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Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance) article 112 CELEX: 02019R0006-20220128 Use of medicinal products outside the terms of the marketing authorisation in non-food-producing 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 non-food-producing 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 species or another 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 medicinal product for human use authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004; (c) if there is no medicinal product as referred to in point (a) or (b) of this paragraph, a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription. |
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance) article 112 CELEX: 02019R0006-20220128 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 responsibility and in particular to avoid causing unacceptable suffering exceptionally treat a non-food-producing animal 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. This Article shall also apply to the treatment by a veterinarian of an animal of the equine species provided that it is declared as not being intended for slaughter for human consumption in the single lifetime identification document referred to in Article 8(4). 5. This Article shall apply also when an authorised veterinary medicinal product is not available in the relevant Member State. |