Regulation (EU) 2019/6 of the European Parliament and of the CouncilDangos y teitl llawn

Article 105 Veterinary prescriptions

1. A veterinary prescription for an antimicrobial medicinal product for metaphylaxis shall only be issued after a diagnosis of the infectious disease by a veterinarian.

2. The veterinarian shall be able to provide justification for a veterinary prescription of antimicrobial medicinal products, in particular for metaphylaxis and for prophylaxis.

3. A veterinary prescription 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.

4. By way of derogation from point (33) of Article 4 and paragraph 3 of this Article, a Member State may allow a veterinary prescription to be issued by a professional, other than a veterinarian, who is qualified to do so in accordance with applicable national law at the time of entry into force of this Regulation. Such prescriptions shall be valid only in that Member State and shall exclude prescriptions of antimicrobial medicinal products and any other veterinary medicinal products where a diagnosis by a veterinarian is necessary.

Veterinary prescriptions issued by a professional, other than a veterinarian shall be, mutatis mutandis, subject to paragraphs 5, 6, 8, 9 and 11 of this Article.

5. A veterinary prescription shall contain at least the following elements:

(a) identification of the animal or groups of animals to be treated;

(b) full name and contact details of the animal owner or keeper;

(c) issue date;

(d) full name and contact details of the veterinarian including, if available, the professional number;

(e) signature or an equivalent electronic form of identification of the veterinarian;

(f) name of the prescribed medicinal product, including its active substances;

(g) pharmaceutical form and strength;

(h) quantity prescribed, or the number of packs, including pack size;

(i) dosage regimen;

(j) for food-producing animal species, withdrawal period even if such period is zero;

(k) any warnings necessary to ensure the proper use including, where relevant, to ensure prudent use of antimicrobials;

(l) if a medicinal product is prescribed in accordance with Articles 112, 113 and 114, a statement to that effect;

(m) if a medicinal product is prescribed in accordance with Article 107(3) and (4), a statement to that effect.

6. The quantity of the medicinal products prescribed shall be limited to the amount required for the treatment or therapy concerned. As regards antimicrobial medicinal products for metaphylaxis or prophylaxis, they shall be prescribed only for a limited duration to cover the period of risk.

7. Veterinary prescriptions issued in accordance with paragraph 3 shall be recognised throughout the Union.

8. The Commission may, by means of implementing acts, set a model format for the requirements set in paragraph 5 of this Article. 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 145(2).

9. The medicinal product prescribed shall be supplied in accordance with applicable national law.

10. A veterinary prescription for antimicrobial medicinal products shall be valid for five days from the date of its issue.

11. In addition to the requirements set out in this Article, Member States may lay down rules on record-keeping for veterinarians when issuing veterinary prescriptions.

12. Notwithstanding Article 34, a veterinary medicinal product classified as subject to veterinary prescription under that Article may be administered without a veterinary prescription by a veterinarian personally, unless otherwise provided for under applicable national law. The veterinarian shall keep records of such personal administration without prescription in accordance with applicable national law.