8 Amendments of Jan HUITEMA related to 2014/0257(COD)
Amendment 172 #
Proposal for a regulation
Recital 40
Recital 40
(40) There is still a lack of sufficiently detailed and comparable data at Union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced. Therefore it is important to collect data on the sales and use of antimicrobials in animals, data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals, humans and food. In particular, better data is needed on how, when, where and why antimicrobials, in particular antibiotics, are being used. To ensure that the information collected can be used effectively, appropriate rules should be laid down concerning the collection and the exchange of data. The Member States should be responsible for collecting data on the use of antimicrobials under the coordination of the Agency.
Amendment 260 #
Proposal for a regulation
Article 4 – paragraph 1 – point 27 a (new)
Article 4 – paragraph 1 – point 27 a (new)
(27a) "good animal husbandry" means the management and care of animals by humans for profit whilst assuring the health and welfare of these animals by respecting and ensuring the specific needs of each species and by minimising as much as possible the need to use veterinary pharmaceutical products;
Amendment 367 #
Proposal for a regulation
Article 22 – paragraph 1 – point c
Article 22 – paragraph 1 – point c
(c) a requirement to conductprovide further data based on either post- authorisation studies. or on data collected on the performance of the product in the field, where data from the field is identified as more appropriate based on benefit-risk assessment.
Amendment 488 #
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Member States shall collect relevant and, comparable and sufficiently detailed data on the volume of sales and the use of veterinary antimicrobialbiotic medicinal products.
Amendment 492 #
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Member States shall send data on the volume of sales and the use of veterinary antimicrobialbiotic medicinal products to the Agency. The Agency shall analyse the data and publish an annual report which should contain guidelines and recommendations as appropriate.
Amendment 660 #
Proposal for a regulation
Article 83 – paragraph 4
Article 83 – paragraph 4
4. The competent authority or the Commission may at any time grant a marketing authorisation valid for an unlimited period of time, provided that the marketing authorisation holder submits the missing comprehensive safety and efficacy data or post authorization data referred to in Article 22(1).
Amendment 780 #
Proposal for a regulation
Article 111 – paragraph 1
Article 111 – paragraph 1
1. Veterinary medicinal products shall be used responsibly in accordance with the principle of good animal husbandry and with the terms of the marketing authorisation.
Amendment 794 #
Proposal for a regulation
Article 111 – paragraph 2 a (new)
Article 111 – paragraph 2 a (new)
2a. Antibiotic veterinary medicinal products must not be used for prophylactic purposes, unless there is a high risk of infection for the individual animal concerned due to trauma, surgery or similar incidents. They must not under any circumstances be used to improve performance or compensate for poor animal husbandry.