6 Amendments of Daniel BUDA related to 2014/0257(COD)
Amendment 42 #
Proposal for a regulation
Recital 14
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 Member States concerned, being taken on the basis of an overall benefit-risk assessment. The authorisation procedure for veterinary medicinal products should be adjusted so as to eliminate bureaucratic procedures that might hamper the development of research and innovation for the purpose of identifying new medicines.
Amendment 54 #
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. 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 58 #
Proposal for a regulation
Recital 36
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 veterinary medicinal products may accelerate the emergence and spread of resistant micro-organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections. Therefore the misuse of antimicrobials should not be allowed. Preventive treatments using antimicrobials should be regulated more strictly and recommended only in certain specific, well-defined cases, in compliance with animal health, biosecurity and nutritional requirements.
Amendment 60 #
Proposal for a regulation
Recital 37
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 102 #
Proposal for a regulation
Article 4 – paragraph 1 – point 8 a (new)
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 368 #
Proposal for a regulation
Article 109 – paragraph 1
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 usedare prescribed by as veterinary medicinal products having those propertiesian.