16 Amendments of Karin KADENBACH related to 2014/0257(COD)
Amendment 149 #
Proposal for a regulation
Recital 34 a (new)
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 273 #
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 timefive years.
Amendment 345 #
Proposal for a regulation
Article 16 – paragraph 6
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 iIn case the marketing authorisation for the reference veterinary medicinal product was granted before 20 July 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product, the applicant must provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment.
Amendment 352 #
Proposal for a regulation
Article 21
Article 21
Amendment 364 #
Proposal for a regulation
Article 22
Article 22
Amendment 383 #
Proposal for a regulation
Article 29 – paragraph 1 – introductory part
Article 29 – paragraph 1 – introductory part
1. A competent authority or the Commission shall classify tThe following veterinary medicinal products ashall be subject to veterinary prescription:
Amendment 387 #
Proposal for a regulation
Article 29 – paragraph 2 – introductory part
Article 29 – paragraph 2 – introductory part
2. A competent authority or the Commission may classify a veterinary medicinal product shall be classified as subject to veterinary prescription where special precautions are contained in the summary of product characteristics referred to in Article 30, and in particular potential risks to:
Amendment 389 #
Proposal for a regulation
Article 29 – paragraph 3 – introductory part
Article 29 – paragraph 3 – introductory part
3. By the way of derogation from paragraph 1, aA competent authority or the Agency may not classify a veterinary medicinal product as not subject to veterinary prescription if paragraphs 1 and 2 do not apply and all of the following conditions are fulfilled:
Amendment 421 #
Proposal for a regulation
Article 32 – paragraph 1 – point i a (new)
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 434 #
Proposal for a regulation
Article 32 – paragraph 4 a (new)
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 573 #
Proposal for a regulation
Article 73 – paragraph 2 – introductory part
Article 73 – paragraph 2 – introductory part
2. Competent authorities, and the Agency and marketing authorisation holders shall make available to healthcare professionals, and animal holders and the environmental authorities of the Member States different means of reporting to them the following events, whether or not the event is considered to be product-related (‘adverse events’'):
Amendment 589 #
Proposal for a regulation
Article 73 – paragraph 2 – point f a (new)
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 700 #
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, and only in the amount required for the treatment concernedbe prohibited from trading in veterinary medicinal products and from any commercial participation in companies which trade in, manufacture or import veterinary medicinal products.
Amendment 710 #
Proposal for a regulation
Article 108 – title
Article 108 – title
Retail of veterinary medicinal products at a distance shall be prohibited.
Amendment 786 #
Proposal for a regulation
Article 111 – paragraph 1 a (new)
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 918 #
Proposal for a regulation
Article 135 – paragraph 4 a (new)
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.