Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Article 113 U.K. Use of medicinal products outside the terms of the marketing authorisation in food-producing terrestrial animal species

1. By way of derogation from Article 106(1), where there is no authorised veterinary medicinal product in a Member State for an indication concerning a food-producing terrestrial animal species, the veterinarian responsible may, under his or her direct personal responsibility, and in particular to avoid causing unacceptable suffering, exceptionally treat the animals concerned with the following medicinal product:

(a) a veterinary medicinal product authorised under this Regulation in the relevant Member State or in another Member State for use in the same or in another food-producing terrestrial animal species for the same indication, or for another indication;

(b) if there is no veterinary medicinal product as referred to in point (a) of this paragraph, a veterinary medicinal product authorised under this Regulation in the relevant Member State for use in a non-food-producing animal species for the same indication;

(c) if there is no veterinary medicinal product as referred to in point (a) or (b) of this paragraph, a medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004; or

(d) if there is no medicinal product as referred to in point (a), (b) or (c) of this paragraph, a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription.

2. Except as regards immunological veterinary medicinal products, where there is no medicinal product available as referred to in paragraph 1, the veterinarian responsible may under his or her direct personal responsibility, and in particular to avoid causing unacceptable suffering, exceptionally treat food-producing terrestrial animals with a veterinary medicinal product authorised in a third country for the same animal species and same indication.

3. The veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian’s responsibility, in accordance with national provisions.

4. Pharmacologically active substances included in the medicinal product used in accordance with paragraphs 1 and 2 of this Article shall be allowed in accordance with Regulation (EC) No 470/2009 and any acts adopted on the basis thereof.

5. This Article shall apply also when an authorised veterinary medicinal product is not available in the relevant Member State.