31 Amendments of Marco AFFRONTE related to 2014/0257(COD)
Amendment 107 #
Proposal for a regulation
Citation 5 a (new)
Citation 5 a (new)
– having regard to the European Parliament resolution of 19 May 2015 on safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance (A8-0142/2015 - 2014/2207(INI);
Amendment 109 #
Proposal for a regulation
Recital 5
Recital 5
(5) The provisions of this act aim to reduce administrative burden, enhance the internal market and increase the availability of veterinary medicinal products, while guaranteeing the highest level of public and animal health and environmental protection. In line with the precautionary principle the pharmaceuticals industry should be required to demonstrate that veterinary medicines produced or placed on the market have neither a harmful effect on human or animal health nor an unsustainable environmental impact.
Amendment 118 #
Proposal for a regulation
Recital 17
Recital 17
(17) However, there may be situations where no suitable authorised veterinary medicinal product is available. In those situations, by way of exception, veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only; however, the administration to animals of off-label antimicrobials authorised solely for human use should be prohibited. In case of food-producing animals, veterinarians should ensure that an appropriate withdrawal period is prescribed, so that harmful residues of those medicinal products do not enter the food chain.
Amendment 126 #
Proposal for a regulation
Recital 20
Recital 20
(20) Directive 2010/63/EU of the European Parliament and of the Council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Clinical trials for veterinary medicinal products are exempted from that Directive. The design and performance of clinical trials, which provide essential information on the safety and efficacy of a veterinary medicinal product, should be such as to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be the least likely todesigned to avoid causeing pain, suffering or distress to animals and should take into account the principles established by Directive 2010/63/EU. __________________ 15 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Amendment 137 #
Proposal for a regulation
Recital 29
Recital 29
(29) Differences in the manufacturing process of biological products or a change in the excipient used may lead to differences in the generic product characteristics. In an application for generic biological veterinary medicinal product the bioequivalence should be demonstrated in order to ensure, based on the existing knowledge, that quality, safety and efficacy are similar.
Amendment 143 #
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 not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricprohibited in the veterinary sector. The rules for advertising of veterinary antimicrobials should be tightenedgeared solely to the provision of scientific information, and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.
Amendment 152 #
Proposal for a regulation
Recital 36 a (new)
Recital 36 a (new)
(36a) The use of antimicrobial veterinary medicinal products should be reduced by phasing out their use for prophylactic purposes and minimising their metaphylactic use in treating diseased animals and preventing healthy animals in the same group from becoming infected.
Amendment 162 #
Proposal for a regulation
Recital 38
Recital 38
(38) If an antimicrobial is administered and used incorrectly, this presents a risk to public or animal health. Therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription. Persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced, directly or indirectly, by economic incentives when prescribing those products. Therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care. Veterinarians should not be allowed to sell antimicrobial veterinary medicinal products, as this could result in conflicts of interest that give rise to over-prescription of such products.
Amendment 186 #
Proposal for a regulation
Recital 56
Recital 56
(56) The conditions governing the supply of veterinary medicinal products to the public should be harmonised in the Union. Veterinary medicinal products should only be supplied by persons authorised to do so by the Member State where they are established. At the same time, in order to improve access to veterinary medicinal products in the Union, retailers that are authorised to supply veterinary medicinal products by the competent authority in the Member State where they are established should be allowed to sell prescription and non-prescription veterinary medicinal products via the Internet to buyers in other Member States. In order to minimise the risk to animal and human health, online sales of antimicrobials should be prohibited.
Amendment 195 #
Proposal for a regulation
Recital 61
Recital 61
(61) Advertising, even on non-prescription medicinal products, could affect public and animal health and distort competition. Therefore, advertising of veterinary medicinal products should satisfy certain criteria. Persons qualified to prescribe or supply can properly evaluate the information available in advertising because of their knowledge, training and experience in animal health. The advertising of veterinary medicinal products to persons who cannot properly appreciate the risk associated with their use may lead to medicine misuse or overconsumption which is liable to h arm public or animal health, or the environment. Comparative advertising should be allowed only for non- prescription products, in accordance with the rules laid down by Member States.
Amendment 304 #
Proposal for a regulation
Article 9 – paragraph 1 – point g a (new)
Article 9 – paragraph 1 – point g a (new)
(ga) details of take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;
Amendment 312 #
Proposal for a regulation
Article 10 – paragraph 1 – point f
Article 10 – paragraph 1 – point f
(f) requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;
Amendment 324 #
Proposal for a regulation
Article 12 – paragraph 1 – point j
Article 12 – paragraph 1 – point j
(j) requirement to use take-back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products;
Amendment 337 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The language or languages of the information on the labelling shall be determined by the Member State where the veterinary medicinal product is made available on the market, with due regard for the rights of linguistic minorities.
Amendment 338 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Veterinary medicinal products may be labelled in several languagesfor export shall be labelled in the languages of the Member States in which they will be placed on the market.
Amendment 405 #
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 the prohibition of off-label use,
Amendment 439 #
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) 140 years for antimicrobial veterinary medicinal products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the Union on the date of the submission of the application;
Amendment 441 #
Proposal for a regulation
Article 34 – paragraph 1 – point c
Article 34 – paragraph 1 – point c
(c) 180 years for veterinary medicinal products for bees;
Amendment 450 #
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 42 years.
Amendment 455 #
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ( ' 'overall period of the protection of technical documentation ' ') shall not exceed 184 years.
Amendment 693 #
Proposal for a regulation
Article 104 – paragraph 5
Article 104 – paragraph 5
5. A wholesale distributor shall supply veterinary medicinal products only to persons permitted to carry out retail activities in the Member States in accordance with Article 107(1), other wholesale distributors and exporters of veterinary medicinal products.
Amendment 699 #
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 not retail antimicrobial products only for animals which are under their care, and only in the amount required for the treatment concerned.
Amendment 709 #
Proposal for a regulation
Article 107 – paragraph 2 a (new)
Article 107 – paragraph 2 a (new)
2a. Given the risks associated with antimicrobial resistance, no economic incentives may be provided in any form, directly or indirectly, by pharmaceutical companies to persons who prescribe veterinary medicinal products.
Amendment 715 #
Proposal for a regulation
Article 108 – paragraph 1
Article 108 – paragraph 1
1. Persons permitted to supply veterinary medicinal products in accordance with Article 107(1) may offer veterinary medicinal products other than products containing antimicrobials by means of information society services within the meaning of Directive 98/34/EC of the European Parliament and of the Council28 to natural or legal persons established in the Union under the condition that those medicinal products comply with the legislation of the destination Member State. __________________ 28 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).
Amendment 722 #
Proposal for a regulation
Article 108 – paragraph 5 – subparagraph 1 – point c a (new)
Article 108 – paragraph 5 – subparagraph 1 – point c a (new)
(ca) information on procedures for the safe disposal of medicinal products, specifying the public or private body responsible at national or local level for the disposal of veterinary medicine residues and the collection points for disposal free of charge.
Amendment 723 #
Proposal for a regulation
Article 108 – paragraph 5 – subparagraph 1 – point c b (new)
Article 108 – paragraph 5 – subparagraph 1 – point c b (new)
(cb) Member States’ websites shall also contain hyperlinks to the web pages of the bodies responsible in Member States for listing authorised national retailers.
Amendment 724 #
Proposal for a regulation
Article 108 – paragraph 6
Article 108 – paragraph 6
6. The Agency shall set up a website providing information on the common logo. The Agency’s website shall explicitly mention that the websites of Member States contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in the Member State concerned. The Agency’s website shall be linked to the web pages of the appropriate Member State bodies listing authorised retailers in Member States.
Amendment 729 #
Proposal for a regulation
Article 108 – paragraph 7 a (new)
Article 108 – paragraph 7 a (new)
7a. Each Member State shall authorise national online retailers and carry out appropriate checks to ensure that their operations are valid. Member States shall respond without delay to concerns raised by other Member States regarding online retailers authorised on their national territory.
Amendment 739 #
Proposal for a regulation
Article 109 – paragraph 1 – subparagraph 1 (new)
Article 109 – paragraph 1 – subparagraph 1 (new)
Member States may decide, in addition, to authorise the sale of anti-parasitic and anti-inflammatory medicinal products for pets through ordinary distribution channels.
Amendment 844 #
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
Amendment 903 #
Proposal for a regulation
Article 125 – paragraph 6
Article 125 – paragraph 6
6. IFinal inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities, and made public.