Procedure : 2018/2185(DEC)
Document stages in plenary
Document selected : A8-0135/2019

Texts tabled :

A8-0135/2019

Debates :

PV 26/03/2019 - 12
CRE 26/03/2019 - 12

Votes :

PV 26/03/2019 - 13.30

Texts adopted :

P8_TA(2019)0271

REPORT     
PDF 187kWORD 70k
1.3.2019
PE 626.799v02-00 A8-0135/2019

on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2017

(2018/2185(DEC))

Committee on Budgetary Control

Rapporteur: Petri Sarvamaa

AMENDMENTS
1. PROPOSAL FOR A EUROPEAN PARLIAMENT DECISION

1. PROPOSAL FOR A EUROPEAN PARLIAMENT DECISION

on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2017

(2018/2185(DEC))

The European Parliament,

–  having regard to the final annual accounts of the European Medicines Agency for the financial year 2017,

–  having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2017, together with the Agency’s reply(1),

–  having regard to the statement of assurance(2) as to the reliability of the accounts and the legality and regularity of the underlying transactions provided by the Court of Auditors for the financial year 2017, pursuant to Article 287 of the Treaty on the Functioning of the European Union,

–  having regard to the Council’s recommendation of 12 February 2019 on discharge to be given to the Agency in respect of the implementation of the budget for the financial year 2017 (05825/2019 – C8‑0075/2019),

–  having regard to Article 319 of the Treaty on the Functioning of the European Union,

–  having regard to 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(3), and in particular Article 208 thereof,

–  having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012(4), and in particular Article 70 thereof

–  having regard to 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(5), and in particular Article 68 thereof,

–  having regard to Commission Delegated Regulation (EU) No 1271/2013 of 30 September 2013 on the framework financial regulation for the bodies referred to in Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council(6), and in particular Article 108 thereof,

–  having regard to Rule 94 of and Annex IV to its Rules of Procedure,

–  having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0135/2019),

1.  Grants the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2017;

2.  Sets out its observations in the resolution below;

3.  Instructs its President to forward this decision, and the resolution forming an integral part of it, to the Executive Director of the European Medicines Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

2. PROPOSAL FOR A EUROPEAN PARLIAMENT DECISION

on the closure of the accounts of the European Medicines Agency for the financial year 2017

(2018/2185(DEC))

The European Parliament,

–  having regard to the final annual accounts of the European Medicines Agency for the financial year 2017,

–  having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2017, together with the Agency’s reply(7),

–  having regard to the statement of assurance(8) as to the reliability of the accounts and the legality and regularity of the underlying transactions provided by the Court of Auditors for the financial year 2017, pursuant to Article 287 of the Treaty on the Functioning of the European Union,

–  having regard to the Council’s recommendation of 12 February 2019 on discharge to be given to the Agency in respect of the implementation of the budget for the financial year 2017 (05825/2019 – C8‑0075/2019),

–  having regard to Article 319 of the Treaty on the Functioning of the European Union,

–  having regard to 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(9), and in particular Article 208 thereof,

–  having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012(10), and in particular Article 70 thereof

–  having regard to 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(11), and in particular Article 68 thereof,

–  having regard to Commission Delegated Regulation (EU) No 1271/2013 of 30 September 2013 on the framework financial regulation for the bodies referred to in Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council(12), and in particular Article 108 thereof,

–  having regard to Rule 94 of and Annex IV to its Rules of Procedure,

–  having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0135/2019),

1.  Approves the closure of the accounts of the European Medicines Agency for the financial year 2017;

2.  Instructs its President to forward this decision to the Executive Director of the European Medicines Agency, the Council, the Commission and the Court of Auditors, and to arrange for its publication in the Official Journal of the European Union (L series).

3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION

with observations forming an integral part of the decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2017

(2018/2185(DEC))

The European Parliament,

–  having regard to its decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2017,

–  having regard to Rule 94 of and Annex IV to its Rules of Procedure,

–  having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0135/2019),

A.  whereas, according to its statement of revenue and expenditure(13), the final budget of the European Medicines Agency (‘the Agency’) for the financial year 2017 was EUR 331 266 000, representing an increase of 7, 41 % compared to 2016; whereas the Agency is a fee-funded agency, with 86 % of its 2017 revenue stemming from fees paid by the pharmaceutical industry for services provided, and 12 % stemming from the Union budget;

B.  whereas the Court of Auditors (‘the Court’) in its report on the annual accounts of the Agency for the financial year 2017 (’the Court's report’), has stated that it has obtained reasonable assurances that the Agency’s annual accounts are reliable and that the underlying transactions are legal and regular;

Budget and financial management

1.  Notes that budget monitoring efforts during the financial year 2017 resulted in a budget implementation rate of 92,92 %, representing a decrease of 3,38 % compared to 2016; notes furthermore that the payment appropriations execution rate was 76,62 %, representing a decrease of 5,73 % compared to 2016;

Cancellation of carryovers

2.  Regrets that the cancellations of carry-overs from 2016 to 2017 amounted to EUR 4 350 908, representing 10, 11 % of the total amount carried-over, showing a notable increase of 5, 65 % in comparison to 2016; calls on the Agency to report to the discharge authority on the measures taken to ensure complete use of the appropriations carried-over, in order to avoid substantial resources being de-committed;

Performance

3.  Acknowledges that the Agency uses several key performance indicators, including a combination of operational, management/governance and communication/stakeholder indicators to measure its workload volumes, its work programme implementation and its stakeholders satisfaction amongst others, in order to assess the added value provided by its activities, and that it furthermore uses budget planning and monitoring methodology to enhance its budget management;

4.  Acknowledges that the Agency implemented in November 2017 a new and improved version of the EudraVigilance system, an information system used to report suspected side effects of medicines;

5.  Reiterates the important role of the Agency in protecting and promoting public and animal health by assessing and supervising medicines for human or veterinary use;

6.  Stresses that a number of the Agency’s activities were delayed or postponed due to Brexit or external circumstances;

7.  Highlights that in 2017, the Agency recommended 110 new medicines for marketing authorisation (92 for human use and 18 for veterinary use), and that those included 42 new active substances (35 for human use and 7 for veterinary use);

8.  Welcomes the fact that in 2017 the Agency implemented a communication plan strengthening collaboration with national competent authorities, patient-and-consumer, and healthcare-professional organisations;

9.  Notes with satisfaction that the Agency cooperates with other Agencies on joint scientific outputs and exchanges support or scientific data; acknowledges furthermore that the Agency has formal working arrangements with its five main Agency partners;

10.  Notes that the Agency’s management board adopted the multiannual work plan 2018-2020, which supports the implementation of the joint strategy for the European medicines regulatory network and furthermore outlines key initiatives and activities for the coming years;

Staff policy

11.  Notes that, on 31 December 2017, the establishment plan was 97,82 % executed, with 583 temporary agents appointed out of 596 temporary agents authorised under the Union budget (compared with 602 authorised posts in 2016); notes that in addition 147 contract agents and 36 seconded national Experts worked for the Agency in 2017; notes that the staff expenses increased by 10 million euros; asks the Agency to report comprehensively on this expenditure; urges the Agency to not replace permanent staff by more expensive contract agents;

12.  Notes that the Agency has adopted the Commission’s model decision on the policy on protecting the dignity of the person and preventing harassment; acknowledges that the Agency put in place a system of confidential counsellors following an inter-agency call for expression and appointed a Harassment Prevention Coordinator;

13.  Notes with concern that, according to the Agency and to the Court’s report, while significant new tasks were assigned to the Agency, the Agency’s staff establishment plan was not increased in 2017, leading to a critical dependence on external expertise in affected areas; welcomes that the management board of the Agency was verbally informed by DG SANTE representative that the Agency’s request to hire up to 40 time-limited contract agents in 2019 has been accepted; welcomes the measures already taken by the Agency to mitigate the risks involved and calls on the Agency to report to the discharge authority on further decisions taken in order to improve the situation;

14.  Welcomes the suggestion of the Court to publish vacancy notices also on the website of the European Personnel Selection Office in order to increase publicity; understands the Agency’s concerns regarding translation costs;

Procurement

15.  Notes that, according to the Court´s report, by the end of 2017 the Agency had not yet introduced all of the tools launched by the Commission aimed at introducing a single solution for the electronic exchange of information with third parties that participate in public procurement procedures (e-procurement); notes that, according to the Agency’s reply, it signed a Memorandum of Understanding with the Commission for access to and the use of e-submission; calls on the Agency to introduce all the necessary tools and report to the discharge authority on the progress made in that field;

Prevention and management of conflicts of interests and transparency

16.   Stresses that the Agency’s clients - the pharmaceutical industry - pay for the procedure, not for the outcome of the Agency’s assessments; understands that according to the Agency it considers its recommendations to be made independently and that they, therefore, do not create conflicts of interest, in respect of which any potential risks are however duly considered, prevented and mitigated;

17.  Welcomes the fact that the Agency also requests all IT consultants to sign individual declarations of interest and confidentiality undertaking at the beginning of their assignment;

18.  Acknowledges the Agency’s existing measures and ongoing efforts to secure transparency, prevention, management of conflicts of interest, and whistle-blower protection; notes with concern that in 2017 the Agency received 25 reports on cases of whistleblowing from an external source, 15 cases were closed in 2017 and 10 cases are still ongoing; calls on the Agency to report to the discharge authority on any developments in that regard;

19.   Highlights that no breach of trust procedure was initiated for management board members, scientific committee members or experts, and that no cases of conflicts of interests were noted in relation to staff members in 2017;

20.  Notes that the Agency meets with external stakeholders and has rules in place to govern its interactions with stakeholders and furthermore that it publishes the minutes of meetings with ‘interest representatives’ on its website; notes with satisfaction that the Agency developed a framework for stakeholder relation management in consultation with the Commission, which encompassed transparency measures;

21.  Notes that, according to the Court’s report, there is a need to strengthen the accounting officer’s independence by making him directly responsible to the Agency’s Executive Director and management board; Notes that, according to the Agency’s reply, it is satisfied with the level of independence provided by the current framework, but it will consider, nevertheless, what changes could be introduced; calls on the Agency to report to the discharge authority on the developments in this regard; notes furthermore from the Agency that it launched the re-validation of its accounting systems in March 2018;

22.  Welcomes the inquiry that the European Ombudsman opened into the arrangements that the Agency has in place for engaging with medicine producers before they apply for authorisations to market their medicines in the Union and welcomes the fact that all interested parties are invited to put forward their comments on this issue, especially since the Agency’s income on fees and charges related to marketing authorisations increased by 14 million euros;

23.  Acknowledges from the Agency that pre-submission meetings contribute to the development of medicines; notes that in the light of the pre-submission meetings, the experts of the Committee for Medicinal Products for Human Use (CHMP) perform both the role of consultant and of evaluator of the marketing authorisation applications; calls upon the Agency to at least publish a list of pre-submission activities, once the marketing authorisation has been given;

Internal audit

24.  Notes with concern that the Commission’s Internal Audit Service carried out an audit of the Agency’s ’Implementation of the pharmacovigilance fees Regulation’(14), which concluded that although the design of the management and the internal control system is adequate, there is a significant weakness, which was recorded as a ‘very important’ recommendation, regarding the Agency's management of the continuous deficit between income from pharmacovigilance fees and the related costs; notes that the Agency prepared an action plan which includes the ongoing evaluation by the Commission of the current fee and remuneration system; calls on the Agency to report to the discharge authority on the corrective actions taken to address the recommendations;

Other Comments

25.  Notes that the Court issued an emphasis of matter paragraph in relation to the two London-based agencies, concerning the United Kingdom’s decision to withdraw from the European Union; notes that the seat of the Agency will move to Amsterdam at the beginning of 2019 and that the Agency’s accounts include provisions for related costs amounting to EUR 18 600 000; regrets that the lease agreement for the London based premises sets a rental period until 2039 with no exit clause; deeply regrets that the notes to the accounts disclose an amount of EUR 489 000 000 remaining rent until 2039, of which a maximum amount of EUR 465 000 000 corresponding to the lease period after the Agency’s planned move to Amsterdam is disclosed as a contingent liability; urges the Agency and the European Commission to do their utmost to minimise the financial, administrative and operational impact of the unfavourable lease agreement and to report to the discharge authority on the developments in this regard;

26.  Acknowledges that the Agency established an operations and relocation preparedness task force to ensure that the Agency takes all the necessary steps to maintain the continuity of its business operations following the United Kingdom’s withdrawal from the European Union and the Agency’s transfer to the Netherlands; notes with satisfaction that in 2017, the Agency took several steps towards the relocation to Amsterdam, including an impact assessment, staff surveys, a dedicated recruitment and selection strategy following the United Kingdom’s decision to withdraw from the European Union and preparations for the relocation of the Agency’s data centres;

27.  Highlights that, according to the Agency, it requires significant resources to be redistributed for relocation tasks and that a shortage of human resources may result in challenges for the Agency to fulfil its core and legislative responsibilities; calls on the Agency to report to the discharge authority on any developments in that regard;

°

°  °

28.  Refers, for other observations of a cross-cutting nature accompanying its decision on discharge, to its resolution of …2019(15) on the performance, financial management and control of the agencies.

23.1.2019

OPINION of the Committee on the Environment, Public Health and Food Safety

for the Committee on Budgetary Control

on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2017

(2018/2185(DEC))

Rapporteur for opinion: Adina‑Ioana Vălean

SUGGESTIONS

The Committee on the Environment, Public Health and Food Safety calls on the Committee on Budgetary Control, as the committee responsible, to incorporate the following suggestions into its motion for a resolution:

1.  Highlights that the Agency is a fee-funded agency, with 88 % of its 2017 revenue stemming from fees paid by the pharmaceutical industry, 9 % stemming from the Union budget and 3 % stemming from external assigned revenue;

2.  Notes that the final budget of the Agency for the financial year 2017 was EUR 331 266 000, representing an increase of 7,4 % compared to 2016;

3.  Stresses that during the financial year 2017 the budget implementation rate reached 92,92%, representing a decrease of 3,38 percentage points compared to 2016; notes furthermore that the payment appropriations execution rate was 82,45%, representing a decrease of 3,06 percentage points compared to 2016;

4.  Notes that 583 posts (out of 596 authorised posts under the 2017 Union budget) were occupied on 31 December 2017 (compared to 587 posts out of 602 authorised posts in 2016); regrets that new tasks were allocated to the Agency without any staff increase, leading to a critical dependence on external expertise; stresses that the relocation of the Agency requires significant resources, leading to shortage of human resources, which may affect negatively the capacity of the Agency to fulfil its core and legislative responsibilities;

5.  Reiterates the important role of the Agency in protecting and promoting public and animal health by assessing and supervising medicines for human or veterinary use;

6.  Stresses that a number of the Agency’s activities were delayed or postponed due to Brexit or external circumstances;

7.  Highlights that in 2017, the Agency recommended 110 new medicines for marketing authorisation (92 for human use and 18 for veterinary use), and that those included 42 new active substances (35 for human use and 7 for veterinary use);

8.  Points out that the management board adopted a decision on protecting the dignity of the person and preventing psychological and sexual harassment;

9.   Highlights that no breach of trust procedure was initiated for management board members, scientific committee members or experts, and that no cases of conflicts of interests were noted in relation to staff members in 2017;

10.  Takes note that the Agency recorded no internal whistleblower cases and received 25 reports from an external source in 2017, 10 of which were still ongoing on 31 December 2017; notes that in two cases a regulatory action was taken at Member State level;

11.  Welcomes the fact that in 2017 the Agency implemented a communication plan strengthening collaboration with national competent authorities, patient-and-consumer, and healthcare-professional organisations;

12.  Notes with satisfaction that the Agency cooperates with other agencies, notably with the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) in the area of antimicrobial resistance;

13.  Welcomes that the Court of Auditors has stated that it has obtained reasonable assurances that the Agency’s annual accounts for 2017 are reliable and that the underlying transactions are legal and regular;

14.  Recommends, based on the facts available, that discharge be granted to the Executive Director of the European Medicines Agency in respect of the implementation of the Agency’s budget for the financial year 2017.

INFORMATION ON ADOPTION IN COMMITTEE ASKED FOR OPINION

Date adopted

22.1.2019

 

 

 

Result of final vote

+:

–:

0:

48

6

2

Members present for the final vote

Margrete Auken, Pilar Ayuso, Catherine Bearder, Ivo Belet, Simona Bonafè, Biljana Borzan, Paul Brannen, Soledad Cabezón Ruiz, Nessa Childers, Birgit Collin-Langen, Miriam Dalli, Seb Dance, Angélique Delahaye, Mark Demesmaeker, Stefan Eck, Bas Eickhout, José Inácio Faria, Karl-Heinz Florenz, Francesc Gambús, Elisabetta Gardini, Arne Gericke, Jens Gieseke, Julie Girling, Sylvie Goddyn, Françoise Grossetête, Jytte Guteland, Anneli Jäätteenmäki, Jean-François Jalkh, Benedek Jávor, Kateřina Konečná, Urszula Krupa, Peter Liese, Valentinas Mazuronis, Susanne Melior, Miroslav Mikolášik, Rory Palmer, Gilles Pargneaux, Bolesław G. Piecha, Pavel Poc, John Procter, Frédérique Ries, Daciana Octavia Sârbu, Annie Schreijer-Pierik, Ivica Tolić, Nils Torvalds, Adina-Ioana Vălean, Damiano Zoffoli

Substitutes present for the final vote

Cristian-Silviu Buşoi, Christophe Hansen, Martin Häusling, Anja Hazekamp, Jan Huitema, Tilly Metz, Bart Staes, Tiemo Wölken

Substitutes under Rule 200(2) present for the final vote

Olle Ludvigsson

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION

48

+

ALDE

Catherine Bearder, Jan Huitema, Anneli Jäätteenmäki, Valentinas Mazuronis, Frédérique Ries, Nils Torvalds

ECR

Mark Demesmaeker

GUE/NGL 

Stefan Eck, Anja Hazekamp, Kateřina Konečná

PPE

Pilar Ayuso, Ivo Belet, Cristian Silviu Buşoi, Birgit Collin Langen, Angélique Delahaye, José Inácio Faria, Karl‑Heinz Florenz, Francesc Gambús, Jens Gieseke, Julie Girling, Françoise Grossetête, Christophe Hansen, Peter Liese, Miroslav Mikolášik, Annie Schreijer Pierik, Ivica Tolić, Adina Ioana Vălean

S&D

Simona Bonafè, Biljana Borzan, Paul Brannen, Soledad Cabezón Ruiz, Miriam Dalli, Seb Dance, Jytte Guteland, Olle Ludvigsson, Susanne Melior, Rory Palmer, Gilles Pargneaux, Pavel Poc, Daciana Octavia Sârbu, Tiemo Wölken, Damiano Zoffoli

VERTS/ALE

Margrete Auken, Bas Eickhout, Martin Häusling, Benedek Jávor, Tilly Metz, Bart Staes

6

-

ECR

Arne Gericke, Urszula Krupa, Bolesław G. Piecha, John Procter

ENF

Jean‑François Jalkh

S&D

Nessa Childers

2

0

EFDD

Sylvie Goddyn

PPE

Elisabetta Gardini

Key to symbols:

+  :  in favour

-  :  against

0  :  abstention

INFORMATION ON ADOPTION IN COMMITTEE RESPONSIBLE

Date adopted

20.2.2019

 

 

 

Result of final vote

+:

–:

0:

20

1

0

Members present for the final vote

Nedzhmi Ali, Inés Ayala Sender, Zigmantas Balčytis, Dennis de Jong, Tamás Deutsch, Martina Dlabajová, Ingeborg Gräßle, Jean-François Jalkh, Wolf Klinz, Monica Macovei, Georgi Pirinski, José Ignacio Salafranca Sánchez-Neyra, Petri Sarvamaa, Claudia Schmidt, Bart Staes, Marco Valli, Derek Vaughan, Tomáš Zdechovský, Joachim Zeller

Substitutes present for the final vote

Karin Kadenbach

Substitutes under Rule 200(2) present for the final vote

Petra Kammerevert

FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

20

+

ALDE

Nedzhmi Ali, Martina Dlabajová, Wolf Klinz

ECR

Monica Macovei

EFDD

Marco Valli

GUE/NGL

Dennis de Jong

PPE

Tamás Deutsch, Ingeborg Gräßle, José Ignacio Salafranca Sánchez-Neyra, Petri Sarvamaa, Claudia Schmidt, Tomáš Zdechovský, Joachim Zeller

S&D

Inés Ayala Sender, Zigmantas Balčytis, Karin Kadenbach, Petra Kammerevert, Georgi Pirinski, Derek Vaughan

VERTS/ALE

Bart Staes

1

-

ENF

Jean-François Jalkh

0

0

 

 

Key to symbols:

+  :  in favour

-  :  against

0  :  abstention

(1)

OJ C 434, 30.11.2018, p. 141.

(2)

OJ C 434, 30.11.2018, p. 141

(3)

OJ L 298, 26.10.2012, p. 1.

(4)

OJ L 193, 30.7.2018, p. 1.

(5)

OJ L 136, 30.4.2004, p. 1.

(6)

OJ L 328, 7.12.2013, p. 42.

(7)

OJ C 434, 30.11.2018, p. 141

(8)

OJ C 434, 30.11.2018, p. 141

(9)

OJ L 298, 26.10.2012, p. 1.

(10)

OJ L 193, 30.7.2018, p. 1.

(11)

OJ L 136, 30.4.2004, p. 1.

(12)

OJ L 328, 7.12.2013, p. 42.

(13)

O.J. C 420/01, 07.12.2017, p.3

(14)

Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (OJ L 189, 27.6.2014, p. 112).

(15)

Texts adopted, P8_TA-(2019)0000.

Last updated: 12 March 2019Legal notice