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Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (Text with EEA relevance) article 5 CELEX: 32019R0004 Composition
1. Medicated feed and intermediate products shall only be manufactured from veterinary medicinal products, including veterinary medicinal products intended to be used in accordance with Article 112, Article 113 or Article 114 of Regulation (EU) 2019/6, authorised for the purpose of the manufacture of medicated feed in accordance with the conditions laid down in that Regulation. |
Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (Text with EEA relevance) article 5 CELEX: 32019R0004 2. The feed business operator manufacturing the medicated feed or intermediate product shall ensure that: (a) the medicated feed or intermediate product is manufactured in compliance with the relevant conditions laid down in the veterinary prescription for medicated feed or, in the cases referred to in Article 8 of this Regulation, in the summary of the product characteristics, related to the veterinary medicinal products to be incorporated in the feed; those conditions shall include particular provisions regarding known interactions between the veterinary medicinal products and the feed that may impair the safety or the efficacy of the medicated feed or intermediate product; (b) a feed additive authorised as a coccidiostat or a histomonostat for which a maximum content is set in the respective authorisation act is not incorporated in the medicated feed or intermediate product if it is already used as active substance in the veterinary medicinal product; (c) where the active substance in the veterinary medicinal product is the same as a substance in a feed additive contained in the feed concerned, the total content of that active substance in the medicated feed does not exceed the maximum content set out in the veterinary prescription for the medicated feed or, in the cases referred to in Article 8, in the summary of product characteristics; (d) the veterinary medicinal products incorporated in the feed combine with it to form a stable mixture for the entire storage life of the medicated feed, and respect the expiry date of the veterinary medicinal product, as referred to in point (f) of Article 10(1) of Regulation (EU) 2019/6, provided that the medicated feed or intermediate product is properly stored and handled. |
Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (Text with EEA relevance) article 5 CELEX: 32019R0004 3. Feed business operators supplying medicated feed to the animal keeper shall ensure that the medicated feed complies with the prescription referred to in Article 16. |