Activities of Jytte GUTELAND related to 2014/0257(COD)
Legal basis opinions (0)
Amendments (10)
Amendment 261 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 a (new)
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 417 #
Proposal for a regulation
Article 32 – paragraph 1 – point d a (new)
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 482 #
Proposal for a regulation
Article 52 – paragraph 3
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 their environmental data.
Amendment 679 #
Proposal for a regulation
Article 92 – paragraph 2 – point c
Article 92 – paragraph 2 – point c
(c) details about the manufacturing site where the veterinary medicinal products are to be manufactured or tested;, including information on discharges and emissions of active pharmaceuticals ingredients
Amendment 682 #
Proposal for a regulation
Article 98 – paragraph 1 – point a
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 689 #
Proposal for a regulation
Article 103 a (new)
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 705 #
Proposal for a regulation
Article 107 – paragraph 2
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. Such retain shall only be made at cost price.
Amendment 791 #
Proposal for a regulation
Article 111 – paragraph 2 a (new)
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 878 #
Proposal for a regulation
Article 118 – title
Article 118 – title
Use of antimicrobial veterinary medicinal productsubstances for species or indications outside the terms of the marketing authorisation
Amendment 888 #
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 1 a (new)
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.