8 Amendments of Anneli JÄÄTTEENMÄKI 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 179 #
Proposal for a regulation
Recital 50
Recital 50
(50) A pharmacovigilance database at Union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the Union. That database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work- sharing between the competent authorities and other concerned authorities such as environmental protection agencies and food safety authorities both on national and Union level.
Amendment 194 #
Proposal for a regulation
Recital 58 a (new)
Recital 58 a (new)
(58a) Member States should be able to subject the supply of medicinal products offered for sale to stricter conditions justified by the protection of public health, animal health and the environment.
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 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 770 #
Proposal for a regulation
Article 110 – paragraph 3 a (new)
Article 110 – paragraph 3 a (new)
3a. Metaphylactic use of antibiotics shall only be allowed, after a proper diagnosis, on animals which are in contact with animals with clinical signs of an infectious disease, to prevent the further spread of the disease. The administration must be accompanied by a health plan specifying measures to take to reduce the need to resort to such use in the future.
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.