Procedure : 2014/0257(COD)
Document stages in plenary
Document selected : A8-0046/2016

Texts tabled :

A8-0046/2016

Debates :

PV 09/03/2016 - 20
CRE 09/03/2016 - 20

Votes :

PV 10/03/2016 - 7.5
CRE 10/03/2016 - 7.5

Texts adopted :

P8_TA(2016)0087

REPORT     ***I
PDF 1826kWORD 1534k
29 February 2016
PE 551.951v02-00 A8-0046/2016

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))

Committee on the Environment, Public Health and Food Safety

Rapporteur: Françoise Grossetête

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
 EXPLANATORY STATEMENT
 OPINION of the Committee on Agriculture and Rural Development
 PROCEDURE – COMMITTEE RESPONSIBLE

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

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))

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2014)0558),

–  having regard to Article 294(2) and Articles 114 and 168(4)(b) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0164/2014)

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

–  having regard to the opinion of the European Economic and Social Committee of 21 January 2015(1),

–  after consulting the Committee of the Regions,

–  having regard to its resolution of 19 May 2015 on safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance(2),

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

–  having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Agriculture and Rural Development (A8-0046/2016),

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

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.

Amendment    1

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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 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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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

 

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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.

__________________

__________________

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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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    12

Proposal for a regulation

Recital 25 a (new)

Text proposed by the Commission

Amendment

 

(25a) The research on antimicrobials 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 antimicrobial 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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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.

__________________

__________________

17 Communication from the Commission on the precautionary principle, COM (2000) 1 (final).

17 Communication from the Commission on the precautionary principle, COM (2000) 1 (final).

Amendment    17

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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

 

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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 on national and Union level.

Amendment    31

Proposal for a regulation

Recital 56

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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 advisorsshould continue to prescribe and supply certain veterinary medicines.

Amendment    33

Proposal for a regulation

Recital 56 b (new)

Text proposed by the Commission

Amendment

 

(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 a key importance in ensuring high-quality epidemiological monitoring of existing and emerging diseases.

Amendment    34

Proposal for a regulation

Recital 57

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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

Text proposed by the Commission

Amendment

(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    37

Proposal for a regulation

Recital 65

Text proposed by the Commission

Amendment

(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 control reports. In order to preserve the effectiveness of the inspections, authorities should perform a certain percentage of unannounced inspections, which percentage should be determined by the Commission by way of a delegated act.

Amendment    38

Proposal for a regulation

Recital 67

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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

 

Text proposed by the Commission

Amendment

(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 – paragraph 1

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

1a. 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)

Text proposed by the Commission

Amendment

 

1b. 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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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 ...).

 

+ OJ: Please insert the number in the text, and in the footnote, the number, date and publication reference of document COD 2014/0255.

Amendment    47

Proposal for a regulation

Article 2 – paragraph 4 – point e c (new)

Text proposed by the Commission

Amendment

 

(ec) feedingstuffs as defined in Regulation (EU) No 767/2009 of the European Parliament and of the Council.

Amendment    48

Proposal for a regulation

Article 3 – paragraph 1 a (new)

 

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(ca) fungal;

Amendment    56

Proposal for a regulation

Article 4 – paragraph 1 – point 2 – point c b (new)

Text proposed by the Commission

Amendment

 

(cb) microbial;

Amendment    57

Proposal for a regulation

Article 4 – paragraph 1 – point 2 – point d

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(da) mineral.

Amendment    59

Proposal for a regulation

Article 4 – paragraph 1 – point 2 a (new)

Text proposed by the Commission

Amendment

 

(2a) ‘active substance‘ means a substance with a pharmacological activity;

Amendment    60

Proposal for a regulation

Article 4 – paragraph 1 – point 3

 

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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 which 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

 

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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 or in the light of continuous health checks on the animal;

Amendment    75

Proposal for a regulation

Article 4 – paragraph 1 – point 25

 

Text proposed by the Commission

Amendment

(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;

 

___________________

 

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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(27f) ʻserious adverse eventsʻ means any adverse events which result 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)

 

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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)

 

Text proposed by the Commission

Amendment

(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)

 

Text proposed by the Commission

Amendment

(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 Article 70 or authorised in accordance with Articles 46 and 48;

Amendment    87

Proposal for a regulation

Article 4 – paragraph 1 – point 27 k (new)

 

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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+.

 

_________________

 

+ OJ: please insert the number in the document 2014/0255(COD).

Amendment    91

Proposal for a regulation

Article 5 – paragraph 1

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

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    99

Proposal for a regulation

Article 7 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

 

5a. When applying for renewal, publicly available, peer-reviewed scientific literature on the active pharmaceutical substance and its relevant metabolites dealing with side-effects on human health, the environment and non-target species and published within the last 10 years before the date of submission of the dossier shall be added by the applicant to the dossier.

Amendment    100

Proposal for a regulation

Article 8 – paragraph 2

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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    112

Proposal for a regulation

Article 21 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

 

3b. A requirement to notify the competent authorities of any adverse event relating to the use of the veterinary medicinal product.

Amendment    113

Proposal for a regulation

Article 22

Text proposed by the Commission

Amendment

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 meeds 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 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 the 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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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.

Amendment    116

Proposal for a regulation

Article 29

Text proposed by the Commission

Amendment

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;

(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)

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(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

 

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(iiia) list of excipients,

Amendment    122

Proposal for a regulation

Article 30 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(ga) the product is a substance of high concern;

Amendment    128

Proposal for a regulation

Article 32 – paragraph 1 – point g b (new)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

(hb) unacceptable side effects or secondary effects on the treated animal;

Amendment    131

Proposal for a regulation

Article 32 – paragraph 1 – point i a (new)

Text proposed by the Commission

Amendment

 

(ia) the veterinary medicinal product contains or is composed of organisms or viruses which, in accordance with

 

Annex I A to Directive 2001/18/EC, have been genetically modified.

Amendment    132

Proposal for a regulation

Article 32 – paragraph 2

 

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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    135

Proposal for a regulation

Article 33 – paragraph 3

Text proposed by the Commission

Amendment

3. Any marketing authorisation or variation to the terms of a marketing authorisation differing from the previously granted marketing authorisation only with regard to strengths, pharmaceutical forms, administration routes or presentations shall be regarded as the same marketing authorisation as the one previously granted for the purpose of applying the rules of the protection of technical documentation.

3. Any marketing authorisation or variation to the terms of a marketing authorisation differing from the previously granted marketing authorisation only with regard to strengths, species, pharmaceutical forms, administration routes or presentations shall be regarded as the same marketing authorisation as the one previously granted for the purpose of applying the rules of the protection of technical documentation.

Amendment    136

Proposal for a regulation

Article 34

Text proposed by the Commission

Amendment

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    137

Proposal for a regulation

Article 34 a

Text proposed by the Commission

Amendment

 

Article 34a

 

Period of protection of new data packages related to existing antimicrobial veterinary medicinal products

 

1. Any new studies and trials, submitted by the applicant for a marketing authorisation to the competent authorities for an existing antimicrobial 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 re-evaluation 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

Text proposed by the Commission

Amendment

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

 

Text proposed by the Commission

Amendment

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    140

Proposal for a regulation

Article 38 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) veterinary medicinal products intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals;

Deleted

Amendment    141

Proposal for a regulation

Article 38 – paragraph 2 – point c

 

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

 

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

 

Text proposed by the Commission

Amendment

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

 

Text proposed by the Commission

Amendment

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

 

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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)

Text proposed by the Commission

Amendment

 

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)

Text proposed by the Commission

Amendment

 

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)

 

Text proposed by the Commission

Amendment

 

Section 2a

 

Imports, parallel imports and parallel distribution

Amendment    168

Proposal for a regulation

Article 56 a (new)

 

Text proposed by the Commission

Amendment

 

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 Article 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)

 

Text proposed by the Commission

Amendment

 

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 Article 56a(1)(b) 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 Article 56a(1)(c) 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 of 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 the environment.

Amendment    170

Proposal for a regulation

Article 57 a (new)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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 Article 7(1)(b).

 

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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 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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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)

Text proposed by the Commission

Amendment

 

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

 

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(ba) information about incidence of adverse events.

Amendment    188

Proposal for a regulation

Article 75 – paragraph 3 a (new)

 

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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)

 

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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    202

Proposal for a regulation

Article 79 – paragraph 5

Text proposed by the Commission

Amendment

5. Competent authorities shall verify by means of inspections referred to in Article 125 that marketing authorisation holders comply with the requirements relating to pharmacovigilance laid down in this Section.

5. Competent authorities shall verify by means of inspections referred to in Article 125 or any other way that marketing authorisation holders comply with the requirements relating to pharmacovigilance laid down in this Section.

Amendment    203

Proposal for a regulation

Article 80 – paragraph 1

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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.

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

 

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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)

Text proposed by the Commission

Amendment

 

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    213

Proposal for a regulation

Article 93 – paragraph 5

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

(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

 

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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)

 

Text proposed by the Commission

Amendment

 

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)

 

Text proposed by the Commission

Amendment

 

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

 

Text proposed by the Commission

Amendment

(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)

 

Text proposed by the Commission

Amendment

 

(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)

 

Text proposed by the Commission

Amendment

 

(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)

 

Text proposed by the Commission

Amendment

 

(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)

 

Text proposed by the Commission

Amendment

 

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 he 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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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)

Text proposed by the Commission

Amendment

 

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)

Text proposed by the Commission

Amendment

 

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

 

Text proposed by the Commission

Amendment

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)

 

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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 7(b), 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.

____________________

____________________

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).

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

Text proposed by the Commission

Amendment

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

 

Text proposed by the Commission

Amendment

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,– should 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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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 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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

2a. Particulars already contained in the prescription or in a delivery note do not 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)

Text proposed by the Commission

Amendment

 

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 informs 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)

Text proposed by the Commission

Amendment

 

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 has to take all necessary steps in order to accomplish the reduction. The husbandman has to 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

Text proposed by the Commission

Amendment

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.

__________________

__________________

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    248

Proposal for a regulation

Article 115 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. By way of a derogation from paragraph 1, homeopathic veterinary medicinal products can be administered to non-food producing animals.

Amendment    249

Proposal for a regulation

Article 116 – paragraph 1

Text proposed by the Commission

Amendment

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 (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 legislation.

Amendment    250

Proposal for a regulation

Article 116 – paragraph 2

Text proposed by the Commission

Amendment

2. 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 aquatic species, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animals concerned with any of the following medicinal products:

2. If there is no product as referred to in paragraph 1, 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 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, may be used to treat the animal concerned. Antimicrobial medicinal products for human use may be employed, subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question, only if treatment with a veterinary medicinal product as referred to in paragraph 1 is not possible.

a. veterinary medicinal products authorised under this Regulation in the Member State concerned for use with another food-producing aquatic species, or for another condition in the same aquatic species;

 

b. 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    251

Proposal for a regulation

Article 116 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

 

(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

 

Text proposed by the Commission

Amendment

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    253

Proposal for a regulation

Article 116 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

 

3a. By way of derogation from paragraphs 1 to 3, homeopathic veterinary 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 Regulation (EU) No 37/2010 as substances for which no maximum limit needs to be set.

Amendment    254

Proposal for a regulation

Article 116 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

4. The Commission may, by means of implementing acts, establish a list of veterinary medicinal products authorised in the Union for use in terrestrial animals which can be used for treatment of food-producing animals of an aquatic species in accordance with paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

4. The Commission may, by means of implementing acts, establish a list of veterinary medicinal products authorised in the Union for use in terrestrial animals which can be used for treatment of food-producing animals of an aquatic species in accordance with paragraph 1 and strictly limited to closed aquatic systems with specific waste water treatment facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Amendment    255

Proposal for a regulation

Article 116 – paragraph 6

 

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(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)

 

Text proposed by the Commission

Amendment

 

2a. Third countries with legislation that authorises 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 legislation 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)

 

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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 [Office of Publications, please insert number and, in a footnote, date, title and the OJ reference for the Regulation on animal health] 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 [Office of Publications, please insert number and, in a footnote, date, title and the OJ reference for the Regulation on animal health] 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 under the legislation of a the third country, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use.

__________________

__________________

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)

Text proposed by the Commission

Amendment

 

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/waste materials at Union level.

Amendment    268

Proposal for a regulation

Article 123 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

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

 

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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)

Text proposed by the Commission

Amendment

 

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, in order to combat fraud.

Amendment    273

Proposal for a regulation

Article 125 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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)

 

Text proposed by the Commission

Amendment

 

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    278

Proposal for a regulation

Article 135 a (new)

Text proposed by the Commission

Amendment

 

Article 135a

 

Antimicrobials reserved for humans

 

1. Veterinary medicinal products containing antimicrobial active substances classed by the Commission, a Member State or the World Health Organisation as reserved for treating specific infections in humans shall be prohibited.

 

2. Veterinary medicinal products as referred to in paragraph 1 which were authorised when this Regulation enters into force shall be taken off the market by the authorisation holders.

Amendment    279

Proposal for a regulation

Article 136 – paragraph 1

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

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

Text proposed by the Commission

Amendment

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 authorities concerned, 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    282

Proposal for a regulation

Article 140 – paragraph 7

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

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 the 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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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)

Text proposed by the Commission

Amendment

 

The environmental risk assessment shall be updated when new information becomes available that would change the estimation of the risk.

Amendment    290

Proposal for a regulation

Annex 3 a (new)

Text proposed by the Commission

Amendment

 

Preventative measures to be used before resorting to antimicrobial treatment of entire groups (metaphylaxis) of food producing animals:

 

(i) using good healthy breeding stock that grows naturally, 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 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))

(1)

  OJ C 0, 0.0.0000, p. 0. / Not yet published in the Official Journal.

(2)

  Texts adopted, P8_TA(2015)0197.


EXPLANATORY STATEMENT

In September 2014 the Commission published its new draft regulation on veterinary medicinal products. The draft regulation is a total overhaul of the existing rules on medicinal products for veterinary use set out in Directive 2001/82/EC and Regulation EC 726/2004. It will govern the authorisation, manufacturing, marketing, distribution, drug safety and use of veterinary medicinal products over their lifetime.

It is clear that a legal framework specifically tailored to the characteristics of the veterinary sector is necessary. Ever since the current legal framework came in to force, problems have arisen in connection with limited supplies of veterinary products (especially on the smallest markets), the administrative burden imposed by the rules, the functioning of the internal market and, of course, resistance to antibiotics.

In view of Article 114 TFEU (on the single market) and Article 168(4)(b) TFEU (on measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health), the Commission has tabled an ambitious proposal with the following main objectives:

•  To improve access to medicinal products and make them more widely available, in   particular for the so-called ‘minor species’,

•  To reduce the administrative burden, in particular where the drug safety process is   concerned,

•  To promote innovation and competitiveness within the sector,

•  To ensure that the internal market for veterinary medicinal products functions   properly,

•  To tackle antibiotic resistance.

The rapporteur gladly welcomes the Commission’s draft regulation, believes that it is a move in the right direction and fully agrees with the Commission’s objectives and its view that the veterinary medicines market should be separated from the human medicines market, which works very differently. The Commission is right to stress the importance of product availability and simpler administrative procedures without sacrificing the principles of public health and the protection of the environment.

Nonetheless, the Commission has not gone far enough on some points and the draft contains a number of loopholes. It should be much more ambitious in its measures relating to antibacterial resistance and should, in particular, provide clear definitions on the different kinds of treatment (curative, control and preventative) and ban the prophylactic use of antibiotics. It is essential that the rules on medicinal products for human use and the rules on medicinal products for veterinary use agree on this point.

The draft report clearly defines the conditions under which veterinary medicine professionals are permitted to prescribe and sell antibiotics. Without suggesting that the two elements should be split apart, which would pose huge practical difficulties, it would seem that there is a need to define the notion of animals ‘under their care’ in Article 107.  

The Commission plans to draw up a list of critical antibiotics reserved exclusively for human consumption. The rapporteur is in favour of this idea provided that the list is based on solid scientific criteria: the European Medicines Agency has made some excellent recommendations which should be used. Contrary to what the Commission is proposing, the sale of antibiotics (and all prescription-only veterinary products) online should be banned as this would pose a serious threat to public health.

It would also be advisable to boost incentives to encourage innovation. The veterinary medicines market is small and highly fragmented and there is little incentive for manufacturers to create and market new products. The draft report recommends extending the data protection periods proposed by the Commission for antibiotics (18 years instead of 14) and extending the initial marketing authorisation to the major species (two extra years instead of just one). The draft text also suggests putting in place a five-year protection period (which cannot be combined with other periods) for certain new studies or tests carried out after authorisation has been issued, in an effort to encourage developments on or improvements to existing products, both originator and generic.

The Commission’s new approach to drug safety, which is based on risk detection, will be a step forward provided that it does not pose a threat to public health. A system which requires regular drug safety reports for the product’s first few years of life and risk analysis and signal detection after this period seems more suitable.

The Commission suggests making the use of off-licence human drugs on animals easier by giving veterinarians the choice. Although there is no doubt that veterinarians would take a responsible approach, it would be preferable to put in place a more rigid framework in which human medicines can only be used for veterinary purposes as a last resort and if there is no better alternative.

Lastly, special attention must be given to protecting the environment. It will be necessary to establish a single decentralised form of assessment using a monograph system in order to avoid repetitive and potentially conflicting assessments of the environmental properties of a substance. In view of the practical difficulties involved in implementing a system of this kind, the Commission is asked to draw up specific proposals on the subject.


OPINION of the Committee on Agriculture and Rural Development (23.7.2015)

for the Committee on the Environment, Public Health and Food Safety

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))

Rapporteur: Marit Paulsen

SHORT JUSTIFICATION

Introduction

There is a pressing need for new legislation which will increase the scope for research into and development and monitoring of veterinary medicinal products and which will increase production and its profitability on the internal market. There is also a growing need for new and better medicines for use in livestock farming, in view of climate change and the worldwide trend towards greater movement. From farmers’ point of view, it is of decisive importance that effective and accessible medicines should be available at a reasonable price when they are needed.

Simplification

In many ways, the production of veterinary medicinal products is considerably more complicated than that of medicinal products for human use, as human beings all belong to a single species, whereas animals are of many different species, which makes the market considerably more fragmented. It is therefore extremely important for the development of veterinary medicinal products that laws and regulations should verge on being over-explicit and simple. This means in turn that the European Parliament must make serious efforts to simplify and clarify the proposal submitted by the Commission. The first requirement is to simplify red tape itself, without reducing checks on new products or monitoring of products’ side-effects and impact on animal welfare and health or their impact on public health and the environment.

Moreover, one detects a certain hesitancy in the Commission proposal, which leaves rather too many decisions to the authorities of the 28 Member States, while assigning too few to European Union level. It is also an open question how the EU is to adopt clear rules on what a certain competence will have to entail, namely what is meant by a ‘competent veterinarian’.

Clarification

Article 4 contains no exact definitions of vital terms such as ‘responsible use of veterinary medicinal products’. Here the definitions formulated by EPRUMA ought to be taken as a point of departure, as this cooperative organisation brings together all parties concerned, such as farmers’ organisations, veterinary associations and the medical profession.

Antimicrobial resistance

The proposal contains surprisingly little in the way of provisions to tackle the problem of constantly growing antimicrobial resistance, which is an extremely serious threat both to animals and to human beings. It is surely vital to human beings and animals that we should as quickly as possible establish a clear picture of how all antimicrobial medicines are used, so that we can without delay greatly reduce their use and stop all abuses.

Even though Article 54 of the proposal provides for a European database on the use of veterinary medicinal products (which is something that the European Parliament was already calling for in May 2011), there is no clear requirement for the responsible authorities in Member States to collect, compile and report precise information on where, when, how and why an antimicrobial medicine – particularly an antibacteriological medicine – has been used. What is required here is that data should be collected on when, where, to which animal and as a result of what diagnosis a medicine has been administered. The requirement to collect information on diagnosis is particularly essential. It should not be permitted to prescribe any antibacteriological medicine without a clear diagnosis of disease having been made.

Article 108 on online retailing of veterinary medicinal products is a step in the right direction, but does not go far enough. It would be reasonable to permit only non-prescription medicines to be sold over the internet.

In the same way, Article 107 on financial incentives for veterinarians to prescribe medicines is welcome but inadequate. It seems strange that such a distinction should be drawn between the competences of practitioners of human and veterinary medicine: doctors are normally well paid for their work and their competence, whereas in some Member States equally well trained and competent veterinarians have to make ends meet by selling medicines. It would seem logical and reasonable that veterinarians – just like doctors – should keep stocks of medicines to meet immediate needs during the time that it would take to obtain medicines in the usual way, but no profit motive should be associated with this.

At all events, on public health grounds the new regulation should allow Member States to maintain or adopt more far-reaching rules on the use and prescription of antimicrobials.

Environmental impact

The consumption of antimicrobial and other veterinary medicinal products is also creating a growing environmental problem, particularly as regards leakage into the natural environment. Nowadays manure, which is the most important of all fertilisers, spreads large quantities, for example, of antibiotic-resistant bacteria in farmland and water. Data collected concerning side-effects as part of pharmacovigilance measures (Section 6) should also be forwarded to other relevant authorities, for example those responsible for the environment.

AMENDMENTS

The Committee on Agriculture and Rural Development calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to take into account the following amendments:

Amendment    1

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(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.

Amendment    2

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission

Amendment

 

(7a) This Regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. The precautionary principle should be applied and 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 any unacceptable effects on the environment.

Amendment    3

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(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 administrative procedures that might hamper the development of research and innovation for the purpose of identifying new medicines.

Justification

Development and innovation with regard to new medicines is sometimes hampered by the risk of the product not being authorised.

Amendment    4

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(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, and accordingly antimicrobial medicinal products for human use may be employed only where a prescription has been issued by a veterinarian and an authorisation granted 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.

Justification

With a view to protecting health and the environment, authorised veterinary medicinal products should be used as a matter of priority. Strict conditions should be laid down to govern the use of medicinal products for human use.

Amendment    5

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(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 the least likely to cause 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    6

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(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    7

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(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 system as it exists until now has led to duplicate testing, wasting of resources, and lack of harmonisation of environmental risk assessments. The pharmacovigilance system has to date not been able to compensate for the effects of this poor level of harmonisation. This particularly applies to veterinary medicinal products authorised before the environmental risk assessment requirement came into force. Therefore, the Commission should establish a substance-based review system for the environmental risk assessment of these veterinary medicinal products. The results of the review system would be published in so-called ‘monographs'.

Amendment    8

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

(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 Member States and all relevant actors. 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. Better information is necessary regarding the utilisation and effects of antimicrobial medicines. It needs to be ensured that measures are proportionally applied in both the human and animal sector and that appropriate warnings and guidance are included on the labels of 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.

Amendment    9

Proposal for a regulation

Recital 36

Text proposed by the Commission

Amendment

(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 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. Preventive treatments using antimicrobials need to be regulated more strictly and recommended only in certain specific, well-defined cases, in compliance with animal health, biosecurity and nutritional requirements.

Amendment    10

Proposal for a regulation

Recital 38

Text proposed by the Commission

Amendment

(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 the veterinarians should together promote responsible use. 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.

Amendment    11

Proposal for a regulation

Recital 38 a (new)

Text proposed by the Commission

Amendment

 

(38a) Prudent use of antimicrobials is key to addressing antimicrobial resistance. The Guidelines for prudent use, drafted by the Commission, need to be considered by Member States.

Amendment    12

Proposal for a regulation

Recital 38 b (new)

Text proposed by the Commission

Amendment

 

(38b) In order to facilitate prudent use, 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 will facilitate correct diagnosis, allow for the targeted use of antibiotics, avoiding the use of critically important antibiotics, and therefore restrain the development of antibiotic resistance. There is clear need for future innovation specifically for on-site diagnostics, and a need to reflect whether more harmonisation or other regulation at Union level in this sector is needed.

Amendment    13

Proposal for a regulation

Recital 40

Text proposed by the Commission

Amendment

(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 is 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.

Justification

Builds on the resolution from the Agriculture Committee on antibiotic resistance, adopted by the European Parliament on 12 May 2011.

Amendment    14

Proposal for a regulation

Recital 40 a (new)

Text proposed by the Commission

Amendment

 

(40a) Commercial sensitivity should not be used as an excuse to deny citizens access to information about chemicals affecting their bodies and those of other non-target species in the wider environment. Maximum transparency should be ensured while protecting the most commercially sensitive information.

Justification

A balance can be found between the two objectives.

Amendment    15

Proposal for a regulation

Recital 49

Text proposed by the Commission

Amendment

(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    16

Proposal for a regulation

Recital 50

Text proposed by the Commission

Amendment

(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 authorities concerned such as environmental protection agencies and food safety authorities both at national and Union level.

Justification

We need a holistic approach on the use of veterinary medicines, for instance as regards the environmental problems connected to the leakage of resistant bacteria into soil and water.

Amendment    17

Proposal for a regulation

Recital 56

Text proposed by the Commission

Amendment

(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 persons, where appropriate, veterinarians,who are 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.

Amendment    18

Proposal for a regulation

Recital 56 a (new)

Text proposed by the Commission

Amendment

 

(56a) 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    19

Proposal for a regulation

Recital 56 b (new)

Text proposed by the Commission

Amendment

 

(56b) Decoupling prescription from supply does not lower the consumption of antibiotics. This is borne out by the fact that the Member States in which antibiotics consumption is highest have already decoupled prescription from supply, while the Member States that have reduced consumption the most are those in which the two are still coupled.

Justification

European Medicines Agency, ‘Sales of veterinary antimicrobial agents in 26 EU/EEA countries in 2012’ http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.pdf

Amendment    20

Proposal for a regulation

Recital 58 a (new)

Text proposed by the Commission

Amendment

 

(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    21

Proposal for a regulation

Recital 62

Text proposed by the Commission

Amendment

(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 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.

Amendment    22

Proposal for a regulation

Recital 65

Text proposed by the Commission

Amendment

(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 control reports. In order to preserve the effectiveness of the inspections, authorities should perform a certain percentage of unannounced inspections, to be determined by a delegated act.

Amendment    23

Proposal for a regulation

Recital 67

Text proposed by the Commission

Amendment

(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    24

Proposal for a regulation

Article 1 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a. 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    25

Proposal for a regulation

Article 1 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

 

1b. The measures referred to in paragraph 1a shall be notified to the Commission.

Amendment    26

Proposal for a regulation

Article 2 – paragraph 2

Text proposed by the Commission

Amendment

2. In addition to the products referred to in paragraph 1, Chapter VI shall also apply to active substances, intermediate products and excipients used as starting materials in veterinary medicinal products.

2. In addition to the products referred to in paragraph 1, Chapter VI shall also apply to intermediate products and active substances used as starting materials in veterinary medicinal products.

Amendment    27

Proposal for a regulation

Article 4 – paragraph 1 – point 1 – point b

Text proposed by the Commission

Amendment

(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    28

Proposal for a regulation

Article 4 – paragraph 1 – point 1 – point c

Text proposed by the Commission

Amendment

(c) its purpose is to be used for euthanasia of animals;

(c) it may be used for euthanasia of animals;

Justification

The definition of a veterinary medicinal product should be clear, in particular in terms of classification of the existing products. There is a body of European Court of Justice rulings which is based on two ‘limbs’, the first being ‘medicinal product by presentation’, and the second, ‘medicinal product by function’. The Commission proposal may lead to different interpretation and, as a result, to unexpected consequences, e.g. re-classification of existing products.

Amendment    29

Proposal for a regulation

Article 4 – paragraph 1 – point 8

Text proposed by the Commission

Amendment

(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    30

Proposal for a regulation

Article 4 – paragraph 1 – point 8 a (new)

Text proposed by the Commission

Amendment

 

(8 a) 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.

Justification

Practical definition as suggested by the multi-stakeholder platform Epruma, representing both veterinarians, farmers and manufacturers of animal medicines.It should specifically address antibacterials and the need to tackle antibiotic resistance in bacteria originating in animals.

Amendment    31

Proposal for a regulation

Article 4 – paragraph 1 – point 8 b (new)

Text proposed by the Commission

Amendment

 

(8b) 'antiparasitic' means a medicinal product or substance used in the treatment of parasitic diseases attributable to various causes;

Justification

Antiparasitic medicines account for over 60% of the total quantity of veterinary medicines sold worldwide.

Amendment    32

Proposal for a regulation

Article 4 – paragraph 1 – point 8 c (new)

Text proposed by the Commission

Amendment

 

(8 c) ʻanti-bacterialʼ means a compound with a direct action on bacteria used for treatment or prevention of infections;

Justification

Practical definition as suggested by the multi-stakeholder platform Epruma, representing both veterinarians, farmers and manufacturers of animal medicines.

Amendment    33

Proposal for a regulation

Article 4 – paragraph 1 – point 11

Text proposed by the Commission

Amendment

(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:

Justification

The Commission proposal introduces a broader interpretation of benefits, which may bring problems in interpretation of benefit-risk for certain products, for example antimicrobials, where the benefits may also include positive effects on zootechnical parameters, like improved yield, which is contrary to the ambitions of the Commission proposal in terms of antimicrobial resistance. It is therefore proposed to define benefits as ‘therapeutic benefits’.

Amendment    34

Proposal for a regulation

Article 4 – paragraph 1 - point 20 – point b

 

Text proposed by the Commission

Amendment

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, sheep reared for meat, pigs, chickens, dogs and cats;

Amendment    35

Proposal for a regulation

Article 4 – paragraph 1 – point 20 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) veterinary medicinal products for animal species the national population of which is not large enough for research and development costs to be amortised during the data protection period specified in Article 34.

Justification

Livestock numbers can vary from Member State to Member State.

Amendment    36

Proposal for a regulation

Article 4 – paragraph 1 – point 21

Text proposed by the Commission

Amendment

(21) pharmacovigilance’ means the process of monitoring and investigating adverse events;

(21) ‘pharmacovigilance’ means the process of monitoring and investigating scientific, control and administrative activities relating to detection, reporting, assessment, understanding, prevention and communication of adverse events which include continuous evaluation of the benefit-risk balance of veterinary medicinal products;

Justification

The proposal of definition only focuses on the process of monitoring and investigating of adverse events. Pharmacovigilance has to be defined in a wider sense, as the monitoring and investigating of adverse events has to translate to measures to ensure that the benefit-risk balance remains positive throughout a product’s lifecycle. This is of particular importance for products the benefit-risk balance of which is prone to change over time, like antimicrobial or anti-parasitic medicines.

Amendment    37

Proposal for a regulation

Article 4 – paragraph 1 – point 24

 

Text proposed by the Commission

Amendment

(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;

Amendment    38

Proposal for a regulation

Article 4 – paragraph 1 – point 27 a (new)

Text proposed by the Commission

Amendment

 

(27 a) 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;

Justification

Practical definition as suggested by the multi-stakeholder platform Epruma, representing both veterinarians, farmers and manufacturers of animal medicines.

Amendment    39

Proposal for a regulation

Article 4 – paragraph 1 – point 27 b(new)

Text proposed by the Commission

Amendment

 

(27b) 'name of veterinary medicinal product' means the name, which may be either an invented name not liable to be confused with the common name, or a common or scientific name accompanied by a trademark or the name of the marketing authorisation holder;

Justification

The name of the medicinal product plays a key part in the regulation of such products and it is not only important for the identification of the product concerned but also plays a role in its safe and effective use and especially in a competition between veterinary medicinal products. The legislation should clearly stipulate that the invented names of products shall be such that they cannot be confused with the common names which are used for naming the constituents of the products.

Amendment    40

Proposal for a regulation

Article 4 – paragraph 1 – point 27 c (new)

Text proposed by the Commission

Amendment

 

(27 c) 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;

Justification

Practical definition based on suggestions by the multi-stakeholder platform Epruma, representing both veterinarians, farmers and manufacturers of animal medicines.

Amendment    41

Proposal for a regulation

Article 4 – paragraph 1 – point 27 d (new)

Text proposed by the Commission

Amendment

 

(27d) '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;

Justification

For the sake of clarity and predictability, it is essential that the new Regulation clearly defines what wholesale distribution means. Without a definition of the wholesale distribution, it would be extremely difficult for the Member State to perform any control activities and to act against illegal activities in the field of veterinary medicinal products.

Amendment    42

Proposal for a regulation

Article 4 – paragraph 1 – point 27 e (new)

Text proposed by the Commission

Amendment

 

(27 e) ʻcurative (therapeutic) treatmentʼ means a treatment of an ill animal or group of animals, after the diagnosis of disease or infection has been made;

Justification

Practical definition as suggested by the multi-stakeholder platform Epruma, representing both veterinarians, farmers and manufacturers of animal medicines.

Amendment    43

Proposal for a regulation

Article 4 – paragraph 1 – point 27 f (new)

Text proposed by the Commission

Amendment

 

(27f) ‘pre-mix for medicated feedingstuffs’ means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs according to Regulation (EU) 2015/... (Medicated Feed).

Justification

The provisions on veterinary medicinal products and on medicated feedingstuffs should be properly interconnected. Antimicrobials are the most important class of drugs used by means of medicated feedingstuffs. The legislation on veterinary medicinal products should clearly require that only medicated pre-mixes can be authorised for use for subsequent manufacture of medicated feedingstuffs.

Amendment    44

Proposal for a regulation

Article 4 – paragraph 1 – point 27 g (new)

Text proposed by the Commission

Amendment

 

(27 g) ʻcontrol treatment (metaphylaxis)ʼ means a 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    45

Proposal for a regulation

Article 4 – paragraph 1 – point 27 h (new)

Text proposed by the Commission

Amendment

 

(27 h) ʻpreventive treatment (prophylaxis)ʼ means a treatment of an animal or a group of animals before clinical signs of disease, in order to prevent the occurrence of disease or infection.

Justification

Practical definition as suggested by the multi-stakeholder platform Epruma, representing both veterinarians, farmers and manufacturers of animal medicines.

Amendment    46

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

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 reassessment.

Amendment    47

Proposal for a regulation

Article 5 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. When a previously authorised veterinary medicinal product has not been present on the market in a 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 exemptions from paragraph (2). Such exemptions shall be duly justified.

Amendment    48

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

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 via a single electronic portal. For all types of applications submitted in accordance with this Regulation, the decentralised procedure or the procedure for mutual recognition, the formats made available by the Agency shall be used.

Justification

Further simplification of the procedures is needed in order to further encourage research and innovation, and consequently the availability of veterinary medicines.

Amendment    49

Proposal for a regulation

Article 7 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(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,

Justification

We need a holistic approach on the use of veterinary medicines, for instance as regards the environmental problems connected to the leakage of resistant bacteria into soil and water.

Amendment    50

Proposal for a regulation

Article 7 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(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    51

Proposal for a regulation

Article 7 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

 

5a. When applying for renewal, publicly available, peer-reviewed scientific literature on the active pharmaceutical substance and its relevant metabolites dealing with side-effects on human health, the environment and non-target species and published within the last 10 years before the date of submission of the dossier shall be added by the applicant to the dossier.

Amendment    52

Proposal for a regulation

Article 8 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

 

(a a) the tested product is an unauthorised veterinary medicinal product and the withdrawal period set by the veterinarian in accordance with Article 117 is respected, or

Justification

In order to further encourage the development of new veterinary medicines, clinical trials of products which have not yet been authorised must be possible, provided that the relevant withdrawal periods are respected so that there are no health risks involved.

Amendment    53

Proposal for a regulation

Article 8 – paragraph 2 – point a b (new)

Text proposed by the Commission

Amendment

 

(ab) the tested product is an unauthorised veterinary medicinal product, all the pharmacological active substances have a maximum residues limit, and the withdrawal period set by the veterinarian in accordance with Article 117 is respected, or

Justification

All pharmacological active substances of the product must have a maximum residues level in order to allow the veterinarian to establish a withdrawal period that avoids any health risk for consumers.

Amendment    54

Proposal for a regulation

Article 8 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba) a provisional maximum residue limit has been established for the tested product.

Justification

Currently, animals and animal products can be marketed after tests have been carried out provided that they comply with provisional maximum residue limits. This should remain possible.

Amendment    55

Proposal for a regulation

Article 8 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

 

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.

Justification

It is important that competent authorities are properly and promptly informed of serious adverse events and human adverse reactions in order to consider whether an additional precaution should be taken or if it is necessary to suspend the clinical trial.

Amendment    56

Proposal for a regulation

Article 9 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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 at least the following information:

Justification

The pack sizes of veterinary medicinal products cover a very wide range, for example from small 10ml vials to large 10 or 25 kg bags. Some labels have much more space than others, and can accommodate more information. For some categories of products that can be sold directly to the public without prescription it may be important to include additional information on the immediate packaging.

Amendment    57

Proposal for a regulation

Article 9 – paragraph 1 – point g a (new)

Text proposed by the Commission

Amendment

 

(ga) a barcode containing all the information listed in points (a) to (g) of paragraph 1, and enabling this information and the information contained in the package leaflet to be provided electronically in a readable form and in all languages at the place of treatment, and making the data available for other documentation systems through standard interfaces.

Justification

The regulation should make use of all the electronic possibilities available in order to provide information on medicinal products in a user-friendly way in the reader’s mother tongue. This can only be achieved by the barcode on the immediate packaging.

Amendment    58

Proposal for a regulation

Article 10 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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 at least the following information:

Justification

The minimum mandatory information that must be included on the outer packaging of a veterinary medicinal product needs to be defined by legislation. The size of veterinary medicinal products can range from small 10ml vials to large 5, 10 or 25 kg bags. Some products have much more space on the outer packaging than others, and can accommodate more information. For products sold direct to the public without prescription it may be important to include additional information on the outer packaging.

Amendment    59

Proposal for a regulation

Article 10 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(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 veterinary medicinal products in accordance with applicable law;

Amendment    60

Proposal for a regulation

Article 10 – paragraph 1 – point g a (new)

Text proposed by the Commission

Amendment

 

(ga) waiting times.

Justification

Where waiting times are prescribed, they should be stated on the outer packaging; where there is no outer packaging, they should be indicated on the immediate packaging (and not just in the package leaflet). This is particularly necessary in the case of retail sales at a distance.

Amendment    61

Proposal for a regulation

Article 11 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

 

(bа) an indication of the presence of genetically modified organisms where the product contains or consists of such organisms;

Amendment    62

Proposal for a regulation

Article 12 – paragraph 1 – point i a (new)

Text proposed by the Commission

Amendment

 

(iа) in the case of veterinary medicinal products which include or consist of genetically modified organisms, information to that effect;

Amendment    63

Proposal for a regulation

Article 12 – paragraph 1 – point m a (new)

Text proposed by the Commission

Amendment

 

(ma) qualitative and quantitative composition;

Justification

The composition of the product is absolutely necessary. It is not understandable why the composition of veterinary medicinal products is not included as for many other health products, food products, etc.

Amendment    64

Proposal for a regulation

Article 12 – paragraph 1 – point m b (new)

Text proposed by the Commission

Amendment

 

(mb) the barcode referred to in point (ga) of Article 9(1).

Amendment    65

Proposal for a regulation

Article 12 – paragraph 3

Text proposed by the Commission

Amendment

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.

Justification

The package leaflet should be readable even in poor light in sheds and barns.

Amendment    66

Proposal for a regulation

Article 16 – paragraph 2

Text proposed by the Commission

Amendment

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 residue behaviour. 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.

Justification

Residue behaviour is of crucial importance for food safety. Unexpected residues can give rise to considerable compensation claims against animal holders and other food business operators.

Amendment    67

Proposal for a regulation

Article 16 – paragraph 5

Text proposed by the Commission

Amendment

5. The summary of the product characteristics of the generic veterinary medicinal product shall be identical to that of the reference veterinary medicinal product. However, that requirement shall not apply to those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law at the time when the generic veterinary medicinal product is authorised.

5. The clinical information of the summary of the product characteristics as defined in point (c) of Article 30(1), excluding point (vi) of the generic veterinary medicinal product shall be identical to that of the reference veterinary medicinal product. However, this requirement shall not apply to:

 

(a) those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law or the protection of technical documentation set out in Articles 33 to 36 at the time when the generic veterinary medicinal product is authorised, or

 

(b) a subsequent amendment of the reference medicinal product.

Amendment    68

Proposal for a regulation

Article 16 – paragraph 6

Text proposed by the Commission

Amendment

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 safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment if a potential environmental risk has been identified for that product.

Amendment    69

Proposal for a regulation

Article 17 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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 where one or more have 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:

Amendment    70

Proposal for a regulation

Article 17 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the applicant can demonstrate that the veterinary medicinal product is a combination of reference veterinary medicinal products as referred to in Article 16(1)(b);

(b) the applicant can demonstrate that the veterinary medicinal product contains a combination with at least one reference veterinary medicinal products as referred to in Article 16(1)(b);

Amendment    71

Proposal for a regulation

Article 17 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) documentation on the safety of that combination is provided.

(d) where needed, appropriate documentation on the safety of that combination is provided.

Amendment    72

Proposal for a regulation

Article 21 – paragraph 2

Text proposed by the Commission

Amendment

2. By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be granted foa a period of 3 years.

deleted

Amendment    73

Proposal for a regulation

Article 25

Text proposed by the Commission

Amendment

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 legislation and 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).

Justification

It should be clearly stated that manufacturers shall comply with EU legislation and not only that they are able to manufacture and control the product in accordance with the application for marketing authorisation.

Amendment    74

Proposal for a regulation

Article 28 – paragraph 3

Text proposed by the Commission

Amendment

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.

Justification

This means granting marketing authorisation would always result in monitoring of antimicrobial use, which allows continuous risk assessment.

Amendment    75

Proposal for a regulation

Article 30 – paragraph 1 – point c – point vi

Text proposed by the Commission

Amendment

(vi) frequency and seriousness of adverse events,

(vi) frequency and seriousness of adverse events or reactions,

Amendment    76

Proposal for a regulation

Article 30 – paragraph 1 – point c – point viii

Text proposed by the Commission

Amendment

(viii) interaction with other medicinal products and other forms of interaction,

(viii) known interaction with other medicinal products and other forms of known interaction.

Amendment    77

Proposal for a regulation

Article 30 – paragraph 1 – point c – point xiii

Text proposed by the Commission

Amendment

(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    78

Proposal for a regulation

Article 30 – paragraph 1 – point ja (new)

Text proposed by the Commission

Amendment

 

(ja) 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    79

Proposal for a regulation

Article 31 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a. Where two products have the same therapeutic effect, comparative assessments may be carried out. Products that are hazardous to the environment or to the treated animals shall be substituted by less hazardous products.

Justification

This introduces the possibility of comparative assessment to allow substitution of a hazardous product with another one with the similar/the same therapeutic effect but less detrimental effects on the animals being treated or on the environment / non-target species.

Amendment    80

Proposal for a regulation

Article 32 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(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    81

Proposal for a regulation

Article 32 – paragraph 1 – point g a (new)

Text proposed by the Commission

Amendment

 

(ga) the product is a substance of high concern;

Justification

These would include substances which are persistent, biocidal and toxic (PBT), very persistent and very toxic (vPvP) or are endocrine disruptors. It follows the terminology of the REACH directive.

Amendment    82

Proposal for a regulation

Article 32 – paragraph 1 – point g b (new)

Text proposed by the Commission

Amendment

 

(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;

Justification

This approach mirrors biocide and pesticide legislations. EMA guidelines EMA/CVMP/ERA/52740/2012 for assessment of PBTs and vPvBs substances are currently being reviewed (see http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/07/WC500130368.pdf)

Amendment    83

Proposal for a regulation

Article 32 – paragraph 1 – point h a (new)

Text proposed by the Commission

Amendment

 

(ha) unacceptable side effects or secondary effects on the treated animal;

Amendment    84

Proposal for a regulation

Article 32 – paragraph 3

Text proposed by the Commission

Amendment

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 Commission, when establishing these rules, shall make decisions on appropriate risk management measures at the class, substance or even the indication level and shall consider also the route of administration.

Justification

In order for the rules to successfully achieve their intended purpose they need to be based on science. This methodology for classifying antimicrobials is the one recommended by the Agency in its report on antimicrobials dated 18 December 2014 (European Medicines Agency, ‘Answers to the requests for scientific advice on the impact on public health and animal health of the use of antibiotics in animals’, 18 December 2014, pp. 6 & 16).

Amendment    85

Proposal for a regulation

Article 32 – paragraph 4

Text proposed by the Commission

Amendment

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, 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).

 

The Commission, when establishing these rules, shall make decisions on appropriate risk management measures at the class, substance or even the indication level and shall consider also the route of administration.

Justification

In order for the rules to successfully achieve their intended purpose they need to be based on science. This methodology for classifying antimicrobials is the one recommended by the Agency in its report on antimicrobials dated 18 December 2014 (European Medicines Agency, ‘Answers to the requests for scientific advice on the impact on public health and animal health of the use of antibiotics in animals’, 18 December 2014, pp. 6 & 16).

Amendment    86

Proposal for a regulation

Article 34 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(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, dogs and cats.

Amendment    87

Proposal for a regulation

Article 34 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

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 .

Justification

The period of the protection of technical documentation may not provide sufficient incentive for the development of new veterinary medicinal products. The prolongation possibilities under Article 35 should be granted at the same time as the initial marketing authorisation.

Amendment    88

Proposal for a regulation

Article 35 – paragraph 1

Text proposed by the Commission

Amendment

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 Article 34 shall be prolonged by two years 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.

Amendment    89

Proposal for a regulation

Article 35 – paragraph 2

Text proposed by the Commission

Amendment

2. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to another species, 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 another species, the period of the protection provided for in Article 34 shall be prolonged by 4 years.

Amendment    90

Proposal for a regulation

Article 35 – paragraph 3

Text proposed by the Commission

Amendment

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 point (a) of Article 34(1)(a). For products referred to in points (b) and (d) of Article 34(1), the period shall not exceed 18 years.

Amendment    91

Proposal for a regulation

Article 35 a (new)

Text proposed by the Commission

Amendment

 

Article 35a

 

Data protection for redevelopment of veterinary medicinal products

 

Where the data protection period as set out in Articles 34 and 35 has elapsed, any applicant may apply for a data protection period for additional innovations to existing veterinary medicinal products, which shall amount to two years for an additional species and one year for an additional indication, additional pharmaceutical form or new withdrawal period.

Justification

Incentive for further development of existing veterinary medicines, which can be done by any company including generic companies. A limited data protection period will be granted for the additional innovation only (the elapsed protection period of the initial marketing authorisation will not be prolonged).

Amendment    92

Proposal for a regulation

Article 38 – paragraph 1

Text proposed by the Commission

Amendment

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.

Amendment    93

Proposal for a regulation

Article 38 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) generic veterinary medicinal products of reference veterinary medicinal products authorised under the centralised authorisation procedure.

deleted

Justification

One of the major motivations of the revision of the veterinary pharmaceutical legislation should be the improvement of availability of veterinary medicinal products and support of innovations. The proposed measure does not fit with the declared goals, as it is extending obligation to authorise certain veterinary medicinal products by means of centralised marketing authorisation procedure.

Amendment    94

Proposal for a regulation

Article 38 – paragraph 3

Text proposed by the Commission

Amendment

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 be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union or if the application concerns a conversion of a marketing authorisation as referred to in Article 57a.

Justification

It should be possible to easily convert existing marketing authorisations into a centralised marketing authorisation. This will reduce the administrative burden (see related amendment on new Article 57a).

Amendment    95

Proposal for a regulation

Article 46 – paragraph 2

Text proposed by the Commission

Amendment

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 an application identical to that submitted to the reference Member State, including an identical dossier as provided under Article 7, to all Member States concerned.

Justification

The legislation must make it clear that all Member States where the marketing authorisation is sought have available data on the base of which the decision shall be granted. This is extremely important not only for the initial marketing authorisation, but also for the entire post-marketing period (pharmacovigilance, variations to the marketing authorisation) and for any market surveillance/control activities where the Member States shall execute their responsibilities.

Amendment    96

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

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 for mutual recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation (‘reference Member State’) and to the Member States where the applicant seeks to obtain recognition of the marketing authorisation (‘concerned Member States’).

Justification

The legislation must make it clear that all Member States where the marketing authorisation is sought have available data on the base of which the decision shall be granted. This is extremely important not only for the initial marketing authorisation, but also for the entire post-marketing period (pharmacovigilance, variations to the marketing authorisation) and for any market surveillance/control activities where the Member States shall execute their responsibilities.

Amendment    97

Proposal for a regulation

Article 48 – paragraph 2

Text proposed by the Commission

Amendment

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

Justification

The introduction of a requirement that companies must wait 6 months between a national procedure and a mutual recognition procedure is unnecessary and could even cause problems if a serious animal health or public health situation arises necessitating the quick authorisation of the product in additional Member States.

Amendment    98

Proposal for a regulation

Article 48 – paragraph 3 – point c

Text proposed by the Commission

Amendment

(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

Justification

In line with current legislation and the draft Regulation, applications must be dealt with by using the mutual recognition procedure. It is proposed to replace this requirement by a requirement for a consolidated marketing authorisation dossier which must be available to the concerned Member State in order that Member States can make evidence based decisions on the initial marketing authorisation and perform any post-authorisation responsibilities.

Amendment    99

Proposal for a regulation

Article 48 – paragraph 4

Text proposed by the Commission

Amendment

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 Member States