13 Amendments of Eleonora EVI related to 2014/0255(COD)
Amendment 21 #
Proposal for a regulation
Citation 5 a (new)
Citation 5 a (new)
Having regard to the European Parliament’s own initiative report entitled ‘Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance’ (A8-9999/2015 of XX/yy/2015),
Amendment 46 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) Although it could, potentially, resolve the administration problems encountered by pet owners, the administration of medicated feed to pets should be the subject of further research, in particular in order to assess the risks of over-administration and under- administration;
Amendment 63 #
Proposal for a regulation
Recital 19
Recital 19
(19) Taking into account the serious public health risk posed by resistance to antimicrobials, it is appropriate to limit the use of medicated feed containing antimicrobials for food-producing animals. PIn particular, the ban on the use of antibiotics as growth promoters should be confirmed, preventive use or use to enhance the performance of food- producing animals should in particular not be allownot be allowed, and all economic incentives that could result in over-use of antibiotics administered through feed should be removed.
Amendment 68 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) Notes with great concern the high number of animals infected with bacteria that are resistant to antibiotics, and the risk of carry-over of these bacteria from infected meat to consumers.
Amendment 70 #
Proposal for a regulation
Recital 19 b (new)
Recital 19 b (new)
(19b) The issue of off-label use of antibiotics is a concern for animal medicine as well as human medicine.
Amendment 85 #
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
Without prejudice to the adoption of delegated acts under Article 16a and Article 19, this Regulation shall not apply to pets.
Amendment 87 #
Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)
Article 2 – paragraph 1 – point c a (new)
(ca) the definition of ‘pet’: the species listed in Annex I to Regulation (EU) No 576/2013 of 12 June 2013;
Amendment 166 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The prescription shall contain the information set out in Annex V. The original prescription shall be kept by the manufacturer or, where appropriate, the distributor. The persoveterinarian issuing the prescription and the animal holder shall keep a copy of the prescription. The original and copies shall be kept for three years from the date of issuance.
Amendment 168 #
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1 a (new)
Article 15 – paragraph 2 – subparagraph 1 a (new)
Metaphylactic use of medicated feed shall be duly justified by the veterinarian issuing the prescription. To that end, prescribing veterinarians shall assess the health and hygiene conditions at animal holdings, including aquaculture holdings, and the preventive bio-safety measures taken there.
Amendment 169 #
Proposal for a regulation
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
2a. Prescribing veterinarians may not sell medicated feed.
Amendment 180 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease. The person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used. The off-label use of medicated feed with antimicrobials authorised for human use only shall be forbidden.
Amendment 181 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The prescribed medicated feed may be used only for animals examined by the persoveterinarian who issued the prescription and only for a diagnosed disease. The persoveterinarian who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds. Furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra-indication or interaction where several medicinal products are used.
Amendment 216 #
Proposal for a regulation
Article 16 a (new)
Article 16 a (new)
Article 16 Authorisation of the use of medicated feed for pets The Commission may adopt delegated acts authorising the production and placing on the market of medicated feed for pets provided that there is sound scientific evidence of the benefits of this method for administering veterinary medicines and the risks of over-administration and under-administration are taken into account. The Commission shall stipulate the species of pet that may be treated with medicated feed.