States may request data beyond.
Amendment 246
Proposal for a regulation
Article 112 b (new)
Article 112b
Reduction of therapy approaches based on antibacterial substances
1.  In order to facilitate the effective reduction regarding the use of pharmaceuticals which contain antibacterial substances, anyone who engages in animal husbandry shall:
(a)  determine, respectively, two months after the disclosure of the key figures in accordance with paragraph 112b established therapy prevalence, if the biannual therapy prevalence concerning his reared animal species, and considering the type-of-use during the elapsed time frame, lies above the average therapy prevalence;
(b)  take immediate record of the results of the assessment under point 1.
2.  In a case where the operational, biannual therapy prevalence of the animal husbandman with respect to his business lies above the biannual average, the animal husbandman under consultation of a veterinarian has to assess the reasons that may have led to exceeding the average, and how the treatment of his cattle with pharmaceuticals containing antibacterial substances may be decreased.
If the assessment of the animal husbandman comes to the result that a therapy by means of the concerned pharmaceuticals may be reduced, the husbandman shall take all necessary steps in order to accomplish the reduction. The husbandman shall consider the wellbeing of his cattle and guarantee the required medical care.
3.  Member States may determine measures extending beyond the above mentioned requirements.
Amendment 247
Proposal for a regulation
Article 115 – paragraph 1
1.  By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with the following:
1.  By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in the interest of animal health and welfare, exceptionally treat the animal concerned with the following, in descending order of preference:
(a)  a medicinal product:
(a)  any veterinary medicinal product authorised under this Regulation with the exception of antimicrobial products used as routine prophylactic measure, unless specifically authorised by the Committee for Medicinal Products for Veterinary Use;
(i)  a veterinary medicinal product authorised under this Regulation in the Member State concerned for use with another animal species, or for another condition in the same species;
(ii)  a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species or in another species, for the same condition or for another condition;
(iii)  a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council30 or Regulation (EC) No 726/2004;
(b)  if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation.
(b)  if there is no product as referred to in point (a):
(i)  a medicinal product for human use authorised in the Member State concerned or another Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council30 or Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may only be employed subject to the issuing of a prescription by a veterinarian and the approval by the veterinary authority responsible for monitoring the work of the veterinarian in question;
(ii)  a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national law.
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30 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
30 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Amendment 303
Proposal for a regulation
Article 115 – paragraph 1 a (new)
1a.  By way of derogation from paragraph 1, homeopathic medicinal products may be administered to non-food producing animals.
Amendment 249
Proposal for a regulation
Article 116 – paragraph 1
1.  By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with any of the following:
1.  By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a food-producing animal of a non-aquatic species, the veterinarian responsible may, under his direct personal responsibility and in the interest of animal health and welfare, exceptionally treat the animal concerned with the following, in descending order of preference:
(a)  a veterinary medicinal product authorised under this Regulation in the Member State concerned for use with another food-producing animal species, or for another condition in the same species;
(a)  any veterinary medicinal product authorised under this Regulation with the exception of antimicrobial products used prophylactically in an individual or a group where there is no diagnosis of disease in any of the animals;
(b)  a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species or in another food-producing species for the same condition or for another condition;
(ba)  if there is no product as referred to in point (a):
(c)  a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, or
(d)  if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation.
(i)  a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may be employed subject to the issuing of a prescription by a veterinarian and the approval by the veterinary authority responsible for monitoring the work of the veterinarian in question and treatment with a veterinary medicinal product as referred to in point (a) or point (ba) is not possible; or
(ii)  a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription issued by a person authorised to do so under national law.
Amendment 251
Proposal for a regulation
Article 116 – paragraph 2 – point b a (new)
(ba)  veterinary medicinal products authorised under this Regulation in another Member State for use in the same aquatic species or in another food-producing aquatic species for the condition in question or for another condition.
Amendment 252
Proposal for a regulation
Article 116 – paragraph 3
3.   By way of derogation from paragraph 2, and until an implementing act referred to in paragraph 4 is established, if there is no product as referred to in subparagraphs (a) and (b) of paragraph 2, a veterinarian may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing animals of an aquatic species on a particular holding with:
3.   By way of derogation from paragraph 2, and until an implementing act referred to in paragraph 4 is established, if there is no product as referred to in subparagraphs (a) and (b) of paragraph 2, a veterinarian may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing animals of an aquatic species on a particular holding with:
(a)   a veterinary medicinal product authorised under this Regulation in the Member State concerned or in another Member State for use with a food-producing non-aquatic species;
(a)   a veterinary medicinal product authorised under this Regulation in the Member State concerned or in another Member State for use with a food-producing non-aquatic species; or
(b)   a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004.
(b)   if there is no product as referred to in point (a), a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004.
Amendment 304
Proposal for a regulation
Article 116 – paragraph 3 a (new)
3a.  By way of derogation from paragraphs 1 to 3, homeopathic medicinal products may be administered to treat food-producing animals under the responsibility of the veterinarian provided that they contain only active ingredients listed in Table 1 of the Annex to Regulation (EU) No 37/2010 as substances for which no maximum limit needs to be set.
Amendment 255
Proposal for a regulation
Article 116 – paragraph 6
6.   Pharmacologically active substances included in the medicinal product used in accordance with paragraph 1 shall be listed in Table 1 of the Annex to Regulation (EU) No 37/2010. The veterinarian shall specify an appropriate withdrawal period in accordance with Article 117.
6.   Pharmacologically active substances included in the medicinal product used in accordance with paragraph 1 and paragraph 3(b) shall be listed in Table 1 of the Annex to Regulation (EU) No 37/2010. The veterinarian shall specify an appropriate withdrawal period in accordance with Article 117.
Amendment 256
Proposal for a regulation
Article 117 – paragraph 4
4.  With regard to homeopathic veterinary medicinal products the withdrawal period shall be established at zero days.
4.  The withdrawal period shall be established at zero days for homeopathic veterinary medicinal products containing solely active substances listed in Table 1 of Regulation (EU) No 37/2010 with the classification "No maximum residue level (MRL) required".
Amendment 257
Proposal for a regulation
Article 117 – paragraph 5 – subparagraph 2 a (new)
Data on the use of antibiotics outside the terms of authorisation shall be collected and mandatorily reported to national authorities in accordance with Article 54.
Amendment 258
Proposal for a regulation
Article 118 – title
Use of antimicrobial veterinary medicinal products for species or indications outside the terms of the marketing authorisation
Use of antimicrobial substances for species or indications outside the terms of the marketing authorisation
Amendment 259
Proposal for a regulation
Article 118 – paragraph 1
1.  Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the use of which would not present a risk to public or animal health.
1.  Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the use of which would not present a risk to public or animal health. Articles 115 and 116 do not apply to critically important antimicrobials as referred to in Article 32(2).
Amendment 260
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 1
2.  The Commission may, by means of implementing acts in accordance with the examination procedure referred to in Article 145(2), and taking into consideration scientific advice of the Agency, establish a list of antimicrobial medicinal products that cannot be used in accordance with paragraph 1, or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions.
2.  The Commission shall, by means of implementing acts in accordance with the examination procedure referred to in Article 145(2), and taking into consideration scientific advice of the Agency, establish a list of antimicrobial substances or groups of substances that cannot be used in accordance with paragraph 1, or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions.
Amendment 261
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 1 a (new)
The principles to be used to establish the list of antimicrobials to be restricted in veterinary medicine shall not interfere with or deter Member States from prohibiting the use of certain antimicrobials in some species if they deem it appropriate.
Amendment 262
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point a
(a)  risks to public health if the antimicrobial product is used in accordance with paragraph 1;
(a)  risks to public health if the antimicrobial product is used in accordance with paragraph 1, including the risks involved in using antimicrobials critical to human health in food producing animals;
Amendment 263
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point c a (new)
(ca)  availability of other farming methods that could prevent the outbreak of the disease;
Amendment 264
Proposal for a regulation
Article 118 – paragraph 2 a (new)
2a.  Third countries with laws that authorise the use of antimicrobial medicinal products on the list referred to in paragraph 2 under different conditions from those laid down in that paragraph may not appear on any of the lists of third countries provided for under Union law from which Member States are authorised to import farm or aquaculture animals or meat or products obtained from such animals.
Amendment 265
Proposal for a regulation
Article 118 – paragraph 2 b (new)
2b.  Member States shall also prohibit the importation from third countries on any of the lists referred to in paragraph 2a of:
(a)  farm or aquaculture animals to which substances on the list referred to in paragraph 2 have been administered, unless those substances were administered in compliance with the conditions laid down in paragraph 1;
(b)  meat or products obtained from animals the importation of which is prohibited under point (a) of this paragraph.
Amendment 266
Proposal for a regulation
Article 119 – paragraph 2
2.  By way of derogation from Article 111, in the event of an outbreak of a listed disease as referred to in Article 5 of Regulation (EC) No…/…. of the European Parliament and the Council31 a competent authority may allow, for a limited period of time and under specific restrictions, the use of an immunological veterinary medicinal product authorised in another Member State.
2.  By way of derogation from Article 111, in the event of an outbreak of a listed disease as referred to in Article 5 of Regulation (EC) No…/…. of the European Parliament and the Council31 or any critical health situation acknowledged by the Chief Veterinary Officer of the Member State a competent authority may allow, for a limited period of time and under specific restrictions, the use of an immunological veterinary medicinal product without a marketing authorisation in the Member State in question but which is authorised either in another Member State or in accordance with the laws of a third country, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use.
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31 Regulation of the European Parliament and the Council of….. on animal health (OJ L……).
31 Regulation of the European Parliament and the Council of….. on animal health (OJ L……).
Amendment 267
Proposal for a regulation
Article 122 – paragraph 1 a (new)
Within two years of entry into force of this Regulation, the Commission shall develop, through delegated acts, a harmonised system for collecting these types of products and waste materials at Union level.
Amendment 268
Proposal for a regulation
Article 123 – paragraph 1 a (new)
1a.  Member States may provide for additional conditions in terms of advertising of veterinary medicinal products to protect public and animal health, animal welfare and the environment including conditions in terms of comparative and misleading advertising or unfair commercial practices.
Amendment 269
Proposal for a regulation
Article 124 – paragraph 2
2.  The prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products.
2.  The prohibition set out in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products.
Amendment 270
Proposal for a regulation
Article 125 – paragraph 1
1.  Competent authorities shall perform controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products regularly, on a risk-basis, in order to verify that the requirements as set out in this Regulation are complied with.
1.  Competent authorities shall perform controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products as well as animals and foodstuff regularly, on a risk-basis, in order to verify that the requirements as set out in this Regulation are complied with.
Amendment 271
Proposal for a regulation
Article 125 – paragraph 1 a (new)
1a.  The Commission shall ensure a harmonised approach to inspections and controls of veterinary medicines throughout the Union.
Amendment 272
Proposal for a regulation
Article 125 – paragraph 1 b (new)
1b.  To combat fraud, the competent authorities shall establish a plan for spot checks on veterinary practices and herds to verify that medicinal products held comply with quality standards.
Amendment 273
Proposal for a regulation
Article 125 – paragraph 4 – subparagraph 2
If necessary, the inspections may be carried out unannounced.
All inspections shall be carried out unannounced.
Amendment 274
Proposal for a regulation
Article 125 – paragraph 4 a (new)
4a.  Inspections may also be carried out on the premises of manufacturers of active substances used as starting materials for veterinary medicinal products where there are grounds for suspecting non-compliance with good manufacturing practices.
Amendment 275
Proposal for a regulation
Article 125 – paragraph 6
6.  Inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities.
6.  Inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities. A summary of the inspection results shall be made publicly available.
Amendment 276
Proposal for a regulation
Article 128 – paragraph 3 a (new)
3a.  The Agency and the Commission shall ensure a harmonised approach to veterinary medicine inspections.
Amendment 277
Proposal for a regulation
Article 132 a (new)
Article 132a
Suspending and withdrawing wholesale distribution authorisations
In cases of non-compliance with the requirements laid down in Articles 104, 105 and 106, the competent authority may:
(a)  suspend the wholesale distribution of the veterinary medicinal products;
(b)  suspend the authorisation for wholesale distribution of a category of veterinary medicinal products;
(c)  withdraw the authorisation for wholesale distribution of a category, or all categories, of veterinary medicinal products.
Amendment 279
Proposal for a regulation
Article 136 – paragraph 1
1.  Member States shall designate the competent authorities to carry out tasks under this Regulation.
1.  Member States shall designate the competent authorities to carry out tasks under this Regulation. The competent authorities shall, inter alia, be responsible for providing the scientific expertise for assessment of all applications under this Regulation.
Amendment 280
Proposal for a regulation
Article 136 – paragraph 1 a (new)
1a.  The management of funds intended for activities connected with requirements provided under this Regulation, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities in order to guarantee the independence of these authorities.
Amendment 281
Proposal for a regulation
Article 136 – paragraph 2
2.  The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States necessary and useful support to this end. Competent authorities shall communicate the appropriate information to each other, particularly regarding compliance with the requirements for the manufacturing and wholesale distribution authorisations, for the certificates of good manufacturing practice or for marketing authorisations.
2.  The competent authorities shall cooperate with each other and other concerned authorities in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States necessary and useful support to this end. Competent authorities shall communicate the appropriate information to each other and other concerned authorities, particularly regarding compliance with the requirements for the manufacturing and wholesale distribution authorisations, for the certificates of good manufacturing practice or for marketing authorisations.
Amendment 305
Proposal for a regulation
Article 140 – paragraph 1 a (new)
1a.  All members, alternate members and accompanying experts shall provide a publicly accessible declaration of interest.
Amendment 282
Proposal for a regulation
Article 140 – paragraph 7
7.  The Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates.
7.  The Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. The co-opted members may act as rapporteurs.
Amendment 283
Proposal for a regulation
Article 141 – paragraph 1 – point h a (new)
(ha)  tackle the contribution of farming practices to the development of antimicrobial resistance, by building on the existing action plans of the Commission and Member States, specifically by developing and implementing strategies to:
–  reduce overall use,
–  reduce the use of antimicrobials that are critically important for human use, and
–  end routine prophylactic use.
That work shall be laid out in a plan submitted by the Committee to the Commission no later than two years after the adoption of this Regulation. That plan shall contain targets for the reductions in use and a timetable for achieving these reductions.
Amendment 284
Proposal for a regulation
Article 144 – paragraph 1 – point b
(b)  examine questions concerning pharmacovigilance of veterinary medicinal products authorised in Member States;
deleted
Amendment 285
Proposal for a regulation
Annex 2 – part 1 – point 1.1 – paragraph 7
Experiments on animals other than clinical trials shall be conducted in accordance with Directive 2010/63/EU.
Member States shall ensure that all experiments on animals shall be conducted in accordance with Directive 2010/63/EU. As specified in Directive 2010/63/EU, it shall be necessary to replace, reduce or refine testing on vertebrate animals. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved.
Amendment 286
Proposal for a regulation
Annex 2 – part 1 – point 1.3 – subpoint 1.3.1 – paragraph 1 – point e
(e)  the potential risks relating to the development of antimicrobial resistance.
(e)  the potential risks relating to the development of antimicrobial resistance during production and use.
Amendment 287
Proposal for a regulation
Annex 2 – part 1 – point 1.3 – subpoint 1.3.1 – paragraph 7 – introductory part
This assessment shall normally be conducted in two phases. The first phase of the assessment shall always be performed and the second phase shall be performed if necessary. The details of the assessment shall be provided in accordance with accepted guidance. The assessment shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items:
This assessment shall normally be conducted in two phases. All available data of sufficient reliability and relevance shall be considered, including information gained during the drug discovery process. The first phase of the assessment shall always be performed and the second phase shall be performed if necessary. The details of the assessment shall be provided in accordance with accepted guidance. The assessment shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items:
Amendment 288
Proposal for a regulation
Annex 2 – part 1 – point 1.3 – subpoint 1.3.1 – paragraph 8
In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with established guidance. The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites, shall be taken into consideration.
In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with established guidance, and taking into account the pharmacological effect of the product as well as any relevant side effects. The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites, shall be taken into consideration.
Amendment 289
Proposal for a regulation
Annex 2 – part 1 – point 1.3 – subpoint 1.3.1 – paragraph 8 a (new)
The environmental risk assessment shall be updated when new information becomes available that would change the estimation of the risk.

(1)The matter was referred back to the committee responsible for reconsideration pursuant to Rule 61(2), second subparagraph (A8-0046/2016).


Authorisation and supervision of veterinary medicinal products ***I
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Amendments adopted by the European Parliament on 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (COM(2014)0557 – C8-0142/2014 – 2014/0256(COD))(1)
P8_TA(2016)0088A8-0035/2016

(Ordinary legislative procedure: first reading)

Text proposed by the Commission   Amendment
Amendment 1
Proposal for a regulation
Recital 1
(1)  Directive 2001/82/EC of the European Parliament and of the Council5 and Regulation (EC) 726/2004 of the European Parliament and of the Council6 constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No […] of the European Parliament and of the Council7 laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted.
(1)  Directive 2001/82/EC of the European Parliament and of the Council5 and Regulation (EC) No 726/2004 of the European Parliament and of the Council6 constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No […] of the European Parliament and of the Council7 laying down procedures for the authorisation and supervision of veterinary medicinal products has been adopted, with a view to harmonisation of the laws of the Member States.
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5 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
5 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
6 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
6 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
7 Regulation … of the European Parliament and of the Council of … … … on veterinary medicinal products (OJ L …, … … …, p. …).
7 Regulation … of the European Parliament and of the Council of … … … on veterinary medicinal products (OJ L …, … … …, p. …).
Amendment 2
Proposal for a regulation
Recital 4
(4)  As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex to technical and scientific progress, determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.
(4)  As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex with regard to technical and scientific progress so as to facilitate the placing on the market of new medicinal products, determining the situations in which post-authorisation efficacy studies may be required, laying down provisions and requirements for granting marketing authorisations subject to certain specific obligations, establishing procedures for the examination of applications for variations to the terms of marketing authorisations and for the examination of applications for the transfer of marketing authorisations and laying down the procedure for investigating the infringements and the imposition of fines or periodic penalty payments to the holders of marketing authorisations granted under this Regulation, the maximum amounts of these penalties as well as the conditions and methods for their collection.
Amendment 3
Proposal for a regulation
Recital 6
(6)  In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council1.
(6)  In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human and veterinary use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council1.
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1 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
1 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 4
Proposal for a regulation
Recital 6 a (new)
(6a)  Advances in alternative testing require the creation of a regulatory framework capable of adapting to new developments in this field, including for example the recognition and evaluation of modeling and simulation technologies.
Amendment 5
Proposal for a regulation
Recital 6 b (new)
(6b)  Animal testing currently plays a key regulatory and scientific role in the development of medicines, and in relation to the replacement, reduction or refinement of animal testing is subject to Directive 2010/63/EU.
Amendment 6
Proposal for a regulation
Recital 6 c (new)
(6c)  In the interest of public health, authorisation decisions adopted under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy.
Amendment 7
Proposal for a regulation
Recital 6 d (new)
(6d)  Provision should be made for the quality, safety and efficacy criteria laid down in Directives 2001/83/EC and 2001/82/EC to apply to medicinal products authorised by the Union and it should be possible to assess the risk-benefit balance of all medicinal products when they are placed on the market, at the time of the renewal of the authorisation and at any other time the competent authority deems appropriate.
Amendment 8
Proposal for a regulation
Recital 6 e (new)
(6e)  Member States have developed an evaluation of the comparative efficacy of medicinal products aimed at positioning a new medicinal product with respect to those that already exist in the same therapeutic class. Similarly, the Council, in its conclusions on medicinal products and public health, adopted on 29 June 2000, emphasised the importance of identifying medicinal products that presented an added therapeutic value. That evaluation should be conducted in the context of the marketing authorisation.
Amendment 9
Proposal for a regulation
Article 1 – point 2 a (new)
Regulation (EC) No 726/2004
Article 1 – paragraph 2
(2a)  In Article 1, the second paragraph is replaced by the following:
The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions. In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies.
"The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions, provided that Member States take into due consideration the reference comparative evaluation of human medicinal product as referred to in Article 9(4). In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies."
Amendment 10
Proposal for a regulation
Article 1 – point 3
Regulation (EC) No 726/2004
Article 2 – paragraph 1
The definitions laid down in Article 1 of Directive 2001/83/EC shall apply for the purposes of this Regulation.
The definitions laid down in Article 1 of Directive 2001/83/EC and, as appropriate, in Article 4 of Regulation (EU) .../... of the European Parliament and of the Council1a shall apply for the purposes of this Regulation.
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1a Regulation (EU) .../... of the European Parliament and of the Council of ... on veterinary medicinal products (OJ L ...) [2014/0257(COD)].
Amendment 11
Proposal for a regulation
Article 1 – point 4 – point a
Regulation (EC) No 726/2004
Article 3 – paragraph 2 – point b
(a)  in paragraph 2, point (b) is replaced by the following:
(a)  paragraph 2 is replaced by the following:
"2. Any medicinal product not appearing in the Annex may be granted a marketing authorisation by the Union in accordance with this Regulation, if:
(a)  the medicinal product contains a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Union; or
(b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients health at Union level.’
(b)  the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients health at Union level."
Amendment 12
Proposal for a regulation
Article 1 – point 5 a (new)
Regulation (EC) No 726/2004
Article 6 – paragraphs 4 a and 4 b (new)
(5a)  In Article 6, the following paragraphs are added:
"4a. The Agency shall verify that applicants for marketing authorisations have acted in accordance with Article 13(1) of Directive 2010/63/EU.
4b.   The Agency shall develop a framework for the regulatory acceptance of alternative models and shall take into consideration the opportunities presented by these new concepts which aim at providing for more predictive medicines. These concepts may be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways."
Amendment 13
Proposal for a regulation
Article 1 – point 5 b (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point d a (new)
(5b)  In Article 9(4), the following point is inserted:
"(da) the comparative evaluation of the human medicinal product;"
Amendment 14
Proposal for a regulation
Article 1 – point 10 a (new)
Regulation (EC) No 726/2004
Article 55 – paragraph 2
(10a)  In Article 55, the second paragraph is replaced by the following:
The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products.
"The Agency shall be responsible for coordinating the scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products for human use, as provided for in this Regulation, and for veterinary use, as provided for in Regulation (EU) .../...+."
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+ 2014/0257(COD).
Amendment 15
Proposal for a regulation
Article 1 – point 10 b (new)
Regulation (EC) No 726/2004
Article 56 – paragraph 2 – subparagraph 1
(10b)  In Article 56(2), the first subparagraph is replaced by the following:
2.  The committees referred to in paragraph 1(a) to (da) may each establish standing and temporary working parties. The committees referred to in paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Articles 5 and 30.
"2. The committees referred to in paragraph 1(a) to (da) may each establish standing and temporary working parties. The committees referred to in paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Article 5 of this Regulation and in Article 141(1) of Regulation (EU) .../...+."
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+ 2014/0257(COD).
Amendment 16
Proposal for a regulation
Article 1 – point 10 c (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – subparagraph 1
(10c)  In Article 57(1), the first subparagraph is replaced by the following:
1.  The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products.
"1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety, efficacy and comparative assessment of medicinal products for human or veterinary use which is referred to it in accordance with the provisions of Community legislation relating to medicinal products."
Amendment 17
Proposal for a regulation
Article 1 – point 10 d (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – subparagraph 2 – point t a (new)
(10d)  In the second subparagraph of Article 57(1), the following point is added:
"(ta) cooperating with the Health Technology Assessment Network, with health technology assessment bodies and other national authorities involved in market access, in particular to facilitate their assessment and reduce disparities in patients’ access to health technologies."
Amendment 18
Proposal for a regulation
Article 1 – point 10 e (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – subparagraph 2 – point t b (new)
(10e)  In the second subparagraph of Article 57(1), the following point is added:
"(tb) in cooperation with EFSA and ECDC annually publishing a report on the use of antimicrobials for human and veterinary medicine as well as the current situation on the antimicrobial resistance in the Union."
Amendment 19
Proposal for a regulation
Article 1 – point 11
Regulation (EC) No 726/2004
Article 57 – paragraph 2 – subparagraph 1
2.  The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product authorised in the Union.
2.  The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product for human use authorised in the Union.
Amendment 20
Proposal for a regulation
Article 1 – point 13
Regulation (EC) No 726/2004
Article 61 – paragraph 1 – subparagraph 1
1.  Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human.
1.  Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human Use.
Amendment 21
Proposal for a regulation
Article 1 – point 13 a (new)
Regulation (EC) No 726/2004
Article 62 – paragraph 2
(13a)  Article 62(2) is replaced by the following:
2.  Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products for human use who, taking into account Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the Committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise.
"2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who, taking into account Article 63(2), would be available to serve on working parties or scientific advisory groups of any of the Committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise.
The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and other experts appointed directly by the Agency. The list shall be updated.
The Agency shall keep an up-to-date list of accredited experts. The list shall include the experts referred to in the first subparagraph and any other experts appointed by the Agency or the Commission. The list shall be updated."
Amendment 22
Proposal for a regulation
Article 1 – point 14
Regulation (EC) No 726/2004
Article 62
(14)  in Article 62(3), the second subparagraph is deleted;
(14)   Article 62 is amended as follows:
(a)  in paragraph 1, the third subparagraph is replaced by the following:
"When consulting the scientific advisory groups referred to in Article 56(2), the Committee shall forward to them the draft assessment report(s) drawn up by the rapporteur or the co-rapporteur. The opinion issued by the scientific advisory group shall be forwarded to the chairman of the relevant Committee in such a way as to ensure that the deadlines laid down in Article 6(3) of this Regulation and in Article 40(3) of Regulation (EU) .../...+ are met.";
(b)  in paragraph 1, the fourth subparagraph is replaced by the following:
"The substance of the opinion shall be included in the assessment report published in accordance with Article 13(3) of this Regulation and Article 40(11) of Regulation (EU) .../...+.";
_____________
+ 2014/0257(COD).
Amendment 23
Proposal for a regulation
Article 1 – point 14 a (new)
Regulation (EC) No 726/2004
Article 64 – paragraph 1
(14a)  Article 64(1) is replaced by the following:
1.  The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post.
"1. The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once by the Management Board, in consultation with the Commission. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post."
Amendment 24
Proposal for a regulation
Article 1 – point 14 b (new)
Regulation (EC) No 726/2004
Article 66 – points a and j
(14b)  Article 66 is amended as follows:
(a)  point (a) is replaced by the following:
(a)  adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use and the Committee for Medicinal Products for Veterinary Use (Article 61);
"(a) adopt an opinion on the rules of procedures of the Committee for Medicinal Products for Human Use (Article 61 of this Regulation) and the Committee for Medicinal Products for Veterinary Use (Article 140 of Regulation (EU) ..../...+);";
(b)  point (j) is deleted.
_____________
+ 2014/0257(COD).
Amendment 25
Proposal for a regulation
Article 1 – point 15
Regulation (EC) No 726/2004
Article 67 – paragraph 3 – subparagraph 1
(15)  the first subparagraph of Article 67(3) is replaced by the following:
(15)  Article 67(3) is replaced by the following:
‘The Agency’s revenue shall consist of a contribution from the Union, fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC and charges for other services provided by the Agency.’
"The Agency’s revenue shall consist of:
(a)   a contribution from the Union;
(b)  a contribution from any European third country with which the Union has concluded agreements;
(c)  the fees paid by undertakings for obtaining and maintaining Union marketing authorisations for human and veterinary medicinal products and for other services provided by the Agency, as provided for in this Regulation and in Regulation (EU) .../...+ , or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC;
(d)   charges for any other services provided by the Agency; and
(e)  other sources of income, including any ad-hoc grants within the scope of Title VI of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council1a.
The European Parliament and the Council (‘the budgetary authority’) shall re-examine, when necessary, the level of the Union contribution, referred to in point (a) of the first subparagraph, on the basis of an evaluation of needs and by taking account of the level of fees."
________________
+ 2014/0257(COD).
1a Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).
Amendment 26
Proposal for a regulation
Article 1 – point 15 a (new)
Regulation (EC) No 726/2004
Article 67 – paragraph 3 – subparagraph 1 a (new)
(15a)  In Article 67(3), the following subparagraph is inserted after the first subparagraph:
"In order to safeguard fluctuations in fee revenue, any positive budget outturn of a financial year (N) shall be set aside as assigned revenue and serve as a reserve in the event that actual fee revenue be below budgeted appropriations. The total amount of such a safeguard fund shall not exceed the Agency's appropriations for the fee revenue of the past year."
Amendment 27
Proposal for a regulation
Article 1 – point 15 b (new)
Regulation (EC) No 726/2004
Article 67 – paragraph 6 – subparagraph 1 a (new)
(15b)  In Article 67(6), the following subparagraph is added:
"The draft establishment plan shall contain the number of staff required by the Agency to provide the services financed through fees and the number of staff financed by the Union budget."
Amendment 28
Proposal for a regulation
Article 1 – point 15 c (new)
Regulation (EC) No 726/2004
Article 67 – paragraph 8
(15c)  Article 67(8) is replaced by the following:
8.  On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty.
"8. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan concerning the staff financed by the Union budget and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty."
Amendment 29
Proposal for a regulation
Article 1 – point 15 d (new)
Regulation (EC) No 726/2004
Article 67 – paragraph 9 – subparagraph 2
(15d)  In Article 67(9), the second subparagraph is replaced by the following:
The budgetary authority shall adopt the establishment plan for the Agency.
"The budgetary authority shall adopt the establishment plan for the staff financed by the Union budget for the Agency."
Amendment 30
Proposal for a regulation
Article 1 – point 15 e (new)
Regulation (EC) No 726/2004
Article 68
(15e)  Article 68 is replaced by the following:
1.  The Executive Director shall implement the budget of the Agency.
"1. The Executive Director shall implement the budget of the Agency.
2.  By 1 March at the latest following each financial year, the Agency's accounting officer shall communicate the provisional accounts to the Commission's accounting officer together with a report on the budgetary and financial management for that financial year. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of the Financial Regulation applicable to the general budget of the European Communities(19) (hereinafter referred to as the "general Financial Regulation").
2.  By 1 March of the following financial year, the Agency's accounting officer shall send the provisional accounts to the Commission's Accounting Officer and to the Court of Auditors.
3.  By 31 March at the latest following each financial year, the Commission's accounting officer shall submit the Agency's provisional accounts to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report on the budgetary and financial management for the financial year shall also be forwarded to the European Parliament and the Council.
3.  By 31 March of the following financial year, the Executive Director shall send the report on the budgetary and financial management to the European Parliament, the Commission, the Council and the Court of Auditors.
4.  On receipt of the Court of Auditors' observations on the Agency's provisional accounts, pursuant to Article 129 of the general Financial Regulation, the Executive Director shall draw up the Agency's final accounts under his own responsibility and submit them to the Management Board for an opinion.
4.   By 31 March of the following financial year, the Commission's accounting officer shall send the Agency's provisional accounts, consolidated with the Commission's provisional accounts, to the Court of Auditors.
On receipt of the Court of Auditors' observations on the Agency's provisional accounts pursuant to Article 148 of the Financial Regulation applicable to the general budget of the Union, the accounting officer shall draw up the Agency's final accounts and the Executive Director shall submit them to the Management Board for an opinion.
5.  The Management Board of the Agency shall deliver an opinion on the Agency's final accounts.
5.  The Management Board shall deliver an opinion on the Agency's final accounts.
6.  The Executive Director shall, by 1 July at the latest following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Management Board's opinion.
6.  The accounting officer shall, by 1 July following each financial year, send the final accounts to the European Parliament, the Council, the accounting officer of the Commission and the Court of Auditors, together with the Management Board's opinion.
7.  The final accounts shall be published.
7.  The final accounts shall be published in the Official Journal of the European Union by 15 November of the following year.
8.  The Agency's Executive Director shall send the Court of Auditors a reply to its observations by 30 September at the latest. He shall also send this reply to the Management Board.
8.  The Executive Director shall send to the Court of Auditors a reply to its observations by 30 September.
9.  The Executive Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for the financial year in question, as laid down in Article 146(3) of the general Financial Regulation.
9.  The Executive Director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for the financial year in question, in accordance with Article 165(3) of the Financial Regulation applicable to the general budget of the Union.
10.  The European Parliament, on a recommendation from the Council acting by a qualified majority, shall, before 30 April of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.
10.   On a recommendation from the Council, the European Parliament shall, before 15 May of year N + 2, give a discharge to the Executive Director in respect of the implementation of the budget for year N.
11.  The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities(20), unless specifically required for the Agency's operation and with the Commission's prior consent.
11.  The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They shall not depart from Commission Delegated Regulation (EU) No 1271/2013 unless specifically required for the Agency's operation and with the Commission's prior consent."
Amendment 31
Proposal for a regulation
Article 1 – point 16
Regulation (EC) No 726/2004
Article 70
(16)  Article 70 is replaced by the following:
deleted
‘Article 70
1.  The Commission shall, on the basis of the principles set out in paragraph 2, adopt implementing acts in accordance with the procedure laid down in Article 87(2) specifying:
(a)  the structure and the level of the fees and charges referred to in Article 67(3);
(b)  the services for which charges may be collected;
(c)  the conditions under which small and medium-sized enterprises may pay reduced fees, defer payment of fees or receive administrative assistance;
(d)  the rules defining the remuneration for work carried out by the member of the relevant committee or the coordination group who acts as a rapporteur; and
(e)  the conditions for payment and remuneration.
The fees shall be set at such a level as to avoid a deficit or a significant accumulation of surplus in the budget of the Agency and be revised when this is not the case.
2.  When adopting the implementing acts referred to in paragraph 1, the Commission shall take the following into account:
(a)  fees shall be set at such a level as to ensure that the revenue derived from them is, in principle, sufficient to cover the costs of the services delivered and shall not exceed what is necessary to cover the costs;
(b)  the level of the fees shall take into account the results of a transparent and objective evaluation of the costs of the Agency and the costs of the tasks carried out by the national competent authorities;
(c)  the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases;
(d)  on public health grounds the fee may be totally or partially waived for a particular category of medicinal products;
(e)  the structure and amount of fees shall take into account whether information has been submitted jointly or separately;
(f)  under exceptional and duly justified circumstances and upon acceptance by the Agency, the whole fee or part of it may be waived;
(g)  the remuneration for the work of the rapporteur shall be paid in principle to the national competent authority employing the rapporteur or, where the rapporteur is not employed by the national competent authority, the Member State that nominated him;
(h)  the time of payment for the fees and charges shall be fixed taking due account of the time limits under the provisions of this Regulation and Regulation (EU) No […]’;
Amendment 32
Proposal for a regulation
Article 1 – point 16 a (new)
Regulation (EC) No 726/2004
Article 70 a (new)
(16a)  The following Article is inserted:
"Article 70a
With regard to the level and the structure of the fees referred to in Article 67(3) of this Regulation, Regulation (EC) No 297/95 and Regulation (EU) No 658/2014 shall be applicable until an amendment of Regulation (EC) No 297/95 or any other relevant provisions on fees are adopted and become applicable."
Amendment 33
Proposal for a regulation
Article 1 – point 16 b (new)
Regulation (EC) No 726/2004
Article 82 – paragraph 3
(16b)  Article 82(3) is replaced by the following:
3.  Without prejudice to the unique, Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4) and in points (a) to (e) of Article 34(4), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation.
"3. Without prejudice to the unique, Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation."
Amendment 34
Proposal for a regulation
Article 1 – point 18
Regulation (EC) No 726/2004
Article 86
At least every ten years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, and in Chapter 4 of Title III of Directive 2001/83/EC.
At least every five years, the Commission shall publish a general report on the experience acquired as a result of the operation of the procedures laid down in this Regulation, in Chapter 4 of Title III of Directive 2001/83/EC and in Regulation (EU) .../...+ .
______________________
+ 2014/0257(COD).
Amendment 35
Proposal for a regulation
Article 1 – point 20
Regulation (EC) No 726/2004
Article 87b – paragraph 2
2.  The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
2.  The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for a period of five years from the date of entry into force of this Regulation. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

(1)The matter was referred back to the committee responsible for reconsideration pursuant to Rule 61(2), second subparagraph (A8-0035/2016).


Towards a thriving data-driven economy
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European Parliament resolution of 10 March 2016 on ‘Towards a thriving data-driven economy’ (2015/2612(RSP))
P8_TA(2016)0089B8-0308/2016

The European Parliament,

–  having regard to the Commission communication of 2 July 2014 entitled ‘Towards a thriving data-driven economy’ (COM(2014)0442),

–  having regard to the question to the Commission on ‘Towards a thriving data-driven economy’ (O-000021/2016 – B8‑0116/2016),

–  having regard to the motion for a resolution of the Committee on Industry, Research and Energy,

–  having regard to Article 8 of the EU Charter of Fundamental Rights and Article 16 of the Treaty on the Functioning of the European Union,

–  having regard to its resolution of 10 December 2013 on unleashing the potential of cloud computing in Europe(1),

–  having regard to the Commission communication of 6 May 2015 entitled ‘A Digital Single Market Strategy for Europe’ (COM(2015)0192),

–  having regard to Rules 128(5) and 123(2) of its Rules of Procedure,

A.  whereas the growth rate in the Big Data market until 2017 will be six times faster than in the overall ICT market and will reach an overall total of EUR 50 billion, according to the International Data Corporation’s Worldwide Big Data Technology and Services Forecast for 2013-2017, which may result in 3,75 million new jobs by 2017 according to the Big Data Value Public-Private Partnership;

B.  whereas the volume of data is growing at an unprecedented pace, so that there will be 16 trillion gigabytes of data by 2020, which corresponds to an annual growth rate of 236 % in data generation;

C.  whereas decisions based on knowledge generated by Big Data may bring about a sizeable increase in productivity and competitiveness, and whereas the benefits of a data-driven economy will bring 1,9 % in additional GDP growth by 2020;

D.  whereas the development of Big Data is an integral part of a new digital market and should ensure the development of innovative and competitive business models while conforming to the EU framework on data protection, as Big Data can entail significant risks and challenges, particularly as regards fundamental rights (including privacy and data protection);

E.  whereas a future thriving data-driven economy can represent an opportunity for growth and employment, including by enabling new business models and services and improved productivity; whereas a good balance has to be achieved in order to create the right framework for economic growth, so as to maintain trust while safeguarding and upholding consumer rights through effective monitoring, assessment and appropriate responses, if necessary by legislative means;

F.  whereas Big Data also brings opportunities for consumers (e.g. convenience, efficiency and savings), businesses (industry 4.0) and government (e-government), and in respect of housing (smart cities), science, medicine (Mhealth), disaster response and fighting crime;

The role of the data-driven economy within the Digital Union strategy

1.  Expects the benefits of a data-driven economy at national and European level to have an impact on society and on all types of enterprise in the value chain; sees the creation of a data-driven economy as being at the core of the Digital Single Market strategy, and appreciates its potential to help Europe regain competitiveness in advanced sectors and to accelerate Europe’s economic recovery, growth investment and innovation across all sectors, which can only be achieved if there is the right business environment and the means to activate the digital transformation, and if these technologies comply with the EU legal framework on data protection so that the associated risks and challenges – particularly with regard to fundamental rights, and especially privacy and data protection – are addressed;

2.  Stresses that the data-driven economy requires advanced skills and is expected to create a significant number of jobs in Europe in the coming years;

3.  Recognises the social and economic benefits associated with the integrated use of data in all sectors of the European economy and all fields of European research, and underlines the importance of transparency with regard to the value and use of collected data, management rules and the ways in which the data are collected and processed; emphasises that individuals should have up-to-date, meaningful rights of access to information about data processing; stresses the need, in this context, to collect accurate statistics on the level of awareness among citizens, businesses and public administrations; stresses that the digitisation of the economy is an important driver of development in the area of Big Data, and therefore requires a horizontal approach in order for the data economy to grow;

4.  Believes that data represent a valuable asset for companies, the value of which could be significantly increased through the development of innovative and smart ways of allowing the integration of company-owned data with open data; asks that initiatives be launched to raise SMEs’ awareness of the value of their data and how they can be used to develop new business models in order to foster growth and to establish SMEs as a main player in Big Data;

5.  Stresses that the processing of certain kinds of data, in particular personal data, falls under the scope of EU data protection law; urges, in this connection, the swift adoption of the Data Protection Package;

6.  Points out that data protection and opportunities arising from the integrated use of data are not mutually exclusive, as the smart use of opportunities can ensure compatibility with data protection; considers that ensuring trust in these technologies should be at the heart of both public policy and business models, as a lack of trust can greatly damage growth and innovation in the digital sector; believes that there is an essential need for a future-proof and uniform legal framework for data protection in order to foster growth and innovation, and acknowledges the open and global character of the internet; recognises that data protection law is technologically neutral and already applies fully to Big Data activities operating in the EU, and must therefore be complied with fully; urges that public policy include privacy by design and privacy by default in the data generation and analysis cycle, while seizing any opportunity to foster the development of the potential of Big Data;

7.  Considers it essential to develop a regulatory framework to tackle the economic, technological, social and cultural challenges of a data-driven economy, such as access to, and control and ownership of, data, in particular public data; considers that security and data protection are a fundamental basis for data-driven industry growth; stresses that finding a synergy between Big Data, data protection, data security and open data is the basis for a new digital start in Europe; asks that the following challenges be addressed: data ownership, possession, management, access and security, interoperability, data limitation and storage, restrictions on the use and reuse of data across Europe, innovative interrupters in intellectual capital, accessibility and infrastructure, transparent transportation rules, cross-border mechanisms and, where applicable, the creation and dissemination of, and access to, open data, and its availability for public administrations and service providers;

Investing in a data-driven economy (infrastructure and R&D)

8.  Notes that a data-driven economy depends on a wider ICT ecosystem to succeed, including the Internet of Things (IoT) for sourcing data, high-speed broadband networks for transporting them and cloud computing for processing them, as well as skilled employees, access to data, and interoperability; points out that this sector requires enormous investments in cloud development, super-computing and high-speed broadband, which are prerequisites for a successful digital economy; calls for a better regulatory framework and environment that target both the private and public sectors; recalls that private-sector investment in network infrastructure should remain essential; encourages, in this connection, the Commission and the Member States to stimulate investments in network infrastructure through a positive regulatory framework and to continue to support broadband infrastructure through existing programmes such as the Connecting Europe Facility, the European Fund for Strategic Investments (EFSI) and the Cohesion Fund, but only in areas with identified market failures;

9.  Expresses concern that the digital divide, insufficient investments and a lack of technical standardisation and future-proof data protection legislation could cause Europe to trail behind technologically and economically in the development of a data‑driven economy;

10.  Acknowledges the importance of interoperability and standards in boosting competitiveness in the ICT sector, and of a proactive role for the Commission in mandating standardising bodies; asks the Commission to develop a Big Data Standard strategy for identifying gaps in standards in the European Big Data industry, including as regards SMEs and key European sectors; supports the development of market‑driven, voluntary, technology-neutral, transparent, internationally compatible and market-relevant standards;

11.  Considers that the ‘ISA2’ programme offers an opportunity to develop interoperability standards for Big Data management within public administrations and in their dealings with businesses and citizens;

12.  Welcomes the Commission proposal to develop an initiative on the free movement of data; welcomes the announcement of a European ‘Free Flow of Data’ initiative, which needs to remove existing barriers to the single market for data; calls on the Commission to carry out a broad and transparent review of the creation of a data-driven economy aimed at anticipating needs as regards the necessary technologies and removing barriers to innovation in Europe; asks that this initiative address the following challenges: data security, interoperability, data ownership, limitation and storage, restrictions on the use and reuse of data across Europe, transparent transportation rules, cross-border mechanisms, and open data exchange between administrations, businesses and civil society;

13.  Notes that Big Data depends on a wider ICT ecosystem to succeed, including the IoT for sourcing data, broadband networks for transporting them and cloud computing for processing them;

14.  Believes that the EU must facilitate procedures for allocating grants and increase funding for research and innovation relating to the integrated use of data, digital innovation and market development in areas identified as bringing added value for citizens, society and the economy and effectively fostering the entry into the market of innovative products and services; considers, in this connection, that a joint European road map for the Member States and the EU for the medium to long term needs to be drawn up and combined with a stable funding framework making it possible to progress towards e-research; believes that free software can play an important role in achieving these aims;

15.  Recognises the Commission’s initiatives to create public-private partnerships (PPPs) based on the development of the data-driven economy, as cooperation between the public and private sectors is crucial for identifying barriers to the development of the necessary technologies; recognises that the Commission and the European data industry have committed to investing EUR 2,5 billion in a PPP to strengthen the data sector and put Europe at the forefront of the global data race by maximising the potential of the digital economy; points out that access to open data portals and research-related e-infrastructure is a possible way to reduce the disadvantages that researchers and SMEs based in remote regions may face;

16.  Welcomes the creation of innovation spaces – areas where a pre-existing concentration of businesses and skills is present and can be increased, allowing experimentation with data-related technologies within innovative clusters which produce ecosystems and cross‑sector industrial platform projects for achieving the networking of the real and digital economy; emphasises that these spaces should serve as business incubators, educating businesses on how to translate the use of data into business opportunities and supporting the growth and internationalisation of SMEs and innovative start-ups; calls for closer partnerships to be established between businesses and universities and research centres in order to foster Big Data innovation; points out, in this connection, the investment made in initiatives such as the Grand Coalition for Digital Jobs and the European e-Skills Week;

17.  Encourages the Commission and the Member States to put in place a modern and future-proof regulatory framework that stimulates and furthers investments in the network infrastructure necessary for the future requirements of the digital connected economy, to adopt policies that enable the IoT to flourish, and to secure adequate data capacities and speeds, expanding mobile technology and encouraging IPv6 deployment;

18.  Stresses that greater coordination is needed in order to apply openness to standards and interoperability in systems and collaboration platforms;

19.  Asks the Commission to adopt policies that remove excessive barriers in innovative sectors, to incentivise investments in research and development and European standardisation and to address the current problem of infringements of standard‑essential patents; considers it necessary to strike an appropriate balance between those who invest in research and innovation aimed at developing such essential patents and those who benefit from the existence of those patents; stresses that standard‑essential patents are an important element of standardisation and, for a significant number of European ICT undertakings, a component of their business model; calls for measures to preserve a high-quality standardisation system that can attract the best technology contributions, deliver interoperable and innovative digital services and applications and enable patent licensing agreements on fair, reasonable and non-discriminatory (FRAND) terms; considers it necessary, however, to make further efforts to facilitate access and remove digital barriers for people with disabilities;

20.  Believes that, in order to reap the greatest benefits from innovation in the field of Big Data, Horizon 2020’s principle of ‘responsible innovation’ should guide the identification of opportunities to accelerate market entrance, especially for SMEs;

21.  Asks the Commission to ensure investment in infrastructure and the future-proof development of cloud services in Europe by improving legal certainty about the obligations and responsibilities of each party, guaranteeing the fulfilment of common security and data protection measures, allowing data to cross borders and fostering the right business environment for an efficient, open and global market to develop;

Creating a data-driven economy for the EU market

22.  Is of the opinion that Big Data has the potential to boost economic productivity and improve consumer and government services; recognises that Big Data may bring more business opportunities and increased availability of knowledge and capital, as long as governments and stakeholders work together in a constructive manner; stresses, however, that the current fragmented single market is undermining the development of a data‑driven economy, Big Data, cloud computing, the IoT and other data-driven technologies;

23.  Believes that the major technological impediments to the development of a data-driven economy include the lack of interoperability and of a common interface framework to facilitate sensor and machine data communication and communication between the virtual and physical world, the insufficient availability of open data and the lack of market conditions enabling entrepreneurs to innovate and grow; asks the Commission to spur shared research to address these issues;

24.  Asks the Commission to spur and promote shared research on the creation of a common interface framework in order to reduce duplicate standards and ensure technical and semantic interoperability with a view to following a standard-setting process driven by consumer and business needs;

25.  Welcomes the announcement of a European ‘Free Flow of Data’ initiative, which needs to remove existing barriers to the single market for data;

26.  Calls for a future-proof regulatory environment that adapts to the changing nature of the sector, is technology-neutral, encourages the creation of start-ups and the entry into the market of new operators, creates a level playing field and fair competition while avoiding excessive regulatory burden, and ensures full compliance with data protection and privacy standards; welcomes, in this context, the Commission’s plans to review the ePrivacy Directive; notes that regulatory action should be market-driven; believes that a level playing field should be a place which enables all operators, small and large, to invest, innovate and compete for the benefit of European end-users in terms of choice and affordability;

27.  Notes the importance of open data as high-quality raw material for the development of value-added information services and products; stresses that the data generated by public institutions and European research programmes using public funds under programmes such as Copernicus and Galileo should be available to European citizens under an open-access model and be accessible to public administrations and private businesses so that they can improve the quality of their services while respecting the intellectual property rights in force;

28.  Notes that more data should be available, with a view to a more competitive and innovative data-driven economy, and that internet platforms should therefore be encouraged to release their datasets as open data in an anonymised and aggregated form, in compliance with data protection rules;

29.  Believes that more effort is needed with regard to the anonymisation and pseudonymisation of data as a precondition for creative data innovation and a major step in lowering market entry barriers for start-ups and SMEs; believes that uptake technologies, including text and data mining, will be an important factor in deriving added value from open datasets; points out, however, that a clear distinction must be made between the processing of personal data and other kinds of data, and that technological solutions that are privacy-enhancing by design must be devised;

30.  Stresses that all the principles laid down in EU data protection law, such as fairness and lawfulness, purpose limitation, the legal basis for processing, consent, proportionality, accuracy and limited data retention periods, must be respected by Big Data providers when processing personal data; recalls, in this context, the opinion of the European Data Protection Supervisor on privacy and competitiveness in the age of Big Data;

Fostering start-ups and SMEs in the data-driven economy

31.  Recognises the need to develop a strong base of service providers, to promote the benefits and assets for the economy and society of the integrated use of data, and to foster trust in big-data-related technologies among SMEs; recognises the need to support the widespread application of Big Data services with a view to improving efficiency in various economic sectors, and to support new service providers; asks that one-stop shops be set up to help SMEs to make better use of their own and public data while adhering to EU laws on data protection;

32.  Regrets the fact that many ideas and opportunities are being lost or realised outside of Europe owing to scalability issues driven by barriers such as administrative burdens and access to finance, all of which negatively affect Europe’s competitiveness; asks that the acquisition of private capital be facilitated through the provision of the right incentives, including efforts to tackle the challenges presented by different national, administrative, regulatory and tax rules; calls for stimulation of the development of ecosystems which bring together public and private institutions providing technology and infrastructure with start-ups providing application ideas;

33.  Recalls that only 1,7 % of companies make full use of advanced digital technologies despite the benefits that digital tools can bring in all economic sectors; urges the Commission and the Member States, therefore, to launch a digital entrepreneurship strategy;

34.  Urges the Commission and the Member States to create European digital economy hubs that include the use of Big Data and other data technologies by entrepreneurs, SMEs and innovative companies and encompass researchers and the broader economy; calls on the Commission and the Member States to promote the establishment of innovation spaces and clusters in order to help develop skills, to create a competitive advantage in the area of intellectual capital and to better understand the perspectives and limitations of Big Data technology;

35.  Asks that the EU and its Member States improve their coordinated efforts within schools and educational facilities to make ICT an attractive vocational field, in particular for women and girls, and believes that such efforts should include measures to foster a more entrepreneurial mind-set and facilitate entry into Big Data entrepreneurship through the founding of new start-ups in this field, thus creating more employment opportunities; points to the importance of adopting a multidisciplinary approach to the training of professionals and team-building;

36.  Asks that initiatives be launched, and funding models recommended, which foster lifelong learning and tailored measures for all, including elderly people, and which facilitate access to education to enable professionals to widen their ICT and data processing skills, so as to increase the number of digitally skilled professionals; calls for the digital transformation of business to be given greater prominence in continuing education, and for e-leadership programmes to be drawn up ; stresses the need to facilitate the movement of skilled workers across the EU and measures to address skills shortages, including specific measures to attract talent;

37.  Supports initiatives to include coding and subjects relating to data handling in national curricula; stresses the multiple advantages of free software in education, and calls for a particular focus on ensuring that these new curricula motivate children to discover their talents and participate in data science and coding;

38.  Considers that the EU and its Member States should step up their efforts to prevent a brain drain of highly educated and skilled experts to other regions outside Europe;

39.  Calls for support for the development of front-end tools to allow casual end-users in SMEs to develop new data-driven business models;

Involving society

40.  Calls for the stimulation of initiatives to increase awareness of, and encourage public debate in Member States and at European and international level on, the benefits and value of digital technologies, particularly in relation to those groups that do not yet have access to digital technologies or are not very familiar with them; calls for initiatives to empower citizens vis-à-vis the use and value of their data, in particular as regards the development of innovative new services, and to increase awareness of the benefits and value of Big Data for society;

41.  Points out that Big Data analytics has the potential to accelerate significantly the development of innovative public services based on the use of open government data and the reuse of public-sector information; welcomes, therefore, the opportunities that digital infrastructure and the integrated use of data bring to increase popular participation and involvement by means of various forms of e-governance and e‑democracy;

42.  Urges the Commission and the Member States to speed up actions to develop e‑governance; recognises, in particular, the value of the IoT, and calls on the Commission to coordinate the Digital Single Market framework with existing Europe 2020 targets; stresses the need also to exploit fully the advantages of the shared economy and the inclusive involvement of civil society and citizens;

o
o   o

43.  Instructs its President to forward this resolution to the Council and the Commission.

(1) Texts adopted, P7_TA(2013)0535.


Situation in Eritrea
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European Parliament resolution of 10 March 2016 on the situation in Eritrea (2016/2568(RSP))
P8_TA(2016)0090RC-B8-0318/2016

The European Parliament,

–  having regard to its previous resolutions on Eritrea, in particular those of 7 February 2002(1), 18 November 2004(2) and 15 September 2011(3) on the human rights situation in the country, including the case of Dawit Isaak,

–  having regard to United Nations Security Council resolutions 751 (1992), 1882 (2009), 1907 (2009), 2023 (2011) and 2244 (2015), which extended the arms embargo on Eritrea until 15 November 2016, and to the report of 19 October 2015 of the Monitoring Group on Somalia and Eritrea,

–  having regard to the report submitted to the Human Rights Council on 19 June 2015 by the Special Rapporteur on the situation of human rights in Eritrea, Sheila B. Keetharuth,

–  having regard to the ACP-EU Partnership Agreement (the Cotonou Agreement), as revised in 2005 and 2010, to which Eritrea is a signatory,

–  having regard to Council Decision 2010/127/CFSP of 1 March 2010 concerning restrictive measures against Eritrea(4), amended by Council Decision 2010/414/CFSP of 26 July 2010(5) and further amended by Council Decision 2012/632/CFSP of 15 October 2012(6),

–  having regard to the conclusions of Scrutiny Working Group A of the Committee on Development of the European Parliament of 11 November 2015,

–  having regard to the statement by the spokesperson of the European External Action Service (EEAS) on political prisoners in Eritrea of 18 September 2014,

–  having regard to the EEAS report on the Eritrea-European Union Partnership of 2015,

–  having regard to the UN Women Country Report on the Government of the State of Eritrea of June 2014,

–  having regard to the National Indicative Programme for Eritrea under the 11th European Development Fund of 3 February 2016,

–  having regard to the statement to the media made by the UN Commission of Inquiry on Human Rights in Eritrea on 8 June 2015,

–  having regard to the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment,

–  having regard to the declarations of 23 November 2011 and 25 June 2013 by the Co‑Presidents of the ACP-EU Joint Parliamentary Assembly on the situation of human rights in Eritrea,

–  having regard to its debate of 27 May 2015 on EU development aid to Eritrea in the light of documented human rights abuses,

–  having regard to the Constitution of Eritrea adopted in 1997, which guarantees civil liberties, including freedom of religion,

–  having regard to International Labour Organisation Conventions No 29 concerning forced labour, No 105 concerning abolition of forced labour and No 87 concerning freedom of association and protection of the right to organise,

–  having regard to the African Charter on Human and Peoples’ Rights of 1981,

–  having regard to the International Covenant on Civil and Political Rights of 1966,

–  having regard to the Universal Declaration of Human Rights of 1948,

–  having regard to Rule 123(2) and (4) of its Rules of Procedure,

A.  whereas the EU has been supporting Eritrea since its independence from Ethiopia in 1993; whereas the initial promise of democracy and the rule of law following the country’s independence has been inhibited by the Government of Eritrea on the pretext of national defence and national service; whereas presidential elections planned for 1997 never took place, and whereas the constitution ratified in the same year has never been implemented; whereas the regional elections of 2009 have yet to be held; whereas even before the National Assembly was disbanded in 2002, laws were passed by government decree;

B.  whereas Eritrea’s independence from Ethiopia in 1993 created expectations within the international community and among the people of Eritrea that this would help the latter to build a country that respects human rights and is free of repression; whereas this has not happened, but instead there has been even greater repression and even more violations of human rights;

C.  whereas the report by the UN Special Rapporteur noted that Eritrea has one of the worst human rights records in the world, with routine human rights violations taking place every day and no improvement recorded in recent years; whereas many young people have fled the country to escape the repressive government and mandatory military conscription, which often starts at a very young age, whereas the statute of an 18-month period of service is often flouted, with most Eritreans serving indefinitely, and whereas such an extended mandatory military conscription inhibits the country’s potential economic growth; whereas any increase in the national service salary is meaningless as the recent devaluation of the nakfa and bank restrictions have led to a current deficiency in the country; whereas many conscripts are used as forced labour and given civilian duties; whereas the majority of those in national service remain in a situation of slavery, in which any work, job applications and the possibility of having a family life are controlled; whereas freedom of worship and conscience, freedom of the media and freedom of expression are not guaranteed;

D.  whereas the UN Commission of Inquiry on Human Rights in Eritrea has found that the violations in the areas of extrajudicial executions, torture (including sexual torture and sexual slavery), national service as a form of slavery, forced labour and the shoot-to-kill policy at the border may constitute crimes against humanity;

E.  whereas Human Rights Watch stresses that there is no freedom of religion in Eritrea; whereas the government severely harasses citizens who practise religions other than the four it recognises; whereas even in the case of recognised religions the government interferes with people’s religious practice;

F.  whereas homosexual activities are illegal in Eritrea, and the government refuses to implement anti-discrimination legislation to protect lesbian, gay, bisexual, transgender and intersex (LGBTI) persons;

G.  whereas discrimination and violence against women are present in all areas of Eritrean society; whereas women are not only at extreme risk of sexual violence within the military and in military training camps, but also in society at large, where violence against women is perpetrated in an environment of impunity; whereas an estimated 89 % of girls in Eritrea have undergone Female Genital Mutilation (FGM); whereas in March 2007 the government issued a proclamation declaring FGM a crime, prohibiting its practice and sponsoring education programmes discouraging the practice over that year; whereas women can lose their entitlement to food coupons and access to land;

H.  whereas a huge number of Eritrean people are arrested for various unjustifiable reasons such as expressing independent views or without any explicit justification, and thus for unspecified time periods; whereas detainees, including children, are held in extremely harsh conditions which in some cases amount to torture and denial of medical care; whereas female detainees are often guarded by male officers, thus increasing the risk of sexual and gender-based violence; whereas, according to the Freedom House Index (report 2015), Eritrea continues to rank among the most repressive media environments and received the lowest score possible which ranked it as the ‘worst of the worst’ and has one of the lowest internet access rates – only 1 % – in the world;

I.  whereas the statement issued in Brussels on 18 September 2014 by the spokesperson for the EEAS expressed concern about the detention of a group of 11 members of parliament and eminent members of the People’s Front for Democracy and Justice (PFDJ) since 18 September 2001 without charge, judgment or the possibility of seeing a lawyer, and about the unlawful detention since 23 September 2001 of 10 independent journalists, including Dawit Isaak, a citizen of Sweden and the only European prisoner of conscience; whereas Patriarch Abune Antonios remains incommunicado and under house arrest since January 2006;

J.  whereas there is no freedom of press, as independent media is forbidden in Eritrea, with the Reporters Without Borders World Press Freedom Index ranking Eritrea last out of the 170-180 evaluated countries for eight years in succession;

K.  whereas Eritrea is ranked 186th out of 188 countries in the Human Development Index for 2015, according to the UNDP Human Development Report of 2015;

L.  whereas according to the UN Special Rapporteur on the situation of human rights in Eritrea there are three key areas of concern, namely: the enjoyment of economic, social and cultural rights, including the right to adequate housing; smuggling and trafficking; and the increasing number of unaccompanied minors who form part of the more than 5 000 people fleeing the country on a monthly basis;

M.  whereas on 26 June 2015 hundreds of Eritrean refugees demonstrated in front of the African Union headquarters, demanding that the regional organisation push for democratic reforms in their home country; whereas protesters accused long-time Eritrean President Isaias Afewerki of being a dictator and urged the African Union to take action;

N.  whereas in November 2015 the UN warned of a severe drought in the Horn of Africa as a result of the current El Niño pattern; whereas the UN stated in December 2015 that this drought is the strongest ever recorded in the region, reducing crops by 50 % to 90 %; whereas, as a result, Eritrea is among the countries which will face the considerable challenge of ensuring food security for its population;

O.  whereas, in total contradiction with the reality of the drought, the Eritrean President has dismissed fears of a food crisis, saying that ‘the country will not face any crisis in spite of reduced agricultural output’;

P.  whereas the EU is an important donor for Eritrea in terms of development aid and assistance;

Q.  whereas the Eritrean Government unilaterally suspended aid in 2011 and does not recognise publicly its collaboration and partnership with the EU; whereas Eritrea does not facilitate the possibility of MEPs visiting Eritrea freely and without controls;

R.  whereas loss of their livelihoods encourages women and children to flee the country; whereas in 2015 Eritreans fleeing their country accounted for the fourth-largest number of people risking the perilous journey to Europe (after Syrians, Iraqis and Afghans), who run the gauntlet of pitiless people-smugglers to make the dangerous Mediterranean crossing; whereas, therefore, the situation in Eritrea directly affects Europe, since if human rights were respected and upheld in the country and people could live there without fear, Eritreans would be able to return to their homeland;

S.  whereas, according to the UN High Commissioner for Refugees, over 400 000 Eritreans, or 9 % of the total population, have fled; whereas UNHCR estimates that some 5 000 Eritreans leave the country every month, this being explained to a large degree by the persistence of severe human rights violations; whereas in 2015 in 69 % of Eritrean asylum cases refugee status was granted in the EU while an additional 27 % of applicants received subsidiary protection, illustrating the gravity of persecution in Eritrea;

T.  whereas human trafficking for ransom with severe torture practices in the Sinai is the cause of numerous killings and disappearances of Eritrean refugees who had been abducted, whilst the severely traumatised survivors have received no care or support; whereas total impunity prevails whilst those responsible have not been brought to justice; whereas particular attention should be paid to unaccompanied child victims of trafficking in human beings, as they need specific assistance and support owing to their situation of particular vulnerability;

U.  whereas on 22 February 2016 the Intergovernmental Authority on Development (IGAD) Security Sector Program (SSP) officially launched, in Addis Ababa (Ethiopia), a study report entitled ‘Human Smuggling and Trafficking on the Horn of Africa-Central Mediterranean Route’;

V.  whereas Eritrea is supportive of the Khartoum Process (an EU and African Union initiative launched on 28 November 2014 with the aim of addressing the issue of migration and human trafficking), which encompasses the implementation of concrete projects, including capacity-building for the judiciary and awareness-raising;

W.  whereas the EU initially imposed sanctions on Eritrea in March 2010 in order to implement UN Security Council Resolution 1907 (2009), and whereas these included an arms embargo, travel restrictions and asset freezes relating to persons who constitute a threat to peace and national reconciliation;

X.  whereas the EU has a vested interest in seeing Eritrea stabilised, as the current situation is forcing a sizeable part of the population to flee, and thousands of people are losing their lives as a result of criminal activities, including smuggling of migrants and trafficking in human beings;

Y.  whereas the regime extends its totalitarian grip to the Eritrean diaspora, extorting funds from its members via a 2 % tax on expatriate incomes, spying on them and targeting family members who have remained in Eritrea on the grounds of perceived wrongdoing; whereas on 28 January 2016 the Eritrean Minister for National Development and the EU Head of Delegation signed the National Indicative Programme (NIP) under the 11th European Development Fund (EDF) in Asmara, worth EUR 200 million for the next five years; whereas actions should focus on renewable energy, governance and public finance management in the energy sector in particular;

Z.  whereas on 13 November 2015 Parliament’s Committee on Development asked the Commission and the EEAS to take into consideration the conclusions sent to the EDF Committee on the draft National Indicative Programme for Eritrea, which referred to the scale and seriousness of the human rights violations committed by the Eritrean regime, the lack of reliability of this regime as a development cooperation partner, the pervasive corruption and the virtually total absence of transparency in public financial management in the country, and the risk of misusing EDF funds for migration management; whereas the Committee on Development called on the EDF Committee not to adopt the NIP pending further discussion; whereas Parliament’s position was ignored;

AA.  whereas the PFDJ has established control and surveillance over the refugee and diaspora communities through the embassies, which are involved in extortion over diaspora taxes and ‘voluntary’ contributions in exchange for services, such as ID papers, passports, birth certificates and essential documents on which refugees may depend; whereas these practices are in breach of the Vienna Convention on Diplomatic Relations; whereas leaders of the PFDJ’s youth organisation in the Netherlands have initiated legal campaigns against Dutch academics, media and government institutions, with the support of the political leadership in Asmara, presumably to silence critics of the regime; whereas the UN Special Rapporteur on the situation of human rights in Eritrea has also been subjected to threats;

1.  Notes with great concern the continuing deplorable human rights situation and the complete absence of rule of law and media freedom in Eritrea;

2.  Stresses that addressing the justice deficit, democratic governance and restoration of the rule of law must be prioritised by ending authoritarian rule by fear of arbitrary and incommunicado detention, of torture and of other human rights violations, some of which may amount to crimes against humanity;

3.  Urges the Government of Eritrea to put an end to the system of indefinite national service by demobilising the conscripts who have completed their mandatory 18 months’ service and effectively ending the practice of engaging conscripts in forced labour after that period, to provide for conscientious objection, and to end the compulsory practice of all school students spending their final year of schooling in a military training camp; calls on the Eritrean Government to ensure that no one undertakes military training before they reach 18 years of age and that no members of the population past the normal conscription age are conscripted; notes that the Eritrean authorities recalled in February 2016 that the EU agreement would not lead to any reform of Eritrea’s military service policy;

4.  Believes that the EDF Committee should have taken into consideration the Committee on Development’s recommendations not to adopt the NIP and to engage in further discussion; considers that the decision to adopt the NIP for Eritrea despite Parliament’s opposition demonstrates a democratic deficit and severely undermines Parliament’s role in ensuring the effective implementation of EU development objectives; calls, in this connection, for Parliament to be given powers of scrutiny over the EDF through a binding interinstitutional agreement under Article 295 of the Treaty on the Functioning of the European Union; stresses that the Committee on Development’s conclusions on draft programming documents should be automatically sent by the Commission to the Permanent Representations of the Member States;

5.  Takes note of the allocation of EUR 200 million over the next five years for the NIP under the 11th European Development Fund, in order to promote poverty reduction and socio-economic development, to tackle the root economic and political causes of migration, and to finance projects relating to renewable energy, energy efficiency and economic governance; recalls that this envelope is complementary to other areas of cooperation such as the European Instrument for Democracy and Human Rights (EIDHR);

6.  Calls on the Commission to ensure that the funding allocated does not benefit the Eritrean Government but is strictly assigned to meeting the needs of the Eritrean people for development, democracy, human rights, good governance and security, and freedom of speech, press and assembly; urges the EU to ensure the conditionality of the recently agreed aid and also to ensure that the NIP supports Eritrea in operating an important shift in its energy policy in order to make energy accessible for all, especially in the rural areas which are currently still without electricity; believes, moreover, that the governance component of the NIP should strongly focus on implementing the recommendations of the UN-led Universal Periodic Review on human rights;

7.  Recalls that an unaccompanied minor is above all a child who is potentially in danger, and that child protection, rather than immigration policies, must be the leading principle for Member States and the EU when dealing with unaccompanied minors, so as to respect the core principle of the child’s best interests; recalls that, without exception, anyone below the age of 18 years is to be regarded as a child and thus as a minor; points out that unaccompanied minors, particularly girls, are twice as susceptible to problems and difficulties as other minors;

8.  Appeals to the international community and Eritrea’s development partners to intervene in the situation and to put pressure on the Eritrean Government to allow foreign aid to support vulnerable communities before the crisis worsens; urges the EU to take urgent and effective measures to help the Eritrean people enhance their resilience to El Niño in order to guarantee food security, access to water and sanitation;

9.  Remains very concerned about the human rights situation in the country; reiterates its call to the Eritrean authorities to release immediately and unconditionally parliamentarians, journalists (including Swedish citizen Dawit Isaak, who has not been heard from since 2005), political prisoners and prisoners of conscience;

10.  Encourages the Commission to seek clear guarantees from the Eritrean Government that it will implement democratic reforms and ensure respect for human rights, including by implementing the recommendations made by the 18th session of the Universal Periodic Review (UPR) Working Group, which it accepted on 7 February 2014; calls on the government to allow access to the country to UN and African Union independent experts, including the UN Special Rapporteur, and to allow the Commission of Inquiry on the Situation of Human Rights in Eritrea to fully exercise its mandate and to cooperate with it, including as regards public finance issues;

11.  Recalls that freedom of religion is a fundamental right, and strongly condemns any violence or discrimination on grounds of religion;

12.  Welcomes the measures taken by the Eritrean Government to fight FGM; calls on the government to enhance in general the promotion and protection of women’s rights, including by taking further measures to combat harmful practices, such as child, early and forced marriage, and to end impunity in cases of sexual violence; calls on the Eritrean Government to respect single female-headed households and ensure that they are supported and protected;

13.  Condemns the use by the Eritrean Government of the ‘Diaspora tax’, which is collected by extortion and other illegal means from Eritreans outside of Eritrea and is used in violation of UN resolutions to fund armed groups in neighbouring countries and thus destabilise the region; urges the government to end the ‘guilt-by-association’ policies that target family members of those who evade national service, seek to flee Eritrea or fail to pay the 2 % income tax imposed by the government on Eritrean expatriates;

14.  Demands that Eritrea sign and immediately enact the UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment and fully uphold its obligations under the International Covenant on Civil and Political Rights and the African Charter on Human and Peoples’ Rights, both of which prohibit torture; notes with concern that public and private actors, including companies, are severely restricted by government control; recognises that the lack of any public finance management, including the absence of a national budget, makes budgetary control impossible, and that the fungibility of financial resources owing to central bank controls by the government may encourage military purchases and thus contribute to terrorism and destabilisation in the region;

15.  Urges all international companies investing in Eritrea to act in respect of the full realisation of human rights and to do no harm;

16.  Urges the EU Member States to investigate the role of the PFDJ and its various wings, including the youth wing, and to prohibit all forms of association and activity that directly support control and surveillance exercises in Europe, undermine democratic principles and the rule of law, and create patterns of intimidation and extortion; urges the Member States to act to end the diaspora tax and to investigate the financial transactions related to any other ‘contributions’ raised by Eritrean government-linked associations abroad, and to fully protect the asylum rights of all Eritrean refugees in Europe;

17.  Instructs its President to forward this resolution to the Council, the Commission, the ACP-EU Joint Parliamentary Assembly, the Council of the African Union, the East African Community, the Secretary-General of the UN, the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy, and the Eritrean authorities.

(1) OJ C 284 E, 21.11.2002, p. 359.
(2) OJ C 201 E, 18.8.2005, p. 123.
(3) OJ C 51 E, 22.2.2013, p. 146.
(4) OJ L 51, 2.3.2010, p. 19.
(5) OJ L 195, 27.7.2010, p. 74.
(6) OJ L 282, 16.10.2012, p. 46.


2015 Report on the former Yugoslav Republic of Macedonia
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European Parliament resolution of 10 March 2016 on the 2015 Report on the former Yugoslav Republic of Macedonia (2015/2895(RSP))
P8_TA(2016)0091B8-0310/2016

The European Parliament,

–  having regard to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and the former Yugoslav Republic of Macedonia, of the other part(1),

–  having regard to UN Security Council resolutions 817 (1993) and 845 (1993),

–  having regard to the judgment of the International Court of Justice on the Application of the Interim Accord of 13 September 1995,

–  having regard to the Presidency Conclusions of the Thessaloniki European Council of 19-20 June 2003 concerning the prospect of the Western Balkan countries joining the Union,

–  having regard to the European Council’s decision of 16 December 2005 to grant the country the status of candidate for EU membership, and to the European Council conclusions of June 2008 and the Council conclusions of 15 December 2015,

–  having regard to the 12th meeting of the Stabilisation and Association Council between the country and the EU, held on 20 July 2015,

–  having regard to the Final Declaration by the Chair of the Vienna Western Balkans Summit of 27 August 2015 and the Recommendations of the Civil Society Organisations for the Vienna Summit 2015,

–  having regard to the Declaration of the High-Level Conference on the Eastern Mediterranean – Western Balkans Route, held in Luxembourg on 8 October 2015, and the Leaders’ Statement issued after the Leaders’ Meeting on refugee flows along the Western Balkan Route, held in Brussels on 25 October 2015,

–  having regard to the OSCE/ODIHR Needs Assessment Mission Report of 27 November 2015,

–  having regard to the Commission’s Urgent Reform Priorities for the former Yugoslav Republic of Macedonia of June 2015,

–  having regard to the Recommendations of the Senior Experts’ Group on systemic Rule of Law issues relating to the interception of communications revealed in Spring 2015,

–  having regard to the fifth meeting of the High Level Accession Dialogue, held in Skopje on 18 September 2015,

–  having regard to the Commission communication of 10 November 2015 entitled ‘EU Enlargement Strategy’ (COM(2015)0611), accompanied by the Commission staff working document entitled ‘The former Yugoslav Republic of Macedonia Report 2015’ (SWD(2015)0212),

–  having regard to the political agreement (the so-called ‘Przhino Agreement’) reached between the four main political parties in Skopje on 2 June and 15 July 2015,

–  having regard to the 13th meeting of the EU-Former Yugoslav Republic of Macedonia Joint Parliamentary Committee (JPC) held in Skopje on 3-4 December 2015,

–  having regard to the conclusions of the European Council of 18 and 19 February 2016,

–  having regard to its previous resolutions on the country,

–  having regard to the work of Ivo Vajgl as the standing rapporteur on the country of the Committee on Foreign Affairs,

–  having regard to Rule 123(2) of its Rules of Procedure,

A.  whereas the prospect of EU membership is a major incentive for further reforms, particularly with regard to the rule of law, the independence of the judiciary and the fight against corruption, and a source of hope for a prosperous future for young generations; whereas opinion polls show considerable public support for EU membership in the former Yugoslav Republic of Macedonia;

B.  whereas the rule of law, media freedom, regional cooperation and good neighbourly relations are key elements in the EU enlargement process;

C.  whereas the country has been a candidate for EU membership for ten years and is still considered among the most advanced candidates in terms of alignment with the acquis;

D.  whereas (potential) candidate countries are judged on their own merits, and the speed and quality of the necessary reforms determine the timetable for accession;

E.  whereas the Commission, supported by Parliament, has repeatedly called for the opening of accession negotiations, stressing the importance of negotiations as a key driver of the process of necessary reforms;

F.  whereas the Council has been blocking progress in the country’s accession process partly owing to the unresolved name issue with Greece; whereas bilateral issues should not be used to obstruct the EU accession process but should be addressed in a constructive spirit as early as possible in the accession process, taking into account the principles and values of the UN and of the EU;

G.  whereas there is consensus between the Commission, the Council and Parliament that the maintenance of the positive recommendation to open accession negotiations with the country shall be conditional on the full implementation of the June/July 2015 political agreement and substantial progress in the implementation of the Urgent Reform Priorities; whereas full implementation of the political agreement would create an environment in which there is a realistic prospect of a negotiated resolution of the name issue with Greece;

H.  whereas the divisive political mentality, the lack of compromise and the collapse of dialogue took the form of a political crisis, which led to the boycott of the country’s parliament by the major opposition party and further undermined confidence in public institutions; whereas it is the shared responsibility of the government and the opposition to ensure sustainable political dialogue and cooperation, which are essential for the country’s democratic development, the pursuit of the European agenda and the common good of its citizens;

I.  whereas the country is facing serious challenges relating to intercepted communications, which have underlined crucial shortcomings and concerns; whereas the recent political crisis has demonstrated the lack of an effective system of checks and balances within the Macedonian institutions and the need to increase transparency and public accountability, including adequate mechanisms for oversight of the main services and internal structures;

J.  whereas full implementation of the political agreement by the leaders of the four main political parties is crucial for the stability of the country; whereas this agreement envisaged, inter alia, a way out of the political stalemate, the opposition’s return to parliament, the implementation of systemic rule of law reforms, the strengthening of good neighbourly relations, the resignation of the incumbent government and the Prime Minister at least 100 days before early parliamentary elections, the establishment of the Office of the Special Prosecutor and free and fair early parliamentary elections;

K.  whereas some of the critical issues in the reform process are political influence in the media, the judiciary and public administration, corruption and the completion of the review of the Ohrid Agreement;

L.  whereas the country has been coping with an unprecedented flow of refugees transiting through its territory;

M.  whereas after more than 10 years, the country and Greece have mutually re-established bilateral visits at Foreign Minister level;

1.  Welcomes the four-party agreement of 2 June and 15 July 2015 and its facilitation by the Commissioner for Enlargement, three Members of the European Parliament and the EU mediator on the ground; urges the political parties to assume their respective responsibilities vis-à-vis the citizens and to ensure without delay the full, constructive and timely implementation of all their commitments in a sustainable and negotiated manner, including their commitment to strengthen good neighbourly relations, also in order to maintain the positive recommendation to open EU membership negotiations; urges them also to constructively engage in political dialogue and to pursue efforts to restore public trust in the institutions in order to maintain political stability and to accelerate the reform agenda to ensure the country’s Euro-Atlantic integration and a European perspective;

2.  Takes note of the fact that a number of obligations envisaged in the June/July 2015 Agreement have been fulfilled according to the agreed deadlines and objectives, but regrets the tendency to delay some of the commitments and some retrograde steps in relation to Urgent Reform Priorities; emphasises the aspects of the Agreement which refer to structural reforms, and the need for all parties to constructively engage in the Working Group convened by the EU mediator on a continuous basis and on the issues of implementing the agreement, even during the election period; calls on all parties to put the interests of the country before party interests and insists that an all-party agreement remains essential in order to fulfil all the elements of the June/July 2015 Agreement, which would put the country back on track towards the Euro-Atlantic perspective; welcomes the return to parliament of the main opposition party SDSM on 1 September 2015; welcomes the appointment of a Special Prosecutor on 15 September 2015 to lead independent and thorough investigations; notes that the amendments to the new electoral code, the law establishing the Inquiry Committee, the law on government and the law on the composition of the new State Election Commission were adopted with delay;

3.  Welcomes the commitment of the main political party leaders under the 2 June 2015 agreement to work towards strengthening good neighbourly relations as an essential element for bringing the country closer to the European Union;

4.  Notes that, according to the June/July 2015 Agreement, the new government was to be sworn in on 15 January 2016, 100 days before the agreed date for early parliamentary elections; takes note of the vote by the Macedonian Parliament on 23 February 2016 to set a new date for early parliamentary elections of 5 June 2016; regrets, however, that an opportunity was missed to find a consensus between all parties; recalls that these elections will in themselves be an important test for the democratic process of the country; insists that all the political parties make efforts to create the conditions for credible early elections and underlines the paramount importance of these elections being free, fair, in full compliance with international standards and in line with OSCE/ODIHR recommendations;

5.  Underlines the need to prepare the elections to the highest international standards, including ensuring free and fair election procedures and enhancing media freedom; expresses concern about the slow pace of the audit of the voters’ list and media reform; emphasises that the State Election Commission must have full capacity to conduct its work and that a methodology for the audit of the voters’ list should be agreed by all parties, with an agreed level of field checks to ensure legitimacy; underlines, moreover, the importance of all political actors respecting the results of the elections and actively taking part in parliamentary activities; notes the shared responsibility of the major political forces for the process of preparation of the elections; urges the international community to be present for election observation;

6.  Considers it of strategic importance to ensure continuity of support to the Macedonian progress towards EU membership; notes that the recommendation to open accession negotiations should be conditional upon the full implementation of the June/July 2015 political agreement and substantial progress on the implementation of the Urgent Reform Priorities; calls on the Council to address this issue at its earliest convenience after the early parliamentary elections, as indicated by the Commission; stresses the need to create the pre-conditions for democratic and fair elections, inter alia by the preparation of a reliable voters register and media freedom; welcomes the high level of alignment with the legislative acquis and the fact that the country has achieved some progress in the last year in 25 out of the 33 acquis chapters;

7.  Considers it essential for the democratic process that the Special Prosecutor be given full support to fulfil her agreed functions and maintain full autonomy, and all resources required to investigate any wrongdoings arising from the wiretaps; calls for an end to obstructions in the courts against referring evidence to the Special Prosecutor, and for support for amendments to the law in order to ensure her autonomous authority as regards witness protection with respect to the cases for which her office is responsible;

8.  Considers it essential for the democratic process that the Urgent Reform Priorities on systemic reforms on the rule of law and fundamental rights be implemented without delay; invites the Commission to report back to Parliament and the Council on the implementation of the political agreement and the Urgent Reform Priorities after the early parliamentary elections, and to give an assessment of the conduct of the elections;

9.  Underlines the key role of the country’s parliament in the democratic development of the country and as the forum for political dialogue and representation; calls for its legislative and oversight functions to be improved and strengthened; calls for the regular convening and smooth operation of the relevant parliamentary committees on interception of communications and on security and counterintelligence; notes that the deadlines in the Political Agreement for reports to be produced by parliamentary committees have not been met; calls for the finalisation of the recommendation of the committee of inquiry into the events which occurred in parliament on 24 December 2012; stresses the need to ensure the committee’s unhindered access to the necessary data, testimonies and technical assistance, and to provide credible parliamentary control of the work of the intelligence services, including the necessary checks and balances on the executive’s power;

10.  Is concerned about the very weak internal and external oversight and control of the intelligence services; calls urgently for the strengthening of the oversight role of the relevant institutions over these services and for full implementation of the recommendations of the Senior Experts’ Group on systemic rule of law issues relating to the communications interception revealed in Spring 2015;

11.  Is concerned that the Macedonian public administration remains subject to political influence; urges the government to enhance professionalism, neutrality and independence at all levels and to ensure the full implementation of the principles of accountability, transparency and merit; calls on the competent authorities to implement in a sustainable manner the Law on Administrative Servants and the Law on Public Employees, in full compliance with the principles of transparency, meritocracy and equal representation, and to adopt a comprehensive public administration reform strategy for 2016-2020, including an action plan, and a public financial management reform programme;

12.  Underlines the need to enhance administrative capacity and inclusive and evidence-based policy-making in order to ensure effective implementation of policies and lines of accountability; calls for the development of a designated training programme for public administration staff; urges the Commission to provide assistance and exchange possibilities in this regard;

13.  Supports the government’s plans to increase accessibility to public services by prioritising the development of e-services; suggests that the government look for twinning opportunities and take stock of existing best practices; notes that e-services would reduce the bureaucratic burden for the state, for citizens and when doing business; considers, furthermore, that e-services would enhance the country’s economic performance and enable the transparency of the public administration and services to be increased;

14.  Notes the well-established legal framework and earlier measures as regards judicial reform, but deplores the cases of selective justice, particularly through the misuse of Article 353 of the Criminal Code; calls once again for political will to depoliticise the appointment and promotion of judges and prosecutors and to ensure the professionalism and independence of the Judicial Council; stresses the need for the efficient functioning, sufficient staffing and independence of administrative courts and for the capacities of the Academy for Judges and Prosecutors to be strengthened; calls for the preparation and proper consultation of stakeholders on a new 2015-2020 Judicial Reform Strategy and action plan;

15.  Considers civil society to be well-organised but remains concerned about the difficult climate surrounding it and the public attacks by politicians and media on civil society organisations (CSOs); calls on the authorities not to discriminate against CSOs on any grounds such as political affiliation, religious views or ethnic composition; regrets the insufficient cooperation with CSOs, at both central and local levels, in policy and law-making; calls on the authorities to encourage CSOs to actively participate in the overview of the whole electoral process; urges the government to acknowledge the added value of the CSOs by consulting with them during the process of drawing up legislation and policy, to develop the relevant 2015-2017 action plan, to establish the Council for Cooperation with CSOs, to facilitate the necessary dialogue and to include CSOs in policymaking in a regular and structured manner; notes with concern the violent clashes between protesters and police during the May 2015 demonstrations and calls on the government to ensure full respect for freedom of assembly;

16.  Reiterates that the authorities and civil society should take appropriate measures to achieve historical reconciliation in order to overcome the divide between and within different ethnic and national groups, including citizens of Bulgarian identity;

17.  Encourages the country to establish joint expert committees with its neighbours on history and education and to refrain from using educational materials which might contain offensive language towards other countries, with the aim of contributing to an objective, fact-based interpretation of history, strengthening academic cooperation and promoting positive attitudes in young people towards their neighbours;

18.  Welcomes the efforts made so far by the authorities to retrieve the relevant Yugoslav secret service archives from Serbia, and encourages them to finalise the process, which would mark an important step towards breaking with the Communist past and moving towards further democratisation, accountability and institutional strength;

19.  Remains concerned about widespread corruption, particularly in state and local administration, public procurement and political party financing; urges the government to fight corruption in a non-selective manner, to develop a credible track record on both prevention and prosecution of high-level corruption, and to ensure that all law enforcement and supervisory bodies have sufficient autonomy to act independently; takes note of the adoption of the law on whistleblower protection in November 2015 and urges the authorities to ensure its implementation in line with European standards; encourages independent CSOs and the media to bring corruption issues to light and support independent and impartial investigations and trials; stresses the need to strengthen the independence of the police, the Public Prosecutor’s Office and the State Commission for the Prevention of Corruption, and to reinforce the Interior Ministry’s staffing and technical capacities for fighting corruption; calls for enhanced scrutiny of potential conflicts of interest and of assets belonging to elected and appointed officials by establishing a central register of such public servants;

20.  Welcomes the fact that the police and the Public Prosecutor’s Office were reinforced in the fight against organised crime and that steps, including regional/international operations, have been taken to prevent and combat trafficking in human beings; commends the cooperation with neighbouring countries, EU Member States and Eurojust in taking down several organised crime networks; encourages further improvement of cooperation between law enforcement agencies, including those in neighbouring countries, and strengthening of the powers and resources of the courts and the Agency for Management of Confiscated Property; calls for the National Coordination Centre for the Fight against Organised Crime to be made operational and for the establishment of a sound track record on combating money laundering; commends the participation of the country in regional initiatives to fight the illegal trafficking of firearms and explosives; urges that cooperation in this field between the Commission and the Macedonian authorities, as well as governments in the region, should be stepped up further;

21.  Notes the important contribution to regional efforts to fight Islamic radicalism; encourages the development of a comprehensive strategy and action plan to prevent and counter radicalisation, in close cooperation with religious leaders and communities, and the pursuit of efforts to identify, prevent and disrupt foreign terrorist fighters; strongly reiterates the need for the government to define a common proactive strategy of foreign, security and defence policy, bearing in mind the current international terrorist threat;

22.  Urges that the investigations into the events at Kumanovo be fully completed; welcomes the declarations from political actors that the events at Kumanovo should not be linked with interethnic relations;

23.  Reminds the government and the political parties of their responsibility in shaping a culture of inclusion and tolerance; reiterates its call for the Anti-Discrimination Law to be aligned with the acquis as regards discrimination on grounds of sexual orientation and gender identity; notes that the new Anti-Discrimination Commission has only one female member and that its members were elected on the grounds of political affiliation to the ruling coalition, which raises the question of whether it can function in an impartial and effective manner; condemns the use of any kind of violence against the LGBTI community and reiterates its request that those responsible for such acts of violence be brought to justice; underlines the need to combat prejudices and discrimination on any grounds against the Roma, and to facilitate their integration and their access to the educational system and the labour market; welcomes the new Law on Combating Domestic Violence, but notes that it fails to recognise all forms of violence; urges the competent authorities to provide support services to victims of domestic violence and to allocate sufficient budget for the implementation of the gender equality strategy and action plan;

24.  Reaffirms that the Anti-Discrimination Law should be amended to bring it into line with the acquis as regards all the categories of discrimination listed in Article 19 of the Treaty on the Functioning of the European Union; condemns hate speech against discriminated groups and calls for prompt, impartial and effective investigation and prosecution of all hate crimes and attacks targeting people for discriminatory reasons;

25.  Welcomes, in this context, the ‘Pristina Declaration’, which calls upon governments and international, intergovernmental and civil society organisations to fully apply the principles of non-discrimination and equality when working and acting on promotion and respect of Roma rights and fighting anti-Gypsyism in the Western Balkans;

26.  Takes note of the progress made in improving respect for children’s rights; underlines the need to increase and monitor enrolment in early childhood development facilities, especially for the most vulnerable children; highlights the importance of improving inclusion of children with disabilities through integrated services; stresses the need to collect disaggregated and reliable data on the situation of Roma children and for legislative changes to prevent child marriage; emphasises the need for increased coordination among professionals to prevent and respond to violence against children;

27.  Notes with concern that interethnic coexistence remains fragile; calls on all political parties and CSOs to actively promote an inclusive and tolerant multi-ethnic and multi-religious society; stresses the need for a more proactive approach to strengthen coexistence and dialogue, and to achieve cohesion among the various ethnic, national and religious communities; reminds the government, institutions and party leaders of their commitment to fully implement the Ohrid Framework Agreement (OFA) and to complete its review, including policy recommendations; invites the Commission to report back to Parliament and the Council on the state of interethnic relations in the country and the implementation of the OFA; calls for better coordination of the strategic decentralisation programme for 2015-2020 and its action plan;

28.  Recalls that education and cultural training can help to create tolerance and promote reconciliation among the various ethnic groups; reiterates the recommendation made in its previous resolution regarding integrated education, and calls on the government and the competent local authorities to ensure an open, transparent and inclusive process as regards the effective implementation of the Strategy for Integrated Education, by allocating sufficient funding and including CSOs in the process of its review and implementation;

29.  Calls on the authorities to ensure that the recommendations of the Ombudsman’s office and other advisory bodies are followed up by all state bodies in full respect of the law and of the principle of accountability, to ensure effective legal sanctions for non-compliance with the requests and recommendations of independent bodies and to ensure that the Ombudsman Law is amended to comply fully with the UN-defined Paris principles on the status and functioning of national institutions for the protection and promotion of human rights;

30.  Reiterates the importance of media freedom and independence as one of the core EU values and a cornerstone of any democracy; deplores the further deterioration of freedom of expression and media freedom; regrets, in this context, that in the index compiled by Reporters Without Borders the country has fallen from 34th place in 2009 to 117th in 2015; is very concerned about political pressure, hate speech, the continued polarisation, lack of independence and pluralism in the media, the widespread illegal wiretapping of journalists, the cases of violence and threats against journalists and intimidation and self-censorship, systemic political interference in the editorial policies and the poor professional and ethical standards of some journalists, as well as the absence of investigative and balanced reporting;

31.  Urges that steps be taken to enhance media freedom; calls on all parties to agree on an urgent media reform which will ensure an independent regulatory body and objective and professional reporting; urges the government to enforce transparent and objective criteria on public service announcements, and to ensure the transparent and non-arbitrary implementation of the new law on electronic communications and audiovisual media services, including the strengthening of the independence and capacity of the media regulator; calls for the members of the council of the audiovisual services regulator to be given full decision-making powers for appointments to that council and to the public service broadcaster on a non-partisan basis and in consultation with the associations of journalists; calls for the editorial and financial independence of the public service broadcaster to be ensured, along with full and equal access to the media for all political parties; calls, in the context of the upcoming elections, for a level playing field also as regards the media;

32.  Welcomes the good level of preparation for the development of a functioning market economy, including the simplification of the regulatory framework which has further eased the overall business environment; notes, however, that the weak enforcement of the rule of law, the inefficient judicial system, the large shadow economy and corruption are serious impediments to doing business; stresses that further strengthening legal certainty for foreign investors as well as domestic companies, avoiding discriminatory practices, strengthening administrative capacities and regulatory and supervisory agencies, and improving the quality of regulation, the rule of law and contract enforcement remain important challenges; calls, furthermore, for Article 353 of the Criminal Code on the misuse of official position and authority to be revised in line with the EU acquis and the principles of a market economy; encourages the removal of non-tariff barriers to trade; underlines the great potential and strategic advantage of agriculture and tourism in the further development of the country;

33.  Is concerned about the high level of public debt; calls for improved fiscal discipline and encourages the principle of balanced budget; calls for budgetary implementation and transparency to be improved;

34.  Welcomes the GDP increase of 3,9 % in real terms in the first quarter of 2015, but is concerned that unemployment remains high at 27,4 % and that labour market participation is very low, especially among young people and women; recalls that employment should not be influenced by political affiliation or used for pressure and intimidation of citizens during election campaigns, as pointed out by the OSCE/ODIHR; urges the government to set up functioning social dialogue, to pursue a policy to tackle long-term and structural unemployment, to promote economic policy cooperation, to better align education with labour market demands and to develop a targeted strategy on how to better integrate young people and women into the labour market; calls on the government to dedicate particular attention to improving the perspectives of young people;

35.  Is concerned about the increasing brain drain, especially among young people; takes note of the challenges faced by the country’s education system and emphasises the need for a comprehensive analysis in this respect; recommends strategic planning for future reforms and legislative changes through the involvement of student movements and organisations, in order to reduce the outflow of highly educated and professional people; with regard to the data and analysis of Eurostat and other international organisations, which indicate serious migration trends, especially among young people, recommends evaluating the 2013-2020 national strategy for networking, cooperation and reduction of the outflow of highly educated and professional people, and making records and statistics of these trends publicly available;

36.  Notes with concern the challenges faced by the country’s education system and emphasises the need for a comprehensive analysis in this respect; recommends strategic planning for future reforms and legislative changes with the involvement of the relevant student movements and organisations, enabling them to fully exercise their rights within this process;

37.  Urges the country’s Agency for Youth and Sport to acknowledge the role and support of, and to establish a permanent mechanism for cooperation with, the country’s National Youth Council; welcomes the process of creating a National Youth Strategy for 2016-2025 and emphasises the need to allocate proper funding for its implementation;

38.  Welcomes the plan to upgrade and modernise parts of the railway network and encourages the Macedonian authorities to continue to develop and further improve public transport in cooperation with the neighbouring countries;

39.  Regrets that energy targets have not been met with regard, in particular, to energy efficiency and the use of renewables, and calls for the swift adoption of the relevant action plans;

40.  Stresses the need to make progress in opening up the internal electricity market, and to fully comply with the Energy Community Treaty; underlines the need to adopt national energy efficiency and renewable energy action plans; is worried about the alarming air pollution levels and urges the government to act immediately in reducing air pollution, especially in urban areas;

41.  Reiterates its concern about the high levels of air and water pollution in the country; points out that significant efforts are needed in the field of the environment and in particular in the area of air quality;

42.  Welcomes the fact that the Food and Veterinary Agency has continued to update the systems for controlling imports of live animals and animal products, thus improving controls on the identification, registration and movement of animals; welcomes the enactment of additional legislation on the non-commercial movement of pets and zoo-technical issues, as well as new legislation on animal welfare;

43.  Remains concerned about the insufficient capacity to programme and absorb Instrument for Pre-accession assistance (IPA) funds; urges the government to strengthen the administrative and financing capacities in order to procure and implement EU funds properly and in a timely manner; calls on the Commission to closely monitor projects financed by the EU in order to avoid misuse of European public money for political and other inappropriate purposes;

44.  Notes that the country has been facing an unprecedented migratory flow, with over 500 000 persons transiting through in 2015; recognises that it has acted as a responsible partner in coping with the huge influx of migrants and refugees and in setting up effective border management measures; is aware of the increasingly tense situation at the border with Greece, and calls on the authorities to continue cooperation and coordination with the EU on migration issues; encourages the stepping-up of measures related to border management to combat illegal migration and human trafficking; notes the economic burden created by this influx; calls on the Commission to enhance support for border management capacity and allow access to the relevant EU instruments and programmes; calls upon the competent authorities to avoid and refrain from any kind of actions, including violence and the use of force, which might discriminate against, and put at risk the lives of, refugees and migrants; notes that all relevant kinds of actions should be in line with EU values and principles and should respect the dignity of human beings and human life; encourages the competent authorities to enhance, with the EU’s help, reception and accommodation facilities, regional coordination and information exchange and effective border management, to extend law enforcement capacities and to combat trafficking in human beings; urges the country to do everything possible to ensure facilities for refugees and migrants, uphold humane conditions, refrain from violent pushbacks and ensure strict respect for the country’s own law and for international law on refugees and asylum; notes that the overall number of unfounded asylum applications filed in Schengen member countries has declined; recalls that special attention must be devoted to the vulnerable situation of refugee and migrant children and unaccompanied minors travelling across the country by providing them with basic services and ensuring outreach of social workers to provide appropriate protection;

45.  Considers that EU negotiations can only positively influence efforts towards resolving bilateral disputes, while also generating momentum and leverage as regards much-needed reforms, particularly in respect of the rule of law, the independence of the judiciary and the fight against corruption, strengthening multiethnic cohesion, and safeguarding the credibility of the EU’s enlargement policy;

46.  Commends the agreement with Greece on 11 confidence-building measures, mainly in the fields of education, culture, energy and internal affairs; notes that cooperation is the best confidence-building measure; welcomes as a positive sign the high-level consultations of the two Foreign Ministers in the respective capitals and the creation of a joint task force aimed at overseeing the implementation of the measures; invites both sides to build upon the outcome of these meetings and engage in further constructive discussion at a high political level, including on the implementation of the confidence-building measures, with a view to enriching bilateral cooperation and strengthening mutual trust; encourages both governments to use the momentum and take concrete steps towards further enhancing mutual trust, including with regard to the name issue; invites the Vice-President/High Representative (VP/HR) and the Commission to support the spirit of cooperation and develop new initiatives to overcome the remaining differences in line with the ruling of the International Court of Justice of 5 December 2011, in order to work, in cooperation with the two countries and the UN Special Representative, towards a mutually acceptable solution on the name issue and to report back to Parliament thereon;

47.  Underlines the importance of regional cooperation and believes that it is an essential element in the EU accession process, bringing stability and prosperity to the region; welcomes the country’s constructive role in regional and international cooperation, and its willingness to participate in high-level visits with neighbouring countries as a means of fostering regional cooperation; notes that open issues in relations with Bulgaria have remained and reiterates the importance of finalising the negotiations on a treaty on friendship, good neighbourliness and cooperation; reiterates its concern over the use of historical arguments in the current debate with neighbours, and welcomes any efforts towards joint celebrations of common historical events with neighbouring EU Member States; considers that this could contribute to a better understanding of history and good neighbourly relations;

48.  Welcomes the country’s active participation in the Western Balkans 6 connectivity agenda by endorsing the agreement on the regional core transport network and other commitments undertaken as part of the Berlin Process; invites the competent authorities to swiftly implement the ‘soft measures’ agreed during the Western Balkans Summit in Vienna in 2015 (e.g. simplifying/aligning border-crossing procedures, railway reforms, information systems) before the next Western Balkans Summit, which will take place in 2016 in France;

49.  Invites the government to improve the overall level of alignment with the EU foreign policy as the rate of alignment (68 %) has remained low; invites the government to comply with the EU Common Positions on the integrity of the Rome Statute;

50.  Calls on the Commission and the Council to include the country in the EU macro-regional strategies for cooperation in South-East Europe; offers its congratulations on the successful completion of the Macedonian Presidency of the Central European Initiative;

51.  Is of the opinion that Macedonian membership of NATO could contribute to achieving greater security and political stability in South-East Europe; hopes for accession negotiations to be opened soon; recalls, however, that the EU and NATO accession processes are independent of each other;

52.  Instructs its President to forward this resolution to the Council, the Commission, the governments and parliaments of the Member States and the government and parliament of the country.

(1) OJ L 84, 20.3.2004, p. 13.


2015 Report on Montenegro
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European Parliament resolution of 10 March 2016 on the 2015 report on Montenegro (2015/2894(RSP))
P8_TA(2016)0092B8-0309/2016

The European Parliament,

–  having regard to the European Council conclusions of 19-20 June 2003 and to the annex thereto entitled ‘The Thessaloniki Agenda for the Western Balkans: moving towards European integration’,

–  having regard to the Stabilisation and Association Agreement (SAA) between the European Communities and their Member States, of the one part, and the Republic of Montenegro, of the other part, of 29 March 2010(1),

–  having regard to the outcome of the seventh meeting of the EU-Montenegro Accession Conference at ministerial level of 21 December 2015,

–  having regard to the Declaration and Recommendations of the 11th Meeting of the EU-Montenegro Stabilisation and Association Parliamentary Committee (SAPC) held in Strasbourg on 16-17 December 2015,

–  having regard to the report from the Commission to the European Parliament and the Council of 22 May 2012 on Montenegro’s progress in the implementation of reforms (COM(2012)0222), and to the Council conclusions of 26 June 2012 deciding to open accession negotiations with Montenegro on 29 June 2012,

–  having regard to the Commission communication of 10 November 2015 entitled ‘EU Enlargement Strategy’ (COM(2015)0611), accompanied by the Commission Staff Working Document entitled ‘Montenegro 2015 Report’ (SWD(2015)0210),

–  having regard to the Final Declaration by the Chair of the Vienna Western Balkans Summit of 27 August 2015,

–  having regard to the conclusions of the General Affairs Council of 15 December 2015 on the enlargement and stabilisation and association process,

–  having regard to the decision taken at the NATO Foreign Ministers meeting of 2 December 2015,

–  having regard to its previous resolutions on Montenegro,

–  having regard to the work of Charles Tannock as the standing rapporteur on Montenegro of the Committee on Foreign Affairs,

–  having regard to Rule 123(2) of its Rules of Procedure,

A.  whereas further progress has been made in the accession negotiations with Montenegro, and at the Intergovernmental Conference in Brussels on 21 December 2015 another two negotiation chapters were opened, concerning transport and energy; whereas Montenegro is the most advanced enlargement country in the negotiation process;

B.  whereas sustainable dialogue and constructive cooperation between the ruling coalition and the opposition are crucial in order to maintain progress in the accession process;

C.  whereas free, fair and transparent parliamentary elections are crucial for the democratic future of Montenegro;

D.  whereas Montenegro should further develop a solid track record on the rule of law, which is a fundamental prerequisite for EU accession;

E.  whereas a strong civil society enhances political accountability, strengthens solidarity within the country and promotes better understanding and ownership of EU-related reforms;

F.  whereas corruption continues to be a serious problem, and whereas organised crime and threats to freedom of expression remain a concern;

G.  whereas further steps should be taken towards combating unemployment, social discrimination and poverty and strengthening labour and trade union rights in line with EU standards;

1.  Welcomes the steady progress in the accession negotiations with Montenegro, noting that 22 negotiation chapters, including chapters 23 and 24, have been opened so far, two of which have been provisionally closed; encourages tangible progress in meeting the benchmarks for the closing of chapters already under negotiation and for the opening of new chapters; stresses that progress in the negotiations must be accompanied by the strict implementation of relevant action plans and strategies; reiterates that overall progress in the negotiations depends on the progress in the implementation of the rule of law and the visible track record thereof;

2.  Urges more parliamentary scrutiny over the accession process; welcomes the adoption of the 2015 action plan for strengthening parliamentary oversight, but emphasises the need to reinforce the capacities of the Montenegrin parliament and to improve its access to accession-related information; welcomes the newly adopted Code of Ethics, and calls for further measures to improve public trust in the Montenegrin parliament;

3.  Is deeply concerned about the polarised domestic climate and the boycott of parliamentary activities by part of the opposition; urges all political forces, in government and opposition alike, to re-engage in sustainable dialogue and constructive cooperation within the Montenegrin parliament; takes note of the failed vote of no-confidence in the Montenegrin parliament on 27 January 2016 and of the following parliamentary dialogue on creating conditions for free and fair elections ; recalls that dialogue and compromise are cornerstones of any democratic decision-making process; welcomes in this respect the plan presented to overcome the political crisis; calls on all opposition parties to consider the invitation to enter the government until the elections in October 2016 in order to ensure, without any further delay, that the conditions for free and fair elections are guaranteed, including completing the modification of the electoral laws and ensuring that no public resources are used for party purposes; considers it essential for a well-functioning democracy that any form of protest be conducted peacefully and in line with the relevant laws; expects the competent authorities to investigate thoroughly and in a timely manner all incidents of violence that occurred during the protests, including any allegations on the excessive use of force by some members of the police force; takes note of the modifications adopted in December 2015 to the law on public gathering;

4.  Calls on the government to fully implement the new electoral legislation prior to any new elections and to further strengthen the State Election Commission, which needs to effectively fulfil its mandate; insists once again on the need for a due political follow-up on the ‘audio-recording affair’, while acknowledging the progress made on the judicial follow-up;

5.  Notes some progress in the government’s 2011-2016 public administration reform, and calls for the timely adoption of a strategy covering the period 2016-2020; encourages further depoliticisation of the public administration; considers it essential to adhere to the principles of merit, depoliticisation, accountability and transparency in public administration and to ensure the citizens’ right to good administration free of corruption; welcomes the amendments to the Law on the Ombudsman; is concerned that the capacity of the Ombudsman’s Office to effectively handle complaints remains limited; stresses the need for a greater number of specialised independent state agencies;

6.  Welcomes the good progress on strengthening the legislative framework to enhance the independence, accountability and professionalism of the judiciary, and looks forward to the full implementation of the relevant rules in practice; notes with satisfaction that the backlog of certain types of cases has further decreased; calls for ensuring the independence of the judiciary and welcomes its increased efficiency; remains concerned about undue influence on judicial independence, especially with regard to the appointment of judges; stresses the need to reinforce the capacity of the Judicial and Prosecutorial Councils, to further improve the efficiency of the Constitutional Court, to strengthen the enforcement of civil and administrative decisions and to implement fully the new recruitment and professional appraisal and promotion systems;

7.  Calls for the improvement of legislative and administrative capacity in the field of asylum and migration, and urges the Commission to provide support to this end; commends the government of Montenegro for the steps it has taken to help stateless people on its territory resolve their status; encourages Montenegro to continue its efforts in this field, especially with regard to children, including by further facilitating birth registration and subsequent or re-registration in civil registers;

8.  Invites the government and prosecution service to intensify their efforts to fight impunity in war crimes and to demonstrate a more proactive approach in following up on outstanding allegations of war crimes, particularly with regard to the responsible officials at the top of the command chain, in order to ensure, in line with international standards, that court rulings are enforced, with a guarantee of fair and just indemnification, and that victims have access to justice and obtain reparations for damage sustained; calls for the full protection of witnesses; reiterates the need to resolve any issues that are not in line with the EU common position on the integrity of the Rome Statute or with the related EU guiding principles on bilateral immunity agreements;

9.  Welcomes the recent EU peer review on child rights, and calls for full implementation and monitoring of child-related policies and laws at all levels; stresses the need to adequately resource child-related policies and services at national and local level and to enhance capacities to produce and use quality, disaggregated, child-focused data for evidence-based policy-making and programming;

10.  Commends the government’s commitment to expanding good quality early childhood education, and welcomes the increases in pre-school enrolments following a targeted campaign; welcomes the efforts to improve the quality of education in general and of early education in particular through standard-setting, enhancing the capacities of education providers and establishing oversight and quality-assurance mechanisms; welcomes the pioneering work to develop socio-emotional and other soft skills among pupils in primary schools;

11.  Acknowledges the government’s commitment and results achieved in the social and child care system reform, and stresses the need for these reforms to be implemented effectively by centres for social welfare through individual case management and coordination of services; points out that the recent legal amendment that allows adults to use the services of day-care centres together with children with disabilities is not in line with international standards; welcomes the government’s commitment to ensuring that no children under three years of age are placed in residential state institutions by 2017; commends the proposed amendments to the Family Law of Montenegro to prohibit corporal punishment in a family setting; calls for further efforts to include the principle of best interests of the child in all civil and administrative proceedings while promoting broader access to justice;

12.  Notes that, despite positive legislative changes, corruption remains a serious concern, particularly in public procurement, health care, education, spatial planning, privatisation and construction; reiterates the need to eliminate corruption at all levels, since it undermines democratic principles and negatively affects social and economic development; calls on the government to make combating corruption one of its priorities by allocating sufficient human and budgetary resources to it; welcomes the establishment of the Special Prosecutor’s Office, whose tasks include combating corruption offences, and urges that it be made fully operational as soon as possible; welcomes the establishment of the Anti-Corruption Agency launched on 1 January 2016; calls for its independence and capacity to conduct administrative investigations to be ensured; recalls the importance of protecting whistle-blowers; calls on the authorities to facilitate and widen access to information about ownership of companies, real estate, and details about public expenditure, in particular in the case of public procurement and privatisation processes;

13.  Calls on the government to further strengthen the legislative and institutional framework in the fight against corruption and to ensure the effective protection of whistle-blowers; calls for more active participation and effective cooperation from the government, all sectors of public life and civil society in the prevention of corruption; reiterates the need to reinforce anti-corruption track records in investigations, prosecutions and convictions at all levels, to strengthen the institutional and operational capacity of prosecutors, judges and police, and to systematically use financial investigations and the power to seize and confiscate assets; calls for criminalising illicit enrichment;

14.  Notes the bringing of criminal charges by the Montenegrin State Prosecutor’s Office in certain Montenegrin municipalities against several officials in relation to high-level corruption; welcomes this as a positive sign in establishing a track record in rooting out high-level corruption, and encourages Montenegro to continue with this practice; reiterates the need to further increase the track record of investigating and bringing to justice high-level corruption cases; commends the good performance of the Podgorica High Court in delivering convictions for corruption-related offences;

15.  Is concerned that the reported number of final convictions in organised crime cases and the number of seizures and confiscations of criminal assets have remained very low; encourages stronger and better cooperation between judicial and law enforcement authorities; welcomes the good cooperation between Montenegro and its neighbouring countries across a broad range of issues; welcomes the Agreement on Cooperation between Eurojust and Montenegro; while noting that the legal framework on money laundering is largely at place, calls for the relevant supervisory framework to be significantly enhanced and for a higher number of investigations, prosecutions and convictions in money laundering cases;

16.  Encourages further measures against trafficking in human beings to complement the relevant legal and institutional aspects, including the setting up of a multi-disciplinary coordination team; calls on the competent authorities to increase the number of financial investigations and the seizure and confiscation of assets, and to more efficiently identify and protect victims and prosecute cases;

17.  Notes that the Montenegrin police have intensified checks throughout the country with a view to preventing possible terrorist attacks and recruitment of Montenegrin nationals to jihadist organisations; welcomes the adoption of the 2016-2018 anti-terrorism strategy and the setting up of an interministerial group to monitor the situation and to assess terrorist threats; calls on the competent authorities to properly implement relevant legal provisions in order to prevent and monitor any potential threat to the security of its citizens; encourages the competent authorities to strengthen regional and international cooperation, including by exchanging information and best practices in a move to prevent radicalisation and respond to terrorist activities; is of the opinion that all measures taken in this direction should ensure respect for human rights and fundamental freedoms in accordance with international standards and instruments; considers that political stability in the region, the promotion of interethnic and interreligious tolerance and dialogue, and further progress towards the EU are essential in order to strengthen cohesion and security in the Western Balkans;

18.  Welcomes recent efforts by the government of Montenegro to step up the fight against illegal trafficking in weapons and explosives; calls for close coordination and sharing of best practices to take place between initiatives in Montenegro, and the wider region, and the Commission on this matter;

19.  Welcomes efforts to improve consultation mechanisms with civil society organisations (CSOs) and to achieve more transparency in policy- and law-making, including by involving them in the process of rule of law reforms and in monitoring the electoral process and the implementation of reforms; appreciates the motivation and efforts of the CSO sector, which has proved to be vocal and effective in many fields; stresses the need to further improve CSOs’ access to accession-related information and to further improve cooperation between local self-governments and CSOs; invites the competent authorities to further develop a sustainable system of public funding for CSOs and to create conditions that are conducive to voluntary work and social entrepreneurship;

20.  Reiterates the importance of media freedom and pluralism, as well as freedom of expression in the broader sense, as one of the core EU values and a cornerstone of any democracy; remains concerned about the freedom of the media in Montenegro, which is ranked 114th in terms of press freedom by the annual ranking of Reporters Without Borders; encourages progress to be made in freedom of expression and decisions to be aligned with European Court of Human Rights case law on freedom of expression; urges measures to ensure the independence of the public service broadcaster RTCG; calls for fair and equal access to media for all parties involved in elections; highlights the importance of self-regulation of media outlets; welcomes the efforts made in the information society and technology sector;

21.  Welcomes the fact that no new attacks against journalists took place in the reporting period; expresses concern, however, at the shortcomings in the investigation of previous cases of violence and intimidation against journalists; urges the competent authorities to resolve the pending cases of violence and threats against journalists, including the murder of Duško Jovanović in 2004, by improving investigations, by identifying and bringing to justice not only the perpetrators but also those behind the attacks and by implementing the recommendations issued by the ad hoc commission set up for monitoring the investigations into cases of violence against journalists; questions the current composition of the commission, of which members of the security services constitute more than 50 %, enabling them to block progress and the adoption of reports if they act together; calls on the government to prolong the mandate of this commission and to provide it with much more information and more competences; is concerned that incidences of intimidation of journalists and media outlets can considerably encourage self-censorship and limit the scope for investigative journalism; condemns the ongoing personal smear campaigns, mostly by one tabloid newspaper, targeting prominent civil society activists and some politicians on a personal basis; recalls that all media outlets must fully respect the established rules of professional reporting; points out that the media community is highly politicised and divided, that professional and ethical standards are weak and that journalists are poorly paid and their jobs insecure; considers it essential for journalists to have full independence, away from any interventions, including by media owners; welcomes the agreement among media practitioners to improve the existing Code of Ethics in order to enhance qualitative journalism; calls for continuing the dialogue facilitated by the Organisation for Security and Cooperation in Europe on improving ethical and professional standards in the media;

22.  Welcomes improvements in the legal framework with regard to the rights of people with disabilities; expresses concern, however, that most public buildings are still not accessible to people with disabilities, including all 13 priority public buildings, such as the parliament, schools, hospitals, social welfare centres and courts, despite the government’s commitment to changing the situation by 31 August 2013; calls for the full utilisation of the Fund for Professional Rehabilitation and Employment of Persons with Disabilities;

23.  Calls on the competent authorities to encourage better representation of ethnic minorities in public sector employment, including in the police and the judiciary; urges them also to adopt a new law on minorities and a law on the legal status of religious communities in line with European standards and after due consultations with all stakeholders, to make further efforts to protect the multi-ethnic identity of Boka Kotorska (Bay of Kotor) and to address the issue of lack of transparency in funds for minority issues; welcomes Montenegro’s policies aimed at creating a climate of tolerance and inclusion for all national minorities;

24.  Notes the improving participation of Roma students in all levels of education, but calls once again for additional measures to facilitate the access of Roma, Egyptian minorities and Ashkali to health care, housing and employment; urges both political and civil society actors to fight hostility, discrimination and hate crime against the LGBTI community, in particular with efforts to educate and inform the public with a view to changing attitudes, and by providing training to the police, prosecutors and judges; calls for the perpetrators of such discrimination and violence to be brought to justice; encourages the authorities to continue and enhance efforts to safeguard the rights of LGBTI people and ensure freedom of assembly; welcomes the fact that the third Montenegro pride parade was well protected and held without any major incidents on 13 December 2015; regrets, however, the ban of the pride march in Nikšić;

25.  Remains concerned about domestic and sexual violence against women and girls, its underreporting, the lack of prosecutions and inefficient support and protection to victims as well as the lenient sentences imposed on perpetrators or outright impunity; urges the competent authorities to take domestic violence seriously, by establishing protection services, enhancing coordination between state institutions and by effectively implementing the convention on preventing and combating violence against women and domestic violence; urges the competent authorities to educate employees in state institutions (social workers, police officers, etc.) for working with victims; stresses the importance of increasing women’s representation in politics during the next elections, as well as access to the labour market for women;

26.  Calls on the government to further reinforce human rights institutions, such as the Ombudsman and the Ministry of Human Rights and Minorities, and to allocate the adequate resources for the enforcement of human rights;

27.  Commends the macroeconomic stability and favourable developments in the economy; notes also that, according to the World Bank’s Doing Business report for 2016, which measures the ease of doing business in a country, Montenegro ranks 46th worldwide, putting it in second place in the Western Balkans; notes, however, that Montenegro ranks 136th among 188 countries in enforcing contracts, which leads to legal uncertainty; notes the efforts to improve the competitiveness of industrial and agricultural products; urges the government to launch further structural reforms, to ensure a business-friendly regulatory environment while protecting consumer and social rights, to pursue efforts to reduce corruption in the economy, to implement economic reforms that will create jobs and growth, to address the country’s large current-account and general budget deficits and the sustainability of public finances, and to implement policies that will help diversify the economy;

28.  Stresses the importance of strengthening the SME sector and of providing support through better legislation, financing, implementation of industrial policy and reducing the informal economy, as well as speeding up electronic registration of companies nation-wide;

29.  Notes with concern that Montenegro is not in alignment with the Third Energy Package and that there has been no progress in the development of the gas market; points out the need to dedicate sufficient resources in the interest of achieving the targets and the need to establish a specialised energy-efficiency agency;

30.  Notes that state aid remains an issue of concern, particularly as regards the independence of the State Aid Control Commission and the State Aid Control Unit, the notification and compatibility of new legislation, and state aid to large investment projects and the KAP aluminium plant; remains concerned about the delay in the resolution of the KAP bankruptcy proceedings as it is in breach of the country’s obligations under the SAA; reiterates its call on the government and involved parties to reach a sustainable and negotiated solution for the KAP bankruptcy proceedings in compliance with state aid rules and the SAA, based on transparency and the rule of law; encourages the commissioning of a full and independent audit of KAP’s finances, from its acquisition by CEAC in 2005 to the present day; calls for special attention to be paid to the plans to build a new highway, which will become the largest ever public project and expenditure in Montenegrin history; calls on the authorities to ensure the appropriate use of public funds and compliance with the relevant law;

31.  Reiterates its concern that in some parts of the country many people are living in relative poverty and that youth and long-term unemployment are at persistently high levels; stresses the importance of including the CSOs and the Social Council in the formulation of labour policies; calls for improvements in social dialogue; notes the skills mismatch between the educational system and the labour market and the widening socio-economic gap between the north and south of the country; calls for more active labour market measures to increase employment, in particular for young people; notes the need to fight tax evasion more effectively and for the establishment of more socially just taxation; encourages the government to accelerate its work in addressing Montenegro’s key challenges regarding social inclusion, poverty reduction and the grey economy; welcomes the adoption of the 2016 action plan on social inclusion; welcomes the memorandum of understanding with the International Labour Organisation;

32.  Calls for further efforts to preserve the biodiversity of the Saline in Ulcinj, in particular, as the most important breeding and wintering site for birds on the eastern Adriatic coast; calls on the government to continue and enhance efforts for the sustainable national and international protection of this unique ecosystem, recognising the functioning of the salt flats as one of the best examples of economic development and environmental protection synergy, since only if they are functional can these salt flats provide a natural service to millions of birds every year; encourages the sustainable development of the coastline, and the protection of the natural environment and biodiversity in line with European standards; reiterates that further efforts should be made towards the adoption of a new law on the environment in conjunction with the need to assess environmental impact and to strengthen relevant administrative and coordination capacities; welcomes the adoption of the Climate Strategy in September 2015; notes the intention of the Montenegrin government to build new hydropower plants; recalls the need for a sound environmental impact assessment in line with the EU acquis and international standards;

33.  Commends Montenegro’s proactive participation and constructive role in regional and international cooperation, including in regional reconciliation and in contributing to crisis management operations under the Common Security and Defence Policy (CSDP); highlights Montenegro’s constructive role in the framework of the ‘Berlin Process’ and the Western Balkan Six initiative; congratulates Montenegro on fully aligning itself with the EU’s Common Foreign and Security Policy (CFSP), and encourages the government to continue the current 100 % alignment; welcomes the adoption of the law on the implementation of international restrictive measures, including in the context of Russia’s illegal annexation of Crimea and events in Eastern Ukraine; encourages other countries in the region to work together with the EU on foreign policy alignment and to follow Montenegro’s example; calls on the Montenegrin authorities to swiftly implement the ‘soft measures’ agreed at the 2015 Western Balkans Summit in Vienna (e.g. simplifying/aligning border-crossing procedures, railway reforms, information systems) before the next Western Balkans Summit in 2016 in France;

34.  Welcomes NATO’s decision to invite Montenegro to join the alliance, and encourages a quick and efficient process of accession negotiations; encourages, in this context, continuing the reform of the security sector; welcomes Montenegro’s participation in EU-led CSDP missions; recalls that the EU accession negotiations are independent from the NATO accession process;

35.  Welcomes the border agreements with Bosnia and Herzegovina and Kosovo, and urges Montenegro to build on this and speed up work to deal with unresolved border issues with Croatia and Serbia, and, should it prove impossible to reach a solution by mutual agreement, calls for disputes to be settled in the Hague International Court of Justice, in accordance with the rules and principles of international law; renews its call on the authorities to help resolve the succession issues related to the legacy of the former Socialist Federal Republic of Yugoslavia (SFRY), including the military and naval legacy; encourages Montenegro to continue to address, in a constructive and neighbourly spirit, outstanding bilateral issues with its neighbours as early as possible in the accession process; calls also on the Montenegrin authorities to broaden cooperation with neighbouring countries by sharing information about the experience of pre-accession negotiations; calls on the Montenegrin authorities to comply fully with the provisions on succession of the former SFRY, especially as regards military assets;

36.  Instructs its President to forward this resolution to the Council, the Commission, the governments and parliaments of the Member States and the government and parliament of Montenegro.

(1) OJ L 108, 29.4.2010, p. 1.


Banking Union – Annual report 2015
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European Parliament resolution of 10 March 2016 on the Banking Union – Annual Report 2015 (2015/2221(INI))
P8_TA(2016)0093A8-0033/2016

The European Parliament,

–  having regard to Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions(1) (SSM Regulation),

–  having regard to the Interinstitutional Agreement between the European Parliament and the European Central Bank on the practical modalities of the exercise of democratic accountability and oversight over the exercise of the tasks conferred on the ECB within the framework of the Single Supervisory Mechanism(2),

–  having regard to the ECB Annual Report on supervisory activities 2014 of March 2015(3),

–  having regard to Regulation (EU) No 468/2014 of the European Central Bank of 16 April 2014 establishing the framework for cooperation within the Single Supervisory Mechanism between the European Central Bank and national competent authorities and with national designated authorities (SSM Framework Regulation)(4),

–  having regard to the Decision of the European Central Bank of 17 September 2014 on the implementation of separation between the monetary policy and supervision functions of the European Central Bank (ECB/2014/39)(5),

–  having regard to the Decision of the European Central Bank of 4 February 2014 identifying the credit institutions that are subject to the comprehensive assessment (ECB/2014/3)(6),

–  having regard to the recent work of the Basel Committee, especially to the Revisions to the Standardised Approach for credit risk and the Revision to the measurement of operational risk,

–  having regard to the comprehensive assessment carried out by the European Central Bank between November 2013 and October 2014(7),

–  having regard to Regulation (EU) 2015/534 of the European Central Bank of 17 March 2015 on reporting of supervisory financial information(8),

–  having regard to Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010(9) (SRM Regulation),

–  having regard to the Agreement between the European Parliament and the Single Resolution Board on the practical modalities of the exercise of democratic accountability and oversight over the exercise of the tasks conferred on the Single Resolution Board within the framework of the Single Resolution Mechanism(10),

–  having regard to Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit guarantee schemes(11),

–  having regard to the Report on Completing Europe’s Economic and Monetary Union (‘Five Presidents’ Report’),

–  having regard to the decision of the Commission to refer the Czech Republic, Luxembourg, the Netherlands, Poland, Romania and Sweden to the Court of Justice of the European Union for failing to implement the Bank Recovery and Resolution Directive (2014/59/EU),

–  having regard to the Council statement of 8 December 2015 on Banking Union and bridge financing arrangements for the Single Resolution Fund,

–  having regard to its resolution of 19 January 2016 on ‘Stocktaking and challenges of the EU Financial Services Regulation: impact and the way forward towards a more efficient and effective EU framework for financial regulation and a capital markets union’(12),

–  having regard to its resolution of 24 June 2015 on the review of the economic governance framework: stocktaking and challenges(13),

–  having regard to the report of the European Systemic Risk Board of March 2015 on the regulatory treatment of sovereign exposures,

–  having regard to the Commission communication of 24 November 2015 entitled ‘Towards the completion of the Banking Union’ (COM(2015)0587),

–  having regard to the Commission proposal of 24 November 2015 for a regulation of the European Parliament and of the Council amending Regulation (EU) No 806/2014 in order to establish a European Deposit Insurance Scheme (COM(2015)0586),

–  having regard to Rule 52 of its Rules of Procedure,

–  having regard to the report of the Committee on Economic and Monetary Affairs (A8-0033/2016),

A.  whereas the Banking Union (BU) is an indispensable component of a monetary union and a fundamental building block of a genuine economic and monetary union (EMU), and whereas participation in this is open to Member States whose currency is not the euro;

B.  whereas the BU is instrumental to ensuring stability and restoring confidence in euro area banks, enhancing financial integration, reducing risk in the European banking system and moral hazard, contributing to breaking the link between sovereigns and banks and fostering risk sharing within the monetary union;

C.  whereas the BU plays a key role in funding investment and therefore in fostering growth and job creation throughout the EU;

D.  whereas in a BU a Single Rulebook should be complemented by a Single Supervisory Mechanism (SSM), a Single Resolution Mechanism (SRM), and a high and uniform level of protection of deposits and an efficient fiscal backstop at EU level;

E.  whereas the SSM is the first pillar of the BU and aims to ensure a uniform and homogeneous supervision of participating Member States’ banks, create a level playing field in the banking market, and contribute to the safety and soundness of credit institutions and the stability of the financial system while respecting the diversity of banks and their business models;

F.  whereas the European Central Bank (ECB) has to date failed to take sufficient account of the proportionality principle in connection with its supervisory activities;

G.  whereas the SRM is the second pillar of the BU and aims to ensure uniform rules and procedures and a common decision-making process for orderly resolution of failing banks with minimum impact on the rest of the financial system, the real economy, ordinary citizens or public finance throughout Europe;

H.  whereas the third pillar of the BU so far consists in an approximation of national DGSs, and a proposal for a European Deposit Insurance Scheme aimed at gradually ensuring a unified level of protection of deposits has only recently been presented by the Commission and will be subject to the co-legislators’ decision through the ordinary legislative procedure;

I.  whereas the SSM Regulation and the SRM Regulation require that the new bodies created under the SSM – in particular the Supervisory Board of the ECB – and under the SRM – in particular the Single Resolution Board – comply with the principles of transparency and accountability in relation to the fulfilment of their tasks; whereas those bodies should be leading examples in this regard as well as in terms of technical competence and integrity;

The Single Supervisory Mechanism (SSM)

1.  Welcomes the establishment of the SSM, which has been successful since its creation both from an operational point of view and in terms of supervisory quality, and considers it a remarkable achievement, taking into account the complexity of the project and the very short timeframe available;

2.  Encourages broad representation in the BU through the future involvement and participation of NCAs of non-participating Member States in accordance with established legal rules and procedures, as well as through enhanced cooperation with third countries outside the EU; reaffirms that closer coordination between NCAs across the EU and internationally is essential for ensuring effective regulation and supervision of systemically important banks;

3.  Welcomes in particular, in relation to the operational set-up:

   (a) the recruitment process, which resulted in a good blend of competences, cultures and gender, thus contributing to the supranational nature of the SSM, and the thorough training activity programme for national competent authorities (NCAs) and ECB staff; points out, however, that ECB contracting practices leave room for improvement, especially in regard to the number of short-term contracts, checks on staff working hours, transparency of the recruitment process and willingness to negotiate with unions; notes the ECB’s announcement that it has appointed its first Chief Services Officer to manage all administrative services, IT services and human resources;
   (b) the drafting, building on national best practices, of the Supervisory Manual laying down common processes, procedures and methods for conducting a euro-wide supervisory review process;
   (c) the set-up of the IT infrastructure and of the supporting analytical tools; stresses the importance of strong and well-functioning IT systems corresponding to the needs of the supervisory functions of the SSM; encourages coordination between the SSM and national supervisory authorities in order to meet the needs of data through a single application;
   (d) the setting up of Joint Supervisory Teams (JSTs) and the dialogue they have established with the supervised credit institutions;
   (e) the processes devised to work off the common procedures (authorisation of qualifying holdings, licensing, passporting, fit and proper assessments);

4.  Notes that a very significant share of work is routinely devoted to administrative procedures, required by the SSM Regulation, which may not always be proportionate, and stands ready to consider proposals aimed at reducing the operational burden on structures at all levels and improving the effectiveness of the SSM supervision, namely by exploiting the potential of streamlining administrative procedures, or by delegating certain decisions on specific administrative issues within clear limits and guidelines;

5.  Notes with satisfaction that the ethics rules of the ECB have been reviewed, and stresses the importance of effective rules on conflict of interests and safeguards against undue influence of the financial industry, on staff as well as on members of the governing bodies;

6.  Believes that while the degree of effectiveness achieved by JSTs in less than a year is remarkable, further improvements can be pursued, including by involving NCAs in a more effective way in the decision-making process;

7.  Takes note of the remarks made by supervised entities about the need for early planning of supervisory actions, in order to enhance their quality and avoid the unintended consequence of affecting banks’ business activities, and considers that there is a great deal of room for improvement in this respect;

8.  Emphasises the need to avoid double reporting requirements and multiple reporting channels, and more generally an unnecessary administrative burden on credit institutions, in particular smaller banks, as well as to ensure that the proportionality principle is upheld; calls for increased effectiveness of data collection, which should abide by the ‘once only’ principle and should be examined for its usefulness, applicability and proportionality;

9.  Calls on the ECB to ensure that the creation of a comprehensive credit risk database (Analytical Credit Dataset, AnaCredit) pays particular attention to the proportionality principle and to the need to avoid disproportionately high administrative costs, especially for smaller institutions; calls, in this context, for the relevant reporting thresholds to be set at an adequate level;

10.  Stresses the importance of close interaction between the ECB’s Directorates-General (DGs) in charge of direct and indirect micro-prudential supervision and the DG in charge of horizontal supervision and expertise services, and emphasises the role of the latter in improving the comprehension, among supervised entities, of a common supervisory approach underlying the concrete individual micro-prudential measures; stresses the importance of a full organisational separation between SSM staff and the staff providing services needed for independent monetary policy purposes;

11.  Calls for a systematic review of comprehensive assessments of ECB-supervised institutions, as well as for appropriate improvements of the methodology in the light of lessons learned, in all cases where an institution is deemed sound under the assessment and subsequently runs into trouble, as well as where an institution is deemed undercapitalised on the basis of a stress test scenario which turns out to be significantly unrealistic; emphasises the limitations of the current stress test methodology which evaluates third-country exposure on the basis of banks’ internal assessment;

12.  Welcomes the fact that the ECB is working on enhancements in the macro stress testing framework in order to integrate more realistic dynamic features in the stress testing model framework, add a proper liquidity stress test component, and integrate contagion effects within the banking system, as well as the two-way interaction with the real economy and the shadow banking sector in the broader framework;

13.  Considers the comprehensive assessment performed ahead of the launch of the SSM to be an important step towards restoring the confidence lost in the crisis years and enhancing the resilience of the euro area banking system by improving its capitalisation and increasing transparency; considers the Supervisory Review and Evaluation Process (SREP) and future comprehensive assessments of bank balance sheets to constitute a necessary tool in identifying banks, which should strengthen their capitalisation and reduce leverage;

14.  Stresses the fact that economic recovery is under way but – in particular due to an insufficient level of structural reforms, convergence and investment and excessive dependence on external factors – is still fragile and modest, while inflation remains below target; against this backdrop, notes that while tangible improvements could be observed in the recent past, credit dynamics are still subdued in many jurisdictions and a large stock of non-performing loans weighs on many European banks’ balance sheets, limiting their capacity to finance the economy;

15.  Recalls that the ability to write off or sell-on non-performing loans is vital, as it frees up capital to fund new loans, in particular to SMEs; stresses the need to address the issue of non-performing loans at European level, notably by facilitating the setting-up of asset management companies in those countries where this is deemed to be necessary, as was the case in Spain and Ireland;

16.  Highlights that effective coordination between macro-prudential and micro-prudential policies is crucial, and underlines the fact that the SSM is fully part of the EU macro-prudential framework and has been given relevant macro-prudential responsibilities, together with the NCAs and the ECB Governing Council; stresses the need to enhance the role of the European Systemic Risk Board (ESRB) in order to complement the powers of NCAs and the SSM by an EU-wide cross-sectoral macro-prudential authority to ensure that macro risks are tackled in the overall European interest; considers that macro-prudential policy must place greater emphasis on preventing large fluctuations in the financial cycle; recalls that the ESRB should address the interconnectedness of financial markets and any other systemic risk affecting the stability of financial markets;

17.  Agrees with the views expressed by senior ECB figures to the effect that macro-prudential policy must place greater emphasis on preventing large fluctuations in the financial cycle, rather than simply increasing resilience to shocks when they occur; welcomes the research by the ECB into the definition of financial stability, and urges the development of tools such as the systemic risk index discussed in the Financial Stability Review November 2015 for monitoring systemic risk as part of an effective toolkit for managing it;

18.  Notes that Banking Structural Reform, which was conceived to reduce systemic risk and address the issue of ‘too big to fail’ institutions, has yet to be implemented; urges a swift legislative agreement;

19.  Notes that the insurance sector is becoming increasingly involved in financial services, and underlines the importance of a level playing field in order to avoid regulatory arbitrage of prudential and consumer protection rules;

20.  Believes that the worldwide drive towards more and better quality bank capital and less leveraged banks is a necessary condition for a sound banking system capable of supporting the economy and for avoiding any repeat of the enormous bailouts witnessed during the crisis; underlines, however, that the development of regulatory, supervisory and other financial sector policies at global level (the Financial Stability Board (FSB), the Basel Committee on Banking Supervision (BCBS), etc.) must not target a particular funding model used in one part of the world;

21.  Notes that an increase in capital requirements beyond a certain threshold may in the short term create unintended consequences, limiting banks’ lending capacity, and that this risk should therefore be considered when determining the level of capital; underlines that the interdependence between capital requirements and credit supply is not linear;

22.  Calls on the Commission, together with the European Supervisory Authorities (ESAs), to conduct a comprehensive assessment of capital requirements embedded in current and future legislation, in particular with a view to analysing their consequences as regards the financing conditions of SMEs and more generally of the real economy, while taking into account the balance between short-term and long-term impact of capital requirements and the need to safeguard financial stability;

23.  Recalls the importance of tools such as the ‘SME Supporting Factor’; suggests that the initiatives for improved SME funding should be expanded to start-ups, micro- enterprises and mid-cap companies;

24.  Considers the stabilisation of the supervisory and regulatory framework to be an important element for restoring investors’ confidence, avoiding uncertainty over regulatory and supervisory action, and supporting growth and financial stability; calls for reducing the complexity of existing regulation in the short term and for establishing in the medium term an integrated European rulebook on financial regulation and consumer rights, replacing the current complex and burdensome silo-like legislation;

25.  Welcomes the development of a common methodology for the 2015 round of the SREP; notes that, partly as a consequence of the swift start of the SSM, many aspects of this methodology were finalised only when the SREP cycle was already under way, and considers that in order to improve the robustness of results and consistency between banks’ risk profiles and capital levels, the process leading to the approval of the common supervisory standards for risk assessment can benefit from further refinement; welcomes the SSM’s willingness to work on bank governance, and in particular on risk management, risk appetite and cyber-risk;

26.  Considers the calculation of Maximum Distributable Amount (MDA) for each individual bank in line with Article 141(6) of the Capital Requirements Directive (CRD) to be an important tool for achieving capital restoration, as an alternative to shrinking balance sheets; underlines that the legislation’s lack of clarity on the hierarchy between pillar two and capital buffers in relation to the MDA threshold and to other sanctioning measures does not prevent the SSM from using a margin of flexibility in order to avoid solutions which are too rigid and might negatively affect the AT1 bond market and the level playing field with other jurisdictions; calls for a legal clarification of the MDA mechanism and of the function of pillar two, which is to address ‘bank-specific risk’, in order to guarantee a level playing field in the EU and to provide more clarity on the aim of the mechanism; considers that the review of those provisions should aim to incorporate them into the regulation;

27.  Stresses that national options and discretion attributed to Member States prevent the SSM from developing a single coherent supervisory approach within the euro area in order to ensure a true level playing field, and believes that the homogenisation of practices and standards should go hand in hand with the completion of the other two pillars of the Banking Union; in this respect, welcomes the publication by the ECB of a draft regulation aiming to close around 35 national options and discretions under the EU banking regulatory framework, as well as of a draft guide to help JSTs make decisions in a more consistent manner in the areas covered by the other options and discretions identified; considers that such a single implementation requires a gradual approach and should aim to address all existing barriers and segmentations; stands ready to cooperate at the legislative level in order to further improve regulatory and supervisory harmonisation; emphasises the need for the review of national options and discretions to guarantee a level playing field across the Banking Union, including between conglomerates and non-conglomerated institutions which have holdings in insurance undertakings;

28.  Recalls that the application of fair value measurement for unrealised gains and losses on exposures to central governments classified under ‘Available for Sale’ not only strengthens the link between banks and sovereigns, but may also lead to own funds volatility; calls on the ECB to maintain the non-application of this measurement until such time as IFRS 9 is applied;

29.  Stresses the fact that both Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and the Capital Requirements Directive (Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms), collectively referred to as ‘CRR/CRDIV’, were adopted by the co-legislators before the establishment of the Single Supervisory Mechanism; encourages the Commission to put forward a proposal for a technical adaptation of CRR/CRDIV in order to align it with the Banking Union framework; urges the Commission to use regulations (which are applicable directly and to all throughout the EU), rather than directives, as the legislative tool to ensure harmonised implementation across the EU and the Banking Union;

30.  Stresses the importance of the work that has been undertaken on the homogenisation of the calculation of risk-weighted assets, which is pivotal for comparability purposes, and on the review of internal models for the calculation of banks’ capital requirements; considers progress in this area, for all portfolios, to be crucial for preserving the effectiveness and credibility of banking supervision in the euro area in order to promote best practice in market and credit risk models;

31.  Welcomes the adoption by the SSM of five high-level priorities to guide its supervision throughout 2016; underlines that the SSM should look beyond credit risk to all forms of bank risk, including non-financial risk; underlines that further steps are necessary to reinforce the supervisory scrutiny of banks’ financial portfolios, especially level 3 financial assets, including derivatives; stresses the need for a reduction of the interlinkages between the regulated and the shadow banking sector, not least via limiting the respective credit risk exposure;

32.  Considers that more appropriate attention should be paid to increased exposure in the form of off-balance sheet items, in particular for global systematically important banks (G-SIBs); underlines in this respect the need to be vigilant over the development of the shadow banking sector;

33.  Takes note of the work of the BCBS and the ESRB on sovereign exposures of banks and other financial intermediaries; calls on the EU institutions to carefully and thoroughly assess possible changes in the medium term to the current regulatory framework, without reducing available funding for Member States, without creating unintended market or competition distortions and without affecting financial stability, and as part of a coordinated effort at the global level; underlines that in order to have a comprehensive risk reduction, parallel measures should be taken among others to reduce level 2 and level 3 assets exposure and to ensure the full convergence of internal ratings-based (IRB) systems for the measurement of credit risk;

34.  Underlines that the SSM and SRM represent a step in the direction of a common market for banking services, making cross-border consolidation more appealing; believes that the introduction of a financial stability and resolvability assessment in the Qualifying Holdings Directive is necessary to avoid new too-big-to-fail problems that may be produced due to a higher number of mergers and acquisitions;

35.  Underlines the important role played by the SSM during the Greek crisis in monitoring the condition of the country’s banking sector, in conducting a comprehensive assessment of the significant Greek institutions and in contributing to the determination of the recapitalisation needs; notes that the recapitalisation needs of Greek banks as assessed by the SSM range from EUR 4,4 billion in a baseline scenario to EUR 14,4 billion in the most risky scenario, while the buffer envisaged under the Programme was as high as EUR 25 billion; asks for clarification with regard to the role of financial consultancies, which were often hired without a public tender and played a role in all the euro area bailouts by providing expertise to the troika of international lenders; calls for more transparency and accountability in the hiring process in order to avoid potential conflicts of interest arising from links to investment funds and other financial service providers; asks the ECB to redefine its role with regard to assistance programmes as one of ‘silent observer’; stresses that emergency liquidity assistance (ELA) is an essential instrument for safeguarding the stability of the financial system by preventing liquidity crises from turning into solvency crises; notes that the responsibility for its provision has not yet been fully transferred to the euro area level; welcomes the remarks made by President Draghi to Parliament’s Committee on Economic and Monetary Affairs hinting at a diligent revision of the ELA regime in the light of the ‘Europeanisation’ of bank supervision;

36.  Believes that the ECB’s supervisory strategy, while avoiding any differentiation along national lines, should reflect and safeguard pluralism and diversity of banking models across the EU, including authentic and healthy mutual, savings and cooperative banks, and should comply with the principle of proportionality;

37.  Considers transparency vis-à-vis market players and the public, including on sensitive topics such as capital targets as a result of the SREP cycle, supervisory practices and other requirements, to be essential for a level playing field between supervised entities, for fair competition in the banking market and for avoiding situations where regulatory uncertainty negatively influences banks’ business strategy; underlines that transparency of both supervisors and supervised entities is also a prerequisite for accountability, as it allows Parliament and the public to be informed about key policy issues and to assess consistency with rules and supervisory practices; calls for more transparency with regard to pillar 2 decisions and justifications;

38.  Highlights that in this regard the publication of a list of Frequently Asked Questions on the SREP could be a useful tool;

39.  Welcomes the efficient and open way in which the ECB has so far fulfilled its accountability obligations towards Parliament, and calls on the ECB to continue to fully engage in this regard and to further contribute to improving Parliament’s capacity to assess SSM policies and activities; views favourably the willingness of the ECB President to further cooperate with Parliament regarding the ECB’s role in banking matters, in particular in the framework of global standards-setting bodies such as the FSB;

40.  Recalls that public audit is an integral part of the mechanisms for ensuring the accountability of institutions to citizens; notes, therefore, with some concern the statement published in June 2015 by the Contact Committee of the Heads of the Supreme Audit Institutions of the European Union and the European Court of Auditors (ECA), which warns against the emergence of audit gaps due to the transfer of supervisory tasks from national authorities to the SSM in a context where the audit mandate of the ECA over the ECB acting as a supervisor is less comprehensive than those of national audit institutions over national supervisors; recommends accordingly that consideration be given to strengthening the audit mandate of the ECA;

41.  Underlines the importance of cooperating with the Single Resolution Board (SRB), the European Banking Authority (EBA) and other authorities within the European System of Financial Supervision, while fully respecting the division of roles and competences and the separation between regulation and supervision in order to help ensure compliance with the EU checks-and-balances structure; stresses in particular that the EBA, with its explicit consumer protection mandate, must enforce and enhance the consumer protection framework for banking services, complementing the SSM’s prudential supervision, and in the Union as a whole;

42.  Welcomes the credibility of the SSM on the international stage; considers it fundamental that the SSM is properly involved in the design of global regulatory standards, in particular the orientations negotiated within the FSB and the BCBS;

Single Resolution Mechanism (SRM)

43.  Welcomes the efficient setting-up of the SRB and the establishment of national resolution authorities (NRAs) in the Member States;

44.  Highlights the importance of establishing efficient cooperation between the SRB and the NRAs for the smooth functioning of the SRM; considers Internal Resolution Teams (IRTs), as an equivalent to the SSM’s JSTs, to be a good basis for organising cooperation within the SRM;

45.  Encourages the conclusion of a memorandum of understanding (MoU) on mutual cooperation and data sharing between the SRB and the ECB as a single supervisor, in order to increase efficiency and avoid double reporting for banks, while allowing the SRB to have access to the SSM data needed for it to fulfil its institutional mandate; underlines the importance of smooth cooperation between the SRM and the national competent authorities (NCAs);

46.  Underlines the discrepancy between banks directly supervised by the SSM and banks under the direct responsibility of the SRB (including other cross-border groups) and its potential consequences in terms of the SRB’s access to information;

47.  Calls for specific arrangements to be created within the Commission and between the SRB and the Commission in order to define efficient procedures for decision-making in the event of resolution;

48.  Encourages the conclusion of cooperation agreements between the SRB and the NRAs of non-participating Member States and third countries for effective mutual cooperation and information exchange;

49.  Welcomes the preparation by the SRB of manuals on resolution activities, in line with the relevant EBA standards, which aim to promote a consistent, effective and proportionate approach to resolution tasks within the SRM;

50.  Calls for timely progress to be made in drawing up resolution plans and setting a minimum requirement for own funds and eligible liabilities (MREL) for institutions falling within the scope of the SRM, in order to be able to ensure an orderly resolution of failing banks with a minimum impact on the real economy and public finances; calls on the Commission to swiftly adopt the regulatory technical standard on MREL, with a high binding standard of at least 8 % MREL for all SRB banks, in line with the Bank Recovery and Resolution Directive (BRRD) (Directive 2014/59/EU of the European Parliament and the Council of 15 May 2014)(14) and minimising the chances of loss of SMEs’ uncovered deposits; takes note of the ongoing work on the implementation of Total Loss Absorbing Capacity (TLAC) and calls on the Commission to ensure consistency with MREL;

51.  Invites the Commission to assess, in the light of experience and in the framework of the review of Regulation (EU) No 806/2014, whether the SRB and the NRAs are equipped with sufficient early intervention powers and sufficient early intervention instruments to prevent the haemorrhaging of banks;

52.  Underlines that according to the SRM regulation the Board should take due care, as a matter of priority, to establish the resolution plans of systemically important institutions, assess their resolvability and take all action necessary to address or remove all of the impediments to their resolvability; further emphasises that the Board has the power to require changes to the structure and organisation of institutions or groups with a view to taking measures which are necessary and proportionate to reduce or remove material impediments to the application of resolution tools and ensure the resolvability of the entities concerned;

53.  Takes note of the double role of the Board members, who are at the same time members of an executive body with decision-making roles and senior managers accountable in that capacity to the Chair, and considers that an evaluation of this structure should be undertaken before the end of the current mandate;

54.  Calls on those Member States which have not yet done so to complete the transposition of the BRRD, and highlights the importance of full implementation and enforcement of its provisions;

55.  Welcomes the ratification by Member States of the Intergovernmental Agreement on the transfer and mutualisation of contributions to a single resolution fund (SRF), which allows the SRM to become fully operational, including the use of the bail-in instrument, as of 1 January 2016 according to the planned schedule; welcomes the establishment of calculation and collection procedures for ex ante contributions to the SRF through the SRB; regrets the decision to set up the SRF through an intergovernmental agreement (IGA) rather than through Union law; calls on the Commission swiftly to take the necessary steps for a quick integration of the IGA into the framework of EU law, as provided for in Article 16 of the Agreement and in the Five Presidents’ Report;

56.  Calls on the Commission to present proposals to further reduce the legal risks of claims under the no-creditor-worse-off-principle;

57.  Calls on the Member States to collect the BRRD and SRM-related contributions fully, effectively and in a timely manner at the national level in order to transfer them to the SRF in accordance with the IGA;

58.  Calls on the Commission to undertake an extremely careful review of the calculation of contributions to the SRF provided for in recital 27 of Delegated Regulation (EU) 2015/63, and when so doing to review in particular the appropriateness of the risk factor in order to ensure that the risk profile of less complex institutions is reflected appropriately;

59.  Recommends, for the successful management of banking crises in the future, careful assessment of the various choices at the disposal of the Board on the basis of the EU legislation (different resolution tools as an alternative to the liquidation of the bank), keeping in mind the importance of safeguarding financial stability and maintaining confidence in the banking system;

60.  Draws attention to the difference in timing between the rules on burden-sharing and those on the full bail-in, which have retroactively affected the effective riskiness of the debt instruments issued before the latter legal provisions, and the definition and implementation of appropriate investment protection rules; invites the SRB to conduct a careful assessment of the transition period and to ensure that, in line with the requirements of the legislation, the new rules are implemented with the necessary proportionality and fairness; asks the Commission and the European Securities and Markets Authority (ESMA) to guarantee appropriate investor protection;

61.  Stresses the need, as a consequence of the existence of the national compartments in the SRF, to rapidly put in place an adequate bridge financing mechanism in order to provide the fund, if necessary, with sufficient resources in the period before its completion and guarantee the effective separation between banks and sovereigns; recalls that the Eurogroup and the ECOFIN ministers identified, in their statement of 18 December 2013, the possibility of having recourse either to national sources, backed by bank levies, or to the European Stability Mechanism (ESM);

62.  Welcomes, nonetheless, the agreement reached to secure public bridge financing to help ensure the availability of funds for concrete resolution action through national resources;

63.  Recalls the ECOFIN statement of 8 December 2015 and the commitment made in it to consider, after completion of the ratification of the IGA, the full transposition of the BRRD and the establishment of the bridge financing arrangements as well as the way forward and timing in order to develop a common backstop to facilitate borrowings by the SRF, to be fully operational at the latest by the end of the transition period; stresses, however, that a common fiscal backstop will be used only as a last resort should the other prudential measures to strengthen supervision and crisis management not be able to eliminate the risk; recalls that the backstop should be fiscally neutral in the medium term, and underlines the importance of avoiding moral hazard; underlines that the banking sector should remain liable for repayment by bank levies in all participating Member States, including ex post;

Third pillar

64.  Recalls that, together with the SSM and the SRM, the capacity to afford a uniform and high level of protection of deposits, irrespective of their location, should be ensured in an effective BU, thus contributing to genuinely breaking the sovereign-bank loop, restoring depositors’ confidence, creating a level playing field and enhancing financial stability; considers that any system of protection of deposits must always avoid the introduction of any moral hazard, while ensuring that risk takers remain liable for their risk taking;

65.  Welcomes the Commission’s package proposed on 24 November 2015 on risk sharing and risk reduction in the BU; takes note of the gradual approach from a reinsurance of national Deposit Guarantee Schemes (DGSs) to a co-insurance scheme and, finally, full insurance for participating national DGSs in the steady state and the risk-based approach to the calculation of contributions; looks forward to engaging in the legislative negotiations on the basis of the position that is adopted;

66.  Notes that the creation of a European Deposit Insurance Scheme (EDIS) requires the implementation of the single rulebook as well as of the first and second pillars of the BU, as well as the transposition of the BRRD and the Deposit Guarantee Schemes Directive (DGSD) by all the participating Member States and further measures to achieve a substantial reduction of risks in the European banking system; stresses that the application of the bail-in tool will introduce a systemic mechanism of risk avoidance, thus reducing the fears of moral hazard which could be induced by the progressive mutualisation of guarantee schemes; underlines the commitment of the Commission to further reduce risks and ensure a level playing field in the BU;

67.  Notes that a well-functioning deposit guarantee scheme funded through contributions from the financial sector is one of the proven ways to prevent bail-outs of banks with taxpayers’ money;

68.  Recalls that the role of the Commission is to guarantee a level playing field across the EU and that it should avoid any fragmentation within the internal market;

o
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69.  Instructs its President to forward this resolution to the Council, the Commission, the European Central Bank and the Single Resolution Board.

(1) OJ L 287, 29.10.2013, p. 63.
(2) OJ L 320, 30.11.2013, p. 1.
(3) https://www.bankingsupervision.europa.eu/ecb/pub/pdf/ssmar2014.en.pdf.
(4) OJ L 141, 14.5.2014, p. 1.
(5) OJ L 300, 18.10.2014, p. 57.
(6) OJ L 69, 8.3.2014, p. 107.
(7) https://www.bankingsupervision.europa.eu/banking/comprehensive/2014/html/index.en.html.
(8) OJ L 86, 31.3.2015, p. 13.
(9) OJ L 225, 30.7.2014, p. 1.
(10) OJ L 339, 24.12.2015, p. 58.
(11) OJ L 173, 12.6.2014, p. 149.
(12) Texts adopted, P8_TA(2016)0006.
(13) Texts adopted, P8_TA(2015)0238.
(14) OJ L 173, 12.6.2014, p. 190.

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