11 Amendments of Michèle RIVASI related to 2014/0257(COD)
Amendment 120 #
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 temporarily 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. 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 123 #
Proposal for a regulation
Recital 18
Recital 18
(18) Member States should be able to temporarily allow exceptional use of veterinary medicinal products without a marketing authorisation where it is necessary to respond to Union listed diseases and where the health situation in a Member State so requires.
Amendment 502 #
Proposal for a regulation
Article 58 – paragraph 3 – point b a (new)
Article 58 – paragraph 3 – point b a (new)
(ba) whether changes have an impact on route of administration
Amendment 784 #
Proposal for a regulation
Article 111 – paragraph 1 a (new)
Article 111 – paragraph 1 a (new)
1a. Medicinal products cannot be used in any mean that could harm the environment. Especially spraying in open air or dissolution in open waters is not allowed.
Amendment 787 #
Proposal for a regulation
Article 111 – paragraph 1 b (new)
Article 111 – paragraph 1 b (new)
1b. If a medicinal product cannot be given to animals individually and has to be put in their environment, this environment must be closed and cleaned after treatment.
Amendment 788 #
Proposal for a regulation
Article 111 – paragraph 1 c (new)
Article 111 – paragraph 1 c (new)
1c. The amount of medicinal products that one can spray or dissolve is limited to the product of the quantity necessary to treat a single animal in confined environment times the number of animals to treat.
Amendment 856 #
Proposal for a regulation
Article 116 – paragraph 2 – introductory part
Article 116 – paragraph 2 – introductory part
2. By way of derogation from Article 111, where there is no authorised veterinary medicinal product or any other treatment in a Member State for a condition affecting a food-producing aquatic species, the veterinarian responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animals concerned with any of the following medicinal products:
Amendment 869 #
Proposal for a regulation
Article 116 – paragraph 4 – subparagraph 2 – point c
Article 116 – paragraph 4 – subparagraph 2 – point c
(c) impact on the competitiveness of certain sectors in aquaculture in the Union if the animal affected by the condition cannot receive treatment with the antimicrobial medicinal product concernedfishermen whose preys can be significantly affected by use of medicines in open-water aquaculture;
Amendment 890 #
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point c a (new)
Article 118 – paragraph 2 – subparagraph 2 – point c a (new)
(ca) availability of other farming methods that could prevent the outbreak of the disease
Amendment 891 #
Proposal for a regulation
Article 118 – paragraph 2 – subparagraph 2 – point e
Article 118 – paragraph 2 – subparagraph 2 – point e
Amendment 898 #
Proposal for a regulation
Article 125 – paragraph 1
Article 125 – paragraph 1
1. Competent authorities shall perform controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products as well as animals and foodstuff regularly, on a risk- basis, in order to verify that the requirements as set out in this Regulation are complied with.