Next event: Final act published in Official Journal 2019/01/07 more...
- Draft final act 2018/12/12
- Final act signed 2018/12/11
- End of procedure in Parliament 2018/12/11
- Act adopted by Council after Parliament's 1st reading 2018/11/26
- Council Meeting 2018/11/26
- Commission response to text adopted in plenary 2018/11/21
- Decision by Parliament, 1st reading 2018/10/25
- Debate in Parliament 2018/10/24
- Debate in Council 2017/06/12
- Council Meeting 2017/06/12
- Results of vote in Parliament 2016/03/10
- Decision by Parliament, 1st reading 2016/03/10
- Matter referred back to the committee responsible 2016/03/10
- Debate in Parliament 2016/03/09
- Committee report tabled for plenary, 1st reading 2016/02/29
- Vote in committee, 1st reading 2016/02/17
- Debate in Council 2015/12/08
- Council Meeting 2015/12/08
- Amendments tabled in committee 2015/11/20
- Amendments tabled in committee 2015/10/02
- Amendments tabled in committee 2015/09/04
- Committee opinion 2015/07/23
- Amendments tabled in committee 2015/06/17
- Amendments tabled in committee 2015/06/17
- Amendments tabled in committee 2015/06/17
Progress: Procedure completed
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | ENVI | GROSSETÊTE Françoise ( PPE) | TĂNĂSESCU Claudiu Ciprian ( S&D), PIECHA Bolesław G. ( ECR), FEDERLEY Fredrick ( ALDE), HÄUSLING Martin ( Verts/ALE), PEDICINI Piernicola ( EFDD) |
Committee Opinion | ITRE | ||
Committee Opinion | IMCO | ||
Committee Opinion | AGRI | MÜLLER Ulrike ( ALDE) | Bas BELDER ( ECR), Nicola CAPUTO ( S&D), Giulia MOI ( EFDD), Miguel VIEGAS ( GUE/NGL) |
Lead committee dossier:
Legal Basis:
RoP 59-p4, TFEU 114, TFEU 168-p4
Legal Basis:
RoP 59-p4, TFEU 114, TFEU 168-p4Subjects
Events
PURPOSE: to adopt new rules on veterinary medicinal products with a view to ensuring a high level of protection of human and animal health and the environment and the proper functioning of the internal market.
LEGISLATIVE ACT: Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC.
CONTENT: the Regulation lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products. It sets high standards of quality, safety and efficacy of veterinary drugs. At the same time, it harmonises the rules on the authorisation of veterinary medicinal products and their placing on the Union market.
Marketing authorisations
The new rules clarify and simplify the procedures for granting a marketing authorization for new medicines, which reduces the administrative burden for businesses, especially small businesses. Member States will have to take the necessary measures to advise SMEs on compliance with the requirements of the Regulation.
A veterinary medicinal product shall be placed on the market only when a competent authority or the Commission, as applicable, has granted a marketing authorisation for that product. A marketing authorisation for a veterinary medicinal product shall only be granted to an applicant established in the Union. It shall be valid for an unlimited period of time. Decisions to grant, refuse, suspend, revoke or amend by way of a variation a marketing authorisation shall be made public.
A marketing authorisation will be refused if, in particular:
- the benefit-risk balance of the veterinary medicinal product is negative;
- the applicant has not provided sufficient information on the quality, safety or efficacy of the veterinary medicinal product;
- the veterinary medicinal 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;
- the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health
Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission, as applicable, may require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive given the potential development of antimicrobial resistance.
Improving the operation of the pharmacovigilance system
Holders of marketing authorisations will be responsible for continuously carrying out pharmacovigilance in order to ensure the continuous evaluation of the benefit-risk balance of the veterinary medicinal products they place on the market. They will, in particular:
- collect reports on suspected adverse events relating to their veterinary medicinal products;
- ensure that the summary of product characteristics, package leaflet and labelling is kept up to date with current scientific knowledge, and
- record in the product database the dates when its authorised veterinary medicinal products are placed on the market, and, as applicable, the dates of any suspension or revocation of the marketing authorisations concerned.
Member States competent authorities will have the power to carry out inspections, including unannounced inspections, at all stages of the production, distribution and use of veterinary medicinal products. To ensure a harmonised approach to controls throughout the Union, the Commission will be able to carry out audits in the Member States to verify the functioning of national control systems.
Prudent use of antimicrobials
The new rules provide that certain critical antimicrobials are reserved for the treatment of certain infections in humans so that their effectiveness is preserved.
Furthermore, the Regulation provides a better framework for the use of antimicrobial agents to prevent their prophylactic (as a preventive measure) and metaphylactic use (for example to treat a group of animals, one of which presents signs of infection):
- antimicrobial medicinal products should not be used for prophylaxis other than in well-defined cases for the administration to an individual animal or restricted number of animals when the risk for infection is very high or its consequences are likely to be severe. Antibiotic medicinal products should not be used for prophylaxis other than in exceptional cases only for the administration to an individual animal;
- antimicrobial medicinal products should be used for metaphylaxis only when the risk of spread of an infection or of an infectious disease in a group of animals is high and where no appropriate alternatives are available.
A veterinary prescription for an antimicrobial medicinal product for metaphylaxis shall only be issued after a diagnosis of the infectious disease by a veterinarian. It shall be issued only after a clinical examination or any other proper assessment of the health status of the animal or group of animals by a veterinarian.
The Regulation also improves the protection of European consumers against the risk that antimicrobial resistance will spread through imports of animals and animal products.
ENTRY INTO FORCE: 27.1.2019.
APPLICATION: from 28.1.2022.
The European Parliament adopted by 583 votes to 16, with 20 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products.
The European Parliament’s position adopted at first reading under the ordinary legislative procedure amended the Commission proposal as follows:
Purpose : the Regulation shall establish rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and the use of veterinary medicinal products. It shall 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 of the environment. At the same time, it shall harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.
It shall not apply to veterinary medicinal products which have not undergone an industrial process such as, for example, non-processed blood.
Marketing authorisations : a veterinary medicinal product may only be placed on the market when a marketing authorisation for that product has been granted by a competent authority or by the Commission. Authorisations may only be granted to applicants established in the Union. Decisions to grant, refuse, suspend, revoke or amend a marketing authorisation shall be made public.
Exemptions may be granted for veterinary medicinal products for animals that are exclusively pets, provided that these medicinal products are not subject to a veterinary prescription.
Decisions to grant marketing authorisations : a marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period. By way of derogation, a marketing authorisation for a limited market shall be valid for five years.
Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission, as applicable, may require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive given the potential development of antimicrobial resistance.
A marketing authorisation shall be refused if : (i) the applicant has not sufficiently demonstrated efficacy on the target species; (ii) the risks to public or animal health or the environment are not sufficiently addressed; (iii) the medicinal product is an antimicrobial veterinary medicinal product presented for use as a performance promoter to accelerate the growth or increase the yield of treated animals ; (iv) the active substance contained in the medicinal product meets the criteria to be considered persistent, bioaccumulative and toxic or very persistent and very bioaccumulative.
Responsibilities of marketing authorisation holders : the marketing authorisation holder shall be responsible for the placing on the market of his veterinary medicinal product. The designation of a representative shall note relieve the marketing authorisation holder of legal liability. In particular, the authorisation holder shall:
ensure, within the limits of its responsibilities, an appropriate and continuous supply of its veterinary medicinal products; ensure that the summary of product characteristics, package leaflet and labelling is kept up to date with current scientific knowledge; not place generic veterinary medicinal products and hybrid veterinary medicinal products on the Union market until the period of the protection of technical documentation for the reference veterinary medicinal product has elapsed; record in the product database the dates when its authorised veterinary medicinal products are placed on the market, information on the availability for each veterinary medicinal product in each relevant Member State and, as applicable, the dates of any suspension or revocation of the marketing authorisations concerned; record in the product database the annual volume of sales for each of its veterinary medicinal products.
Prudent use of antibiotics : given that resistance to antimicrobial drugs for human and veterinary use is a growing health problem in the EU and worldwide, the amended text emphasised the need to limit the veterinary use of critically important antimicrobial agents to the prevention or treatment of life-threatening human infections and to encourage and facilitate the development of new antimicrobials.
According to the amended text:
antimicrobial drugs shall only be used for prophylactic purposes (as a preventive measure) in well-defined cases of treatment of an animal or a limited number of animals, if the risk of infection is very high or if the consequences of such infection can have serious consequences. Antibiotic drugs shall only be used for prophylactic purposes in exceptional cases and only for a specific animal; antimicrobial drugs should only be used for metaphylaxis (e. g. to treat a group of animals, one of which shows signs of infection) if there is a high risk of spreading an infection or infectious disease in a group of animals and no other solution exists.
Veterinarians shall always issue a veterinary prescription when supplying a veterinary medicinal product subject to a veterinary prescription only and not administering it themselves. Whenever the veterinarians administer such medicinal products themselves it shall be left up to national provisions to specify whether a veterinary prescription needs to be issued. However, veterinarians shall always keep records of the medicinal products that they have administered.
The amended text provides that third country operators will have to comply with certain basic conditions relating to antimicrobial resistance for animals and products of animal origin exported to the Union. It also provides incentives to encourage research and innovation , in particular on antimicrobials.
The European Parliament adopted amendments to the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products.
The matter has been referred back to the committee. The vote on the legislative resolution has been postponed to a subsequent sitting .
The main elements adopted in plenary are as follows:
Aim : 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.
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
Antibacterial resistance : in order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, Members considered it necessary to reserve those antimicrobials for humans only . 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.
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.
Use of prophylactic and metaphylactic medicines : Members considered that the routine prophylactic (preventive) and metaphylactic (mass medication of a group of animals to eliminate or minimize an expected outbreak of disease) 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.
Routine prophylactic use of antimicrobials is therefore prohibited . Prophylactic use of antimicrobial veterinary medicines will 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 will be restricted to use in clinically-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.
According to the amended text, antimicrobial veterinary medicines shall not under any circumstances serve to improve performance or compensate for poor animal husbandry.
Research and innovation : to encourage research into new antimicrobials, Parliament advocated the following incentives:
longer periods of protection for technical documentation on new medicines; commercial protection of innovative active substances, and protection for significant investments in data generated to improve an existing antimicrobial product or to keep it on the market.
A new article on the period of protection of new data packages related to existing veterinary medicinal products stipulated that any new studies and trials , submitted by the applicant for a marketing authorisation to the competent authorities for an existing veterinary medicinal product no longer covered by any protection period shall benefit from a stand-alone period of protection of four years under certain conditions.
Animals under the care of veterinary professionals : Parliament narrowed the definition of persons entitled to retail veterinary medicines and states that 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 animals 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
On-line sales : a ntimicrobials, psychotropic and biological or immunological veterinary medicinal products may not be offered on the internet . Other products may be sold online under strict criteria e.g that the veterinary medicinal products and the prescriptions comply with the law of the destination Member State.
The Commission shall adopt guidelines supporting the Member States in the development of a harmonised system of digital prescription across the Union, including measures for controlling cross-border veterinary prescriptions.
Environmental protection : no later than six months before the date of application of the Regulation, the Commission must present a report 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.
The Committee on the Environment, Public Health and Food Safety adopted the report by Françoise GROSSETÊTE (EPP, FR) on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products.
The committee recommended that Parliament make the following amendments to the Commission proposal:
Antibacterial resistance for humans only: the Committee agreed with the Commission that in order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, those antimicrobials should be reserved for humans only. 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, the Commission will designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans.
Prophylactic use of medicines: Members considered that 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. Routine prophylactic use of antimicrobials is therefore prohibited. Prophylactic use of antimicrobial veterinary medicines will 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 will be restricted to use in clinically-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.
Innovation: to encourage research into new antimicrobials, Members advocate incentives, including:
longer periods of protection for technical documentation on new medicines; commercial protection of innovative active substances, and protection for significant investments in data generated to improve an existing antimicrobial product or to keep it on the market.
A new article on data protection for redevelopment of veterinary medicinal products states that where the data protection period 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.
Any new studies and trials , submitted by the applicant for a marketing authorisation 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 fulfil certain conditions.
Animals under the care of veterinary professionals: the committee narrowed the definition of persons entitled to retail veterinary medicines and states that 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 animals 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.
On-line sales: Members tightened the rules on sales online. Antimicrobials, psychotropic and biological or immunological veterinary medicinal products may not be offered on the internet . Other products may be sold online under strict criteria e.g that the veterinary medicinal products and the prescriptions comply with the law of the destination Member State.
Environmental protection: no later than six months before the date of application of the Regulation, the Commission must present a report 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.
PURPOSE: to ensure a high level of public health protection, high standards of quality and safety of veterinary medicinal products and the optimal functioning of the internal market.
PROPOSED ACT: Regulation of the Council and the European Parliament.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: in 2001, all the rules on production, marketing, distribution and use were consolidated in a veterinary medicines code (Directive 2001/82/EC); this was followed by Regulation (EC) No 726/2004 .
The current EU legislation on veterinary medicinal products provides the legal environment on authorisation, production, marketing, distribution and use of veterinary medicinal products. It brought some harmonisation to the procedures and rules required to place veterinary medicinal products on the EU market.
However, the Commission considers that there is evidence that the existing provisions do not deliver a functioning internal market:
diverging or incomplete transposition of the rules and the existence of numerous national requirements imply that companies are confronted with different rules and interpretation in countries and have also led to different levels of public and animal health protection; that needs of the veterinary sector differ substantially from those of the human sector in relation to medicines: in the veterinary sector there are many different animal species , which creates both a fragmented market and the need for major investments in order to extend the authorisation of medicines existing for one animal species to another; the price-setting mechanisms in the veterinary sector follow a completely different logic. Consequently, prices for veterinary medicines are typically substantially lower than for medicinal products for human use; the size of the animal pharmaceutical industry is only a small fraction of the size of the pharmaceutical industry for human medicines.
The Commission considers that it is critically important to have a single market for veterinary medicinal products . The current confined and fragmented markets do not allow the pharmaceutical sector to have a positive return on investments for developing new products for certain animal species.
The ambition to improve the availability of medicines in the Union and the functioning of the internal market and market competition can only be carried out at EU level.
IMPACT ASSESSMENT: the consultation and a study, An assessment of the impact of the revision of veterinary pharmaceutical legislation, formed the basis of an impact assessment carried out for the Commission between November 2009 and June 2011. The Commission’s Impact Assessment Board (IAB) released its final opinion in September 2013.
CONTENT: the revision of Directive 2001/82/EC and other legislation on veterinary medicinal products seek to put in place, while safeguarding public health, animal health, food safety and the environment, an up-to-date, proportionate body of legislation tailored to the specificities of the veterinary sector.
Specific objectives aim to:
expand the market beyond the top four animal species, simplify procedures for obtaining a marketing authorisation in multiple national markets, review data requirements in marketing authorisation procedures, simplify post authorisation requirements, review incentives for breakthrough medicines.
The proposal also tackles the issue of antimicrobial resistance and introduces provisions to minimise risks to public health arising from the use of antimicrobials in veterinary medicine.
BUDGETARY IMPLICATION: the costs for the EMA for implementing and applying the new rules are entirely covered by fees charged to industry. Therefore, the proposal is not expected to have any financial impact on the budget of the EU .
The additional resource needs for EMA are approximately 8 staff plus expenditure for meetings, translation, IT, etc. The level of fees, their structure and modalities and exceptions will be set at a later stage by the Commission by way of implementing acts.
DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the treaty on the Functioning of the European Union.
Documents
- Final act published in Official Journal: Regulation 2019/6
- Final act published in Official Journal: OJ L 004 07.01.2019, p. 0043
- Draft final act: 00045/2018/LEX
- Commission response to text adopted in plenary: SP(2018)755
- Decision by Parliament, 1st reading: T8-0421/2018
- Debate in Council: 3547
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament, 1st reading: T8-0087/2016
- Committee report tabled for plenary, 1st reading: A8-0046/2016
- Debate in Council: 3437
- Amendments tabled in committee: PE572.829
- Amendments tabled in committee: PE569.532
- Amendments tabled in committee: PE565.208
- Committee opinion: PE552.056
- Amendments tabled in committee: PE551.949
- Amendments tabled in committee: PE560.753
- Amendments tabled in committee: PE560.760
- Committee draft report: PE551.951
- Economic and Social Committee: opinion, report: CES5960/2014
- Contribution: COM(2014)0558
- Contribution: COM(2014)0558
- Legislative proposal: COM(2014)0558
- Legislative proposal: EUR-Lex
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2014)0273
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2014)0274
- Legislative proposal: COM(2014)0558 EUR-Lex
- Document attached to the procedure: EUR-Lex SWD(2014)0273
- Document attached to the procedure: EUR-Lex SWD(2014)0274
- Economic and Social Committee: opinion, report: CES5960/2014
- Committee draft report: PE551.951
- Amendments tabled in committee: PE551.949
- Amendments tabled in committee: PE560.753
- Amendments tabled in committee: PE560.760
- Committee opinion: PE552.056
- Amendments tabled in committee: PE565.208
- Amendments tabled in committee: PE569.532
- Amendments tabled in committee: PE572.829
- Commission response to text adopted in plenary: SP(2018)755
- Draft final act: 00045/2018/LEX
- Contribution: COM(2014)0558
- Contribution: COM(2014)0558
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Amendments | Dossier |
426 |
2014/0257(COD)
2015/05/07
AGRI
426 amendments...
Amendment 100 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 – point c (c) it
Amendment 101 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 (8) ‘antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to
Amendment 102 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 a (new) (8a) Antiparasitic — a medicinal product/ substance used in the treatment of parasitic diseases attributable to various causes;
Amendment 103 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 a (new) (8a) ‘antimicrobial': an active substance of synthetic or natural origin which destroys microorganisms, suppresses their growth or their ability to reproduce in animals or humans;
Amendment 104 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 b (new) (8b) ‘antimicrobial substance’ means a compound with a direct action on microorganisms used for treatment or prevention of infections. Antimicrobial substances include antibacterials, antivirals, antifungals and antiprotozoals; in the context of this Regulation, antimicrobial substance refers to an antibacterial.
Amendment 105 #
Proposal for a regulation Article 4 – paragraph 1 – point 11 – introductory part (11) ‘benefit-risk balance’ means an evaluation of the
Amendment 106 #
Proposal for a regulation Article 4 – paragraph 1 – point 11 – introductory part (11) ‘benefit-risk balance
Amendment 107 #
Proposal for a regulation Article 4 – paragraph 1 – point 11 – point c (
Amendment 108 #
Proposal for a regulation Article 4 – paragraph 1 – point 12 (12) ‘common name
Amendment 109 #
Proposal for a regulation Article 4 – paragraph 1 – point 20 – point b (b) veterinary medicinal products for animal species other than cattle,
Amendment 110 #
Proposal for a regulation Article 4 – paragraph 1 – point 20 – point b (b) veterinary medicinal products for animal species other than cattle,
Amendment 111 #
Proposal for a regulation Article 4 – paragraph 1 – point 20 – point b (b) veterinary medicinal products for animal species other than cattle, sheep (only meat obtained from sheep), pigs, chickens, dogs and cats;
Amendment 112 #
Proposal for a regulation Article 4 – paragraph 1 – point 20 – point b a (new) (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.
Amendment 113 #
Proposal for a regulation Article 4 – paragraph 1 – point 21 (21) ‘pharmacovigilance’ means the process of monitoring and investigating
Amendment 114 #
Proposal for a regulation Article 4 – paragraph 1 – point 24 (24) ‘veterinary prescription’ means any prescription for a veterinary medicinal product
Amendment 115 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 a (new) (27a) '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 116 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 b (new) (27b) '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 authorized or entitled to supply medicinal products to the public in accordance with applicable national law;
Amendment 117 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 c (new) (27c) ‘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 the Regulation (...Regulation on medicated feedingstuffs...).
Amendment 118 #
Proposal for a regulation Article 5 – paragraph 1 1. A veterinary medicinal product shall be placed on the market only when a marketing authorisation has been granted in respect of the product by a competent authority in accordance with Articles 44, 46 or 48
Amendment 119 #
Proposal for a regulation Article 5 – paragraph 2 2. A marketing authorisation for a veterinary medicinal product shall be valid for
Amendment 120 #
Proposal for a regulation Article 5 – paragraph 2 2. An initial marketing authorisation for a veterinary medicinal product shall be valid for
Amendment 121 #
Proposal for a regulation Article 5 – paragraph 2 2. A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time, except where new scientific knowledge gives grounds for reassessment.
Amendment 122 #
Proposal for a regulation Article 5 – paragraph 2 a (new) 2a. After the first period of five years the marketing authorisation shall be limited to a period not exceeding 15 years. After that period the applicant may apply for another 15 years authorisation. The renewal assessment shall be based on the current state of scientific knowledge and techniques and must take into account adverse effects reported under Article 76.
Amendment 123 #
Proposal for a regulation Article 5 – paragraph 2 a (new) 2a. When a previously authorised veterinary medicinal product has not been present on the market in a Member State for a period of three 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 the previous paragraph. Such exemptions shall be duly justified.
Amendment 124 #
Proposal for a regulation Article 6 – paragraph 3 3. Applications shall be submitted electronically
Amendment 125 #
Proposal for a regulation Article 7 – paragraph 2 – point a (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 126 #
Proposal for a regulation Article 7 – paragraph 2 – point а (
Amendment 127 #
Proposal for a regulation Article 7 – paragraph 2 – point b (b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product, 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 128 #
Proposal for a regulation Article 7 – paragraph 2 – point b (b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product, including that the product is not to be used as a routine prophylactic measure in food producing animals, unless specifically authorised by CVMP.
Amendment 129 #
Proposal for a regulation Article 7 – paragraph 2 – point b (
Amendment 130 #
Proposal for a regulation Article 7 – paragraph 5 a (new) 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 131 #
Proposal for a regulation Article 8 – paragraph 2 – point a a (new) (aa) 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
Amendment 132 #
Proposal for a regulation Article 8 – paragraph 2 – point b a (new) (ba) a provisional maximum residue limit has been established for the tested product.
Amendment 133 #
Proposal for a regulation Article 8 – paragraph 6 a (new) 6a. The holder of the clinical trial authorization shall notify the competent authority of every serious adverse events and all human adverse reactions shall be notified promptly and in any case not later than 15 days following receipt of the information.
Amendment 134 #
Proposal for a regulation Article 9 – paragraph 1 – introductory part 1. The immediate packaging of a veterinary medicinal product shall contain
Amendment 135 #
Proposal for a regulation Article 9 – paragraph 1 – introductory part 1. The immediate packaging of a veterinary medicinal product shall
Amendment 136 #
Proposal for a regulation Article 9 – paragraph 1 – point b a (new) (bа) an indication of the presence of genetically modified organisms where the product contains or consists of such organisms;
Amendment 137 #
Proposal for a regulation Article 9 – paragraph 1 – point f (
Amendment 138 #
Proposal for a regulation Article 9 – paragraph 1 – point g a (new) (ga) a barcode containing all the information listed in paragraph 1, points (a) to (g), 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.
Amendment 139 #
Proposal for a regulation Article 10 – paragraph 1 – introductory part 1. The outer packaging of a veterinary medicinal product shall contain
Amendment 140 #
Proposal for a regulation Article 10 – paragraph 1 – point d Amendment 141 #
Proposal for a regulation Article 10 – paragraph 1 – point f (f)
Amendment 142 #
Proposal for a regulation Article 10 – paragraph 1 – point f (f) requirement to use take-back schemes for veterinary medicinal products for the disposal of
Amendment 143 #
Proposal for a regulation Article 10 – paragraph 1 – point g a (new) (ga) waiting times.
Amendment 144 #
Proposal for a regulation Article 11 – paragraph 1 – point b a (new) (bа) an indication of the presence of genetically modified organisms where the product contains or consists of such organisms;
Amendment 145 #
Proposal for a regulation Article 11 – paragraph 1 – point d (
Amendment 146 #
Proposal for a regulation Article 12 – paragraph 1 – point i a (new) (iа) in the case of veterinary medicinal products which include or consist of genetically modified organisms, information to that effect;
Amendment 147 #
Proposal for a regulation Article 12 – paragraph 1 – point m a (new) (ma) Qualitative and quantitative composition.
Amendment 148 #
Proposal for a regulation Article 12 – paragraph 1 a – point m a (new) (ma) the barcode referred to in Article 9(1)(ga).
Amendment 149 #
Proposal for a regulation Article 12 – paragraph 3 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 150 #
Proposal for a regulation Article 13 – paragraph 1 – point d (d) the expiry date, in the format: " mm/yyyy " , preceded by the abbreviation " Exp
Amendment 151 #
Proposal for a regulation Article 13 – paragraph 1 – point h (h) a special warning if necessary for the medicinal product (e.g. presence of genetically modified organisms);
Amendment 152 #
Proposal for a regulation Article 14 – paragraph 3 a (new) 3a. The information on the labelling shall be provided in the national language of every Member State where the veterinary medicinal product is made available on the market.
Amendment 153 #
Proposal for a regulation Article 16 – paragraph 2 2. For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety
Amendment 154 #
Proposal for a regulation Article 16 – paragraph 5 5. The clinical information of the summary of the product characteristics (as defined in Article 30(1)(c), excluding point (vi)) of the generic veterinary
Amendment 155 #
Proposal for a regulation Article 16 – paragraph 6 Amendment 156 #
Proposal for a regulation Article 16 – paragraph 6 6.
Amendment 157 #
Proposal for a regulation Article 16 – paragraph 6 6. A competent authority or the Agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment i
Amendment 158 #
Proposal for a regulation Article 16 – paragraph 6 6.
Amendment 159 #
Proposal for a regulation Article 16 – paragraph 7 Amendment 160 #
Proposal for a regulation Article 17 – paragraph 1 – introductory part By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances
Amendment 161 #
Proposal for a regulation Article 17 – paragraph 1 – point b (b) the applicant can demonstrate that the veterinary medicinal product
Amendment 162 #
Proposal for a regulation Article 17 – paragraph 1 – point d (d) where needed, appropriate documentation on the safety of that combination is provided.
Amendment 163 #
Proposal for a regulation Article 19 – paragraph 1 By way of derogation from Article 16(1)(b), an applicant for a marketing authorisation for a
Amendment 164 #
Proposal for a regulation Article 21 – paragraph 1 – point а (а) the benefit of the immediate availability on the market of the veterinary medicinal product to
Amendment 165 #
Proposal for a regulation Article 21 – paragraph 2 2. By way of derogation from Article 5(2), a marketing authorisation for a limited market shall be
Amendment 166 #
Proposal for a regulation Article 21 – paragraph 2 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. 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.
Amendment 167 #
Proposal for a regulation Article 22 – paragraph 1 – introductory part Amendment 168 #
Proposal for a regulation Article 25 The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries comply with EU legislation applicable 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).
Amendment 169 #
Proposal for a regulation Article 28 – paragraph 3 3. Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission
Amendment 170 #
Proposal for a regulation Article 28 – paragraph 3 Amendment 171 #
Proposal for a regulation Article 29 – paragraph 1 – introductory part 1. A competent authority
Amendment 172 #
Proposal for a regulation Article 29 – paragraph 1 – point c (
Amendment 173 #
Proposal for a regulation Article 29 – paragraph 3 – introductory part 3.
Amendment 174 #
Proposal for a regulation Article 29 – paragraph 3 – point h (
Amendment 175 #
Proposal for a regulation Article 30 – paragraph 1 – point c – point vi (vi) frequency and seriousness of adverse events or reactions,
Amendment 176 #
Proposal for a regulation Article 30 – paragraph 1 – point c – point viii (viii) known interaction with other medicinal products and other known forms of interaction
Amendment 177 #
Proposal for a regulation Article 30 – paragraph 1 – point c – point xii (
Amendment 178 #
Proposal for a regulation Article 30 – paragraph 1 – point c – point xiii (xiii) special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance, and specifying that the product is not to be used as a routine preventative measure in food producing animals, or in prophylactic group treatments where there has been no diagnosis of disease,
Amendment 179 #
Proposal for a regulation Article 30 – paragraph 1 – point c – point xiii (xiii) special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance, and specifying that the product is not to be used as a routine preventative measure in food producing animals,
Amendment 180 #
Proposal for a regulation Article 30 – paragraph 1 – point c – point xiii (
Amendment 181 #
Proposal for a regulation Article 30 – paragraph 1 – point e – point viii (viii)
Amendment 182 #
Proposal for a regulation Article 30 – paragraph 1 – point e – point viii a (new) (viiia) when the veterinary medicinal product is authorised to be administered via medicated feed, information on known incompatibilities between the veterinary medicinal product and the feed ingredients impairing the safety or the efficacy of the medicated feed.
Amendment 183 #
Proposal for a regulation Article 30 – paragraph 1 – point j a (new) (ja) When the veterinary medical product is authorised to be administered via medicated feed, information on the possibility to have interaction between the VMP and the feed impairing the safety or the efficacy of the medicated feed shall be provided through a list of incompatibilities.
Amendment 184 #
Proposal for a regulation Article 30 – paragraph 1 – point j a (new) (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 185 #
Proposal for a regulation Article 30 – paragraph 1 – point j b (new) (jb) ecotoxicological information including effects on non-target species and persistence of active substances and active metabolites in soil and water.
Amendment 186 #
Proposal for a regulation Article 31 – paragraph 2 2. The competent authority
Amendment 187 #
Proposal for a regulation Article 31 – paragraph 2 a (new) 2a. Where two products have the same therapeutic effect, comparative assessments may be carried out. Products that are hazardous to the environment or to the treated animals shall be substituted by less hazardous products.
Amendment 189 #
Proposal for a regulation Article 32 – paragraph 1 – point c (c) the product is a
Amendment 190 #
Proposal for a regulation Article 32 – paragraph 1 – point d (d) the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals, or to
Amendment 191 #
Proposal for a regulation Article 32 – paragraph 1 – point g (g) risk for public health
Amendment 192 #
Proposal for a regulation Article 32 – paragraph 1 – point g (
Amendment 193 #
Proposal for a regulation Article 32 – paragraph 1 – point g a (new) (ga) the product is a substance of high concern;
Amendment 194 #
Proposal for a regulation Article 32 – paragraph 1 – point g b (new) (gb) active substances within the product which meet the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to EMA guidelines, or are considered as having endocrine-disrupting properties that risk causing adverse effects in the environment;
Amendment 195 #
Proposal for a regulation Article 32 – paragraph 1 – point h a (new) (ha) unacceptable side effects or secondary effects on the treated animal;
Amendment 196 #
Proposal for a regulation Article 32 – paragraph 2 Amendment 197 #
Proposal for a regulation Article 32 – paragraph 2 Amendment 198 #
Proposal for a regulation Article 32 – paragraph 3 Amendment 199 #
Proposal for a regulation Article 32 – paragraph 3 Amendment 200 #
Proposal for a regulation Article 32 – paragraph 3 Amendment 201 #
Proposal for a regulation Article 32 – paragraph 3 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, will make decisions on appropriate risk management measures at the class, substance or even the indication level and will consider also the route of administration.
Amendment 202 #
Proposal for a regulation Article 32 – paragraph 3 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 and based on the latest scientific advice in order to establish rules for the designation of the antimicrobials which are to be reserved for treatment of certain
Amendment 203 #
Proposal for a regulation Article 32 – paragraph 4 Amendment 204 #
Proposal for a regulation Article 32 – paragraph 4 Amendment 205 #
Proposal for a regulation Article 32 – paragraph 4 Amendment 206 #
Proposal for a regulation Article 32 – paragraph 4 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, will make decisions on appropriate risk management measures at the class, substance or even the indication level and will consider also the route of administration.
Amendment 207 #
Proposal for a regulation Article 32 – paragraph 4 4. The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials
Amendment 208 #
Proposal for a regulation Article 33 – paragraph 3 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
Amendment 209 #
Proposal for a regulation Article 34 – paragraph 1 – point a (a) 10 years for the veterinary medicinal products for cattle,
Amendment 210 #
Proposal for a regulation Article 34 – paragraph 1 – point a (a) 10 years for the veterinary medicinal products for cattle,
Amendment 211 #
Proposal for a regulation Article 34 – paragraph 1 – point a (a) 10 years for the veterinary medicinal products for cattle, sheep (only for meat), pigs, chickens, dogs and cats
Amendment 212 #
Proposal for a regulation Article 34 – paragraph 1 – point b (b) 1
Amendment 213 #
Proposal for a regulation Article 34 – paragraph 1 – point b (b) 1
Amendment 214 #
Proposal for a regulation Article 34 – paragraph 1 – point b (b) 14 years for antimicrobial veterinary medicinal products for cattle,
Amendment 215 #
Proposal for a regulation Article 34 – paragraph 1 – point b (b) 14 years for antimicrobial veterinary medicinal products for cattle,
Amendment 216 #
Proposal for a regulation Article 34 – paragraph 1 – point b (
Amendment 217 #
Proposal for a regulation Article 34 – paragraph 1 – point c (c)
Amendment 218 #
Proposal for a regulation Article 34 – paragraph 1 – point c (c) 1
Amendment 219 #
Proposal for a regulation Article 34 – paragraph 1 – point d (d) 1
Amendment 220 #
Proposal for a regulation Article 34 – paragraph 1 – point d (d) 1
Amendment 221 #
Proposal for a regulation Article 34 – paragraph 2 a (new) 2a. The period shall be extended in line with the prolongation periods provided for in Article 35 where the veterinary medicinal product has been authorised for more than one species.
Amendment 222 #
Proposal for a regulation Article 35 – title Amendment 223 #
Proposal for a regulation Article 35 – paragraph 1 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
Amendment 224 #
Proposal for a regulation Article 35 – paragraph 1 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 granted period of the protection provided for in that Article shall be
Amendment 225 #
Proposal for a regulation Article 35 – paragraph 1 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
Amendment 226 #
Proposal for a regulation Article 35 – paragraph 1 1. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to another species
Amendment 227 #
Proposal for a regulation Article 35 – paragraph 1 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
Amendment 228 #
Proposal for a regulation Article 35 – paragraph 2 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
Amendment 229 #
Proposal for a regulation Article 35 – paragraph 2 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
Amendment 230 #
Proposal for a regulation Article 35 – paragraph 2 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
Amendment 231 #
Proposal for a regulation Article 35 – paragraph 2 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
Amendment 232 #
Proposal for a regulation Article 35 – paragraph 3 Amendment 233 #
Proposal for a regulation Article 35 – paragraph 3 3. The period of the protection of the first marketing authorisation shall not be prolonged by any additional periods
Amendment 234 #
Proposal for a regulation Article 35 – paragraph 3 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 1
Amendment 235 #
Proposal for a regulation Article 35 – paragraph 3 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 (
Amendment 236 #
Proposal for a regulation Article 35 – paragraph 4 a (new) 4a. Any grant of periods for protection of technical documentation should also be equally applied to innovation performed to generic veterinary medicines, and not only to originators.
Amendment 237 #
Proposal for a regulation Article 35 a (new) Article 35 a 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.
Amendment 239 #
Proposal for a regulation Article 38 – paragraph 1 1. Centralised marketing authorisations shall be granted by the Commission in accordance with this Section. They shall be valid throughout the Union and considered the priority procedure.
Amendment 240 #
Proposal for a regulation Article 38 – paragraph 2 – point c Amendment 241 #
Proposal for a regulation Article 38 – paragraph 2 – point e Amendment 242 #
Proposal for a regulation Article 38 – paragraph 2 – point e Amendment 243 #
Proposal for a regulation Article 38 – paragraph 3 3. For veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union or if the application concerns a conversion of a marketing authorisation as referred to in Article 57a.
Amendment 244 #
Proposal for a regulation Article 38 – paragraph 4 Amendment 245 #
Proposal for a regulation Article 38 – paragraph 4 Amendment 247 #
Proposal for a regulation Article 41 Amendment 248 #
Proposal for a regulation Article 46 – paragraph 1 (1) Applications for decentralised marketing authorisation shall be submitted to the Member State chosen by the applicant (‘reference Member State’). It shall also forward the applications to all Member States for information.
Amendment 249 #
Proposal for a regulation Article 46 – paragraph 2 2. The application shall list Member States where the applicant seeks to obtain a marketing authorisation (‘Member States concerned
Amendment 250 #
Proposal for a regulation Article 48 – paragraph 1 (1) Applications for mutual recognition of
Amendment 251 #
Proposal for a regulation Article 48 – paragraph 1 1. Applications for mutual recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation (‘reference Member State
Amendment 252 #
Proposal for a regulation Article 48 – paragraph 1 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 is the (‘reference Member State
Amendment 253 #
Proposal for a regulation Article 48 – paragraph 2 Amendment 254 #
Proposal for a regulation Article 48 – paragraph 2 2. A minimum of
Amendment 255 #
Proposal for a regulation Article 48 – paragraph 3 – point c Amendment 256 #
Proposal for a regulation Article 48 – paragraph 4 4. Within
Amendment 257 #
Proposal for a regulation Article 48 – paragraph 4 4. Within 90 days of receipt of a valid application, the reference Member State shall prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all concerned Member States and the applicant. , together with the list of Member States where the applicant seeks to obtain recognition of the marketing authorisation
Amendment 258 #
Proposal for a regulation Article 49 – paragraph 1 1. If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet, 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
Amendment 259 #
Proposal for a regulation Article 49 – paragraph 2 Amendment 260 #
Proposal for a regulation Article 49 – paragraph 4 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 261 #
Proposal for a regulation Article 50 – paragraph 1 1. Within 15 days after receipt of the assessment report referred to in Article 46(3) or in Article 48(4) the applicant may provide written notice to the
Amendment 262 #
Proposal for a regulation Article 51 – paragraph 4 Amendment 263 #
Proposal for a regulation Article 51 – paragraph 6 Amendment 264 #
Proposal for a regulation Article 51 a (new) Article 51a Feasibility study for monograph review system By the 1st June 2018, the Commission shall present a report to the European Parliament and the Council on establishing a substance-based review system (monographs) for the environmental risk assessment of veterinary medicinal products, to be accompanied by a legislative proposal if appropriate.
Amendment 265 #
Proposal for a regulation Article 52 – paragraph 3 3. The general public shall have access to information in the product database
Amendment 266 #
Proposal for a regulation Article 52 – paragraph 3 a (new) 3a. Commercial sensitivity must 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. Maximal transparency shall be ensured while protecting the most commercially sensitive information.
Amendment 267 #
Proposal for a regulation Article 54 – title Collection of data on the sales and use of
Amendment 268 #
Proposal for a regulation Article 54 – title Amendment 269 #
Proposal for a regulation Article 54 – paragraph 1 1. Member States shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products. These data shall include: (a) volume of sales in terms of weight and monetary value for each antimicrobial type; (b) use of antimicrobials including species treated, disease or infection being treated, and method of treatment.
Amendment 270 #
Proposal for a regulation Article 54 – paragraph 1 1. Member States shall collect relevant and comparable data on the volume of sales
Amendment 271 #
Proposal for a regulation Article 54 – paragraph 1 Amendment 272 #
Proposal for a regulation Article 54 – paragraph 1 a (new) 1a. These data should provide detail at least by species and by antibiotic class and on a per-farm level.
Amendment 273 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States shall send to the Agency data on the volume of sales
Amendment 274 #
Proposal for a regulation Article 54 – paragraph 2 Amendment 275 #
Proposal for a regulation Article 54 – paragraph 3 Amendment 276 #
Proposal for a regulation Article 54 – paragraph 3 Amendment 277 #
Proposal for a regulation Article 54 – paragraph 3 a (new) 3a. Member States shall collect relevant and comparable data on the volume of sales and the use of anti-parasitic and hormonal veterinary medicinal products, and make these available to the Agency.
Amendment 278 #
Proposal for a regulation Article 54 – paragraph 4 Amendment 279 #
Proposal for a regulation Article 56 Amendment 280 #
Proposal for a regulation Article 57 – paragraph 1 – point c (c)
Amendment 281 #
Proposal for a regulation Article 57 a (new) Article 57a Subsequent conversion into centralised marketing authorisation 1. After completion of a decentralised procedure laid down in Article 46, a mutual recognition procedure laid down in Article 48, or a marketing authorisation harmonisation procedure laid down in Article 69, the marketing authorisation holder may submit an application to convert the existing marketing authorisations for the veterinary medicinal product into a centralised marketing authorisation granted by the Commission and 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, summary of the product characteristics, 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, decentralised procedure or marketing authorisation harmonisation procedure after the date of the application of this Regulation.
Amendment 282 #
Proposal for a regulation Article 58 Amendment 283 #
Proposal for a regulation Article 58 – paragraph 1 1. Variation to the terms of a marketing authorisation
Amendment 284 #
Proposal for a regulation Article 58 – paragraph 2 2. The Commission shall
Amendment 285 #
Proposal for a regulation Article 58 – paragraph 3 Amendment 286 #
Proposal for a regulation Article 58 – paragraph 3 – introductory part 3.
Amendment 287 #
Proposal for a regulation Article 58 – paragraph 3 – point a Amendment 288 #
Proposal for a regulation Article 58 – paragraph 3 – point а (
Amendment 289 #
Proposal for a regulation Article 58 – paragraph 3 – point b Amendment 290 #
Proposal for a regulation Article 58 – paragraph 3 – point c Amendment 291 #
Proposal for a regulation Article 59 Amendment 292 #
Proposal for a regulation Article 60 Amendment 293 #
Proposal for a regulation Article 60 Amendment 294 #
Proposal for a regulation Article 60 – paragraph 2 2. If necessary, competent authorities
Amendment 295 #
Proposal for a regulation Article 61 Amendment 296 #
Proposal for a regulation Article 62 Amendment 297 #
Proposal for a regulation Article 63 Amendment 298 #
Proposal for a regulation Article 63 – paragraph 1 1. When applying for variations to the terms of several marketing authorisations held by the same marketing authorisation holder and granted by different competent authorities
Amendment 300 #
Proposal for a regulation Article 65 Amendment 301 #
Proposal for a regulation Article 65 – paragraph 1 1. Within 30 days of the completion of the procedure laid down in Article 64(6) and (7) a competent authority
Amendment 302 #
Proposal for a regulation Article 66 Amendment 303 #
Proposal for a regulation Article 67 Amendment 304 #
Proposal for a regulation Article 69 – paragraph 4 Amendment 305 #
Proposal for a regulation Article 69 – paragraph 4 – point c (c) the
Amendment 306 #
Proposal for a regulation Article 70 – paragraph 3 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
Amendment 307 #
Proposal for a regulation Article 72 – paragraph 2 2. Competent authorities and the Agency shall supervise the pharmacovigilance
Amendment 308 #
Proposal for a regulation Article 73 – paragraph 1 1. Member States, the Commission, the Agency and marketing authorisation holders shall collaborate in setting up and maintaining a system to monitor the safety and efficacy of authorised veterinary medicinal products, enabling them to fulfil their responsibilities as listed in Articles 77 and 79 (‘Union pharmacovigilance system').
Amendment 309 #
Proposal for a regulation Article 73 – paragraph 2 – point b (b) any observation of a lack of efficacy of a veterinary medicinal product
Amendment 310 #
Proposal for a regulation Article 73 – paragraph 2 – point b (b) any observation of a lack of efficacy of a veterinary medicinal product, including signs of antimicrobial resistance, following administration to an animal in accordance with the summary of product characteristics;
Amendment 311 #
Proposal for a regulation Article 73 – paragraph 2 – point c (c) any
Amendment 312 #
Proposal for a regulation Article 73 – paragraph 2 – point c (c) any environmental incidents observed following administration of a veterinary medicinal product to an animal, including incidents of leakage of antibiotic residues into soil and water;
Amendment 313 #
Proposal for a regulation Article 73 – paragraph 2 – point d Amendment 314 #
Proposal for a regulation Article 73 – paragraph 2 – point e (e) any noxious re
Amendment 315 #
Proposal for a regulation Article 73 – paragraph 2 – point f a (new) (fa) any suspected transmission via a veterinary medicinal product of any infectious agent.
Amendment 316 #
Proposal for a regulation Article 73 – paragraph 2 – point f a (new) (fa) any relevant documentation and data on the direct or indirect risks to the environment from the use of antimicrobial medicines in animals.
Amendment 317 #
Proposal for a regulation Article 74 – paragraph 1 1. The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the ‘pharmacovigilance database
Amendment 318 #
Proposal for a regulation Article 74 – paragraph 2 2. The Agency shall, in co
Amendment 319 #
Proposal for a regulation Article 74 – paragraph 2 2. The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the pharmacovigilance database. 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 320 #
Proposal for a regulation Article 74 – paragraph 3 3. The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made publicly accessible in accordance with Article 75.
Amendment 321 #
Proposal for a regulation Article 76 – paragraph 2 2. Marketing authorisation holders shall
Amendment 322 #
Proposal for a regulation Article 76 – paragraph 2 2. Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, within 30 days following the receipt of the adverse event report. Different requirements shall apply for adverse events observed in clinical trials.
Amendment 323 #
Proposal for a regulation Article 76 – paragraph 3 3. Competent authorities
Amendment 324 #
Proposal for a regulation Article 76 – paragraph 3 3.
Amendment 325 #
Proposal for a regulation Article 76 – paragraph 3 Amendment 326 #
Proposal for a regulation Article 76 – paragraph 4 Amendment 327 #
Proposal for a regulation Article 76 – paragraph 5 Amendment 328 #
Proposal for a regulation Article 77 – paragraph 2 2.
Amendment 329 #
Proposal for a regulation Article 77 – paragraph 4 Amendment 330 #
Proposal for a regulation Article 77 – paragraph 6 – subparagraph 1 The marketing authorisation holder shall not communicate information regarding adverse events to the general public in relation to the veterinary medicinal product without
Amendment 331 #
Proposal for a regulation Article 77 – paragraph 6 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 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.
Amendment 332 #
Proposal for a regulation Article 78 – paragraph 1 – point a (a) elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder
Amendment 333 #
Proposal for a regulation Article 78 – paragraph 1 – point b (b) allocating reference numbers to the pharmacovigilance system master file and communicating the relevant reference number of the pharmacovigilance master file
Amendment 334 #
Proposal for a regulation Article 78 – paragraph 1 – point j (j)
Amendment 335 #
Proposal for a regulation Article 78 – paragraph 1 – point l (l) communicating any regulatory measure that is taken in a 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.
Amendment 336 #
Proposal for a regulation Article 78 – paragraph 1 – subparagraph l a (new) Unless other requirements have been laid down as a condition for the granting of the marketing authorisation or subsequently established by the competent authority, reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety report, immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market, yearly for the following two years and thereafter at three-yearly intervals. The periodic safety reports shall include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product. Unless other requirements have been laid down as a condition for the granting of the marketing authorisation or subsequently established by competent authority, reports of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety report, immediately upon request or at least every six months after authorisation until the placing on the market. Periodic safety reports shall also be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market, yearly for the following two years and thereafter at three-yearly intervals. The periodic safety reports shall include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product.
Amendment 337 #
Proposal for a regulation Article 79 – paragraph 1 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 338 #
Proposal for a regulation Article 79 – paragraph 3 3. Competent authorities may impose specific requirements on marketing authorisation holders, veterinarians and other healthcare professionals in respect of the reporting of adverse events. The Agency and the competent authorities may organise meetings or a network for groups of veterinarians or other healthcare professionals, where there is a specific need for collecting, collating or analysing specific pharmacovigilance data.
Amendment 339 #
Proposal for a regulation Article 79 – paragraph 4 a (new) 4a. Competent authorities and the Agency shall ensure that veterinarians receive feedback on adverse events reported and regular feedback on all adverse reactions reported.
Amendment 34 #
Proposal for a regulation Recital 2 (2) In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the need for the legal framework for veterinary medicinal products
Amendment 340 #
Proposal for a regulation Article 79 – paragraph 6 6. The Agency shall evaluate the adverse events to the centrally authorised veterinary medicinal products, manage risks and recommend measures to the
Amendment 341 #
Proposal for a regulation Article 80 – paragraph 1 1. A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent public authority in another Member State subject to the written agreement of the latter.
Amendment 342 #
Proposal for a regulation Article 81 – paragraph 2 Amendment 343 #
Proposal for a regulation Article 81 – paragraph 3 3. The Agency and the
Amendment 344 #
Proposal for a regulation Article 81 – paragraph 4 4. The results of the signal management process, except for nationally authorised products, shall be agreed upon by the competent authorities and, where appropriate, the Agency. The lead authority shall record the results in the pharmacovigilance database.
Amendment 345 #
Proposal for a regulation Article 81 – paragraph 5 5. Where necessary, based on the results of the signal management process referred to in paragraph 4 the competent authorities
Amendment 346 #
Proposal for a regulation Article 82 – paragraph 1 1.
Amendment 347 #
Proposal for a regulation Article 82 – paragraph 3 3. When an application for re-examination has been submitted, the limited market marketing authorisation shall remain valid
Amendment 348 #
Proposal for a regulation Article 82 – paragraph 5 5. The competent authority
Amendment 349 #
Proposal for a regulation Article 83 – paragraph 3 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
Amendment 35 #
Proposal for a regulation Recital 4 (4) Experience has shown that the needs of the veterinary sector differ substantially from those of the human sector in relation to medicines. In particular, the drivers for investment for the human and the veterinary medicines markets are different.
Amendment 350 #
Proposal for a regulation Article 83 – paragraph 4 4. The competent authority
Amendment 351 #
Proposal for a regulation Article 84 – paragraph 1 Amendment 352 #
Proposal for a regulation Article 98 – paragraph 1 – point c a (new) (ca) comply with the rules on good manufacturing practice for medicinal products established in the Union and use as starting materials only active substances which have been manufactured in accordance with the rules on good manufacturing practice for starting materials established in the Union;
Amendment 353 #
Proposal for a regulation Article 98 – paragraph 1 – point d (d) give prior notice to the competent authority of any changes which he may wish to make to any of the particulars supplied pursuant to Article 92 and inform the competent authority immediately if the qualified person referred to in Article 100 is replaced;
Amendment 354 #
Proposal for a regulation Article 100 – paragraph 1 1. The holder of a manufacturing authorisation shall have permanently and continuously at his disposal the services of at least one qualified person who fulfils the conditions laid down in this Article and is responsible, in particular, for carrying out the duties specified in Article 101. The holder of the manufacturing authorisation may himself assume the responsibility referred to in this paragraph, if he personally fulfils the conditions for qualified persons provided for by this Regulation.
Amendment 355 #
Proposal for a regulation Article 100 – paragraph 2 2. The qualified person shall be in possession of a diploma, certificate or other evidence of appropriate qualification and shall have acquired sufficient experience in the field of manufacturing. The holder of the authorisation may himself assume the responsibility referred to in paragraph 1, if
Amendment 356 #
Amendment 357 #
Proposal for a regulation Article 107 – paragraph 1 1. The retail of veterinary medicinal products shall be conducted only by persons who are permitted to carry out such operations under national law, veterinarians where appropriate.
Amendment 358 #
Proposal for a regulation Article 107 – paragraph 2 2.
Amendment 359 #
Proposal for a regulation Article 107 – paragraph 2 2.
Amendment 36 #
Proposal for a regulation Recital 6 (6)
Amendment 360 #
Proposal for a regulation Article 107 – paragraph 2 2.
Amendment 361 #
Proposal for a regulation Article 107 – paragraph 2 2. Persons qualified to prescribe veterinary
Amendment 362 #
Proposal for a regulation Article 107 – paragraph 2 2.
Amendment 363 #
Proposal for a regulation Article 107 – paragraph 2 Amendment 365 #
Proposal for a regulation Article 108 – paragraph 1 (1)
Amendment 366 #
Proposal for a regulation Article 108 – paragraph 7 a (new) 7a. Strict control mechanisms, in particular regarding the control of cross- border veterinary prescriptions, shall be in place, leading to dissuasive penalties or prosecutions in case of illegal activity or failure to act according to the professional Code of Conduct. Member States shall develop a system of digital prescription at national level. The Commission shall promote the development of a harmonized system of digital prescription across Europe and assist Member States in its implementation. Delivering and control of prescriptions shall be at national level, at least until a European system enabling the control of cross border prescriptions is in place. A technology system of E- submission of prescriptions on a national database, directly linked to all pharmacies (shops and internet ones), national competent authorities and veterinarians shall be put in place as on-line cross checking by the pharmacy and the prescriber will prevent from frauds and abuse.
Amendment 367 #
Proposal for a regulation Article 108 a (new) Article 108a Prohibition on marketing veterinary medicinal products online Veterinary medicinal products requiring authorisation may not be marketed via the Internet.
Amendment 368 #
Proposal for a regulation Article 109 – paragraph 1 1. Only manufacturers, wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which
Amendment 369 #
Proposal for a regulation Article 109 – paragraph 3 – subparagraph 1 – introductory part Those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase
Amendment 37 #
Proposal for a regulation Recital 6 (
Amendment 370 #
Proposal for a regulation Article 109 – paragraph 3 – subparagraph 1 – point d (d) name and address of the supplier in the event of purchase
Amendment 371 #
Proposal for a regulation Article 110 – paragraph 1 – point a (a) identification of the animal or group of animals under treatment;
Amendment 372 #
Proposal for a regulation Article 110 – paragraph 1 – point d (d) full name and contact details, qualifications and professional membership number of the
Amendment 373 #
Proposal for a regulation Article 110 – paragraph 1 – point e (e) signature or an equivalent electronic form of identification of the
Amendment 374 #
Proposal for a regulation Article 110 – paragraph 1 – point f a (new) (fa) the condition which is being treated;
Amendment 375 #
Proposal for a regulation Article 110 – paragraph 2 2. A veterinary prescription
Amendment 376 #
Proposal for a regulation Article 110 – paragraph 2 2. A veterinary prescription shall only be issued by a
Amendment 377 #
Proposal for a regulation Article 110 – paragraph 2 2. A veterinary
Amendment 378 #
Proposal for a regulation Article 110 – paragraph 2 2. A veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law, a veterinarian where appropriate and only after a veterinary diagnosis. These persons shall, by reason of their initial and continuing training, have the skills necessary to prescribe and issue veterinary medicinal products for all the species they treat.
Amendment 379 #
Proposal for a regulation Article 110 – paragraph 2 2. A veterinary prescription shall only be issued by a
Amendment 38 #
Proposal for a regulation Recital 7 (
Amendment 380 #
Proposal for a regulation Article 110 – paragraph 3 3. Where a veterinary medicinal product is
Amendment 381 #
Proposal for a regulation Article 110 – paragraph 3 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 prophylactic use of antibiotics shall be permissible only in certain cases specified by the Agency.
Amendment 382 #
Proposal for a regulation Article 110 – paragraph 3 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. Preventive use of antimicrobials shall be prohibited.
Amendment 383 #
Proposal for a regulation Article 110 – paragraph 3 a (new) 3a. In the case of antimicrobials critically important for human use, the prescribed medication may only be used for the animals examined by the person who issued the prescription. The prescribed medication may only be used for the diagnosed disease.
Amendment 384 #
Proposal for a regulation Article 111 – paragraph 1 1. Veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation. Nevertheless, the veterinarian should be able, in justified circumstances, to prescribe veterinary medicinal products in different terms to the ones authorised for the product.
Amendment 385 #
Proposal for a regulation Article 111 – paragraph 1 a (new) 1a. Antimicrobials may only be issued under prescription by a vet or a suitably qualified animal health professional to food producing animals after all the preventive measures listed under Annex 3a have been fulfilled. Preventative or prophylactic mass medication in drink or water when no disease has been diagnosed shall be prohibited. No antimicrobial group treatments should be permitted, except for where disease has been diagnosed in some of the animals.
Amendment 386 #
Proposal for a regulation Article 114 – paragraph 1 – introductory part 1. A veterinarian
Amendment 387 #
Proposal for a regulation Article 114 – paragraph 1 – point a Amendment 388 #
Proposal for a regulation Article 114 – paragraph 1 – point b Amendment 389 #
Proposal for a regulation Article 114 – paragraph 1 – point c Amendment 39 #
Proposal for a regulation Recital 7 a (new) (7a) This regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. 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 390 #
Proposal for a regulation Article 114 – paragraph 1 – point d Amendment 391 #
Proposal for a regulation Article 114 – paragraph 1 – point e Amendment 392 #
Proposal for a regulation Article 114 – paragraph 1 – point f Amendment 393 #
Proposal for a regulation Article 114 – paragraph 2 Amendment 394 #
Proposal for a regulation Article 115 – paragraph 1 1.
Amendment 395 #
Proposal for a regulation Article 115 – paragraph 1 1. By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with the following
Amendment 396 #
Proposal for a regulation Article 115 – paragraph 1 – introductory part 1. By way of derogation from Article 111,
Amendment 397 #
Proposal for a regulation Article 115 – paragraph 1 – introductory part 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, with the exception of anticrobial products used as routine prophylactic measure, unless specifically authorised by the CVMP:
Amendment 398 #
Proposal for a regulation Article 115 – paragraph 1 – introductory part 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
Amendment 399 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point iii (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. Antimicrobial medicinal products for human use may only 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, if treatment with a medicinal product as referred to in letter (a)(i) or (ii) is not possible;
Amendment 40 #
Proposal for a regulation Recital 7 a (new) (7a) This regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. 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 unacceptably harmful effects on human or animal health or any unacceptable effects on the environment.
Amendment 400 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point iii (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
Amendment 401 #
Proposal for a regulation Article 116 – paragraph 1 1.
Amendment 402 #
Proposal for a regulation Article 116 – paragraph 1 – introductory part 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, 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:
Amendment 403 #
Proposal for a regulation Article 116 – paragraph 1 – introductory part 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
Amendment 404 #
Proposal for a regulation Article 116 – paragraph 1 – introductory part 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
Amendment 405 #
Proposal for a regulation Article 116 – paragraph 1 – point a (a) a veterinary medicinal product authorised under this Regulation in the Member State concerned for
Amendment 406 #
Proposal for a regulation Article 116 – paragraph 1 – point b (b) a veterinary medicinal product authorised under this
Amendment 407 #
Proposal for a regulation Article 116 – paragraph 1 – point c (c) a veterinary medicinal product
Amendment 408 #
Proposal for a regulation Article 116 – paragraph 1 – point c (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
Amendment 409 #
Proposal for a regulation Article 116 – paragraph 1 – point c (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
Amendment 41 #
Proposal for a regulation Recital 14 (14) Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment,
Amendment 410 #
Proposal for a regulation Article 116 – paragraph 1 – point d (d)
Amendment 411 #
Proposal for a regulation Article 116 – paragraph 1 – point d a (new) (da) 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.
Amendment 412 #
Proposal for a regulation Article 116 – paragraph 2 Amendment 413 #
Proposal for a regulation Article 116 – paragraph 2 – introductory part 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 (in descending order of preference):
Amendment 414 #
Proposal for a regulation Article 116 – paragraph 2 – point b (b) veterinary medicinal products authorised under this Regulation in
Amendment 415 #
Proposal for a regulation Article 116 – paragraph 2 – point b a (new) (ba) veterinary medicinal products authorised under this Regulation in another Member State for use in the same aquatic species or in another food- producing aquatic species for the condition in question or for another condition.
Amendment 416 #
Proposal for a regulation Article 116 – paragraph 3 Amendment 417 #
Proposal for a regulation Article 116 – paragraph 3 – point b a (new) (ba) 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.
Amendment 418 #
Proposal for a regulation Article 116 – paragraph 4 Amendment 419 #
Proposal for a regulation Article 116 – paragraph 4 – subparagraph 1 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. This provision is 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 42 #
Proposal for a regulation Recital 14 (14) Where a Member State or the Commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment, a scientific evaluation of the product should be undertaken at Union level, leading to a single decision on the area of disagreement, binding on the
Amendment 420 #
Proposal for a regulation Article 116 – paragraph 4 – subparagraph 1 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. This provision is 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 421 #
Proposal for a regulation Article 116 – paragraph 4 – subparagraph 2 – point a (a) risks to the environment if aquatic animals are treated with these medicinal products, in line with Annex II ;
Amendment 422 #
Proposal for a regulation Article 116 – paragraph 4 – subparagraph 2 – point b (
Amendment 423 #
Proposal for a regulation Article 116 – paragraph 5 Amendment 425 #
Proposal for a regulation Article 118 – paragraph 1 1. Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and
Amendment 426 #
Proposal for a regulation Article 118 – paragraph 1 1. Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the proper use of which would not present a risk to public or animal health.
Amendment 427 #
Proposal for a regulation Article 118 – paragraph 1 Amendment 428 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 1 Amendment 429 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 1 a (new) The principles to be used to establish the list of antimicrobials which will be restricted in veterinary medicine should not interfere with or deter Member States from prohibiting the use of certain antimicrobials in some species if they deem it appropriate.
Amendment 43 #
Proposal for a regulation Recital 14 a (new) (14a) In the event of disagreement, the Member State should be free to ban a substance it regards as dangerous (including in food derived from imported animals).
Amendment 430 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 2 – point a (a) risks to public health if the antimicrobial product is used in accordance with paragraph 1
Amendment 431 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 2 – point a (
Amendment 432 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 2 – point b (
Amendment 433 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 2 – point d (
Amendment 434 #
Proposal for a regulation Article 119 – paragraph 1 Amendment 435 #
Proposal for a regulation Article 124 – paragraph 2 2. The prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to use, prescribe or supply veterinary medicinal products.
Amendment 436 #
Proposal for a regulation Article 125 – paragraph 1 1. Competent authorities shall perform controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products regularly, at predetermined intervals laid down in Member States, and on a risk
Amendment 437 #
Proposal for a regulation Article 125 – paragraph 1 1. Competent authorities shall
Amendment 438 #
Proposal for a regulation Article 125 – paragraph 1 a (new) 1a. The Commission shall ensure a harmonised approach to inspections and controls of veterinary medicines throughout the Union.
Amendment 439 #
Proposal for a regulation Article 125 – paragraph 1 a (new) 1a. To combat fraud, the competent authorities shall establish a plan for spot checks on veterinary practices and herds to verify that medicinal products held comply with quality standards.
Amendment 44 #
Proposal for a regulation Recital 17 (17) However, there may be situations where no suitable authorised veterinary
Amendment 440 #
Proposal for a regulation Article 125 – paragraph 2 – point d (
Amendment 441 #
Proposal for a regulation Article 125 – paragraph 4 – subparagraph 2 Amendment 442 #
Proposal for a regulation Article 125 – paragraph 4 – subparagraph 2 Amendment 443 #
Proposal for a regulation Article 125 – paragraph 6 6. Inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities. Final inspection results shall be made public.
Amendment 444 #
Proposal for a regulation Article 125 – paragraph 6 6.
Amendment 445 #
Proposal for a regulation Article 128 – paragraph 3 a (new) 3a. The Agency and the Commission shall ensure a harmonised approach to veterinary medicine inspections.
Amendment 446 #
Proposal for a regulation Article 130 – paragraph 1 1. In the event of a risk to public or animal health or to the environment that requires urgent action, the competent authorities
Amendment 447 #
Proposal for a regulation Article 130 – paragraph 2 2. Member States
Amendment 448 #
Proposal for a regulation Article 131 – paragraph 1 1. The competent authority
Amendment 449 #
Proposal for a regulation Article 131 – paragraph 2 2. The competent authority
Amendment 45 #
Proposal for a regulation Recital 20 (20) Directive 2010/63/EU of the European Parliament and of the Council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential
Amendment 450 #
Proposal for a regulation Article 131 – paragraph 3 – introductory part 3. The competent authority
Amendment 451 #
Proposal for a regulation Article 131 – paragraph 4 4. For the purpose of paragraphs 1 to 3, before taking action, the Commission shall request
Amendment 452 #
Proposal for a regulation Article 135 Amendment 453 #
Proposal for a regulation Article 136 – paragraph 1 1. Member States shall designate the competent authorities to carry out tasks under this Regulation. The competent authorities shall be, inter alia, responsible for providing the scientific expertise for assessment of all applications under this Regulation.
Amendment 454 #
Proposal for a regulation Article 141 – paragraph 1 – point h a (new) (ha) tackle the contribution of farming practices to the development of antimicrobial resistance, by building on the existing action plans of the Commission and Member States, specifically by developing and implementing strategies to: – reduce overall use, – reduce the use of antimicrobials that are critically important for human use, and – end routine prophylactic use. This work shall be laid out in a plan submitted to the Commission no later than two years from adoption of this Regulation. The plan shall contain targets for the reductions in use and a timetable for achieving reductions.
Amendment 455 #
Proposal for a regulation Article 144 – paragraph 1 – point b Amendment 456 #
Proposal for a regulation Annex 2 – part 1 – section 1.1 – paragraph 4 Amendment 457 #
Proposal for a regulation Annex 2 – part 1 – section 1.3 – subsection 1.3.1 – paragraph 1 – point e (
Amendment 458 #
Proposal for a regulation Annex 2 – part 1 – section 1.3 – subsection 1.3.2 – point А – point А.4 – point А.4.3 Amendment 459 #
Proposal for a regulation Annex 2 – part 1 – section 1.4 – subsection 1.4.2 – point А – point А.5 Amendment 46 #
Proposal for a regulation Recital 25 (25) Tests, pre-clinical studies and clinical trials represent a major investment for companies which they need to make in order to submit the necessary data with the application for a marketing authorisation or to establish a maximum residue limit for pharmaceutical active substances in the veterinary medicinal product. That investment should be protected in order to stimulate research and innovation, 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 460 #
Proposal for a regulation Annex 3 a (new) Amendment 47 #
Proposal for a regulation Recital 27 (27) It is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment. Therefore, where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment, it is appropriate to require data on the potential effect on the environment in order to safeguard the environment. In such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals. The system as it stood until now has led to duplicate testing, wasting 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 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 48 #
Proposal for a regulation Recital 28 (28) The protection of technical documentation should be applied both to new veterinary medicinal products
Amendment 49 #
Proposal for a regulation Recital 30 Amendment 50 #
Proposal for a regulation Recital 30 a (new) (30a) In the interest of safety and public, animal and environmental health, the approval period for pharmaceutical substances and veterinary medicinal products should be limited in time. At the time of subsequent approvals, any developments in science and technology should be taken into account when any decision regarding the renewal of an approval is taken. The renewal of the approval should be for a period not exceeding 15 years.
Amendment 51 #
Proposal for a regulation Recital 33 (33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that measures are proportionally applied in both the humane and animal sector. And appropriate warnings and guidance are included on the labels of
Amendment 52 #
Proposal for a regulation Recital 33 (
Amendment 53 #
Proposal for a regulation Recital 33 (33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide, 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. 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
Amendment 54 #
Proposal for a regulation Recital 33 (33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. Better information is necessary regarding the utilisation and effects of antimicrobial medicines. 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.
Amendment 55 #
Proposal for a regulation Recital 34 (
Amendment 56 #
Proposal for a regulation Recital 35 (
Amendment 57 #
Proposal for a regulation Recital 36 (
Amendment 58 #
Proposal for a regulation Recital 36 (36) The development of new
Amendment 59 #
Proposal for a regulation Recital 37 (
Amendment 60 #
Proposal for a regulation Recital 37 (37) In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, it may be necessary to reserve those antimicrobials for humans only. Therefore it should be possible to decide that certain antimicrobials, following the scientific recommendations of the Agency, should not be available on the market in the veterinary sector. In order to maintain animal health and welfare, a list of preventive treatments for use in various seasonal and climatic conditions should be drawn up to deal with seasonal disorders affecting different animal species.
Amendment 61 #
Proposal for a regulation Recital 38 (38) If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials
Amendment 62 #
Proposal for a regulation Recital 38 (
Amendment 63 #
Proposal for a regulation Recital 38 a (new) (38a) Prudent use of antimicrobials is a cornerstone in addressing antimicrobial resistance. The Guidelines for prudent use, drafted by the Commission, need to be considered by Member States.
Amendment 64 #
Proposal for a regulation Recital 38 a (new) (38a) 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 as to perform antibiotic sensitivity testing. This will facilitate correct diagnosis, allow for a targeted use of antibiotics, avoiding the use of critically important antibiotics, and therefore restrain from 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 EU regulation in this sector is needed.
Amendment 65 #
Proposal for a regulation Recital 39 (
Amendment 66 #
Proposal for a regulation Recital 40 (40) There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to
Amendment 67 #
Proposal for a regulation Recital 40 (
Amendment 68 #
Proposal for a regulation Recital 40 (40) There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. In particular, better data are needed on how, when, where and why antimicrobials are being used, as well as data on adverse events (reactions) resulting from the use of antimicrobials. 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 69 #
Proposal for a regulation Recital 49 (49) I
Amendment 70 #
Proposal for a regulation Recital 56 (56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should not be allowed to sell prescription and non-prescription veterinary medicinal products via the Internet to buyers in other Member States.
Amendment 71 #
Proposal for a regulation Recital 56 (56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons - 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 72 #
Proposal for a regulation Recital 56 a (new) (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 73 #
Proposal for a regulation Recital 56 b (new) (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.
Amendment 74 #
Proposal for a regulation Recital 57 a (new) (57a) The online sale of medicinal products should be prohibited.
Amendment 75 #
Proposal for a regulation Recital 58 (58) When examining the compatibility with Union law of the conditions for the supply of medicinal products, the Court of Justice of the European Union has recognised, in the context on medicinal products for human use, the very particular nature of medicinal products whose therapeutic effects distinguish them substantially from other goods. The Court of Justice has also held that health and life of humans rank foremost among the assets and interests protected by the Treaty and that it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved. Since that level may vary from one Member State to another, Member States must be allowed some discretion as regards the conditions for the supply on their territory of medicinal products to the public. Therefore Member States should be able to subject the supply of medicinal products offered for sale
Amendment 76 #
Proposal for a regulation Recital 58 (58) When examining the compatibility with Union law of the conditions for the supply of medicinal products, the Court of Justice of the European Union has recognised, in the context on medicinal products for human use, the very particular nature of medicinal products whose therapeutic effects distinguish them substantially from other goods. The Court of Justice has also held that health and life of humans rank foremost among the assets and interests protected by the Treaty and that it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved. Since that level may vary from one Member State to another, Member States must be allowed some discretion as regards the conditions for the supply on their territory of medicinal products to the public. Therefore
Amendment 77 #
Proposal for a regulation Recital 59 Amendment 78 #
Proposal for a regulation Recital 61 (61) Advertising, even on non-prescription medicinal products, could affect public and animal health and distort competition. Therefore, advertising of veterinary medicinal products should satisfy certain criteria. Persons qualified to prescribe or supply can properly evaluate the information available in advertising
Amendment 79 #
Proposal for a regulation Recital 62 (62) Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a
Amendment 80 #
Proposal for a regulation Recital 62 (62) Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a
Amendment 81 #
Proposal for a regulation Recital 62 (62) Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a member of a regulated animal health profession for an individual animal or group of animals, it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another Member State. The removal of regulatory and administrative barriers to such recognition
Amendment 82 #
Proposal for a regulation Recital 65 (65) The verification of compliance with the legal requirements through controls is of fundamental importance to ensure that the objectives of the Regulation are effectively achieved across the Union. Therefore the competent authorities of the Member States should have the power to perform inspections at all stages of production, distribution and use of veterinary medicinal products and should publish annual control reports. In order to preserve the effectiveness of the inspections, authorities should
Amendment 83 #
Proposal for a regulation Recital 67 (67) In certain cases failures in Member States’ control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal
Amendment 84 #
Proposal for a regulation Recital 70 (70) Companies and authorities are frequently confronted with the need to distinguish between veterinary medicinal products, feed additives, biocidal products and other products. In order to avoid inconsistencies in the treatment of such products, to increase legal certainty, and to facilitate the decision process by Member States, a coordination group of Member States should be established, and among other tasks it should provide on a case-by- case basis a recommendation whether a product falls within the definition of a veterinary medicinal product.
Amendment 85 #
Proposal for a regulation Recital 72 Amendment 86 #
Proposal for a regulation Recital 73 Amendment 87 #
Proposal for a regulation Recital 74 Amendment 88 #
Proposal for a regulation Recital 75 Amendment 89 #
Proposal for a regulation Recital 75 (
Amendment 90 #
Proposal for a regulation Recital 76 Amendment 91 #
Proposal for a regulation Recital 77 Amendment 92 #
Proposal for a regulation Recital 77 (
Amendment 93 #
Proposal for a regulation Recital 78 Amendment 94 #
Proposal for a regulation Recital 79 Amendment 95 #
Proposal for a regulation Recital 79 (
Amendment 96 #
Proposal for a regulation Recital 80 Amendment 97 #
Proposal for a regulation Article 2 – paragraph 2 2. In addition to the products referred to in paragraph 1, Chapter VI shall also apply to
Amendment 98 #
Proposal for a regulation Article 2 – paragraph 4 – point e a (new) (ea) substances used to raise animal productivity levels.
Amendment 99 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 – point b (b) it
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Rules of Procedure of the European Parliament EP 150
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activities/0/docs/0/celexid |
CELEX:52014PC0558:EN
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EC |
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2014-09-10T00:00:00 |
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Legislative proposal published |
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2016-02-02T00:00:00 |
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