5 Amendments of Aldo PATRICIELLO related to 2014/0257(COD)
Amendment 35 #
Proposal for a regulation
Recital 4
Recital 4
(4) Experience has shown that the needs of the veterinary sector differ substantially from those of the human sector in relation to medicines. In particular, the drivers for investment for the human and the veterinary medicines markets are different. For example, in the veterinary sector there are many different animal species, which creates both a fragmented market and the need forBecause of the great number of animal species, the veterinary sector is fragmented and requires major investments in order to extend the authorisation of medicines existing for one animal species to another. Moreover, the price-setting mechanisms in the veterinary sector follow a completely different logic. Consequently, prices for veterinary medicines are typically substantially lower than for medicinal products for human use. The size of the animal pharmaceutical industry is only a small fraction of the size of the pharmaceutical industry for human medicines. It is therefore considered appropriate to develop a regulatory framework addressing the characteristics and specificities of the veterinary sector, which cannot be considered as a model for the human medicines market.
Amendment 45 #
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 asoptimised in order to provide the most satisfactory results whilst using the minimum number of animals, the procedures should be the least likely to cause 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 48 #
Proposal for a regulation
Recital 28
Recital 28
(28) The protection of technical documentation should be applied both to new veterinary medicinal products, as well asnd to data developed for supporting innovations of products with or referring to an existing marketing authorisation, for example in the case of extending use of an existing product to an additional animal species. In this case the variation or marketing authorisation application may refer partly to data submitted in a former marketing authorisation or variation applications, and should include new data specifically developed to support the required innovation of the existing product.
Amendment 147 #
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. Given that the effects on humans are not the same as those on animals, a thorough investigation should be conducted into possible contraindications. 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 assessed before being allowed, on a restricted basis, in the veterinary sector. The rules for advertising veterinary antimicrobials should be tightened, and the authorisation requirements shouldmust sufficiently address the risks and benefits of antimicrobial veterinary medicinal products.
Amendment 189 #
Proposal for a regulation
Recital 57
Recital 57
(57) The illegal sale of veterinary medicinal products to the public via the Internet may represent a threat to public and animal health, as falsified or substandard medicines may reach the public in this way. It is necessary to address this threatA system needs to be introduced that will ensure that such products are properly sold and will place controls on the distribution and falsification of substances that are potentially dangerous for human use. Account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at Union level and, therefore, Member States may impose conditions for supplying medicinal products to the public within the limits of the Treaty.