9 Amendments of Sirpa PIETIKÄINEN related to 2014/0257(COD)
Amendment 145 #
Proposal for a regulation
Recital 33
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 168 #
Proposal for a regulation
Recital 39
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 the EU should be active advocating the context of cooperation with third countriesreation of and international organisations addressingstrategy to combat antimicrobial resistance, in order the ensure consistency with their activities and policiesline with the recent Global Action Plan adopted by the World health Organisation.
Amendment 297 #
Proposal for a regulation
Article 8 – paragraph 2 – point b a (new)
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)
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 402 #
Proposal for a regulation
Article 30 – paragraph 1 – point c – point xiii
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 in particular a statement that antimicrobials shall not be used routinely for prophylaxis or metaphylaxis in groups of food producing animals,
Amendment 412 #
Proposal for a regulation
Article 32 – paragraph 1 – point d
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 707 #
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 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 790 #
Proposal for a regulation
Article 111 – paragraph 2 a (new)
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 797 #
Proposal for a regulation
Article 111 a (new)
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.