Regulation (EU) 2019/4 of the European Parliament and of the CouncilShow full title

Article 16 Prescription

1. The supply of medicated feed to animal keepers shall be subject to:

(a) the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription for medicated feed; and

(b) the conditions laid down in paragraphs 2 to 10.

2. A veterinary prescription for medicated feed shall be issued only after a clinical examination or any other proper assessment of the health status of the animal or group of animals by a veterinarian and only for a diagnosed disease.

3. By way of derogation from paragraph 2, a veterinary prescription for medicated feed containing immunological veterinary medicinal products may be issued also in the absence of a diagnosed disease.

4. By way of derogation from paragraph 2, if it is not possible to confirm the presence of a diagnosed disease, a veterinary prescription for medicated feed containing antiparasitics without antimicrobial effects may be issued based on the knowledge of the parasite infestation status in the animal or group of animals.

5. By way of derogation from point (h) of Article 3(2) and paragraph 2 of this Article, a Member State may allow a veterinary prescription for medicated feed to be issued by a professional person qualified to do so in accordance with applicable national law on 27 January 2019.

Such prescriptions shall exclude prescription of medicated feed containing antimicrobial veterinary medicinal products or any other veterinary medicinal products where a diagnosis by a veterinarian is necessary and shall be valid only in that Member State.

The professional person referred to in the first subparagraph shall, when issuing such a prescription, make any necessary verifications in accordance with national law.

Paragraphs 6, 7, 8 and 10 of this Article shall apply, mutatis mutandis, to such prescriptions.

6. The veterinary prescription for medicated feed shall contain the information set out in Annex V.

The original veterinary prescription for medicated feed shall be kept by the manufacturer or, where appropriate, the feed business operator supplying the medicated feed to the animal keeper. The veterinarian, or the professional person referred to in paragraph 5, issuing the prescription and the keeper of food-producing or fur animal shall keep a copy of the veterinary prescription for medicated feed.

The original and copies shall be kept for five years from the date of issuance.

7. With the exception of medicated feed for non-food-producing animals, other than fur animals, medicated feed shall not be used for more than one treatment under the same veterinary prescription for medicated feed.

The duration of a treatment shall comply with the summary of product characteristics of the veterinary medicinal product incorporated in the feed and, where not specified, shall not exceed one month, or two weeks in case of a medicated feed containing antibiotic veterinary medicinal products.

8. The veterinary prescription for medicated feed shall be valid from the date of its issuance for a maximum period of six months for non-food-producing animals other than fur animals and three weeks for food-producing animals and fur animals. In the case of medicated feed containing antimicrobial veterinary medicinal products, the prescription shall be valid from the date of its issuance for a maximum period of five days.

9. The veterinarian issuing the veterinary prescription for medicated feed shall verify that that medication is justified for the target animals on veterinary grounds. Furthermore that veterinarian 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. In particular, the veterinarian shall not prescribe medicated feed with more than one veterinary medicinal product containing antimicrobials.

10. The veterinary prescription for medicated feed shall:

(a) comply with the summary of the product characteristics of the veterinary medicinal product, except for veterinary medicinal products intended to be used in accordance with Article 112, Article 113 or Article 114 of Regulation (EU) 2019/6;

(b) indicate the daily dose of the veterinary medicinal product which is to be incorporated in a quantity of medicated feed that ensures the uptake of the dosage by the target animal considering that the feed uptake of diseased animals might differ from a normal daily ration;

(c) ensure that the medicated feed containing the dosage of the veterinary medicinal product corresponds to at least 50 % of the daily feed ration on a dry matter basis and that, for ruminants, the daily dose of the veterinary medicinal product is contained in at least 50 % of the complementary feed except for mineral feed;

(d) indicate the inclusion rate of the active substances, calculated on the basis of the relevant parameters.

11. Veterinary prescriptions for medicated feed issued in accordance with paragraphs 2, 3 and 4 shall be recognised throughout the Union.

12. The Commission may, by means of implementing acts, set a model format for the information set out in Annex V. That model format shall also be made available in electronic version. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21(2).