2014/0257(COD) Veterinary medicinal products
Next event: Final act published in Official Journal 2019/01/07 more...
Lead committee dossier:
Next event: Final act published in Official Journal 2019/01/07 more...
- Draft final act 2018/12/12
- 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
- Council Meeting 2018/11/26
- Commission response to text adopted in plenary 2018/11/21
- 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
- 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
- Council Meeting 2015/12/08
- Amendments tabled in committee 2015/11/20
- Amendments tabled in committee 2015/11/20
- Amendments tabled in committee 2015/10/02
- Amendments tabled in committee 2015/10/02
- Amendments tabled in committee 2015/09/04
- Amendments tabled in committee 2015/09/04
- Committee opinion 2015/07/23
- Committee opinion 2015/07/23
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),
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
2019/01/07
Final act published in Official Journal
Details
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.
2018/12/12
CSL - Draft final act
Documents
2018/12/12
CSL - Draft final act
Documents
2018/12/11
CSL - Final act signed
2018/12/11
EP - End of procedure in Parliament
2018/11/26
EP/CSL - Act adopted by Council after Parliament's 1st reading
2018/11/26
CSL - Council Meeting
2018/11/26
CSL - Council Meeting
2018/11/21
EC - Commission response to text adopted in plenary
Documents
2018/11/21
EC - Commission response to text adopted in plenary
Documents
2018/10/25
EP - Decision by Parliament, 1st reading
Details
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.
Documents
2018/10/24
EP - Debate in Parliament
2017/06/12
CSL - Debate in Council
Documents
2017/06/12
CSL - Council Meeting
2017/06/12
CSL - Council Meeting
2016/03/10
EP - Results of vote in Parliament
Documents
2016/03/10
EP - Decision by Parliament, 1st reading
Details
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.
Documents
2016/03/10
EP - Matter referred back to the committee responsible
2016/03/09
EP - Debate in Parliament
2016/02/29
EP - Committee report tabled for plenary, 1st reading
Details
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.
Documents
2016/02/17
EP - Vote in committee, 1st reading
2015/12/08
CSL - Debate in Council
Documents
2015/12/08
CSL - Council Meeting
2015/12/08
CSL - Council Meeting
2015/11/20
EP - Amendments tabled in committee
Documents
2015/11/20
EP - Amendments tabled in committee
Documents
2015/10/02
EP - Amendments tabled in committee
Documents
2015/10/02
EP - Amendments tabled in committee
Documents
2015/09/04
EP - Amendments tabled in committee
Documents
2015/09/04
EP - Amendments tabled in committee
Documents
2015/07/23
EP - Committee opinion
Documents
2015/07/23
EP - Committee opinion
Documents
2015/06/17
EP - Amendments tabled in committee
Documents
2015/06/17
EP - Amendments tabled in committee
Documents
2015/06/17
EP - Amendments tabled in committee
Documents
2015/06/17
EP - Amendments tabled in committee
Documents
2015/06/17
EP - Amendments tabled in committee
Documents
2015/06/17
EP - Amendments tabled in committee
Documents
2015/04/14
EP - Committee draft report
Documents
2015/04/14
EP - Committee draft report
Documents
2015/01/21
ESC - Economic and Social Committee: opinion, report
Documents
2015/01/21
ESC - Economic and Social Committee: opinion, report
Documents
2014/12/03
IT_SENATE - Contribution
Documents
2014/12/03
IT_SENATE - Contribution
Documents
2014/11/26
ES_PARLIAMENT - Contribution
Documents
2014/11/26
ES_PARLIAMENT - Contribution
Documents
2014/11/13
EP - GROSSETÊTE Françoise (PPE) appointed as rapporteur in ENVI
2014/11/13
EP - GROSSETÊTE Françoise (PPE) appointed as rapporteur in ENVI
2014/11/07
EP - MÜLLER Ulrike (ALDE) appointed as rapporteur in AGRI
2014/11/07
EP - MÜLLER Ulrike (ALDE) appointed as rapporteur in AGRI
2014/10/20
EP - Committee referral announced in Parliament, 1st reading
2014/09/10
EC - Legislative proposal
Details
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
2014/09/10
EC - Document attached to the procedure
Documents
2014/09/10
EC - Document attached to the procedure
Documents
2014/09/10
EC - Legislative proposal
Details
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
2014/09/10
EC - Document attached to the procedure
Documents
2014/09/10
EC - Document attached to the procedure
Documents
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
- Draft final act: 00045/2018/LEX
- Commission response to text adopted in plenary: SP(2018)755
- 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: PE572.829
- Amendments tabled in committee: PE569.532
- Amendments tabled in committee: PE569.532
- Amendments tabled in committee: PE565.208
- Amendments tabled in committee: PE565.208
- Committee opinion: PE552.056
- Committee opinion: PE552.056
- Amendments tabled in committee: PE551.949
- Amendments tabled in committee: PE560.753
- Amendments tabled in committee: PE560.760
- Amendments tabled in committee: PE551.949
- Amendments tabled in committee: PE560.753
- Amendments tabled in committee: PE560.760
- Committee draft report: PE551.951
- Committee draft report: PE551.951
- Economic and Social Committee: opinion, report: CES5960/2014
- Economic and Social Committee: opinion, report: CES5960/2014
- Contribution: COM(2014)0558
- Contribution: COM(2014)0558
- 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
- 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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- Tim AKER
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- Marina ALBIOL GUZMÁN
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- Jean ARTHUIS
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- Marie-Christine ARNAUTU
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- Inés AYALA SENDER
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- Zigmantas BALČYTIS
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- Hugues BAYET
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- Xabier BENITO ZILUAGA
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- José BLANCO LÓPEZ
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- Renata BRIANO
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- Gianluca BUONANNO
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- Soledad CABEZÓN RUIZ
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- Alain CADEC
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- James CARVER
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- Nicola CAPUTO
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- Nessa CHILDERS
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- David COBURN
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- Birgit COLLIN-LANGEN
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- Jane COLLINS
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- Therese COMODINI CACHIA
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- Andi CRISTEA
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- Javier COUSO PERMUY
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- Edward CZESAK
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- Daniel DALTON
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- Michel DANTIN
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- Angélique DELAHAYE
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- Isabella DE MONTE
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- Mark DEMESMAEKER
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- Norbert ERDŐS
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- Georgios EPITIDEIOS
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- Edouard FERRAND
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- Doru-Claudian FRUNZULICĂ
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- Tania GONZÁLEZ PEÑAS
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- Françoise GROSSETÊTE
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- Antanas GUOGA
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- Sergio GUTIÉRREZ PRIETO
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- Takis HADJIGEORGIOU
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- Marian HARKIN
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- Mike HOOKEM
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- Cătălin Sorin IVAN
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- Diane JAMES
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- Marc JOULAUD
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- Ivan JAKOVČIĆ
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- Barbara KAPPEL
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- Afzal KHAN
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- Elisabeth KÖSTINGER
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- Constance LE GRIP
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- Giovanni LA VIA
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- Marine LE PEN
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- Paloma LÓPEZ BERMEJO
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- Ivana MALETIĆ
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- Andrejs MAMIKINS
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- Dominique MARTIN
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- Notis MARIAS
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- Barbara MATERA
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- David MARTIN
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- Valentinas MAZURONIS
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- Miroslav MIKOLÁŠIK
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- Louis MICHEL
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- Bernard MONOT
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- Marlene MIZZI
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- Sophie MONTEL
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- Renaud MUSELIER
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- József NAGY
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- Liadh NÍ RIADA
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- Franz OBERMAYR
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- Rolandas PAKSAS
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- Margot PARKER
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- Ioan Mircea PAŞCU
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- Alojz PETERLE
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- Marijana PETIR
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- Andrej PLENKOVIĆ
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- Franck PROUST
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- Julia REID
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- Sofia RIBEIRO
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- Liliana RODRIGUES
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- Claude ROLIN
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- Daciana Octavia SÂRBU
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- Lola SÁNCHEZ CALDENTEY
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- Remo SERNAGIOTTO
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- Jill SEYMOUR
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- Maria Lidia SENRA RODRÍGUEZ
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- Siôn SIMON
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- Branislav ŠKRIPEK
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- Monika SMOLKOVÁ
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- Davor ŠKRLEC
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- Renato SORU
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- Davor Ivo STIER
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- Catherine STIHLER
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- Patricija ŠULIN
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- Kay SWINBURNE
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- Neoklis SYLIKIOTIS
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- Adam SZEJNFELD
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- Tibor SZANYI
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- Hannu TAKKULA
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- Dario TAMBURRANO
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- Pavel TELIČKA
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- Mihai ŢURCANU
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- Mylène TROSZCZYNSKI
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- Ramon TREMOSA i BALCELLS
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- Miguel VIEGAS
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- Pablo ZALBA BIDEGAIN
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- Anna ZÁBORSKÁ
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| Amendments | Dossier |
| 1266 |
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
source: 557.134
2015/06/17
ENVI
840 amendments...
Amendment 107 #
Proposal for a regulation Citation 5 a (new) – having regard to the European Parliament resolution of 19 May 2015 on safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance (A8-0142/2015 - 2014/2207(INI);
Amendment 108 #
Proposal for a regulation Recital 2 (2) In the light of the experience acquired and following the assessment by the Commission of the functioning of the market for veterinary medicinal products, the legal framework for veterinary medicinal products should be adapted to scientific progress, the current market conditions and economic reality, with respect for animals, nature and their interaction with man.
Amendment 109 #
Proposal for a regulation Recital 5 (5) The provisions of this act aim to reduce administrative burden, enhance the internal market and increase the availability of veterinary medicinal products, while guaranteeing the highest level of public and animal health and environmental protection. In line with the precautionary principle the pharmaceuticals industry should be required to demonstrate that veterinary medicines produced or placed on the market have neither a harmful effect on human or animal health nor an unsustainable environmental impact.
Amendment 110 #
Proposal for a regulation Recital 6 (6) Animals may suffer from a broad range of diseases which can be prevented or treated. The impact of animal diseases and the measures necessary to control them can be devastating for individual animals, animal populations, animal keepers and the economy. Animal diseases transmissible to humans may also have a significant impact on public health. Therefore sufficient and effective veterinary medicinal products should be available in the Union in order to ensure high standards of animal and public health, and for the development of the agriculture and aquaculture sectors. To this end, good husbandry and management practices have to be put place in order to improve animal welfare, limit the spread of diseases, prevent antimicrobial resistance and ensure proper nutrition of livestock.
Amendment 111 #
Proposal for a regulation Recital 7 (7) This Regulation should set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health and the environment. At the same time, this Regulation should harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.
Amendment 112 #
Proposal for a regulation Recital 8 (8) With a view to harmonising the internal market for veterinary medicinal products in the Union
Amendment 113 #
Proposal for a regulation Recital 9 (9) The scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the Union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells. Thought should also be given to medicinal products that may be developed in the future and care should be taken to lay down, in advance, a legal framework to support their development and, at the same time, ensure that they comply with Union regulations. At the same time, in order to ensure the widest possible availability of veterinary medicinal products in the Union, the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products. Particular care must be taken in all cases to control generics, in order to ensure that they meet high quality standards.
Amendment 114 #
Proposal for a regulation Recital 10 (10) The national procedure for authorising veterinary medicinal products should be maintained because of varying needs in different geographical areas of the Union as well as the business models of small and medium sized enterprises (SMEs).
Amendment 115 #
Proposal for a regulation Recital 10 (10) The national procedure for authorising veterinary medicinal products should be maintained because of varying needs in different geographical areas of the Union as well as the business models of small and medium sized enterprises (SMEs). It should be ensured that marketing authorisations granted in one Member State
Amendment 116 #
Proposal for a regulation Recital 12 (12) In order to avoid unnecessary administrative and financial burdens for applicants and competent authorities, a full in-depth assessment of an application for the authorisation of a veterinary medicinal product should be carried out only once.
Amendment 117 #
Proposal for a regulation Recital 17 (17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain, and particular care must therefore be taken when administering antibiotics to food- producing animals.
Amendment 118 #
Proposal for a regulation Recital 17 (17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only; however, the administration to animals of off-label antimicrobials authorised solely for human use should be prohibited. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.
Amendment 119 #
Proposal for a regulation Recital 17 (17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only; in such cases antimicrobial medicinal products for human use may be employed only subject to the issuing of a prescription by a veterinarian and the granting of authorisation by the veterinary authority responsible for monitoring the work of the veterinarian in question. In case of food-producing animals,
Amendment 120 #
Proposal for a regulation Recital 17 (17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be temporarily allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only. In case of food- producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.
Amendment 121 #
Proposal for a regulation Recital 18 Amendment 122 #
Proposal for a regulation Recital 18 (18) Member States should be able to allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases or new diseases and where the health situation in a Member State so requires.
Amendment 123 #
Proposal for a regulation Recital 18 (18) Member States should be able to temporarily allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases and where the health situation in a Member State so requires.
Amendment 124 #
Proposal for a regulation Recital 19 (19) Taking into account the need for simple rules on changes to the marketing authorisations of veterinary medicinal products,
Amendment 125 #
Proposal for a regulation Recital 19 (19) Taking into account the need for simple rules on changes to the marketing authorisations of veterinary medicinal products, only changes that may affect animal health, public health or the environment should require a scientific assessment. In any case, such changes may only apply to use within the same species.
Amendment 126 #
Proposal for a regulation Recital 20 (20) Directive 2010/63/EU of the European Parliament and of the Council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be such as to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be
Amendment 127 #
Proposal for a regulation Recital 23 (23) Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in some cases it should be possible to grant marketing authorisations without a complete application dossier having been submitted
Amendment 128 #
Proposal for a regulation Recital 23 (23) Companies have less interest in developing veterinary medicinal products for markets of a limited size. In order to promote the availability of veterinary medicinal products within the Union for those markets, in
Amendment 129 #
Proposal for a regulation Recital 23 (23) Companies have less interest in developing veterinary medicinal products for markets of a limited size, which are subject to the same regulatory constraints as those of larger markets. In order to promote the availability of veterinary medicinal products within the Union for
Amendment 130 #
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 131 #
Proposal for a regulation Recital 26 (26) Certain particulars and documents that are normally to be submitted with an application for a marketing authorisation
Amendment 132 #
Proposal for a regulation Recital 26 a (new) (26a) The potential risk to the environment needs to be assessed for all veterinary medicinal products. Marketing authorisation holders should therefore provide an environmental risk assessment within two years after the entry into force of this Regulation.
Amendment 133 #
Proposal for a regulation Recital 26 b (new) (26b) The establishment of a single decentralised assessment of the environmental properties of active substances for veterinary use by means of a monograph system should be established in the future. The Commission should therefore submit a report to Parliament and the Council as soon as possible, as well as a legislative proposal, if appropriate.
Amendment 134 #
Proposal for a regulation Recital 27 (27) It is recognised that the potential effect of a product on the environment may
Amendment 135 #
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
Amendment 136 #
Proposal for a regulation Recital 27 a (new) (27a) In accordance with Directive 2010/63/EU, it is necessary to replace, reduce or refine testing on vertebrate animals. Implementation of this Regulation should be based on the use of alternative test methods, suitable for the assessment of health and environmental hazards of products, wherever possible.
Amendment 137 #
Proposal for a regulation Recital 29 (29)
Amendment 138 #
Proposal for a regulation Recital 30 Amendment 139 #
Proposal for a regulation Recital 30 (30) In order to avoid unnecessary administrative and financial burdens both for the competent authorities and for the pharmaceutical industry, as a general rule a marketing authorisation for a veterinary medicinal product should be granted for an
Amendment 140 #
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 141 #
Proposal for a regulation Recital 31 (31) It is recognised that, in some cases, a scientific risk assessment alone cannot provide all the information on which a risk management decision should be based, and other relevant factors should also be taken into account including societal, economical, ethical, environmental and welfare factors and the feasibility of controls.
Amendment 142 #
Proposal for a regulation Recital 32 (32) In certain circumstances where a significant animal, environmental or public health concern exists but scientific uncertainty persists, appropriate measures can be adopted taking into account Article 5(7) of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures which has been interpreted for the Union in
Amendment 143 #
Proposal for a regulation Recital 33 (33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials. Use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be
Amendment 144 #
Proposal for a regulation Recital 33 (33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials. Use
Amendment 145 #
Proposal for a regulation Recital 33 (33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials. Use of last-line antibiotics in animals should be prohibited. 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 146 #
Proposal for a regulation Recital 33 (33) Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-threatening infections in humans. In order to fight antimicrobial resistance a number of measures should be taken. It needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary and human 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 147 #
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. Given that the effects on humans are not the same as those on animals, a thorough investigation should be conducted into possible contraindications. 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
Amendment 148 #
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 any measures to be put in place are proportionately applied to both human and animal sector. Appropriate warnings and guidance are included on the labels of human and veterinary antimicrobials. Use not covered by the terms of the marketing authorisation of certain new or
Amendment 149 #
Proposal for a regulation Recital 34 a (new) (34a) The routine prophylactic and metaphylactic use of antimicrobials in groups of food-producing animals should be brought to an end. Disease should be prevented not by routine recourse to antimicrobials but by good hygiene, husbandry and housing and sound management practices.
Amendment 150 #
Proposal for a regulation Recital 35 (35) The combined use of several
Amendment 151 #
Proposal for a regulation Recital 36 (36) The development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials. Given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible. The use of antimicrobials in
Amendment 152 #
Proposal for a regulation Recital 36 a (new) (36a) The use of antimicrobial veterinary medicinal products should be reduced by phasing out their use for prophylactic purposes and minimising their metaphylactic use in treating diseased animals and preventing healthy animals in the same group from becoming infected.
Amendment 153 #
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
Amendment 154 #
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; the decisive criteria should be that the antibiotic is used in human medicine when other antibiotic therapies are no longer effective and that there is evidence that resistance in human beings cannot be excluded by use in animals.
Amendment 155 #
Proposal for a regulation Recital 37 (37) In order to preserve as long as possible the efficacy of certain
Amendment 156 #
Proposal for a regulation Recital 37 a (new) (37a) As Antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the Union and worldwide there must soon also action be taken in the field of human medicine for example in the form of an instrument incentivising the development of new antibiotics for human use similar to that already proposed within this regulation.
Amendment 157 #
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.
Amendment 158 #
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.
Amendment 159 #
Proposal for a regulation Recital 38 (38) If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced, directly or indirectly, by
Amendment 160 #
Proposal for a regulation Recital 38 (38) If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care and only once a veterinary diagnosis has been established following a clinical examination of the animals concerned, or in the light of regular health visits of the animal(s) concerned.
Amendment 161 #
Proposal for a regulation Recital 38 (38) If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by those
Amendment 162 #
Proposal for a regulation Recital 38 (38) If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the
Amendment 163 #
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. Veterinarians have a legal obligation as part of their professional code of conduct and consequently they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care.
Amendment 164 #
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 165 #
Proposal for a regulation Recital 38 a (new) (38a) In order to facilitate responsible 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, support using as little as possible critically important antibiotics and therefore restrain from the development of antibiotic resistance. There is clear need for future innovation specifically for pen-site diagnosis, and a need to consider carefully whether there is a case for more harmonisation and regulation in this sector.
Amendment 166 #
Proposal for a regulation Recital 38 a (new) (38a) One of the main reasons for human and animal resistance to antibiotics is the use of broad-spectrum antibiotics owing to uncertainty about which bacterial strain to treat. Veterinarians should be encouraged to use rapid, on-the-spot diagnostic tests to determine precisely which microbial agent is responsible for the infection and its sensitivity to different antibiotics.
Amendment 167 #
Proposal for a regulation Recital 39 (39) It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the Union. Moreover, antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore,
Amendment 168 #
Proposal for a regulation Recital 39 (39) It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. An
Amendment 169 #
Proposal for a regulation Recital 39 (39) It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. An
Amendment 170 #
Proposal for a regulation Recital 39 (39) It is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the Union. Moreover, antimicrobial resistant organisms can spread to humans and animals in the Union through consumption of products of animal origin imported from third countries, from direct contact with animals or humans in third countries or by other means. Therefore, measures restricting the use of veterinary antimicrobials in the Union should be based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressing antimicrobial resistance in order the ensure consistency with their activities and policies. To this end, it is necessary to develop an international strategy to combat antimicrobial resistance.
Amendment 171 #
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
Amendment 172 #
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
Amendment 173 #
Proposal for a regulation Recital 41 (41) The majority of the veterinary medicinal products on the market have been authorised under national procedures. The lack of harmonisation of summary of product characteristics for veterinary medicinal products authorised nationally in more than one Member State creates
Amendment 174 #
Proposal for a regulation Recital 42 (42) In order to reduce administrative burden and maximise the availability of veterinary medicinal products in the Member States, simplified rules should be laid down as to how their packaging and labelling are to be presented. The textual information provided should be reduced and, if possible, replaced by pictograms and abbreviations. Pictograms and abbreviations should be standardised across the Union. Care should be taken so that those rules do not jeopardise public and animal health and environmental safety. Care should also be taken to ensure that the new, simplified presentation does not result in deliberate concealment of important information on the medicinal product.
Amendment 175 #
Proposal for a regulation Recital 44 Amendment 176 #
Proposal for a regulation Recital 47 (47) Holders of marketing authorisations should be responsible for continuously carrying out pharmacovigilance of the veterinary medicinal products they place on the market. They should collect reports on adverse events relating to their products, including those concerning use outside the terms of the granted marketing authorisation. However, final responsibility and competence for pharmacovigilance must rest in all cases with the Member States.
Amendment 177 #
Proposal for a regulation Recital 49 (49) I
Amendment 178 #
Proposal for a regulation Recital 49 (49) It is necessary
Amendment 179 #
Proposal for a regulation Recital 50 (50) A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work- sharing between the competent authorities and other concerned authorities such as environmental protection agencies and food safety authorities both on national and Union level.
Amendment 180 #
Proposal for a regulation Recital 51 (51) It is necessary to exercise control over the entire chain of distribution of veterinary medicinal products, from manufacture or import into the Union through supply to the end-user. Veterinary medicinal products from third countries should comply with the same requirements
Amendment 181 #
Proposal for a regulation Recital 53 (53) The quality of veterinary medicinal products manufactured within the Union should be guaranteed by requiring compliance with the principles of good manufacturing practice for medicinal products irrespective of the final destination of the medicinal products. The same requirements must apply to veterinary medicinal products manufactured in third countries and imported into the Union.
Amendment 182 #
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
Amendment 183 #
Proposal for a regulation Recital 56 (56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products, with the exception of antimicrobials, via the Internet to buyers in other Member States.
Amendment 184 #
Proposal for a regulation Recital 56 (56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products, depending on the type of medicinal product, via the Internet to buyers in other Member States.
Amendment 185 #
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 veterinarians or other persons authorised to do so by the Member State where they are established; however, countries which do not allow prescriptions to be issued by persons other than veterinarians may refuse to recognise such prescriptions issued in other countries in accordance with those countries’ national laws. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non- prescription veterinary medicinal products via the Internet to buyers in other Member States.
Amendment 186 #
Proposal for a regulation Recital 56 (56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products via the Internet to buyers in other Member States. In order to minimise the risk to animal and human health, online sales of antimicrobials should be prohibited.
Amendment 187 #
Proposal for a regulation Recital 56 (56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell
Amendment 188 #
Proposal for a regulation Recital 56 a (new) (56a) In order to ensure that the lines of distribution and the supply of veterinary medicines are not restricted, where Member States have a legally defined, professionally qualified animal medicines advisor, they shall continue to prescribe and supply certain veterinary medicines;
Amendment 189 #
Proposal for a regulation Recital 57 (57) The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way.
Amendment 190 #
Proposal for a regulation Recital 57 (57) The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. It is necessary to address this threat. Account should be taken of the fact that specific conditions for supply of medicinal products to the public
Amendment 191 #
Proposal for a regulation Recital 57 (57) The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. It is necessary to address this threat. Account should be taken of the fact that specific conditions for the supply of medicinal products to the public have not been harmonised at Union level and, therefore
Amendment 192 #
Proposal for a regulation Recital 57 (57) The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public
Amendment 193 #
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
Amendment 194 #
Proposal for a regulation Recital 58 a (new) (58a) Member States should be able to subject the supply of medicinal products offered for sale to stricter conditions justified by the protection of public health, animal health and the environment.
Amendment 195 #
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 because of their knowledge, training and experience in animal health. The advertising of veterinary medicinal products to persons who cannot properly appreciate the risk associated with their use may lead to medicine misuse or
Amendment 196 #
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 197 #
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
Amendment 198 #
Proposal for a regulation Recital 67 (67) In certain cases failures in Member States' control system can substantially hinder the achievement of the objectives of this Regulation and may lead to the emergence of risks to public and animal health and the environment. T
Amendment 199 #
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
Amendment 200 #
Proposal for a regulation Recital 71 (71) Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications. Immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate. The quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules. Furthermore, it is desirable to generally allow the use of homeopathic medicinal products designed for human use, including immunological homeopathic products, that have a potency starting from D4, on all animals, including food producing animals, under certain conditions.
Amendment 201 #
Proposal for a regulation Recital 71 (71) Having regard to the special characteristics of homeopathic veterinary medicinal products, especially the constituents of these products, it is desirable to establish a special, simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications.
Amendment 202 #
Proposal for a regulation Recital 71 a (new) Amendment 203 #
Proposal for a regulation Recital 71 a (new) (71a) "The usual rules governing the authorisation to market veterinary medicinal products must be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which may present risks which must be balanced against the desired therapeutic effect. Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products, provided that they notify them to the Commission."
Amendment 204 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation lays down rules for the placing on the market, development, manufacture, import, export, wholesale distribution, retail supply, pharmacovigilance, control and use of veterinary medicinal products.
Amendment 205 #
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 206 #
Proposal for a regulation Article 2 – paragraph 4 – point e a (new) (ea) substances or preparations which are intended exclusively for external use in animals, to clean or groom them or to alter their appearance or body odour, provided that no substances or preparations subject to veterinary prescription have been added to them.
Amendment 207 #
Proposal for a regulation Article 2 – paragraph 4 – point e a (new) (ea) substances or preparations which are intended exclusively for external use in animals, to clean or groom them or to alter their appearance or body odour, provided that no substances or preparations subject to veterinary prescription have been added to them.
Amendment 208 #
Proposal for a regulation Article 2 – paragraph 4 – point e a (new) (ea) medicated feed and intermediate products as defined in article 2.2 a) and b) of Regulation YYYY/XXX on medicated feed.
Amendment 209 #
Proposal for a regulation Article 2 – paragraph 4 – point e b (new) (eb) feedingstuffs as defined in Regulation (EU) No 767/2009 of the European Parliament and of the Council.
Amendment 210 #
Proposal for a regulation Article 2 – paragraph 4 a (new) 4a. Feedingstuffs as defined in Regulation (EU) No 767/2009 of the European Parliament and of the Council.
Amendment 211 #
Proposal for a regulation Article 2 – paragraph 4 a (new) 4a. Substances or preparations of substances that are only intended to be applied externally on the animal for cleaning or care, or for influencing the appearance or body odour, as far as no substances or preparations are added which are excluded from marketing outside pharmacies.
Amendment 212 #
Proposal for a regulation Article 3 – paragraph 1 1.
Amendment 213 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 – point b (b) it
Amendment 214 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 – point c (c) it
Amendment 215 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 – introductory part (2)
Amendment 216 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 – point a (a) human, e.g. human blood and human blood products;
Amendment 217 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 – point b (b) animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;
Amendment 218 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 – point c (c) vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts;
Amendment 219 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 – point c a (new) (ca) fungal
Amendment 220 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 – point c b (new) (cb) microbial
Amendment 221 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 – point d (d) chemical
Amendment 222 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 – point d a (new) (da) mineral;
Amendment 223 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 a (new) (2a) active substance is a substance with a pharmacological activity
Amendment 224 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 (7) ‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States; a homeopathic veterinary medicinal product may contain a number of active ingredients.
Amendment 225 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 (7) ‘homeopathic veterinary medicinal product' means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States; A homeopathic veterinary medicinal product may contain a number of principles.
Amendment 226 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 Directive 2001/82/EC Article 4 – paragraph 1 – point 7 (7) ‘homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States
Amendment 227 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 (7) ‘homeopathic veterinary medicinal product' means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias
Amendment 228 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 (7) ‘homeopathic veterinary medicinal product' means a veterinary medicinal product prepared
Amendment 229 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 a (new) (7a) ‘herbal medicinal product’ means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations;
Amendment 230 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 a (new) (7a) Herbal medicinal products are medicinal products containing as the sole active pharmaceutical ingredient one or more vegetable substances or one or more vegetable preparations or one or more such vegetable substances in combination with one or more such vegetable preparations.
Amendment 231 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 a (new) (7a) 'antimicrobial' means an active substance of synthetic or natural origin which destroys microorganisms, suppresses their growth or their ability to reproduce in animals or humans;
Amendment 232 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 b (new) (b) ‘anthroposophic medicinal product’ means a medicinal product which has been developed in accordance with the anthroposophic approach to human life and the natural world, using a homeopathic procedure described by the European Pharmacopeia or, in the absence thereof, by the pharmacopoeias used officially in Member States, or using a special anthroposophic procedure, and which are intended to be used in accordance with anthroposophic principles.
Amendment 233 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 (8) 'antimicrobial resistance' means the ability of
Amendment 234 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 a (new) (8a) “antimicrobials” mean any compound with a direct action on micro- organisms used for treatment or prevention of infections. Antimicrobials include anti-bacterials, anti-virals, antifungals and anti-protozoals. Antibiotics are synonymous with anti- bacterials.
Amendment 235 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 (9) ‘clinical trial' means a s
Amendment 236 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 (9) ‘clinical trial' means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice
Amendment 237 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 (9) ‘clinical trial' means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice
Amendment 238 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 (10) 'pre-clinical study' means a study not covered by the definition of clinical trial
Amendment 239 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 (10) 'pre-clinical study' means a study not covered by the definition of clinical trial conducted in accordance with good laboratory practice 1 a, which aims to investigate the safety or efficacy of a veterinary medicinal product for the purpose of obtaining a marketing authorisation or a change
Amendment 240 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 (10) 'pre-clinical study' means a study not covered by the definition of clinical trial which aims to investigate the safety or efficacy of a veterinary medicinal product
Amendment 241 #
Proposal for a regulation Article 4 – paragraph 1 – point 11 – introductory part (11)
Amendment 242 #
Proposal for a regulation Article 4 – paragraph 1 – point 12 (12)
Amendment 243 #
Proposal for a regulation Article 4 – paragraph 1 – point 18 (18)
Amendment 244 #
Proposal for a regulation Article 4 – paragraph 1 – point 20 – introductory part (20)
Amendment 245 #
Proposal for a regulation Article 4 – paragraph 1 – point 20 – point a Amendment 246 #
Proposal for a regulation Article 4 – paragraph 1 – point 20 – point b Amendment 247 #
Proposal for a regulation Article 4 – paragraph 1 – point 20 – point b (b) veterinary medicinal products for animal species other than cattle,
Amendment 248 #
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 249 #
Proposal for a regulation Article 4 – paragraph 1 – point 21 (21)
Amendment 250 #
Proposal for a regulation Article 4 – paragraph 1 – point 24 (24) ‘veterinary prescription‘ means any prescription for a veterinary medicinal product issued by a
Amendment 251 #
Proposal for a regulation Article 4 – paragraph 1 – point 24 (24) 'veterinary prescription‘ means any prescription for a veterinary medicinal product
Amendment 252 #
Proposal for a regulation Article 4 – paragraph 1 – point 24 (24) 'veterinary prescription‘ means any prescription for a veterinary medicinal product issued by a veterinarian or another professional person qualified to do so in accordance with applicable national law; ("if adopted, modification needed throughout the whole text")
Amendment 253 #
Proposal for a regulation Article 4 – paragraph 1 – point 24 (24) 'veterinary prescription‘ means any prescription for a veterinary or human medicinal product issued by a
Amendment 254 #
Proposal for a regulation Article 4 – paragraph 1 – point 24 (24) 'veterinary prescription‘ means any prescription for a veterinary medicinal product issued by a
Amendment 255 #
Proposal for a regulation Article 4 – paragraph 1 – point 25 (25) 'withdrawal period' means the
Amendment 256 #
Proposal for a regulation Article 4 – paragraph 1 – point 26 (26) ‘making available on the market' means any supply of a veterinary medicinal product for distribution, consumption or use on the
Amendment 257 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 (27) 'placing on the market' means the first making available of a veterinary medicinal
Amendment 258 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 a (new) (27a) “industrial process" referring to veterinary medicinal products containing autologous or allogeneic cells or tissues include list all process that should be considered as industrial for these specific product.
Amendment 259 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 a (new) (27a) "Marketing authorisation holder": the holder of an authorisation granted in accordance with the legislation.
Amendment 260 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 a (new) (27a) "good animal husbandry" means the management and care of animals by humans for profit whilst assuring the health and welfare of these animals by respecting and ensuring the specific needs of each species and by minimising as much as possible the need to use veterinary pharmaceutical products;
Amendment 261 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 a (new) (27a) Good manufacturing practice shall mean the part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use, including the requirements that follow from article 98 and 103 a new.
Amendment 262 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 b (new) (27b) "Summary product characteristics" is the resume of the product technical characteristics on quality, safety and efficacy for the healthcare professionals.
Amendment 263 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 b (new) (27b) "Periodic safety update report" is the report that collect all adverse events known by the marketing authorisation holder of a product that shall be submitted to the competent authorities.
Amendment 264 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 c (new) (27c) "Adverse events" is any of the undesirable events described in art. 73 (2).
Amendment 265 #
Proposal for a regulation Article 4 – paragraph 1 – point 27 d (new) (27d) "Serious adverse events" is an adverse events which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated.
Amendment 266 #
Proposal for a regulation Article 4 – paragraph 1 a (new) '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 267 #
Proposal for a regulation Article 4 – paragraph 1 b (new) '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 268 #
Proposal for a regulation Article 4 – paragraph 1 c (new) 'pre-mix for medicated feedingstuffs' means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feeding stuffs according to the Regulation 2014/0255(COD) on the Manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EC
Amendment 269 #
Proposal for a regulation Article 5 – paragraph 1 1.
Amendment 270 #
Proposal for a regulation Article 5 – paragraph 2 Amendment 271 #
Proposal for a regulation Article 5 – paragraph 2 2. A marketing authorisation for a veterinary medicinal product shall be valid for
Amendment 272 #
Proposal for a regulation Article 5 – paragraph 2 2. An initial marketing authorisation for a veterinary medicinal product shall be valid for
Amendment 273 #
Proposal for a regulation Article 5 – paragraph 2 2. A marketing authorisation for a veterinary medicinal product shall be valid for
Amendment 274 #
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 275 #
Proposal for a regulation Article 5 – paragraph 2 2.
Amendment 276 #
Proposal for a regulation Article 5 – paragraph 2 a (new) 2a. The authorisation may be renewed after five years on the basis of a re- evaluation of the risk-benefit balance based on the latest state of scientific knowledge, taking into account adverse effects reported under Article 76. The renewal of an authorisation shall be limited to periods not exceeding 15 years.
Amendment 277 #
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 278 #
Proposal for a regulation Article 5 – paragraph 2 a (new) 2a. The marketing authorisation holder shall be responsible for marketing the medicinal product. The designation of a representative shall not relieve the marketing authorisation holder of his legal responsibility.
Amendment 279 #
Proposal for a regulation Article 6 – paragraph 1 – point b (b) the decentralised procedure laid down in Articles 45, 46 and
Amendment 280 #
Proposal for a regulation Article 6 – paragraph 1 – point c (c) the mutual recognition procedure laid down in Articles 47, 48 and
Amendment 281 #
Proposal for a regulation Article 6 – paragraph 3 3. Applications shall be submitted electronically
Amendment 282 #
Proposal for a regulation Article 6 – paragraph 3 3. Applications shall be submitted electronically using a single digital portal. For all applications submitted
Amendment 283 #
Proposal for a regulation Article 6 – paragraph 5 5. With
Amendment 284 #
Proposal for a regulation Article 7 – paragraph 1 Amendment 285 #
Proposal for a regulation Article 7 – paragraph 1 a (new) Amendment 286 #
Proposal for a regulation Article 7 – paragraph 2 – point a (a) documentation on the direct or indirect risks to public
Amendment 287 #
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 288 #
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, also stating that the product is not to be used as routine preventative measure in food producing animals.
Amendment 289 #
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, in particular when used for control treatment (metaphylaxis).
Amendment 290 #
Proposal for a regulation Article 7 – paragraph 3 3. Where the application concerns a veterinary medicinal product intended for food-producing target species and containing pharmacologically active substances that are not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in question, a document shall be submitted in addition to the information listed in paragraph 1 certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council
Amendment 291 #
Proposal for a regulation Article 7 – paragraph 5 Amendment 292 #
Proposal for a regulation Article 7 – paragraph 5 a (new) 5a. When applying for renewal, publically 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 293 #
Proposal for a regulation Article 7 – paragraph 7 7.
Amendment 294 #
Proposal for a regulation Article 8 – paragraph 2 – introductory part 2. Approvals of clinical trials shall be granted on condition that food-producing animals used in the clinical trials or their produce do not enter the human food chain
Amendment 295 #
Proposal for a regulation Article 8 – paragraph 2 – point a Amendment 296 #
Proposal for a regulation Article 8 – paragraph 2 – point b Amendment 297 #
Proposal for a regulation Article 8 – paragraph 2 – point b a (new) (ba) data are provided to support an experimental withdrawal period
Amendment 298 #
Proposal for a regulation Article 8 – paragraph 4 a (new) 4a. The principles of replacement, reduction and refinement concerning the care and use of live animals for scientific purposes should be taken into account during the design and performance of clinical trials.
Amendment 299 #
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 300 #
Proposal for a regulation Article 9 – paragraph 1 – introductory part 1. The immediate packaging of a veterinary medicinal product shall contain only the
Amendment 301 #
Proposal for a regulation Article 9 – paragraph 1 – introductory part 1. The immediate packaging of a veterinary medicinal product shall
Amendment 302 #
Proposal for a regulation Article 9 – paragraph 1 – introductory part 1. The immediate packaging of a veterinary medicinal product shall contain
Amendment 303 #
Proposal for a regulation Article 9 – paragraph 1 – point e (e) the target species and the time required for elimination from the food chain for food-producing animals, for each species;
Amendment 304 #
Proposal for a regulation Article 9 – paragraph 1 – point g a (new) (ga) details of take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;
Amendment 305 #
Proposal for a regulation Article 9 – paragraph 1 – point g a (new) (ga) whether it can be used in organic farming, and the necessary precautions, where applicable;
Amendment 306 #
Proposal for a regulation Article 9 – paragraph 2 2. The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union. In exceptional cases, the applicant(s), or the competent authority may request additional text to be included where this is justified to ensure safe and correct administration of the product.
Amendment 307 #
Proposal for a regulation Article 10 – paragraph 1 – introductory part 1. The outer packaging of a veterinary medicinal product shall contain only the
Amendment 308 #
Proposal for a regulation Article 10 – paragraph 1 – introductory part 1. The outer packaging of a veterinary medicinal product shall contain only the
Amendment 309 #
Proposal for a regulation Article 10 – paragraph 1 – introductory part 1. The outer packaging of a veterinary medicinal product shall contain
Amendment 310 #
Proposal for a regulation Article 10 – paragraph 1 – point d (d) a common pictogram warning that the veterinary medicinal product is for animal treatment only;
Amendment 311 #
Proposal for a regulation Article 10 – paragraph 1 – point f (f)
Amendment 312 #
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 unused veterinary medicinal products or waste materials derived from the use of such products and
Amendment 313 #
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 unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Amendment 314 #
Proposal for a regulation Article 10 – paragraph 1 – point g a (new) (ga) waiting period.
Amendment 315 #
Proposal for a regulation Article 10 – paragraph 2 2. The information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters, or, where appropriate, abbreviations or pictograms common throughout the Union. In exceptional cases, the applicant or the competent authority may request additional text to be included where this is justified to ensure the safe and correct administration of the product.
Amendment 316 #
Proposal for a regulation Article 11 – paragraph 1 – introductory part By way of derogation from Article 9,
Amendment 317 #
Proposal for a regulation Article 11 – paragraph 1 – introductory part By way of derogation from Article 9, small immediate packaging units shall contain only the following information
Amendment 318 #
Proposal for a regulation Article 11 – paragraph 1 – point b Amendment 319 #
Proposal for a regulation Article 11 – paragraph 1 – point b (b) the quantitative particulars of the active substances, unless the product exists in only one concentration or the concentration is reflected in the brand name;
Amendment 320 #
Proposal for a regulation Article 11 – paragraph 1 – point d (d) the expiry date, in the format: ‘mm/yyyy', preceded by the abbreviation
Amendment 321 #
Proposal for a regulation Article 11 – paragraph 1 – point d a (new) (da) (e) route of administration
Amendment 322 #
Proposal for a regulation Article 12 – paragraph 1 – introductory part 1. The package leaflet shall be a
Amendment 323 #
Proposal for a regulation Article 12 – paragraph 1 – point d (d) the target species, the dosage for each species, the method and route of administration and advice on correct administration, if necessary; whether it can be used for organically- farmed animals;
Amendment 324 #
Proposal for a regulation Article 12 – paragraph 1 – point j (j) requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and
Amendment 325 #
Proposal for a regulation Article 12 – paragraph 1 – point m Amendment 326 #
Proposal for a regulation Article 12 – paragraph 1 – point m a (new) (ma) Qualitative and quantitative composition.
Amendment 327 #
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 328 #
Proposal for a regulation Article 13 – paragraph 1 – point a (a) the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used officially in Member States; if the homeopathic veterinary medicinal product is composed of more than one stock, the scientific names of the stocks may be supplemented by a brand name in the label;
Amendment 329 #
Proposal for a regulation Article 13 – paragraph 1 – point a (a) the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the European Pharmacopoeia or, in the absence thereof,
Amendment 330 #
Proposal for a regulation Article 13 – paragraph 1 – point d Amendment 331 #
Proposal for a regulation Article 13 – paragraph 1 – point d Amendment 332 #
Proposal for a regulation Article 13 – paragraph 1 – point g (g) target species; dosage levels for the different target species;
Amendment 333 #
Proposal for a regulation Article 13 – paragraph 1 – point g (g) target species, and the dosage for each species, where applicable;
Amendment 334 #
Proposal for a regulation Article 13 – paragraph 1 – point g (g) target species and dosage levels for the different target species;
Amendment 335 #
Proposal for a regulation Article 13 – paragraph 1 – point i Amendment 336 #
Proposal for a regulation Article 13 – paragraph 1 – point i Amendment 337 #
Proposal for a regulation Article 14 – paragraph 1 1. The language or languages of the information on the labelling shall be determined by the Member State where the veterinary medicinal product is made available on the market, with due regard for the rights of linguistic minorities.
Amendment 338 #
Proposal for a regulation Article 14 – paragraph 3 3. Veterinary medicinal products
Amendment 339 #
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 340 #
Proposal for a regulation Article 16 – paragraph 5 5. The clinical information in the summary of the product characteristics (as defined in Article 30(1)(c), excluding point (vi)) of the generic veterinary medicinal product shall be identical to that of the reference veterinary medicinal product. However, that requirement shall not apply to
Amendment 341 #
Proposal for a regulation Article 16 – paragraph 5 – point a (new) (a) those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law or arrangements for the protection of technical documentation (Articles 33 to 36) at the time when authorisation is granted for the generic veterinary medicinal product or
Amendment 342 #
Proposal for a regulation Article 16 – paragraph 5 – point b (new) (b) any subsequent changes to the reference medicinal product.
Amendment 343 #
Proposal for a regulation Article 16 – paragraph 6 Amendment 344 #
Proposal for a regulation Article 16 – paragraph 6 6.
Amendment 345 #
Proposal for a regulation Article 16 – paragraph 6 6.
Amendment 346 #
Proposal for a regulation Article 16 – paragraph 6 6.
Amendment 347 #
Proposal for a regulation Article 17 – paragraph 1 – introductory part By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products
Amendment 348 #
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 349 #
Proposal for a regulation Article 17 – paragraph 1 – point b (b) the applicant can demonstrate that the veterinary medicinal product
Amendment 350 #
Proposal for a regulation Article 17 – paragraph 1 – point d (d) where necessary, appropriate documentation on the safety of that combination is provided.
Amendment 351 #
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 352 #
Proposal for a regulation Article 21 Amendment 353 #
Proposal for a regulation Article 21 – paragraph 1 – introductory part 1. By way of derogation from Article 7(1)(b),
Amendment 354 #
Proposal for a regulation Article 21 – paragraph 1 – point a (a) the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain
Amendment 355 #
Proposal for a regulation Article 21 – paragraph 1 – point b (b) the applicant provides the evidence that the veterinary medicinal product is intended for a limited market, detailing his sales prospects, in units, over the first five years of sale and the development costs.
Amendment 356 #
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
Amendment 357 #
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
Amendment 358 #
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 359 #
Proposal for a regulation Article 21 – paragraph 2 a (new) 2a. Member States may ban the use of veterinary medicinal products for limited markets.
Amendment 360 #
Proposal for a regulation Article 21 – paragraph 3 3. Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only
Amendment 361 #
Proposal for a regulation Article 21 – paragraph 3 3. Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality and/or efficacy has been conducted due to the lack of comprehensive efficacy and/or quality data. The packaging shall bear a warning with the same information.
Amendment 362 #
Proposal for a regulation Article 21 – paragraph 3 a (new) 3a. A requirement to notify the competent authorities of any adverse event relating to the use of the veterinary medicinal product.
Amendment 363 #
Proposal for a regulation Article 21 – paragraph 3 a (new) 3a. A veterinary medicinal product that has been granted marketing authorisation in accordance with this article may only be issued on the basis of a prescription.
Amendment 364 #
Proposal for a regulation Article 22 Amendment 365 #
Proposal for a regulation Article 22 – paragraph 1 – point a (a) a requirement to introduce conditions or restrictions
Amendment 366 #
Proposal for a regulation Article 22 – paragraph 1 – point b (b) a requirement to notify the competent authorities of any
Amendment 367 #
Proposal for a regulation Article 22 – paragraph 1 – point c (c) a requirement to
Amendment 368 #
Proposal for a regulation Article 22 – paragraph 1 – point c (c) a requirement to
Amendment 369 #
Proposal for a regulation Article 22 – paragraph 1 – point c (c) a requirement to
Amendment 370 #
Proposal for a regulation Article 22 – paragraph 3 3. Where a medicinal product has been granted a marketing authorisation in accordance with this Article, the summary of product characteristics shall clearly state that only a limited assessment of quality, safety and/or efficacy has been conducted due to the lack of comprehensive quality, safety and/or efficacy data. The packaging shall bear a warning with the same information.
Amendment 371 #
Proposal for a regulation Article 22 – paragraph 3 a (new) 3a. A veterinary medicinal product that has been granted marketing authorisation in accordance with this article may only be issued on the basis of a prescription.
Amendment 372 #
Proposal for a regulation Article 23 – paragraph 1 – introductory part 1. The competent authority or the
Amendment 373 #
Proposal for a regulation Article 23 – paragraph 1 – point b (b) assess the veterinary medicinal product as such as well as in comparison to the standard reference treatment regarding the quality, safety and efficacy documentation provided.
Amendment 374 #
Proposal for a regulation Article 23 – paragraph 2 Amendment 375 #
Proposal for a regulation Article 23 – paragraph 2 2. During the process of assessing applications for marketing authorisations for veterinary medicinal products containing or consisting of genetically modified organisms as referred to in Article 7(5), the necessary consultations shall be held by the
Amendment 376 #
Proposal for a regulation Article 24 – paragraph 1 – introductory part 1. The competent authority or the
Amendment 377 #
Proposal for a regulation Article 25 – paragraph 1 The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries comply with EU legislation applicable, 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 378 #
Proposal for a regulation Article 25 – paragraph 1 The competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned and/or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with Article 7(1) and that they minimize environmental pollution.
Amendment 379 #
Proposal for a regulation Article 26 – paragraph 1 The competent authority or the
Amendment 380 #
Proposal for a regulation Article 28 – paragraph 1 – introductory part 1. I
Amendment 381 #
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 382 #
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 383 #
Proposal for a regulation Article 29 – paragraph 1 – introductory part 1.
Amendment 384 #
Proposal for a regulation Article 29 – paragraph 1 – introductory part 1. A competent authority or the Commission shall classify the following veterinary medicinal products as subject to mandatory veterinary prescription:
Amendment 385 #
Proposal for a regulation Article 29 – paragraph 1 a (new) 1a. Member States may on their territories provide for additional legal subcategories in accordance with the respective national legislation.
Amendment 386 #
Proposal for a regulation Article 29 – paragraph 1 b (new) 1b. Where the veterinary medicinal product authorised under Article 38 is classified as not subject to veterinary prescription, the Member State may, in order to safeguard animal health or welfare, public health or the environment, classify such product as subject to veterinary prescription in accordance with the respective national legislation.
Amendment 387 #
Proposal for a regulation Article 29 – paragraph 2 – introductory part 2. A
Amendment 388 #
Proposal for a regulation Article 29 – paragraph 2 – introductory part 2. A competent authority or the Commission may classify a veterinary medicinal product as subject to mandatory veterinary prescription where special precautions are contained in the summary of product characteristics referred to in Article 30, and in particular potential risks to:
Amendment 389 #
Proposal for a regulation Article 29 – paragraph 3 – introductory part 3.
Amendment 390 #
Proposal for a regulation Article 29 – paragraph 3 – introductory part 3. By the way of derogation from paragraph 1, a competent authority or the Agency
Amendment 391 #
Proposal for a regulation Article 29 – paragraph 3 – introductory part 3. By the way of derogation from paragraph 1, a competent authority or the
Amendment 392 #
Proposal for a regulation Article 29 – paragraph 3 – introductory part 3. By the way of derogation from paragraph 1, a competent authority or the Agency may not classify a veterinary medicinal product as subject to mandatory veterinary prescription if all of the following conditions are fulfilled:
Amendment 393 #
Proposal for a regulation Article 29 – paragraph 3 – point a (a) the administration of the veterinary medicinal product is restricted to pharmaceutical forms requiring no particular knowledge or skill in using the products (e.g. s.c. injection);
Amendment 394 #
Proposal for a regulation Article 29 – paragraph 3 – point c (c) the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious
Amendment 395 #
Proposal for a regulation Article 29 – paragraph 3 – point f Amendment 396 #
Proposal for a regulation Article 29 – paragraph 3 – point f Amendment 397 #
Proposal for a regulation Article 29 – paragraph 3 – point h (h) there is no risk to public or animal health as regards the development of
Amendment 398 #
Proposal for a regulation Article 29 – paragraph 3 – point h (h) there is no risk to public or animal health as regards the development of resistance to antimicrobial or anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly.
Amendment 399 #
Proposal for a regulation Article 29 – paragraph 3 a (new) 3a. In contrast to paragraph 1, medicinal products for veterinary use shall be without prescription if: (a) they are registered as single homeopathic products and released for sale in pharmacies, have a dilution of not less than D4 (1:10 000) and are not produced using alcohol. (b) they are registered as complex homeopathic products, contain no individual components below a dilution of D4, are released for sale in pharmacies and are not produced using alcohol.
Amendment 400 #
Proposal for a regulation Article 30 – paragraph 1 – point b (b) qualitative and quantitative composition of the active substances
Amendment 401 #
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 402 #
Proposal for a regulation Article 30 – paragraph 1 – point c – point xiii (xiii) special conditions for use, including
Amendment 403 #
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 preventive measure in food producing animals, or in group treatments where there has been no diagnosis of disease
Amendment 404 #
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
Amendment 405 #
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 the prohibition of off-label use,
Amendment 406 #
Proposal for a regulation Article 30 – paragraph 1 – point e – point iii a (new) (iiia) list of excipients
Amendment 407 #
Proposal for a regulation Article 30 – paragraph 1 – point e – point viii (viii)
Amendment 408 #
Proposal for a regulation Article 30 – paragraph 1 – point e a (new) (ea) Information from the environmental risk assessment of the product, in particular environmental endpoints and risk characterisation data, including ecotoxicological information on effects on non-target species and persistence of active substances and active metabolites in soil and water
Amendment 409 #
Proposal for a regulation Article 30 – paragraph 1 – point j a (new) (ja) risk characterisation data from the environmental risk assessment of the product
Amendment 410 #
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 411 #
Proposal for a regulation Article 30 – paragraph 1 – point j a (new) (ja) information as to whether the veterinary medicinal product is only available on prescription.
Amendment 412 #
Proposal for a regulation Article 32 – paragraph 1 – point d (d) the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals, or for routine prophylactic or metaphylactic use in groups of food-producing animals;
Amendment 413 #
Proposal for a regulation Article 32 – paragraph 1 – point d (d) the product is a
Amendment 414 #
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
Amendment 415 #
Proposal for a regulation Article 32 – paragraph 1 – point d a (new) (da) the product is intended for preventive purposes for food producing animals, or for group treatment of food producing animals without any diagnosis of disease;
Amendment 416 #
Proposal for a regulation Article 32 – paragraph 1 – point d a (new) (da) The product is an antimicrobial veterinary medicinal product presented for use in food-producing animals to prevent diseases other than for shorter time periods and under exceptional circumstances.
Amendment 417 #
Proposal for a regulation Article 32 – paragraph 1 – point d a (new) (da) The product is an antimicrobial veterinary medicinal product presented for use in animals to prevent diseases other than for shorter periods of time and under exceptional circumstances.
Amendment 418 #
Proposal for a regulation Article 32 – paragraph 1 – point e (e) the proposed withdrawal period
Amendment 419 #
Proposal for a regulation Article 32 – paragraph 1 – point h a (new) (ha) the product poses significantly higher risks to the treated animal, public health or the environment compared to the standard reference treatment;
Amendment 420 #
Proposal for a regulation Article 32 – paragraph 1 – point i a (new) (ia) the product contains or consists of genetically modified organisms within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council.
Amendment 421 #
Proposal for a regulation Article 32 – paragraph 1 – point i a (new) (ia) (j) the veterinary medicinal product contains or is composed of organisms or viruses which, in accordance with Annex I A of Directive 2001/18/EC, have been genetically modified.
Amendment 422 #
Proposal for a regulation Article 32 – paragraph 2 Amendment 423 #
Proposal for a regulation Article 32 – paragraph 2 2. A marketing authorisation for an antimicrobial veterinary medicinal product or a group of antimicrobial veterinary medicinal products shall be refused if the antimicrobial is reserved for treatment of certain infections in humans.
Amendment 424 #
Proposal for a regulation Article 32 – paragraph 2 2. A marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans. Fluoroquinolones, 3rd and 4th generation cephalosporins, macrolides and glycopeptides shall be considered as reserved for treatment of certain infections in humans. Member States may consider further antimicrobials as reserved for treatment of certain infections in humans.
Amendment 425 #
Proposal for a regulation Article 32 – paragraph 3 Amendment 426 #
Proposal for a regulation Article 32 – paragraph 3 3. The Co
Amendment 427 #
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 428 #
Proposal for a regulation Article 32 – paragraph 3 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establish rules for the further 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 shall, when establishing these rules, draw on the scientific opinions of the Agency, not least in respect of species of animals, indications and routes of administration.
Amendment 429 #
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 430 #
Proposal for a regulation Article 32 – paragraph 4 4. The Commission shall, by means of implementing acts and drawing on the scientific recommendations made by the Agency, designate further antimicrobials or groups of antimicrobials reserved for treatment of certain infections
Amendment 431 #
Proposal for a regulation Article 32 – paragraph 4 4. The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). When adopting those implementing acts, the Commission shall take into account the work of EU agencies, as well as existing lists published by WHO and the OIE. The Commission should prioritize the evaluation of certain antibiotics such as modern cephalosporins and fluoroquinolones.
Amendment 432 #
Proposal for a regulation Article 32 – paragraph 4 4. The Commission shall, by means of implementing acts, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 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 433 #
Proposal for a regulation Article 32 – paragraph 4 a (new) 4a. The rules and criteria to be used by the European Commission for determining which antimicrobials are to be reserved for treatment of specific infections in humans should not interfere with Member States' right to restrict the use of certain antimicrobials in livestock. The EU list should not constrain Member State(s) that implement or wish to implement stricter rules, or have restricted/prohibited the use of some antimicrobials in certain species.
Amendment 434 #
Proposal for a regulation Article 32 – paragraph 4 a (new) 4a. Antimicrobials or groups of antimicrobials identified by the WHO or a Member State as reserve antibiotics or as reserved for the treatment of certain infections in humans, shall constitute products in the meaning of paragraph 2.
Amendment 435 #
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, species, pharmaceutical forms, administration routes or presentations shall be regarded as the same marketing authorisation as the one previously granted for the purpose of applying the rules of the protection of technical documentation.
Amendment 436 #
Proposal for a regulation Article 33 – paragraph 3 a (new) 3a. Safety information with regard to the environmental effects of veterinary medicinal products shall not be protected.
Amendment 437 #
Proposal for a regulation Article 34 – paragraph 1 – point a (a) 10 years for the veterinary medicinal products for cattle, sheep (reared for meat), pigs, chickens, salmons, dogs and cats
Amendment 438 #
Proposal for a regulation Article 34 – paragraph 1 – point a (a) 10 years for the veterinary medicinal products for cattle,
Amendment 439 #
Proposal for a regulation Article 34 – paragraph 1 – point b (b) 1
Amendment 440 #
Proposal for a regulation Article 34 – paragraph 1 – point b (b) 14 years for antimicrobial veterinary medicinal products for cattle,
Amendment 441 #
Proposal for a regulation Article 34 – paragraph 1 – point c (c) 1
Amendment 442 #
Proposal for a regulation Article 34 – paragraph 1 – point c (c)
Amendment 443 #
Proposal for a regulation Article 34 – paragraph 1 – point d (d) 1
Amendment 444 #
Proposal for a regulation Article 34 a (new) Article 34a Period of protection of new technical documentation for existing products Any new trials and studies submitted by the holder of a marketing authorisation to the competent authorities for an existing product no longer covered by a data protection period shall have a non-cumulative period of protection of five years, provided that they are: (a) needed to extend a marketing authorisation in respect of species, dosages, pharmaceutical forms or routes of administration, or (b) needed for a re-evaluation requested by the Agency or the competent authorities post-authorisation. No other applicant may use those trials or studies for that five-year period without the written consent of the holder of the marketing authorisation in the form of a letter of access to those trials or studies.
Amendment 445 #
Proposal for a regulation Article 35 – title Amendment 446 #
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
Amendment 447 #
Proposal for a regulation Article 35 – paragraph 1 1. Where the first marketing authorisation application relating to more than one species or a variation is approved in accordance with Article 65 extending the marketing authorisation to another species listed in Article 34(1)(a), the period of the protection provided for in that Article shall be prolonged by
Amendment 448 #
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 449 #
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 450 #
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 451 #
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
Amendment 452 #
Proposal for a regulation Article 35 – paragraph 2 2. Where the first marketing authorisation relating to more than one species or a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34(1)(a) or (d) shall be prolonged by 4 years.
Amendment 453 #
Proposal for a regulation Article 35 – paragraph 3 Amendment 454 #
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 455 #
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 456 #
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 457 #
Proposal for a regulation Article 35 – paragraph 4 a (new) 4a. Any grant of periods for protection of technical documentation should also the equally applied to innovation performed to generic veterinary medicines, and not only to originators.
Amendment 458 #
Proposal for a regulation Article 38 – paragraph 2 – point b Amendment 459 #
Proposal for a regulation Article 38 – paragraph 2 – point c Amendment 460 #
Proposal for a regulation Article 38 – paragraph 2 – point c (c) veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application, with the exception of veterinary medicinal products subject to authorisation under Article 21;
Amendment 461 #
Proposal for a regulation Article 38 – paragraph 2 – point e Amendment 462 #
Proposal for a regulation Article 38 – paragraph 2 – point e Amendment 463 #
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 464 #
Proposal for a regulation Article 38 – paragraph 4 Amendment 465 #
Proposal for a regulation Article 46 – paragraph 1 1. Applications and the dossier for decentralised marketing authorisation shall be submitted to all the Member States. The Member State chosen by the applicant
Amendment 466 #
Proposal for a regulation Article 46 – paragraph 2 2. The application shall list Member States where the applicant seeks to obtain a marketing authorisation (
Amendment 467 #
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 (
Amendment 468 #
Proposal for a regulation Article 48 – paragraph 1 1.
Amendment 469 #
Proposal for a regulation Article 48 – paragraph 2 Amendment 470 #
Proposal for a regulation Article 48 – paragraph 3 – point c (c)
Amendment 471 #
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
Amendment 472 #
Proposal for a regulation Article 49 – paragraph 1 1. If a Member State raises, within the time period referred to in Article 46(4) or Article 48(5) its objections to the assessment report, proposed summary of product characteristics or proposed labelling and package leaflet, a detailed statement of the reasons shall be provided to the reference Member State, the other Member States and the applicant. The
Amendment 473 #
Proposal for a regulation Article 49 – paragraph 2 Amendment 474 #
Proposal for a regulation Article 49 – paragraph 4 4. In the event of an opinion in favour of granting a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and
Amendment 475 #
Proposal for a regulation Article 50 Amendment 476 #
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 477 #
Proposal for a regulation Article 51 – paragraph 1 1. A
Amendment 478 #
Proposal for a regulation Article 51 – paragraph 2 – point a (a) veterinary medicinal products authorised within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets, and lists of sites where each product is manufactured and reference numbers to the pharmacovigilance system master file;
Amendment 479 #
Proposal for a regulation Article 51 – paragraph 8 a (new) 8a. Within 24 months of the date of entry into force of this regulation, the Commission shall submit a report to the European Parliament and the Council on the desirability and possible details of the creation of an environmental monograph system for the active substance to assess the environmental impact of veterinary medicinal products and potential alternatives, accompanied, if necessary, by a legislative proposal.
Amendment 480 #
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 the establishment of 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 481 #
Proposal for a regulation Article 52 – paragraph 2 2. Marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations and limited access to other products.
Amendment 482 #
Proposal for a regulation Article 52 – paragraph 3 3. The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics
Amendment 483 #
Proposal for a regulation Article 52 – paragraph 3 3. The general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products, their summaries of product characteristics and package leaflets, and all safety information.
Amendment 484 #
Proposal for a regulation Article 54 – title Collection of data on the sales and use of
Amendment 485 #
Proposal for a regulation Article 54 – paragraph 1 1. Member States shall collect relevant and comparable data on the volume of sales
Amendment 486 #
Proposal for a regulation Article 54 – paragraph 1 1. 1. Member States shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products on a yearly basis. These data shall include: (a) the volume of sales in terms of weight and monetary value for each antimicrobial type at national level; (b) the quantity of antimicrobials used, the species treated, the disease or infection being treated, and method of treatment, at per farm-level.
Amendment 487 #
Proposal for a regulation Article 54 – paragraph 1 1. Member States shall collect relevant and comparable data on the volume of sales in terms of weight and cost for each antimicrobial type and the use of veterinary antimicrobial medicinal products, broken down by species, condition and method of treatment, as geographically narrowed down as feasible.
Amendment 488 #
Proposal for a regulation Article 54 – paragraph 1 1. Member States shall collect relevant
Amendment 489 #
Proposal for a regulation Article 54 – paragraph 1 1. Member States shall collect relevant
Amendment 490 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States shall send to the Agency data on the volume of sales and the use of veterinary antimicrobial medicinal products
Amendment 491 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the
Amendment 492 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States shall send data on the volume of sales and the use of veterinary anti
Amendment 493 #
Proposal for a regulation Article 54 – paragraph 3 a (new) Amendment 494 #
Proposal for a regulation Article 54 – paragraph 4 a (new) 4a. Data requirements for adopting those implementing acts shall include animal species, the dose, the duration and type of treatment, the number of animals treated and the administration route(s). In addition any off-label use of antimicrobials should be mandatorily reported to national authorities.
Amendment 495 #
Proposal for a regulation Article 54 – paragraph 4 b (new) 4b. The use of antibiotics in drinking water should be restricted to cases where most of the animals or the whole herd are sick. Five years after the entry into force of this Regulation, the European Commission shall publish a report examining the different routes used to administer antibiotics to food-producing animals, and in particular the oral routes used through feed and water, and their subsequent impact on antimicrobial resistance.
Amendment 496 #
Proposal for a regulation Article 56 Amendment 497 #
Proposal for a regulation Article 57 – paragraph 1 – point c (c)
Amendment 498 #
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 499 #
Proposal for a regulation Article 58 Amendment 500 #
Proposal for a regulation Article 58 – paragraph 2 2. The Commission shall, by means of implementing acts, establish a list of variations to the terms of a marketing authorisation for a veterinary medicinal product requiring assessment (‘variations requiring assessment’). These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). Such acts shall remain subject to the opinion of the Member States, in line with Regulation 182/2011.
Amendment 501 #
Proposal for a regulation Article 58 – paragraph 3 Amendment 502 #
Proposal for a regulation Article 58 – paragraph 3 – point b a (new) (ba) whether changes have an impact on route of administration
Amendment 503 #
Proposal for a regulation Article 58 a (new) Amendment 504 #
Proposal for a regulation Article 59 Amendment 505 #
Proposal for a regulation Article 60 Amendment 506 #
Proposal for a regulation Article 60 Amendment 507 #
Proposal for a regulation Article 61 Amendment 508 #
Proposal for a regulation Article 62 Amendment 509 #
Proposal for a regulation Article 63 Amendment 511 #
Proposal for a regulation Article 64 – paragraph 1 1. If a variation application fulfils the requirements laid down in Article 61, the competent authority or the Agency, or a competent authority assigned in accordance with Article 63(3) shall acknowledge receipt of a complete application in 15 days.
Amendment 512 #
Proposal for a regulation Article 65 Amendment 513 #
Proposal for a regulation Article 66 Amendment 514 #
Proposal for a regulation Article 67 Amendment 515 #
Proposal for a regulation Article 68 Amendment 516 #
Proposal for a regulation Article 68 – paragraph 1 1. A harmonised summary of product characteristics including key elements of the application as defined in Article 7 relating to the quality of the product shall be prepared in accordance with the procedure laid down in Article 69 for groups of similar veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances
Amendment 517 #
Proposal for a regulation Article 68 – paragraph 1 1. A harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in Article 69 for veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances
Amendment 518 #
Proposal for a regulation Article 68 – paragraph 1 1.
Amendment 519 #
Proposal for a regulation Article 68 – paragraph 1 1. A harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in Article 69 for groups of similar veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and have been shown to be bio-equivalents, for which national marketing authorisations have been granted in different Member States before
Amendment 520 #
Proposal for a regulation Article 68 – paragraph 1 a (new) 1a. The marketing authorisation holder could in accordance with Article 69 apply for a harmonisation of different national marketing authorisations that have been granted for the same veterinary medicinal product. A single, approved quality data set and a harmonised summary of product characteristics shall be prepared for such products. The coordination group shall draw up detailed rules of procedure for the harmonisation of 'same products' from the same marketing authorisation holder.
Amendment 521 #
Proposal for a regulation Article 68 – paragraph 2 a (new) 2a. Marketing authorisation holders may, pursuant to Article 69, request a harmonisation of the various national marketing authorisations granted for the same veterinary medicinal product.
Amendment 522 #
Proposal for a regulation Article 68 – paragraph 2 b (new) 2b. A single set of quality data and a harmonised summary of product characteristics shall be prepared for veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and marketing authorisation holder, and for which national marketing authorisations have been granted in different Member States (‘same products’). The coordination group shall establish procedural rules for the harmonisation of ‘same products’.
Amendment 523 #
Proposal for a regulation Article 68 – paragraph 2 c (new) 2c. National marketing authorisations may be harmonised with decentralised marketing authorisations and/or mutual recognition marketing authorisations if they are for the same product.
Amendment 524 #
Proposal for a regulation Article 68 a (new) Article 68a 1. A marketing authorisation holder may in accordance with Article 69 apply for a harmonisation of different national marketing authorisations that have been granted for the same veterinary medicinal product. 2. A single, approved Quality data set and a harmonised summary of product characteristics shall be prepared for veterinary medicinal products, other than homeopathic veterinary medicinal products, which have the same qualitative and quantitative composition of their active substances, the same pharmaceutical form and the same marketing authorisation holder ('same products') and for which national marketing authorisations have been granted in different Member States. The coordination group shall draw up detailed rules of procedure for harmonisation. 3. National marketing authorisations may be harmonised with decentralised and/or mutual recognition marketing authorisations if they are for the same product.
Amendment 525 #
Proposal for a regulation Article 68 a (new) Article 68a 1. Harmonization should be based on individual products or closely related product (e.g. the same products authorized by different marketing authorization holders in different Member States considered to be "one entity" as defined in the Commission Communication 98/C 229/03), and it should not be based on groups of independent products which may differ significantly in terms of their quality, safety and efficacy 2. Harmonization shall be based on a consolidated dossier which shall be prepared by the marketing authorization holder – the SPC resulting from the harmonization exercise shall be based on the scientific evidence data for the respective product 3. The responsibility to propose the harmonized SPC shall rest with the marketing authorization holders 4. Where species/indications are not supported by scientific evidence in the dossier for the product, the Member States must not be forced to accept such indications 5. withdrawal periods must be based on product related residue depletion data and Member States must have the right to refuse withdrawal periods which are not justified due to public health protection as well as huge impacts on trade with animal products containing residues above the established maximum residue limits 6. As the dossiers for nationally authorized products are available to the national competent authorities, Committee for Veterinary Medicinal products should not be involved in identification of products which shall be subject to harmonization but this task should be conferred to the Co-ordination group 7. Rules need to be clear to ensure transparent and predictable legal environment 8. Regarding the regulatory procedure, a workable procedure shall be used for the harmonization exercise – e.g. Type II variation procedure 9. As a part of the harmonization procedure, the products shall be upgraded to the "MRP status" (products authorized under the Mutual Recognition Procedure) 10. Relationships between originators and generics, and responsibilities of marketing authorisation holders for both types of products, must be carefully balanced and in principle, where the originator product has been authorized, the generic product shall follow such harmonization.
Amendment 526 #
Proposal for a regulation Article 69 Amendment 527 #
Proposal for a regulation Article 69 – paragraph 1 1. By [12 months after the date of application of this Regulation for OP to
Amendment 528 #
Proposal for a regulation Article 69 – paragraph 1 1. By [12 months after the date of application of this Regulation for OP to insert the actual date] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted
Amendment 529 #
Proposal for a regulation Article 69 – paragraph 2 2. The coordination group shall establish groups of essentially similar products according to article 68(1) where they consider there are unacceptable differences in SmPCs. For each of these groups of essentially similar products, the coordination group shall appoint one member to act as a rapporteur.
Amendment 530 #
Proposal for a regulation Article 69 – paragraph 2 a (new) 2a. The marketing authorisation holders shall submit to the coordination group their requests to harmonise the marketing authorisations for a particular product. All registrations pertaining to the same product in the Union will be included in the harmonisation procedure, subject to Article 69(3). The coordination group shall appoint one member to act as a rapporteur and propose a start date for the procedure.
Amendment 531 #
Proposal for a regulation Article 69 – paragraph 2 a (new) 2a. The marketing authorisation holders shall submit to the coordination group their requests to harmonise the marketing authorisations for a particular product. All registrations pertaining to the same product in the Union will be included in the harmonisation procedure, subject to Article 69(3). The coordination group shall appoint one member to act as a rapporteur and propose a start date for the procedure.
Amendment 532 #
Proposal for a regulation Article 69 – paragraph 3 3. Within 120 days of his appointment, the rapporteur shall present the coordination group a report
Amendment 533 #
Proposal for a regulation Article 69 – paragraph 3 3. Within 120 days of his appointment, the rapporteur shall present the coordination group a report
Amendment 534 #
Proposal for a regulation Article 69 – paragraph 3 3. Within 120 days of his appointment, the rapporteur shall present the coordination group a report
Amendment 535 #
Proposal for a regulation Article 69 – paragraph 3 3. Within 120 days of his appointment, the rapporteur shall present to the coordination group a report
Amendment 536 #
Proposal for a regulation Article 69 – paragraph 4 Amendment 537 #
Proposal for a regulation Article 69 – paragraph 4 – introductory part 4. Harmonised
Amendment 538 #
Proposal for a regulation Article 69 – paragraph 4 – introductory part 4. Harmonised
Amendment 539 #
Proposal for a regulation Article 69 – paragraph 4 – point a (a) all species mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group;
Amendment 540 #
Proposal for a regulation Article 69 – paragraph 4 – point a (a) all species mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group;
Amendment 541 #
Proposal for a regulation Article 69 – paragraph 4 – point b (b) all therapeutic indications and dosages mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group
Amendment 542 #
Proposal for a regulation Article 69 – paragraph 4 – point b (b) all therapeutic indications and posology mentioned in the marketing authorisations granted by Member States in respect of the similar products in the group;
Amendment 543 #
Proposal for a regulation Article 69 – paragraph 4 – point b (b) all therapeutic indications and dosages mentioned in the marketing authorisations granted by Member States in respect of the essentially similar products in the group, except for indications regarding the prophylactic use of antimicrobials;
Amendment 544 #
Proposal for a regulation Article 69 – paragraph 4 – point c (c)
Amendment 545 #
Proposal for a regulation Article 69 – paragraph 4 – point c (c)
Amendment 546 #
Proposal for a regulation Article 69 – paragraph 4 – point c a (new) (ca) all relevant impacts on the environment.
Amendment 547 #
Proposal for a regulation Article 69 – paragraph 5 5. Upon presentation of a report, the coordination group shall act by a majority of the votes cast by the members of the coordination group represented at the meeting. The rapporteur shall record the agreement, close the procedure and inform Member States and the marketing authorisation holder
Amendment 548 #
Proposal for a regulation Article 69 – paragraph 5 5. Upon presentation of a report, the coordination group shall act by a majority of the votes cast by the members of the coordination group represented at the meeting. The rapporteur shall record the agreement, close the procedure and inform Member States and the marketing authorisation holder
Amendment 549 #
Proposal for a regulation Article 69 – paragraph 6 6. In the event of an opinion in favour of adopting a harmonis
Amendment 550 #
Proposal for a regulation Article 69 – paragraph 6 6. In the event of an opinion in favour of adopting a harmonis
Amendment 551 #
Proposal for a regulation Article 69 – paragraph 6 6. In the event of an opinion in favour of adopting a harmonis
Amendment 552 #
Proposal for a regulation Article 69 – paragraph 6 6. In the event of an opinion in favour of adopting a harmonis
Amendment 553 #
Proposal for a regulation Article 70 Amendment 554 #
Proposal for a regulation Article 70 – paragraph 1 1. By way of derogation from Article 69, the Committee may recommend to the Commission groups of similar veterinary medicinal products for which a scientific reassessment is necessary before a harmonised summary of the product characteristics
Amendment 555 #
Proposal for a regulation Article 70 – paragraph 3 3. By way of derogation from Article 69, veterinary medicinal products authorised before
Amendment 556 #
Proposal for a regulation Article 71 Amendment 557 #
Proposal for a regulation Article 71 – paragraph 1 Upon request from the coordination group or the Agency, holders of
Amendment 558 #
Proposal for a regulation Article 71 – paragraph 1 Upon request from the coordination group or the Agency, holders of the marketing
Amendment 559 #
Proposal for a regulation Article 71 – paragraph 1 Upon request from the coordination group or the Agency, holders of
Amendment 560 #
Proposal for a regulation Article 71 – paragraph 1 Upon request from the coordination group or the Agency, holders of the marketing authorisations for products included in a group of essentially similar products identified for a harmonisation of the summaries of the product characteristics
Amendment 561 #
Proposal for a regulation Article 72 – paragraph 1 1. Marketing authorisation holders shall carry out regular evaluations of their products and ensure a positive benefit/risk assessment. They shall elaborate and maintain a system for collecting and evaluating information on the risks of veterinary medicinal products as regards animal health, public health and the environment
Amendment 562 #
Proposal for a regulation Article 72 – paragraph 1 1. Marketing authorisation holders shall e
Amendment 563 #
Proposal for a regulation Article 72 – paragraph 1 1. Marketing authorisation holders shall elaborate and maintain a system for collecting information on the
Amendment 564 #
Proposal for a regulation Article 72 – paragraph 2 2. Competent authorities and
Amendment 565 #
Proposal for a regulation Article 72 – paragraph 2 2. Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders and authorise them.
Amendment 566 #
Proposal for a regulation Article 72 – paragraph 2 2. Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders. The supervisors shall not have any conflicts of interest with regard to the marketing authorisation holder.
Amendment 567 #
Proposal for a regulation Article 73 – paragraph 1 1. Member States, the Commission
Amendment 568 #
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 (
Amendment 569 #
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
Amendment 570 #
Proposal for a regulation Article 73 – paragraph 2 – introductory part 2. Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals and animal holders different means of reporting to them the
Amendment 571 #
Proposal for a regulation Article 73 – paragraph 2 – introductory part 2. Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals, an
Amendment 572 #
Proposal for a regulation Article 73 – paragraph 2 – introductory part 2. Competent authorities, the Agency and marketing authorisation holders shall make available to healthcare professionals
Amendment 573 #
Proposal for a regulation Article 73 – paragraph 2 – introductory part 2. Competent authorities
Amendment 574 #
Proposal for a regulation Article 73 – paragraph 2 – point a (a) any response in an animal to a veterinary or human medicinal product, that is noxious and unintended, regardless of whether the product can be related to the outcome, which manifests after any use of the product (off-label or on-label);
Amendment 575 #
Proposal for a regulation Article 73 – paragraph 2 – point a (a) any response in an animal to a veterinary
Amendment 576 #
Proposal for a regulation Article 73 – paragraph 2 – point b (b) any observation of a lack of efficacy of a veterinary medicinal product following
Amendment 577 #
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 578 #
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 579 #
Proposal for a regulation Article 73 – paragraph 2 – point c (c) a
Amendment 580 #
Proposal for a regulation Article 73 – paragraph 2 – point c (c) any
Amendment 581 #
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, in particular, any contamination from effluent or contamination of water by veterinary medicinal products shall be considered an adverse effect and be measured by the relevant local authorities;
Amendment 582 #
Proposal for a regulation Article 73 – paragraph 2 – point d Amendment 583 #
Proposal for a regulation Article 73 – paragraph 2 – point d (d) any infringements of withdrawal period following administration to an animal of a veterinary
Amendment 584 #
Proposal for a regulation Article 73 – paragraph 2 – point e (e) any noxious re
Amendment 585 #
Proposal for a regulation Article 73 – paragraph 2 – point f (f) any finding
Amendment 586 #
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 of use of antimicrobial medicines in animals;
Amendment 587 #
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 588 #
Proposal for a regulation Article 73 – paragraph 2 – point f a (new) (fa) Detection of a substance in the environment, especially in ground water or surface water.
Amendment 589 #
Proposal for a regulation Article 73 – paragraph 2 – point f a (new) (fa) (f) any finding of an active substance in the environment, particularly in groundwater or surface water.
Amendment 590 #
Proposal for a regulation Article 73 – paragraph 2 a (new) 2a. any finding of an active substance in the environment, particularly in groundwater or surface water.
Amendment 591 #
Proposal for a regulation Article 73 – paragraph 2 a (new) Amendment 592 #
Proposal for a regulation Article 73 – paragraph 2 a (new) 2a. Competent authorities and the Agency shall, in addition to the events provided under Paragraph 2, make available to healthcare professionals and animal holders different means of reporting to them any response in an animal to a human medicinal product.
Amendment 593 #
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 " ). Maintaining the database shall include electronic archiving of the original reports, related subsequent reports and continuous quality control of the data.
Amendment 594 #
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') that is linked with the Product database.
Amendment 595 #
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
Amendment 596 #
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
Amendment 597 #
Proposal for a regulation Article 74 – paragraph 2 2. The Agency shall, in co
Amendment 598 #
Proposal for a regulation Article 74 – paragraph 2 2.
Amendment 599 #
Proposal for a regulation Article 74 – paragraph 3 3. The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made accessible in accordance with
Amendment 600 #
Proposal for a regulation Article 74 – paragraph 3 a (new) 3a. The Agency shall ensure that the movement of information between the EU’s pharmacovigilance database and the national pharmacovigilance databases of the individual Member States is safeguarded.
Amendment 601 #
Proposal for a regulation Article 75 – paragraph 2 a (new) 2a. Veterinarians shall have dedicated access to the database, enabling them to investigate the observed effects in a detailed manner. The database shall include a warning system for veterinarians, whose representatives shall be regularly consulted in order to improve the system.
Amendment 602 #
Proposal for a regulation Article 75 – paragraph 3 – point a (a) the number of adverse events reported each year, broken down by product and active substance, animal species and type of adverse event;
Amendment 603 #
Proposal for a regulation Article 75 – paragraph 3 – point a (a) the number of adverse events reported each year, broken down by type of product, animal species and type of adverse event;
Amendment 604 #
Proposal for a regulation Article 75 – paragraph 3 – point b a (new) (ba) Information about incidence of adverse events.
Amendment 605 #
Proposal for a regulation Article 76 – paragraph 1 1. Competent authorities shall record
Amendment 606 #
Proposal for a regulation Article 76 – paragraph 1 1. Competent authorities shall record in the pharmacovigilance database and copied to the Marketing authorisation holders all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their Member State, within 30 days following the receipt of the adverse event report.
Amendment 607 #
Proposal for a regulation Article 76 – paragraph 1 1. Competent authorities shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of
Amendment 608 #
Proposal for a regulation Article 76 – paragraph 2 2. Marketing authorisation holders shall
Amendment 609 #
Proposal for a regulation Article 76 – paragraph 2 2. Marketing authorisation holders shall record
Amendment 610 #
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 611 #
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
Amendment 612 #
Proposal for a regulation Article 76 – paragraph 3 3. Competent authorities may, on their own initiative or on a request from the Agency, request the marketing authorisation holder to
Amendment 613 #
Proposal for a regulation Article 76 – paragraph 3 3.
Amendment 614 #
Proposal for a regulation Article 76 – paragraph 3 3. Competent authorities may
Amendment 615 #
Proposal for a regulation Article 76 – paragraph 3 a (new) 3a. Marketing authorisation holders shall submit reports on their ongoing risk- benefit balance evaluation on a regular basis and as required in response to requests from the competent authorities. The reporting intervals and requisite data lock points, with associated submission deadlines, shall be set by the competent authorities, in accordance with a risk- based approach, when marketing authorisations are issued. Data lock points already determined under a harmonised EU-wide approach for existing authorisations shall continue to apply.
Amendment 616 #
Proposal for a regulation Article 76 – paragraph 4 Amendment 617 #
Proposal for a regulation Article 76 – paragraph 5 Amendment 618 #
Proposal for a regulation Article 77 – paragraph 1 1. The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation and shall take all appropriate steps to encourage members of the health professions and animal holders to report adverse events.
Amendment 619 #
Proposal for a regulation Article 77 – paragraph 1 1. The marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation. To this end, the holder of a marketing authorisation for a veterinary medicinal product shall establish a contact point for adverse events reporting in each Member State where the veterinary medicinal product is authorised to facilitate averse events reporting by the animal health professionals and animal owners in the official language in that Member State. Such contact point shall be a part of the marketing authorisation holder´s pharmacovigilance master file and shall be under the supervision of the competent authority in that Member State.
Amendment 620 #
Proposal for a regulation Article 77 – paragraph 1 a (new) 1a. Marketing authorisation holders shall ensure, by regularly conducting and updating evaluations of their veterinary medicinal products using signal-detection methods, and taking any measures thus found to be necessary, that the risk- benefit balance is favourable.
Amendment 621 #
Proposal for a regulation Article 77 – paragraph 1 a (new) Amendment 622 #
Proposal for a regulation Article 77 – paragraph 2 2. Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party
Amendment 623 #
Proposal for a regulation Article 77 – paragraph 2 a (new) 2a. The marketing authorisation holder shall be required to check regularly that the contractor is carrying out the work in accordance with the stipulations of the contract.
Amendment 624 #
Proposal for a regulation Article 77 – paragraph 3 3. The marketing authorisation holder shall permanently have at his disposal
Amendment 625 #
Proposal for a regulation Article 77 – paragraph 3 3. The marketing authorisation holder shall permanently have at his disposal one or more appropriately qualified persons
Amendment 626 #
Proposal for a regulation Article 77 – paragraph 4 4. Where the tasks of the qualified person responsible for pharmacovigilance listed in Article 78 have been contracted out to a third party, th
Amendment 627 #
Proposal for a regulation Article 77 – paragraph 5 5. The marketing authorisation holder shall,
Amendment 628 #
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 629 #
Proposal for a regulation Article 78 – paragraph 1 – introductory part Qualified persons responsible for pharmacovigilance as referred to in Article
Amendment 630 #
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 631 #
Proposal for a regulation Article 78 – paragraph 1 – point a a (new) (aa) elaborating and maintaining a detailed description of the pharmaceutical business’s pharmacovigilance system;
Amendment 632 #
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 633 #
Proposal for a regulation Article 78 – paragraph 1 – point b (b) allocating a reference number
Amendment 634 #
Proposal for a regulation Article 78 – paragraph 1 – point d (d) establishing and maintaining a system which ensures that all adverse events, including on non-target species and the environment, which are brought to the attention of the marketing authorisation holder are
Amendment 635 #
Proposal for a regulation Article 78 – paragraph 1 – point e (e) preparing the adverse event reports referred to in Article 76 and reports referred to in Article 77(5);
Amendment 636 #
Proposal for a regulation Article 78 – paragraph 1 – point j (j)
Amendment 637 #
Proposal for a regulation Article 78 – paragraph 1 – point k (k) ensuring that all personnel involved in the performance of pharmacovigilance activities receive
Amendment 638 #
Proposal for a regulation Article 78 – paragraph 1 – point k a (new) (ka) To document for each product, in the EU pharmacovigilance database, the outcome of a yearly review of the full pharmacovigilance information available on the product concerned, and to inform the relevant competent authorities or the Agency immediately in case of new findings that may call into question the use of the product or potentially reduce the overall benefit-risk balance;
Amendment 639 #
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 640 #
Proposal for a regulation Article 78 – paragraph 1 – point l a (new) (la) The authorisation holder shall be required to ensure that the qualified person responsible for pharmacovigilance is authorised to maintain and develop the pharmacovigilance system and to improve compliance with requirements.
Amendment 641 #
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 642 #
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 643 #
Proposal for a regulation Article 79 – paragraph 4 4. Competent authorities and the Agency shall provide the general public, veterinarians and other healthcare professionals with all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication.
Amendment 644 #
Proposal for a regulation Article 79 – paragraph 4 4. Competent authorities and the Agency shall
Amendment 645 #
Proposal for a regulation Article 79 – paragraph 5 5. Competent authorities shall verify by means of inspections referred to in Article 125 or any other way that marketing authorisation holders comply with the requirements relating to pharmacovigilance laid down in this Section.
Amendment 646 #
Proposal for a regulation Article 81 – paragraph 1 1. Marketing authorisation holders, Competent authorities and the Agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit-risk balance of veterinary medicinal products with a view to detecting risks to animal health, public health and protection of the environment (
Amendment 647 #
Proposal for a regulation Article 81 – paragraph 1 1. Competent authorities, other concerned authorities and the Agency shall cooperate in monitoring the data in
Amendment 648 #
Proposal for a regulation Article 81 – paragraph 2 Amendment 649 #
Proposal for a regulation Article 81 – paragraph 3 3. The Agency and the
Amendment 650 #
Proposal for a regulation Article 81 – paragraph 4 4. Given that the marketing authorisation holder is the primary source of expertise and information concerning the product(s) under his/her responsibility, the lead authority could where necessary consult the marketing authorisation holder(s) during the signal management process. The results of the signal management process shall be agreed upon by the competent authorities and, where appropriate, the Agency. The lead authority shall record the results in the pharmacovigilance database.
Amendment 651 #
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 652 #
Proposal for a regulation Article 81 – paragraph 4 a (new) 4a. To support the signal management process referred to in paragraph 1, marketing authorisation holders shall submit safety pharmacovigilance signal update reports on a regular basis during the first three years after the product is placed on the market. The periodic nature of these reports shall be defined by the Commission in accordance with the guidelines laid down in EudraLex - Volume 9.
Amendment 653 #
Proposal for a regulation Article 81 – paragraph 5 a (new) 5a. 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 updated 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 updated reports shall include a scientific evaluation of the risk- benefit balance of the veterinary medicinal product.
Amendment 654 #
Proposal for a regulation Article 81 a (new) Article 81a (a) Marketing authorisations shall be valid for five years. (b) An authorisation may be renewed after five years on the basis of a re- evaluation of the risk-benefit balance. An authorisation holder seeking such renewal shall submit all requisite documentation concerning the quality, safety and effectiveness of the product in question at least six months before expiry of the existing authorisation. (c) Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal in accordance with subparagraph (b).
Amendment 655 #
Proposal for a regulation Article 82 – paragraph 1 1.
Amendment 656 #
Proposal for a regulation Article 82 – paragraph 1 1.
Amendment 657 #
Proposal for a regulation Article 82 – paragraph 1 1. Before the expiry of the period of validity of
Amendment 658 #
Proposal for a regulation Article 82 – paragraph 2 2. The application for a re-examination shall be submitted to the competent authority that granted the authorisation or to the Agency
Amendment 659 #
Proposal for a regulation Article 83 – paragraph 4 4. The competent authority or the Commission may at any time grant a marketing authorisation valid for an unlimited period of time, provided that the m
Amendment 660 #
Proposal for a regulation Article 83 – paragraph 4 4. The competent authority or the Commission may at any time grant a
Amendment 661 #
Proposal for a regulation Article 84 – paragraph 1 1. Where the interests of the Union are involved, a
Amendment 662 #
Proposal for a regulation Article 84 – paragraph 1 1. Where the interests of the Union or national interests are involved, and in particular the interests of public or animal health or of the environment related to the quality, safety or efficacy of veterinary medicinal products or the free movement of products within the Union, any Member State or the Commission may refer its concern to the Agency for the application of the procedure laid down in Article 85. The matter of concern shall be clearly identified.
Amendment 663 #
Proposal for a regulation Article 88 – paragraph 1 1. By way of derogation from Article 5, homeopathic veterinary medicinal products that satisfy the requirements set out in Article 89
Amendment 664 #
Proposal for a regulation Article 88 – paragraph 1 1. By way of derogation from Article 5,
Amendment 665 #
Proposal for a regulation Article 88 – paragraph 1 1. By way of derogation from Article 5 paragraph 1, homeopathic veterinary medicinal products that satisfy the requirements set out in Article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with Article 90.
Amendment 666 #
Proposal for a regulation Article 88 – paragraph 1 a (new) 1a. By way of derogation from the requirements laid down in the first paragraph, Member States may exempt minor remedies from registration.
Amendment 667 #
Proposal for a regulation Article 88 – paragraph 2 a (new) 2a. Each member state shall ensure that reports of suspected serious adverse events, and suspected adverse events in humans, that have occurred within its territory are communicated to the Agency and to the other member states without delay, at the latest within 15 calendar days of becoming known.
Amendment 668 #
Proposal for a regulation Article 88 – paragraph 2 b (new) 2b. The veterinary homeopathic medicinal products not subject to Article 89 paragraph 1 shall be authorised in accordance with the general regulations. For the safety tests, preclinical and clinical trials of veterinary homeopathic medicinal products not subject to Article 89 paragraph 1 a Member State may introduce or retain on its territory specific rules in accordance with the principles and characteristics as practised in that Member State.
Amendment 669 #
Proposal for a regulation Article 89 – paragraph 1 – point b (b) there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular
Amendment 670 #
Proposal for a regulation Article 89 – paragraph 1 – point b (b) there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product shall not contain more than one part per 10 000 of the mother tincture
Amendment 671 #
Proposal for a regulation Article 89 – paragraph 1 a (new) 1a. Registration shall not be required in the case of medicinal products placed on the market by a pharmaceutical business in volumes of up to 1 000 packets in a year unless: (a) they contain preparations made from the bodies of animals, including living animals, human or animal body parts, components or metabolites in processed or unprocessed form, or micro-organisms, including viruses, or components or metabolites thereof; (b) they contain more than the one- hundredth part of the minimum dose of a non-homeopathic medicine subject to prescription; (c) any of the following apply: – the medicinal product does not meet recognised pharmaceutical quality standards, – there is reason to suspect that, when used according to the instructions, the medicinal product may have harmful effects to a degree that is medically unacceptable, – the specified withdrawal period is insufficient, – the medicinal product is subject to medical prescription, except in the case of products containing exclusively substances listed in the Annex to Regulation (EU) No 37/2010 as substances for which no maximum limits need to be set, – the medicinal product has not been produced in accordance with a process described in the homeopathic section of the pharmacopoeia, – marketing the medicinal product or using it on animals would be unlawful.
Amendment 672 #
Proposal for a regulation Article 90 – paragraph 1 – point a (a) scientific name or other name given in a pharmacopoeia or documented in a monograph of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered;
Amendment 673 #
Proposal for a regulation Article 90 – paragraph 1 – point a (a) scientific name or other name given in a pharmacopoeia or documented in a monograph of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered;
Amendment 674 #
Proposal for a regulation Article 91 – paragraph 1 – point a (a) to produce
Amendment 675 #
Proposal for a regulation Article 91 – paragraph 1 – point b a (new) (ba) In addition to a manufacturing authorisation, the manufacturers in question shall be required to have proof and confirmation of compliance with good manufacturing practices (GMP).
Amendment 676 #
Proposal for a regulation Article 91 – paragraph 2 2. Notwithstanding paragraph 1, a manufacturing authorisation shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out solely for retail in accordance with Articles 107 and 108. A manufacturing authorisation shall also not be required for preparation, filling or changes in packaging or presentation where these processes are carried out solely for dispensing by pharmacists in a pharmacy or by veterinarians in a veterinary practice.
Amendment 677 #
Proposal for a regulation Article 91 – paragraph 2 2. Notwithstanding paragraph 1, a manufacturing authorisation shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out solely for retail in accordance with Articles 107 and 108. A manufacturing authorisation shall also not be required for preparation, filling or changes in packaging or presentation where these processes are carried out solely for dispensing by pharmacists in a pharmacy or by veterinarians in a veterinary practice;
Amendment 678 #
Proposal for a regulation Article 92 – paragraph 2 – point c (c) details about the manufacturing site where the veterinary medicinal products are to be manufactured or tested, including data about emissions, discharges and losses of the active substance and its precursors to the environment;
Amendment 679 #
Proposal for a regulation Article 92 – paragraph 2 – point c (c) details about the manufacturing site where the veterinary medicinal products are to be manufactured or tested
Amendment 680 #
Proposal for a regulation Article 93 – paragraph 5 5. A manufacturing authorisation may be granted conditionally where minor shortcomings are identified, subject to a requirement for the applicant to
Amendment 681 #
Proposal for a regulation Article 93 – paragraph 5 5. A manufacturing authorisation may be granted conditionally, subject to a requirement for the applicant to undertake actions or introduce specific procedures within a given time period. The manufacturing authorisation may be suspended if these requirements are not complied with. The manufacturing authorisation shall be refused if manufacturing causes unacceptable risks to the environment.
Amendment 682 #
Proposal for a regulation Article 98 – paragraph 1 – point a (a) have at his disposal suitable and sufficient premises, technical equipment and testing facilities, including equipment for elimination of discharges and emissions of active pharmaceutical ingredients into the environment, for the manufacture, export or import of the veterinary medicinal products stated in the manufacturing authorisation;
Amendment 683 #
Proposal for a regulation Article 98 – paragraph 1 – point c a (new) (ca) comply with the rules 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 684 #
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 685 #
Proposal for a regulation Article 98 – paragraph 1 a (new) Amendment 686 #
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 conditions for qualified persons provided for by this Regulation.
Amendment 687 #
Proposal for a regulation Article 100 – paragraph 2 2. The qualified person shall be in possession of a diploma, certificate or other evidence of
Amendment 688 #
Proposal for a regulation Article 100 – paragraph 2 a (new) 2a. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized manufacturers, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of veterinary medicinal products. The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.
Amendment 689 #
Proposal for a regulation Article 103 a (new) Article 103a Emission limits of active pharmaceutical ingredients The commission will no later than 2017 present a legislative proposal on the emission limits of active pharmaceutical ingredients for the implementation of article 98.
Amendment 690 #
Proposal for a regulation Article 104 – paragraph 3 3. Supplies of small quantities of veterinary medicinal products from one retailer to another shall not be regarded as wholesale distribution. The Commission shall define the maximum scope of "small quantities" of veterinary medicinal products in retail through delegated acts.
Amendment 691 #
Proposal for a regulation Article 104 – paragraph 3 3. Supplies of small quantities of veterinary medicinal products required for courses of treatment lasting a week or longer, if the characteristics of the medicinal product thus dictate, from one retailer to another shall not be regarded as wholesale distribution.
Amendment 692 #
Proposal for a regulation Article 104 – paragraph 4 a (new) 4a. On the basis of the best practices model that already exists for medicinal products for human use, the Commission is urged to adopt – within 24 months of the entry into force of this regulation – principles and guidelines, to which wholesalers shall be obliged to adhere, for best practices in the wholesale distribution of veterinary medicinal products.
Amendment 693 #
Proposal for a regulation Article 104 – paragraph 5 5. A wholesale distributor shall supply veterinary medicinal products
Amendment 694 #
Proposal for a regulation Article 105 – paragraph 3 – point a (a) has at his disposal technically competent staff, including at least one veterinarian or person authorised to issue prescriptions in line with national rules, and suitable and sufficient premises complying with the requirements laid down by the Member State concerned as regards the storage and handling of veterinary medicinal products;
Amendment 695 #
Proposal for a regulation Article 107 – paragraph 2 2.
Amendment 696 #
Proposal for a regulation Article 107 – paragraph 2 2.
Amendment 697 #
Proposal for a regulation Article 107 – paragraph 2 2.
Amendment 698 #
Proposal for a regulation Article 107 – paragraph 2 2.
Amendment 699 #
Proposal for a regulation Article 107 – paragraph 2 2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall not retail antimicrobial products
Amendment 700 #
Proposal for a regulation Article 107 – paragraph 2 2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall
Amendment 701 #
Proposal for a regulation Article 107 – paragraph 2 2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail
Amendment 702 #
Proposal for a regulation Article 107 – paragraph 2 2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall
Amendment 703 #
Proposal for a regulation Article 107 – paragraph 2 2.
Amendment 704 #
Proposal for a regulation Article 107 – paragraph 2 2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care,
Amendment 705 #
Proposal for a regulation Article 107 – paragraph 2 2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals
Amendment 706 #
Proposal for a regulation Article 107 – paragraph 2 2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care, subject to a veterinary diagnosis based on clinical examination of the animal concerned, and only in the amount required for the treatment concerned.
Amendment 707 #
Proposal for a regulation Article 107 – paragraph 2 2. Persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail with no economic benefit antimicrobial products only for animals which are under their care, and only in the amount required for the treatment concerned.
Amendment 708 #
Proposal for a regulation Article 107 – paragraph 2 a (new) 2a. Members States may impose stricter conditions, justified on grounds of public health, animal health and environment protection, for the retail of veterinary medicinal products on their territory.
Amendment 709 #
Proposal for a regulation Article 107 – paragraph 2 a (new) 2a. Given the risks associated with antimicrobial resistance, no economic incentives may be provided in any form, directly or indirectly, by pharmaceutical companies to persons who prescribe veterinary medicinal products.
Amendment 710 #
Proposal for a regulation Article 108 – title Retail of veterinary medicinal products at a distance shall be prohibited.
Amendment 711 #
Proposal for a regulation Article 108 – paragraph 1 1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products not subject to veterinary prescription as referred to in Article 29, in particular no antimicrobials, by means of information society services within the meaning of Directive 98/34/EC of the European Parliament and of the Council28 to natural or legal persons established in the Union under the condition that those medicinal products comply with the legislation of the destination Member State. __________________ 28 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).
Amendment 712 #
Proposal for a regulation Article 108 – paragraph 1 1. Persons permitted to supply veterinary
Amendment 713 #
Proposal for a regulation Article 108 – paragraph 1 1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products by means of information society services in the meaning of Directive 98/34/EC of the European Parliament and of the Council28 to natural or legal persons established in the Union under the condition that those medicinal products comply with the legislation of the destination Member State.
Amendment 714 #
Proposal for a regulation Article 108 – paragraph 1 1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer
Amendment 715 #
Proposal for a regulation Article 108 – paragraph 1 1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products other than products containing antimicrobials by means of information society services within the meaning of Directive 98/34/EC of the European Parliament and of the Council
Amendment 716 #
Proposal for a regulation Article 108 – paragraph 1 1. Persons permitted to supply veterinary medicinal products in accordance with
Amendment 717 #
Proposal for a regulation Article 108 – paragraph 1 1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer
Amendment 718 #
Proposal for a regulation Article 108 – paragraph 1 1.
Amendment 719 #
Proposal for a regulation Article 108 – paragraph 1 1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products without a prescription, exclusively for animals kept as pets, by means of information society services in the meaning of Directive 98/34/EC of the European Parliament and of the Council28 to natural or legal persons established in the Union under the condition that those medicinal products comply with the legislation of the destination Member State. __________________ 28 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of
Amendment 720 #
Proposal for a regulation Article 108 – paragraph 2 – point b (b) a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5; in all EU languages
Amendment 721 #
Proposal for a regulation Article 108 – paragraph 5 – subparagraph 1 – introductory part Each Member State shall set up a website regarding sale of veterinary medicinal products at a distance, providing at least the following information, in all EU languages:
Amendment 722 #
Proposal for a regulation Article 108 – paragraph 5 – subparagraph 1 – point c a (new) (ca) information on procedures for the safe disposal of medicinal products, specifying the public or private body responsible at national or local level for the disposal of veterinary medicine residues and the collection points for disposal free of charge.
Amendment 723 #
Proposal for a regulation Article 108 – paragraph 5 – subparagraph 1 – point c b (new) (cb) Member States’ websites shall also contain hyperlinks to the web pages of the bodies responsible in Member States for listing authorised national retailers.
Amendment 724 #
Proposal for a regulation Article 108 – paragraph 6 6. The Agency shall set up a website providing information on the common logo. The Agency’s website shall explicitly mention that the websites of Member
Amendment 725 #
Proposal for a regulation Article 108 – paragraph 6 6. The Agency shall set up a website providing information on the common logo. The Agency's website shall explicitly mention that the websites of Member States contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in the Member State concerned. The Agency's website shall also link to the page on the website of the responsible body in each Member State which lists that Member State's authorised retailers.
Amendment 726 #
Proposal for a regulation Article 108 – paragraph 7 7. Member
Amendment 727 #
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 (shop and internet ones), national competent authorities and veterinarians shall be put in place as on-lime cross checking by the pharmacy and the prescriber will prevent from frauds and abuse.
Amendment 728 #
Proposal for a regulation Article 108 – paragraph 7 a (new) 7a. Retail of biological/immunological veterinary medicinal products at a distance shall be prohibited.
Amendment 729 #
Proposal for a regulation Article 108 – paragraph 7 a (new) 7a. Each Member State shall authorise national online retailers and carry out appropriate checks to ensure that their operations are valid. Member States shall respond without delay to concerns raised by other Member States regarding online retailers authorised on their national territory.
Amendment 730 #
Proposal for a regulation Article 109 – title Retail of prescription only veterinary medicinal products or active substances, with anabolic, anti-infectious, anti- parasitic, anti-inflammatory, hormonal or psychotropic
Amendment 731 #
Proposal for a regulation Article 109 – title Retail of prescription only veterinary medicinal products or active substances, with anabolic, anti-infectious, anti- parasitic, anti-inflammatory, hormonal or psychotropic
Amendment 732 #
Proposal for a regulation Article 109 – title Retail o
Amendment 733 #
Proposal for a regulation Article 109 – title Retail of anabolic, anti-infectious, anti- parasitic, anti-inflammatory, hormonal, immunological or psychotropic veterinary medicinal products
Amendment 734 #
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 prescription only veterinary medicinal products which have anabolic, anti-
Amendment 735 #
Proposal for a regulation Article 109 – paragraph 1 1. Only manufacturers, wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic, anti- infectious, anti-parasitic, anti- inflammatory, hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties.
Amendment 736 #
Proposal for a regulation Article 109 – paragraph 1 1. Only manufacturers, wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic, anti- infectious, anti-parasitic, anti- inflammatory, hormonal, immunological or psychotropic properties or substances which may be used as veterinary medicinal products having those properties.
Amendment 737 #
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
Amendment 738 #
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 prescription veterinary medicinal products which have anabolic, anti-
Amendment 739 #
Proposal for a regulation Article 109 – paragraph 1 – subparagraph 1 (new) Member States may decide, in addition, to authorise the sale of anti-parasitic and anti-inflammatory medicinal products for pets through ordinary distribution channels.
Amendment 740 #
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 and sale transaction of prescription only veterinary medicinal products:
Amendment 741 #
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 742 #
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 and sale transaction of prescription only veterinary medicinal products:
Amendment 743 #
Proposal for a regulation Article 109 – paragraph 3 – subparagraph 1 – introductory part Those manufacturers and suppliers shall keep detailed records of the following
Amendment 744 #
Proposal for a regulation Article 109 – paragraph 3 – subparagraph 1 – point c (c) quantity received
Amendment 745 #
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 746 #
Proposal for a regulation Article 110 – paragraph 1 – point a (a) identification of the animal or class of animal under treatment;
Amendment 747 #
Proposal for a regulation Article 110 – paragraph 1 – point a a (new) (aa) the disease to be treated
Amendment 748 #
Proposal for a regulation Article 110 – paragraph 1 – point e (e) signature or an equivalent electronic form of identification of the person
Amendment 749 #
Proposal for a regulation Article 110 – paragraph 1 – point e (e) signature or an equivalent electronic form of identification of the person
Amendment 750 #
Proposal for a regulation Article 110 – paragraph 1 – point f (f) name of the prescribed product and the active substance(s);
Amendment 751 #
Proposal for a regulation Article 110 – paragraph 1 – point f (f) active substance or name of the prescribed product;
Amendment 752 #
Proposal for a regulation Article 110 – paragraph 1 – point f a (new) (fa) the condition which is being treated,
Amendment 753 #
Proposal for a regulation Article 110 – paragraph 1 – point h (h) quantity; in cases where the treatment has to be repeated, it should also contain the number of times it can be repeated;
Amendment 754 #
Proposal for a regulation Article 110 – paragraph 1 – point l a (new) (la) the condition to be treated;
Amendment 755 #
Proposal for a regulation Article 110 – paragraph 2 2. A veterinary prescription shall only be issued by a
Amendment 756 #
Proposal for a regulation Article 110 – paragraph 2 2. A veterinary prescription shall only be issued by a
Amendment 757 #
Proposal for a regulation Article 110 – paragraph 2 2. A veterinary prescription shall only be issued by a
Amendment 758 #
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; only a veterinarian shall be authorised to issue prescriptions for antimicrobials; In duly exceptional cases this right could be granted to a qualified person.
Amendment 759 #
Proposal for a regulation Article 110 – paragraph 2 2. A veterinary prescription shall only be issued by a veterinarian or other person qualified to do so in accordance with applicable national law.
Amendment 760 #
Proposal for a regulation Article 110 – paragraph 2 2. A veterinary prescription shall only be issued by a
Amendment 761 #
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 and after a clinical diagnosis.
Amendment 762 #
Proposal for a regulation Article 110 – paragraph 2 a (new) Amendment 763 #
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 764 #
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 maximum quantity of veterinary antimicrobials authorized on one prescription may not, however, exceed six month's treatment for companion animals, and one month's treatment for food producing animals.
Amendment 765 #
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 maximum quantity of veterinary medicinal products supplied at one time may not, however, exceed one month's treatment. For chronic diseases and for periodic treatments the maximum quantity should not exceed three month's treatment.
Amendment 766 #
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. This quantity shall in particular take account of the strictly necessary duration of treatment.
Amendment 767 #
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. Prophylactic use of antibiotics shall not be allowed.
Amendment 768 #
Proposal for a regulation Article 110 – paragraph 3 a (new) 3a. A veterinary medicinal product supplied on prescription shall be exclusively administered to the animals examined and diagnosed with a disease by the prescription issuer.
Amendment 769 #
Proposal for a regulation Article 110 – paragraph 3 a (new) 3a. Methaphylactic use of antibiotics may be allowed in cases where the diagnosis of clinical disease has been established or the agent responsible for subclinical disease has been identified by appropriate testing.
Amendment 770 #
Proposal for a regulation Article 110 – paragraph 3 a (new) 3a. Metaphylactic use of antibiotics shall only be allowed, after a proper diagnosis, on animals which are in contact with animals with clinical signs of an infectious disease, to prevent the further spread of the disease. The administration must be accompanied by a health plan specifying measures to take to reduce the need to resort to such use in the future.
Amendment 771 #
Proposal for a regulation Article 110 – paragraph 4 4. Veterinary prescriptions, including in electronical format, shall be recognised throughout the Union. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.
Amendment 772 #
Proposal for a regulation Article 110 – paragraph 4 4. Veterinary prescriptions shall be recognised throughout the Union. The removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.
Amendment 773 #
Proposal for a regulation Article 110 – paragraph 4 4. Veterinary prescriptions issued by a veterinarian shall be recognised throughout the Union. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.
Amendment 774 #
Proposal for a regulation Article 110 – paragraph 4 a (new) 4a. The provisions of paragraph 4 shall not apply to prescriptions issued by anyone other than a veterinarian. In cases where someone other than a veterinarian has issued a prescription, Member States may refuse to recognise it if their national systems do not allow for the possibility of prescriptions being issued by anyone other than a veterinarian. If the Member States take steps in accordance with this paragraph, they shall immediately notify the Commission, which shall forward this information to all of the Member States.
Amendment 775 #
Proposal for a regulation Article 110 – paragraph 4 a (new) 4a. The Commission shall carry out a study on the introduction of two groups of veterinary medicinal products, based on prescription-only and non-prescription veterinary medicinal products.
Amendment 776 #
Proposal for a regulation Article 111 – paragraph 1 1. Veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation or registration.
Amendment 777 #
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 778 #
Proposal for a regulation Article 111 – paragraph 1 1. Veterinary medicinal products shall be used in accordance with the terms of
Amendment 779 #
Proposal for a regulation Article 111 – paragraph 1 1.
Amendment 780 #
Proposal for a regulation Article 111 – paragraph 1 1. Veterinary medicinal products shall be used responsibly in accordance with the principle of good animal husbandry and with the terms of the marketing authorisation.
Amendment 781 #
Proposal for a regulation Article 111 – paragraph 1 – point 1 (new) Amendment 782 #
Proposal for a regulation Article 111 – paragraph 1 – point 2 (new) (2) The metaphylactic use of antimicrobial veterinary medicines should be restricted to use in clinically ill animals and to those healthy animals that are identified as being at a high risk of contamination.
Amendment 783 #
Proposal for a regulation Article 111 – paragraph 1 a (new) 1a. Antibiotics may be supplied to food producing animals only on a veterinarian’s prescription and only where all possible preventive measures have been taken. Preventative or prophylactic medication via drink or water when no disease has been diagnosed shall be prohibited.
Amendment 784 #
Proposal for a regulation Article 111 – paragraph 1 a (new) 1a. Medicinal products cannot be used in any mean that could harm the environment. Especially spraying in open air or dissolution in open waters is not allowed.
Amendment 785 #
Proposal for a regulation Article 111 – paragraph 1 a (new) 1a. Antimicrobials may only be administered under prescription by a veterinary doctor or a suitably qualified animal health professional for group treatment of food producing animals after all the preventive measures listed under Annex IIIa have been taken.
Amendment 786 #
Proposal for a regulation Article 111 – paragraph 1 a (new) 1a. Antimicrobial veterinary medicinal products shall not be used routinely for prophylaxis or metaphylaxis in groups of food-producing animals.
Amendment 787 #
Proposal for a regulation Article 111 – paragraph 1 b (new) 1b. If a medicinal product cannot be given to animals individually and has to be put in their environment, this environment must be closed and cleaned after treatment.
Amendment 788 #
Proposal for a regulation Article 111 – paragraph 1 c (new) 1c. The amount of medicinal products that one can spray or dissolve is limited to the product of the quantity necessary to treat a single animal in confined environment times the number of animals to treat.
Amendment 789 #
Proposal for a regulation Article 111 – paragraph 2 a (new) 2a. Antibiotic veterinary medicinal products shall not be used for preventive treatment (prophylaxis), unless the risk for infection is very high and the consequences are severe. Prophylactic use has to be applied for individual treatment and has to be carefully scrutinized to ensure that the intended use complies with prudent use principles. Prophylaxis with antimicrobials shall never be applied routinely nor to compensate for poor hygiene or for inadequate husbandry conditions.
Amendment 790 #
Proposal for a regulation Article 111 – paragraph 2 a (new) 2a. Antimicrobial veterinary medicinal products shall not be used routinely for prophylaxis or metaphylaxis in groups of food-producing animals. This provision shall not prevent non-routine prophylactic or metaphylactic use of such products in an individual animal or a group of animals.
Amendment 791 #
Proposal for a regulation Article 111 – paragraph 2 a (new) 2a. Antibiotic veterinary medicinal products must not be used on animals to prevent disease except under extraordinary circumstances and during a short period of time subject to a veterinary diagnosis based on clinical examination.
Amendment 792 #
Proposal for a regulation Article 111 – paragraph 2 a (new) 2a. Antimicrobial veterinary medicinal products must not be used on food- producing animals for prophylactic purposes, unless there is a high risk of infection. They must not under any circumstances be used to improve performance or compensate for poor animal husbandry.
Amendment 793 #
Proposal for a regulation Article 111 – paragraph 2 a (new) 2a. Antimicrobial veterinary medicinal products must not be used to prevent disease except for a short period of time. They must not under any circumstances be used to compensate for poor animal husbandry or to improve performance.
Amendment 794 #
Proposal for a regulation Article 111 – paragraph 2 a (new) 2a. Antibiotic veterinary medicinal products must not be used for prophylactic purposes, unless there is a high risk of infection for the individual animal concerned due to trauma, surgery or similar incidents. They must not under any circumstances be used to improve performance or compensate for poor animal husbandry.
Amendment 795 #
Proposal for a regulation Article 111 – paragraph 2 a (new) 2a. Antibacterial veterinary medicinal products must not be used on food- producing animals for prophylactic purposes except for preoperative or perioperative purposes or in drying-off therapy. They must not under any circumstances be used to improve breeding performance or compensate for poor animal husbandry.
Amendment 796 #
Proposal for a regulation Article 111 – paragraph 2 a (new) 2a. The use of antibiotics to prevent infections, the spread of disease within a herd when infection occurs, and as a growth stimulant must be prohibited. Sustainable husbandry practices should prevail. This includes encouraging immunization in order to prevent antimicrobial resistance. Vaccination can also reduce infection rates, dependence on antibiotics as well as the risk that antibiotic-resistant organisms develop and spread through the food chain.
Amendment 797 #
Proposal for a regulation Article 111 a (new) Article 111 a Supply and use of antimicrobials 1. Member State may restrict or prohibit the supply and/or use of certain antimicrobials in animals on their territory if either of the following conditions is fulfilled: (a) the antimicrobials are critically important for use in humans; or (b) the administration of antimicrobials to animals is contradictory to the implementation of a national policy on prudent use of antimicrobials and that the policy is in line with the precautionary principle. 2. Before adopting measures referred to in paragraph 1, Member State shall ensure that relevant stakeholders have been consulted. 3. Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of protection of animal and public health. 4. The Members State shall inform the Commission of all the measures adopted on the basis of paragraph 1.
Amendment 798 #
Proposal for a regulation Article 111 a (new) Amendment 799 #
Proposal for a regulation Article 112 – paragraph 1 1. Owners or, where the animals are not kept by the owners, keepers of food-
Amendment 800 #
Proposal for a regulation Article 112 – paragraph 2 – point a (a) date of administering the veterinary medicinal product to the animal and the disease treated;
Amendment 801 #
Proposal for a regulation Article 112 – paragraph 2 – point d (d) name and address of the supplier and, if applicable, a copy of the delivery note;
Amendment 802 #
Proposal for a regulation Article 112 – paragraph 2 a (new) 2a. Particulars already contained in the prescription or in a delivery note need not be recorded again if a clear reference can be made to the corresponding prescription and delivery note.
Amendment 803 #
Proposal for a regulation Article 112 a (new) Amendment 804 #
Proposal for a regulation Article 112 b (new) Article 112 b Reduction of therapy approaches based on antibacterial substances (1) In order to facilitate the effective reduction regarding the use of pharmaceuticals which contain antibacterial substances, anyone who engages in animal husbandry has to: 1. determine, respectively, two months after the disclosure of the key figures of the in accordance with paragraph 112b established therapy prevalence, if the biannual therapy prevalence concerning his reared animal species, and considering the type-of-use during the elapsed time frame, lies above the average therapy prevalence. 2. take immediate record of the results of the assessment under #1 (2) In a case where the operational, biannual therapy prevalence of the animal husbandman with respect to his business lies above the biannual average, the animal husbandman under consultation of a veterinarian has to assess the reasons that may have led to exceeding the average, and how the treatment of his cattle with pharmaceuticals containing antibacterial substances may be decreased. If the assessment of the animal husbandman comes to the result that a therapy by means of the concerned pharmaceuticals may be reduced, the husbandman has to take all necessary steps in order to accomplish the reduction. The husbandman has to consider the wellbeing of his cattle and guarantee the required medical care. (3) Member States may determine measures extending beyond the above mentioned requirements
Amendment 805 #
Proposal for a regulation Article 115 – paragraph 1 – introductory part 1.
Amendment 806 #
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 the life expectancy of a non-food producing animal, the veterinarian responsible may,
Amendment 807 #
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 808 #
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 (in descending order of preference):
Amendment 809 #
Proposal for a regulation Article 115 – paragraph 1 – point a Amendment 810 #
Proposal for a regulation Article 115 – paragraph 1 – point a – introductory part (a) a veterinary medicinal product
Amendment 811 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point i Amendment 812 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point i Amendment 813 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point ii Amendment 814 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point ii Amendment 815 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point ii (ii) in the absence thereof, a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species for another condition or, non-cumulatively, in another species, for the same condition
Amendment 816 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point iii Amendment 817 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point iii Amendment 818 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point iii (iii) a medicinal product for human use (with the exception of medicinal products as referred to in Article 32(4)) 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 819 #
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 or another Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council30 or Regulation (EC) No 726/2004. Antimicrobial medicinal products for human use may only be employed, subject to the issuing of a prescription by a veterinarian and 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 point (a)(i) or (ii) is not possible; __________________ 30 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Amendment 820 #
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, with the exception of antimicrobials; __________________ 30 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Amendment 821 #
Proposal for a regulation Article 115 – paragraph 1 – point a – point iii a (new) Amendment 822 #
Proposal for a regulation Article 115 – paragraph 1 – point a a (new) (aa) (a) a veterinary medicinal product authorised under this Regulation in the Member State concerned for use with another animal species, or for another condition in the same species; (b) a veterinary medicinal product authorised under this regulation in the Member State concerned for the same or another condition in a different species; (c) a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species or in another species, for the same condition or for another condition; (d) 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 Council or Regulation (EC) No 726/2004; (e) only if there is no products as referred to in points (a) -(d), 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 823 #
Proposal for a regulation Article 115 – paragraph 1 – point b Amendment 824 #
Proposal for a regulation Article 115 – paragraph 1 – point b (b) if there is no product as referred to in point (a),
Amendment 825 #
Proposal for a regulation Article 115 – paragraph 1 – point b (b) if there is no product as referred to in point (a), a veterinary medicinal product prepared extemporaneously in accordance with the terms of a
Amendment 826 #
Proposal for a regulation Article 115 – paragraph 1 – point b – point i (new) (i) a medicinal product authorised for human use in the Member State concerned in accordance with Directive 2001/83/EC of the European Parliament and of the Council or under Regulation (EC) No 726/2004, or
Amendment 827 #
Proposal for a regulation Article 115 – paragraph 1 – point b – point ii (new) (ii) in accordance with specific national measures, a veterinary medicinal product authorised in another Member State in accordance with this Regulation for use in the same species or in another species for the condition in question or for another condition; or
Amendment 828 #
Proposal for a regulation Article 115 – paragraph 1 – point b a (new) (c) if there is no product as referred to in subparagraph (b), and within the limits of the law of the Member State concerned, a veterinary medicinal product prepared extemporaneously by a person authorised to do so under national legislation in accordance with the terms of a veterinary prescription. The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian's responsibility.
Amendment 829 #
Proposal for a regulation Article 115 – paragraph 1 a (new) 1a. Homoeopathic veterinary medicinal products may be given to non-food producing animals by way of derogation from paragraph 1.
Amendment 830 #
Proposal for a regulation Article 115 – paragraph 2 2. The veterinarian may administer the medicinal product personally or allow another person to do so under
Amendment 831 #
Proposal for a regulation Article 116 – paragraph 1 – introductory part 1.
Amendment 832 #
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,
Amendment 833 #
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 834 #
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, or where a veterinary medicinal product is not available on the market for logistical reasons, for example, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal
Amendment 835 #
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
Amendment 836 #
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
Amendment 837 #
Proposal for a regulation Article 116 – paragraph 1 – point a (a) a veterinary medicinal product authorised
Amendment 838 #
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 839 #
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 use
Amendment 840 #
Proposal for a regulation Article 116 – paragraph 1 – point b (b)
Amendment 841 #
Proposal for a regulation Article 116 – paragraph 1 – point b (b) a veterinary medicinal product authorised under this Regulation in
Amendment 842 #
Proposal for a regulation Article 116 – paragraph 1 – point b (b) a veterinary medicinal product authorised under this Regulation in another Member State for use in the same species
Amendment 843 #
Proposal for a regulation Article 116 – paragraph 1 – point b a (new) (ba) if there is no product as referred to in point (a), a veterinary medicinal product which does not contain antimicrobial agents, prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation;
Amendment 844 #
Proposal for a regulation Article 116 – paragraph 1 – point c Amendment 845 #
Proposal for a regulation Article 116 – paragraph 1 – point c (c) a veterinary medicinal product
Amendment 846 #
Proposal for a regulation Article 116 – paragraph 1 – point c (c)
Amendment 847 #
Proposal for a regulation Article 116 – paragraph 1 – point c (c) a medicinal product for human use (with the exception of medicinal products referred to in Article 32(4)) authorised in the Member State concerned in accordance with Directive 2001/83/EC or
Amendment 848 #
Proposal for a regulation Article 116 – paragraph 1 – point c (c) a medicinal product
Amendment 849 #
Proposal for a regulation Article 116 – paragraph 1 – point c (c) a medicinal product for human use
Amendment 850 #
Proposal for a regulation Article 116 – paragraph 1 – point c (c) if there is no product as referred to in points (a) and (b), a medicinal product for human use authorised in the Member State concerned in accordance with Directive 2001/83/EC or under Regulation (EC) No 726/2004, or
Amendment 851 #
Proposal for a regulation Article 116 – paragraph 1 – point d Amendment 852 #
Proposal for a regulation Article 116 – paragraph 1 – point d (d)
Amendment 853 #
Proposal for a regulation Article 116 – paragraph 1 – point d d)
Amendment 854 #
Proposal for a regulation Article 116 – paragraph 1 – point d a (new) (da) (e) 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 855 #
Proposal for a regulation Article 116 – paragraph 1 – point d a (new) (da) in the case of milk-producing animals, the medicinal product referred to in paragraphs (a) to (d) must without fail be authorised for another milk-producing species;
Amendment 856 #
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 or any other treatment 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:
Amendment 857 #
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 858 #
Proposal for a regulation Article 116 – paragraph 2 – point b (b) veterinary medicinal products authorised under this Regulation in
Amendment 859 #
Proposal for a regulation Article 116 – paragraph 2 – point b a (new) (ba) (c) 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 860 #
Proposal for a regulation Article 116 – paragraph 3 – introductory part Amendment 861 #
Proposal for a regulation Article 116 – paragraph 3 – point a Amendment 862 #
Proposal for a regulation Article 116 – paragraph 3 – point b Amendment 863 #
Proposal for a regulation Article 116 – paragraph 3 – point b – point 1 (new) (1) By way of a derogation from paragraphs 1 to 3, homeopathic veterinary medicinal products may be administered to food-producing species under the responsibility of a veterinarian the active constituents of which appear in Tab. 1 of the Regulation (EU) No. 37/2010 with the classification "No maximum residue level (MRL) required"
Amendment 864 #
Proposal for a regulation Article 116 – paragraph 3 a (new) 3a. By way of derogation from paragraphs 1 to 3, homoeopathic veterinary medicinal products may be administered to treat food-producing animals under the responsibility of the veterinarian provided that they exclusively contain active ingredients listed in Table 1 of Regulation (EU) No 37/2010 as substances for which no maximum limit needs to be set.
Amendment 865 #
Proposal for a regulation Article 116 – paragraph 3 a (new) 3a. By way of derogation from paragraphs 1 to 3, homoeopathic veterinary medicinal products may be administered to treat food-producing animals provided that they exclusively contain active ingredients listed in Table 1 of Regulation (EU) No 37/2010 as substances for which no maximum limit needs to be set.
Amendment 866 #
Proposal for a regulation Article 116 – paragraph 3 a (new) 3a. By way of derogation from paragraphs 1 to 3, homeopathic veterinary medicinal products may be administered to food- producing species under the responsibility of a veterinarian the active constituents of which appear in Table 1 of the Regulation (EU) No. 37/2010 with the classification "No maximum residue level (MRL) required".
Amendment 867 #
Proposal for a regulation Article 116 – paragraph 4 Amendment 868 #
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 869 #
Proposal for a regulation Article 116 – paragraph 4 – subparagraph 2 – point c (c) impact on the competitiveness of
Amendment 870 #
Proposal for a regulation Article 116 – paragraph 5 5. For the purpose of treatment in accordance with paragraph
Amendment 871 #
Proposal for a regulation Article 117 – paragraph 1 – point b – point i (i) the longest withdrawal period provided in the summary of the product characteristics for
Amendment 872 #
Proposal for a regulation Article 117 – paragraph 1 – point b – point ii (ii) if the product is not authorised for any milk producing species,
Amendment 873 #
Proposal for a regulation Article 117 – paragraph 2 2. The Commission shall
Amendment 874 #
Proposal for a regulation Article 117 – paragraph 3 3. For bees, the
Amendment 875 #
Proposal for a regulation Article 117 – paragraph 4 4.
Amendment 876 #
Proposal for a regulation Article 117 – paragraph 5 – subparagraph 2 a (new) Data on the use of antibiotics outside the terms of authorisation should be collected and mandatorily reported to national authorities in accordance with article 54 of this Regulation.
Amendment 877 #
Proposal for a regulation Article 118 – title Use of antimicrobial
Amendment 878 #
Proposal for a regulation Article 118 – title Use of antimicrobial
Amendment 879 #
Proposal for a regulation Article 118 – title Use of anti
Amendment 880 #
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,
Amendment 881 #
Proposal for a regulation Article 118 – paragraph 1 1. Antimicrobial medicinal products shall only be used in accordance with Articles 115 and 116 to treat conditions for which there is no other treatment available, and the use of which would not present a risk to public or animal health. Antimicrobial products shall not be used as a routine preventive measure.
Amendment 882 #
Proposal for a regulation Article 118 – paragraph 1 1. Anti
Amendment 883 #
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,
Amendment 884 #
Proposal for a regulation Article 118 – paragraph 1 1. Antimicrobial medicinal products shall only be used in accordance with Articles
Amendment 885 #
Proposal for a regulation Article 118 – paragraph 1 a (new) 1a. Articles 115 and 116 do not apply to critically important antimicrobials as referred to in Article 32(2).
Amendment 886 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 1 The Commission
Amendment 887 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 1 The Commission may, by means of implementing acts in accordance with the examination procedure referred to in Article 145(2), and taking into consideration scientific advice of the Agency, establish a list of anti
Amendment 888 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 1 a (new) Member States may, in accordance with their national legislation, prohibit or restrict the supply and use of antimicrobial medicines in animals on their territory, if justified by national policies against antimicrobial resistance.
Amendment 889 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 2 – point a (a) risks to public health if the anti
Amendment 890 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 2 – point c a (new) (ca) availability of other farming methods that could prevent the outbreak of the disease
Amendment 891 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 2 – point e Amendment 892 #
Proposal for a regulation Article 118 – paragraph 2 – subparagraph 2 – point e a (new) (ea) The Commission should prioritize the evaluation of certain antibiotics such as modern cephalosporins and fluoroquinolones.
Amendment 893 #
Proposal for a regulation Article 118 – paragraph 2 a (new) 2a. Member States may, in accordance with national legislation, restrict or prohibit the supply and/or use of antimicrobial substances in animals on their territory, if justified by national policies against antimicrobial resistance.
Amendment 894 #
Proposal for a regulation Article 119 – paragraph 2 2. By way of derogation from Article 111, in the event of an outbreak of a listed disease as referred to in Article 5 of Regulation (EC) No…/…. of the European Parliament and the Council31 [Office of Publications, please insert number and, in a footnote, date, title and the OJ reference for the Regulation on animal health] or any critical health situation acknowledged by the Chief Veterinary Officer of the Member State a competent authority may allow, for a limited period of time and under specific restrictions, the use of an immunological veterinary medicinal product without a marketing authorization in the Member State in question but which is authorised either in another Member State or under the legislation of a the third country, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use. __________________ 31 Regulation of the European Parliament and the Council of….. on animal health (OJ L……).
Amendment 895 #
Proposal for a regulation Article 123 – paragraph 1 a (new) 1a. Member States may provide for additional conditions in terms of advertising of veterinary medicinal products to protect public and animal health, animal welfare and the environment including conditions in terms of comparative and misleading advertising or unfair commercial practices.
Amendment 896 #
Proposal for a regulation Article 124 – paragraph 2 2. The prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products if such supply is performed under the authority of a veterinarian.
Amendment 897 #
Proposal for a regulation Article 124 – paragraph 2 2. The prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to prescribe
Amendment 898 #
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 as well as animals and foodstuff regularly, on a risk-
Amendment 899 #
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 900 #
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, in order to combat fraud.
Amendment 901 #
Proposal for a regulation Article 125 – paragraph 4 – subparagraph 2 Amendment 902 #
Proposal for a regulation Article 125 – paragraph 4 a (new) 4a. Inspections may also be carried out on the premises of manufacturers of active substances used as starting materials for veterinary medicinal products where there are grounds for suspecting non- compliance with GMP.
Amendment 903 #
Proposal for a regulation Article 125 – paragraph 6 6.
Amendment 904 #
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. A summary of the inspection results shall be made publicly available.
Amendment 905 #
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 906 #
Proposal for a regulation Article 129 – paragraph 4 Amendment 907 #
Proposal for a regulation Article 129 – paragraph 5 – subparagraph 1 Amendment 908 #
Proposal for a regulation Article 129 – paragraph 5 – subparagraph 2 Amendment 909 #
Proposal for a regulation Article 129 – paragraph 6 Amendment 910 #
Proposal for a regulation Article 129 – paragraph 7 Amendment 911 #
Proposal for a regulation Article 129 – paragraph 7 – subparagraph 1 Amendment 912 #
Proposal for a regulation Article 129 – paragraph 7 – subparagraph 2 Amendment 913 #
Proposal for a regulation Article 129 – paragraph 8 Amendment 914 #
Proposal for a regulation Article 129 – paragraph 9 Amendment 915 #
Proposal for a regulation Article 129 – paragraph 10 Amendment 916 #
Proposal for a regulation Article 129 – paragraph 11 Amendment 917 #
Proposal for a regulation Article 133 a (new) Article 133a Prohibiting supply of antimicrobials reserved for humans 1. Veterinary medicinal products containing antimicrobial agents that are classified as reserved for the treatment of certain infections of humans by the Commission are prohibited. 2. Veterinary medicinal products referred to in paragraph 1 that are approved for use at the time of entry into force of this Regulation shall be withdrawn from the market by the respective authorisation holders.
Amendment 918 #
Proposal for a regulation Article 135 – paragraph 4 a (new) 4a. Antimicrobials reserved for humans 1. Veterinary medicinal products containing antimicrobial active substances classed by the Commission, a Member State or the World Health Organisation as reserved for treating specific infections in humans shall be prohibited. 2. Veterinary medicinal products as referred to in paragraph 1 which were authorised when this Regulation enters into force must be taken off the market by the authorisation holders.
Amendment 919 #
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, inter alia, be responsible for providing the scientific expertise for assessment of all applications under this Regulation.
Amendment 920 #
Proposal for a regulation Article 136 – paragraph 1 a (new) 1a. The management of funds intended for activities connected with requirements provided under this Regulation, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities in order to guarantee the independence of these authorities.
Amendment 921 #
Proposal for a regulation Article 136 – paragraph 2 2. The competent authorities shall cooperate with each other and other concerned authorities in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States necessary and useful support to this end. Competent authorities shall communicate the appropriate information to each other, particularly regarding compliance with the requirements for the manufacturing and
Amendment 922 #
Proposal for a regulation Article 140 – paragraph 1 1. Each Member State shall
Amendment 923 #
Proposal for a regulation Article 140 – paragraph 1 a (new) Amendment 924 #
Proposal for a regulation Article 140 – paragraph 2 2. Members and alternate
Amendment 925 #
Proposal for a regulation Article 140 – paragraph 3 Amendment 926 #
Proposal for a regulation Article 140 – paragraph 4 Amendment 927 #
Proposal for a regulation Article 140 – paragraph 5 Amendment 928 #
Proposal for a regulation Article 140 – paragraph 7 7. The Committee may co-opt a maximum of five additional members chosen on the basis of their specific scientific competence. These members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. The co-opted members may act as rapporteurs.
Amendment 929 #
Proposal for a regulation Article 140 a (new) Amendment 930 #
Proposal for a regulation Article 141 – paragraph 1 – point f Amendment 931 #
Proposal for a regulation Article 141 – paragraph 1 – point g a (new) (ga) "Curb the development of antimicrobial resistance through farming practice; specifically by developing and implementing strategies to reduce overall antimicrobial use, reduce the use of critically important antimicrobials and end routine preventative use. To that end, the Committee shall submit a plan to the Commission no later than two years from the entry into force of this regulation, setting out targets and a timeframe for reductions in the use of antimicrobial products.
Amendment 932 #
Proposal for a regulation Article 141 – paragraph 1 – point h a (new) (ha) provide guidance on the contribution of farming practices to reduce the development of antimicrobial resistance, building on the existing action plans of the European Commission and Member States, specifically by developing guidance on the reduction of overall use of antimicrobials.
Amendment 933 #
Proposal for a regulation Article 144 – paragraph 1 – point b Amendment 934 #
Proposal for a regulation Annex 2 – section 1 – part 1.1 – paragraph 1 The technical documentation shall include a detailed and full description of the tests, studies and trials conducted or referred to, including the methods used. The data shall be relevant and of sufficient quality to demonstrate the quality, safety and efficacy of the veterinary product. The technical documentation shall contain data on the quality, safety and efficacy of the standard reference treatment.
Amendment 935 #
Proposal for a regulation Annex 2 – section 1 – part 1.1 – paragraph 7 Amendment 936 #
Proposal for a regulation Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 1 – point d (d) the potential risks for the environment resulting from the production of use of the veterinary medicinal product;
Amendment 937 #
Proposal for a regulation Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 1 – point e (e) the potential risks relating to the development of antimicrobial resistance during production and use.
Amendment 938 #
Proposal for a regulation Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 6 An environmental risk assessment shall be submitted regarding any undesirable effects which the production or use of the veterinary medicinal product may have on the environment and the risk of such effects. The assessment shall also identify any precautionary measures which may be necessary to reduce such risk.
Amendment 939 #
Proposal for a regulation Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 7 – introductory part This assessment shall normally be conducted in two phases. All available data of sufficient reliability and relevance shall be considered, including information gained during the drug discovery process. The first phase of the assessment shall always be performed and the second phase shall be performed if necessary. The details of the assessment shall be provided in accordance with accepted guidance. The assessment shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items:
Amendment 940 #
Proposal for a regulation Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 7 – point c a (new) (ca) An assessment of potential mixture effects including an estimate of the total environmental exposure to the active ingredient from different products and other active ingredients that act via a similar mode of action.
Amendment 941 #
Proposal for a regulation Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 8 In the second phase, further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted, in accordance with established guidance, and taking into account the pharmacological effect of the product as well as any relevant side effects. The extent of exposure of the product to the environment, and the available information about the physical/chemical, pharmacological and/or toxicological properties of the substance(s) concerned, including metabolites, shall be taken into consideration.
Amendment 942 #
Proposal for a regulation Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 8 a (new) The environmental risk assessment shall be updated when new information becomes available that would change the estimation of the risk.
Amendment 943 #
Proposal for a regulation Annex 2 – section 1 – part 1.3 – subpart 1.3.1 – paragraph 8 b (new) A follow up assessment shall always be performed within two years of market introduction that provides an assessment of the emissions from all manufacturing sites (API production and formulation). For each manufacturing site, the assessment should include: 1. A description of how solid and liquid waste is managed, including volumes discharged to water and land per year, treatment technologies used in relation to best available technologies, and estimated yearly average dilution of treated wastewater in the recipient. If waste is treated by third parties, a similar assessment shall be performed and reported for these sites. 2. MEC/PNEC ratios of the active pharmaceutical ingredient (API) (MEC= measured environmental concentrations; PNEC= predicted no effect concentrations) in the recipient for algae, daphnia and fish as well as for antimicrobial resistance during production when discharges are most likely to occur. The MEC shall be derived by analyses of whole effluent and a calculated dilution in the recipient, rather than direct measures in the recipient. In case no APIs are detected, the applicant shall show that the level of quantification of the validated analytical method is applied is at least 100 times below the lowest PNEC or if that is not possible show that the best available analytical technology has been used. 3. A measure of the toxicity of the treated effluent (dilution causing 50% effect) to algae and daphnia according to OECD guidelines. 4. In case of antibiotic production, measures taken to avoid environmental discharges of antibiotic-resistance bacteria from the production chain shall be described.
Amendment 944 #
Proposal for a regulation Annex 2 – section 2 – part 2.3 – subpart 2.3.1 – paragraph 5 The environmental risk assessment shall evaluate the potential harmful effects, which the production or use of the product may cause to the environment and identify any precautionary measures, which may be necessary to reduce such risks.
Amendment 945 #
Proposal for a regulation Annex 3 – part 4 – paragraph 2 a (new) For combinations of antimicrobial substances, the risks and benefits need to be assessed for the long term.
Amendment 946 #
Proposal for a regulation Annex 3 a (new) Preventative measures to be used before resorting to antimicrobial treatment of entire groups (metaphylaxis) of food producing animals: – using good healthy breeding stock that grows naturally, with suitable genetic diversity – conditions that respect the behavioural needs of the species, including social interactions/hierarchies – stocking densities that do not increase risk of disease transmission – isolation of sick animals away from the rest of the group – (for chickens and smaller animals) subdivision of flocks into smaller, physically separated groups – Implementation of existing animal welfare rules already in cross compliance under the Common Agricultural Policy's horizontal Regulation 1306/2013, annex II, SMRs 11, 12, 13 (Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23) Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs (OJ L 340, 11.12.1991, p. 33), Council Directive 91/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves (OJ L 340, 11.12.1991, p. 28))
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2017-06-28Show (1) Changes | Timetravel
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2017-03-19Show (2) Changes | Timetravel
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2017-03-14Show (1) Changes | Timetravel
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2017-03-13Show (1) Changes | Timetravel
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2016-12-27Show (1) Changes | Timetravel
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2016-05-25Show (1) Changes | Timetravel
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2016-05-07Show (1) Changes | Timetravel
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2016-04-29Show (1) Changes | Timetravel
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2016-04-26Show (1) Changes | Timetravel
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2016-04-25Show (1) Changes | Timetravel
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2016-04-21Show (1) Changes | Timetravel
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2016-04-14Show (1) Changes | Timetravel
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