31 Amendments of Susanne MELIOR related to 2014/0257(COD)
Amendment 206 #
Proposal for a regulation
Article 2 – paragraph 4 – point e a (new)
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 210 #
Proposal for a regulation
Article 2 – paragraph 4 a (new)
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 241 #
Proposal for a regulation
Article 4 – paragraph 1 – point 11 – introductory part
Article 4 – paragraph 1 – point 11 – introductory part
(11) ‘'benefit-risk balance' means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the following risks relating to the use of that product:
Amendment 247 #
Proposal for a regulation
Article 4 – paragraph 1 – point 20 – point b
Article 4 – paragraph 1 – point 20 – point b
(b) veterinary medicinal products for animal species other than cattle, sheep, pigs, chickens, dogs and cats;
Amendment 249 #
Proposal for a regulation
Article 4 – paragraph 1 – point 21
Article 4 – paragraph 1 – point 21
(21) ‘'pharmacovigilance' means the process of monitscientific, control and administrative activities relating to detection, reporting, and inssessment, understanding, prevesntigating adverse evenon and communication of adverse events which include continuous evaluation of the benefit risk balance of veterinary medicinal products;
Amendment 250 #
Proposal for a regulation
Article 4 – paragraph 1 – point 24
Article 4 – paragraph 1 – point 24
(24) ‘veterinary prescription‘ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance wiveterinarian following the provision of a veterinary diagnosis in the context of clinical examination of the applicable national lawnimal or of a check on the state of health of the animal;
Amendment 255 #
Proposal for a regulation
Article 4 – paragraph 1 – point 25
Article 4 – paragraph 1 – point 25
(25) 'withdrawal period' means the minimum period between the last administration of a veterinary medicinal product to an animal under normal conditions of use and in accordance with the provisions of this Regulation and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public healthcomply with requirements laid down pursuant to Regulation (EC) 470/2009;
Amendment 268 #
Proposal for a regulation
Article 4 – paragraph 1 c (new)
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 274 #
Proposal for a regulation
Article 5 – paragraph 2
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 293 #
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to amend Annexes I and II to adapt the information and documentation requirements to technical and scientific progressAnnex I shall be adopted by the Council and European Parliament acting under the conditions provided for by the Treaty on a proposal from the Commission.
Amendment 314 #
Proposal for a regulation
Article 10 – paragraph 1 – point g a (new)
Article 10 – paragraph 1 – point g a (new)
(ga) waiting period.
Amendment 322 #
Proposal for a regulation
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
1. The package leaflet shall be available forttached to each veterinary medicinal product and shall contain at least the following information:
Amendment 327 #
Proposal for a regulation
Article 12 – paragraph 3
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 339 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. For the purpose of this Section, where the active substance consists of salts, esters, ethers, isomers and mixtures of isomers, complexes or derivatives differing from the active substance used in the reference veterinary medicinal product, it shall be considered to be the same active substance as that used in the reference veterinary medicinal product, unless it differs significantly in respect of properties with regard to safety or, efficacy and behaviour of residues. Where it differs significantly in respect of those properties, the applicant shall submit additional information in order to prove the safety and/or efficacy of the various salts, esters or derivatives of the authorised active substance of the reference veterinary medicinal product.
Amendment 385 #
Proposal for a regulation
Article 29 – paragraph 1 a (new)
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)
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 397 #
Proposal for a regulation
Article 29 – paragraph 3 – point h
Article 29 – paragraph 3 – point h
(h) there is no risk to public or animal health as regards the development of resistance to anthelmintic subantimicrobial or antiparasitic resistances even where the veterinary medicinal products containing those substances are used incorrectly.
Amendment 426 #
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 146 in order to establishuncil and European Parliament acting under the conditions provided for by the Treaty on a proposal from the Commission shall be empowered to adopt 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.
Amendment 466 #
Proposal for a regulation
Article 46 – paragraph 2
Article 46 – paragraph 2
2. The application shall list Member States where the applicant seeks to obtain a marketing authorisation (‘'Member States concerned'). The applicant shall send application identical to that submitted to the reference Member State, including identical dossier as provided under Article 7, to all Member States concerned.
Amendment 468 #
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
1. AIdentical applications for mutual recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation (‘reference"reference Member State") and the Member States where the applicant seeks to obtain recognition of the marketing authorisation ('concerned Member States').
Amendment 569 #
Proposal for a regulation
Article 73 – paragraph 1
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, on a continuous basis benefit-risk balance of authorised veterinary medicinal products, and enabling them to fulfil their responsibilities as listed in Articles 77 and 79 (‘'Union pharmacovigilance system').
Amendment 590 #
Proposal for a regulation
Article 73 – paragraph 2 a (new)
Article 73 – paragraph 2 a (new)
2a. any finding of an active substance in the environment, particularly in groundwater or surface water.
Amendment 607 #
Proposal for a regulation
Article 76 – paragraph 1
Article 76 – paragraph 1
1. Competent authorities shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their Member State, within 30 days following the receipt of the adverse event report. Serious adverse event in animals, noxious response in humans to a veterinary medicinal product and environmental incidents observed following administration of a veterinary medicinal product to an animal shall be reported within 15 days following the receipt of such adverse event report.
Amendment 611 #
Proposal for a regulation
Article 76 – paragraph 2
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. Serious adverse event in animals, noxious response in humans to a veterinary medicinal product and environmental incidents observed following administration of a veterinary medicinal product to an animal shall be reported within 15 days following the receipt of such adverse event report.
Amendment 696 #
Proposal for a regulation
Article 107 – paragraph 2
Article 107 – paragraph 2
2. Persons qualified to prescribeVeterinarians shall retail veterinary medicinal products in accordance with applicable national law shall retailthat are subject to medical prescription, particularly antimicrobial products, only for animals which are under their care, subject to a veterinary diagnosis based on clinical examination of the animal concerned or, exceptionally, permanent monitoring of its health, and only in the amount required for the treatment concerned.
Amendment 726 #
Proposal for a regulation
Article 108 – paragraph 7
Article 108 – paragraph 7
7. Members States may impose conditions, justified on grounds of public healthand animal health, animal welfare and environmental protection, for the retail on their territory of medicinal products offered for sale at a distance to the public by means of information society services.
Amendment 755 #
Proposal for a regulation
Article 110 – paragraph 2
Article 110 – paragraph 2
2. A veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national lawveterinarian.
Amendment 783 #
Proposal for a regulation
Article 111 – paragraph 1 a (new)
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 818 #
Proposal for a regulation
Article 115 – paragraph 1 – point a – point iii
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; if no medicinal product as referred to in point (i) or (ii) can be used; __________________ 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 847 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
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 under Regulation (EC) No 726/2004, orif no medicinal product as referred to in point (a) or (b) can be used;
Amendment 895 #
Proposal for a regulation
Article 123 – paragraph 1 a (new)
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.