19 Amendments of Marit PAULSEN 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 287 #
Proposal for a regulation
Article 7 – paragraph 2 – point a
Article 7 – paragraph 2 – point a
(a) documentation on the direct or indirect risks to public or animal health or the environment of use of the antimicrobial veterinary medicinal product in animals,
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 644 #
Proposal for a regulation
Article 79 – paragraph 4
Article 79 – paragraph 4
4. Competent authorities and the Agency shall provide the general public, veterinarians and other healthcare professionals withmake public all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication.
Amendment 647 #
Proposal for a regulation
Article 81 – paragraph 1
Article 81 – paragraph 1
1. Competent authorities, other concerned authorities and the Agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit- risk balance of veterinary medicinal products with a view to detecting risks to animal health, public health and protection of the environment (‘signal management process').
Amendment 702 #
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 retaildispense antimicrobial products only for animals which are under their careimmediate care and after a clinical diagnosis, and only in the amount required for the treatment concerned.
Amendment 708 #
Proposal for a regulation
Article 107 – paragraph 2 a (new)
Article 107 – paragraph 2 a (new)
2a. Members States may impose stricter conditions, justified on grounds of public health, animal health and environment protection, for the retail of veterinary medicinal products on their territory.
Amendment 761 #
Proposal for a regulation
Article 110 – paragraph 2
Article 110 – paragraph 2
2. A veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law and after a clinical diagnosis.
Amendment 762 #
Proposal for a regulation
Article 110 – paragraph 2 a (new)
Article 110 – paragraph 2 a (new)
Amendment 767 #
Proposal for a regulation
Article 110 – paragraph 3
Article 110 – paragraph 3
3. Where a veterinary medicinal product is supplied on prescription, the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned. Prophylactic use of antibiotics shall not be allowed.
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 773 #
Proposal for a regulation
Article 110 – paragraph 4
Article 110 – paragraph 4
4. Veterinary prescriptions issued by a veterinarian shall be recognised throughout the Union. A veterinary medicinal product prescribed shall be supplied in accordance with applicable national law.
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.
Amendment 921 #
Proposal for a regulation
Article 136 – paragraph 2
Article 136 – paragraph 2
2. The competent authorities shall cooperate with each other and other concerned authorities in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States necessary and useful support to this end. Competent authorities shall communicate the appropriate information to each other, particularly regarding compliance with the requirements for the manufacturing and wholesale distribution authorisations, for the certificates of good manufacturing practice or for marketing authorisations.