22 Amendments of Stanislav POLČÁK related to 2014/0255(COD)
Amendment 92 #
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
1a. This Regulation shall not apply to finished veterinary medicinal products to be orally administered that have been approved for use via feed as oral powders intended for small group medication or for use via drinking water.
Amendment 99 #
Proposal for a regulation
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) the definitions of 'veterinary medicinal product', 'withdrawal period', 'strength' and´, 'veterinary prescription' and ´premix for medicated feedingstuffs´ as laid down in Article 1 of Directive 2001/82/EC.
Amendment 116 #
Proposal for a regulation
Article 2 – paragraph 2 – point i a (new)
Article 2 – paragraph 2 – point i a (new)
(ia) "antimicrobials" mean any compound with a direct action on microorganisms used for treatment or prevention of infections. Antimicrobials include anti-bacterials, anti-virals, anti- fungals and anti-protozoals.
Amendment 123 #
Proposal for a regulation
Article 2 – paragraph 2 – point i e (new)
Article 2 – paragraph 2 – point i e (new)
(ie) 'preventive treatment (prophylaxis)': treatment of an animal or a group of animals before the emergence of clinical signs of a disease, in order to prevent the occurrence of a disease or an infection;
Amendment 130 #
Proposal for a regulation
Article 2 – paragraph 2 – point i f (new)
Article 2 – paragraph 2 – point i f (new)
(if) 'control treatment (metaphylaxis)': treatment of a group of animals, after a diagnosis of a clinical disease in part of the group has been made, with the aim of treating the clinically sick animals and controlling the spread of disease to animals in close contact and at risk which may already be (sub-clinically) infected;
Amendment 132 #
Proposal for a regulation
Article 2 – paragraph 2 – point i g (new)
Article 2 – paragraph 2 – point i g (new)
(ig) 'curative (therapeutic) treatment': treatment of an ill animal or group of animals, when a diagnosis of a disease or an infection has been made;
Amendment 143 #
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
A Member State may introduce national provisions prohibiting or regulating, within its territory, mobile mixers.
Amendment 151 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Medicated feed and intermediate products shall only be manufactured from veterinary medicinal productmedicated premixes authorised for the purpose of the manufacture of medicated feed in accordance with the conditions laid down in Directive 2001/82/EC (or adequate link to the new Regulation).
Amendment 152 #
Proposal for a regulation
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
(a) the veterinary medicinalmedicated premix or intermediate product is incorporated into the feed in accordance with Annex II;the conditions as established in prescription of the attending veterinarian.
Amendment 153 #
Proposal for a regulation
Article 5 – paragraph 2 – point b
Article 5 – paragraph 2 – point b
(b) the medicated feed is manufactured in compliance with the relevant conditions laid down in the prescription of the attending veterinarian and in the summary of the product characteristics referred to in Articles 14... of Directive 2001/82/ECRegulation (EU) 2015/... (Veterinary Medicinal Products), related to the veterinary medicinal products to be incorporated in the medicated feed;
Amendment 158 #
Proposal for a regulation
Article 5 – paragraph 2 – point d
Article 5 – paragraph 2 – point d
(d) a feed additive for which a maximum content is set incoccidiostats or histomonostats are not present in the feed used for the production of medicated feed if they are also present as active substance in the veterinary medicinal product. For other feed additives, the manufacturer, when formulating the medicated feed, shall ask for the advice the veterinarian from the perespective authorisation act is not incorporated in the medicated feed if it is already used as active substance in the veterinary medicinal productof compatibilities, possible impacts on safety and efficacy profile of the final medicated feed and take into account their eventual presence in the feed used for the production of medicated feed, especially for those cases when they are also present as active substance in the medicated premix.
Amendment 160 #
Proposal for a regulation
Article 5 – paragraph 2 – point d b (new)
Article 5 – paragraph 2 – point d b (new)
(db) the feed used for the production of medicated feed complies with all relevant conditions of Union legislation concerning animal feedingstuffs;
Amendment 161 #
Proposal for a regulation
Article 5 – paragraph 2 – point d c (new)
Article 5 – paragraph 2 – point d c (new)
(dc) the medicated feed is produced in line with the rules defined in the summary of the product characteristics in such a way as to ensure its stability during the prescribed treatment period;
Amendment 184 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point a
Article 7 – paragraph 2 – subparagraph 2 – point a
(a) for antimicrobial active substancessubstances with potential for resistance selection, 1% of the active substance in the last batch of medicated feed or of intermediate product produced before the production of non-target feed;
Amendment 212 #
Proposal for a regulation
Article 12 – paragraph 1 a (new)
Article 12 – paragraph 1 a (new)
Member States should establish competent authorities for approval of the manufacturers and wholesalers of medicated feedingstuffs.
Amendment 220 #
Proposal for a regulation
Article 15 – paragraph 3 – subparagraph 1a (new)
Article 15 – paragraph 3 – subparagraph 1a (new)
The duration of the treatment should follow the valid SPC of the authorised medicated premix incorporated into the medicated feed and should not exceed three weeks in case of medicated feed with incorporated medicated premixes containing active substances with the potential to select resistance.
Amendment 223 #
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. The prescription shall be valid from the date of issuance for a maximum period of six months for non- food producing animals and threewo weeks for food-producing animals. In case of medicated feed containing veterinary medicinal products containing substances with potential to select resistance, the prescription shall be valid from the date of issuance for a maximum period of one week.
Amendment 228 #
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 persoattending veterinarian 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 productated premixes are used.
Amendment 251 #
Proposal for a regulation
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
Amendment 273 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. Medicated feed containing antimicrobial veterinary medicinal products shall not be used tofor prevent diseases in food-producingive treatment (prophylaxis). Prophylaxis with antimals or to enhance their performanceicrobials shall never be applied routinely nor to compensate for poor hygiene or for inadequate husbandry conditions.
Amendment 290 #
Proposal for a regulation
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
Business operators shall provide data needed for calculation of the volume of the sales of veterinary medicinal products incorporated into the final medicated feed to the competent national authority of the Member State. Member States shall collect relevant and comparable data on the volume of sales of medicated feed containing antimicrobial active substances. Member States shall send data on the volume of sales of medicated feed containing antimicrobial active substances to the competent European authority. That European authority shall analyse the data and publish an annual report.
Amendment 317 #
Proposal for a regulation
Annex 3 – point 6
Annex 3 – point 6
(6) the veterinary medicinal products with name, active substance, strength, added amount, marketing authorisation holder and marketing authorisation number, preceded by the heading ‘'medication';