L 52/6
EN
Official Journal of the European Union
20.2.2023
(r) ‘equine animal’ as an animal of species of solipeds belonging to the genus Equus (including horses, asses, and zebras) and the offspring of crossings of those species; (s) ‘day-old chicks’ means all poultry less than 72 hours old. 2.
In addition to the definitions laid down in paragraph 1, the definitions of ‘veterinary medicinal product’, ‘immuno­ logical veterinary medicinal product’ and ‘antimicrobial’ set out in Article 4(1), (5) and (12) of Regulation (EU) 2019/6 shall apply.
Article 3 Prohibitions and restrictions on the use of vaccines in animals for the prevention and control of category A and certain category B diseases 1.
Member States may allow the use of vaccines in animals for the prevention and control of category A diseases, except for the diseases listed in Part 1 of Annex I, only under the control of the competent authority and if they are used: (a) as a part of the official measures put in place by the competent authority for prevention and control of those diseases; (b) under the conditions laid down in this Regulation. 2.
The conditions for the use of vaccines against category A diseases, laid down in the first subparagraph, shall not apply to certain uses of vaccines against infection with Newcastle disease virus, notably to routine precautionary use or to use in the framework of trade, that the Member States may allow outside the official disease prevention and control measures referred to in paragraph 1 for purposes other than responding to an outbreak. 3.
Member States may allow the use of vaccines in animals for prevention and control of category B diseases, except for the diseases listed in Part 2 of Annex I, in those listed species for which the corresponding diseases have been classified as category B. Article 4 Prohibitions and restrictions on the use of certain veterinary medicinal products, other than vaccines, in animals, for the prevention and control of category A and B diseases Member States shall prohibit the use of the following veterinary medicinal products in animals for the prevention and control of category A and B diseases unless they are used for the prevention and control of the diseases listed in Part 3 of Annex I and their use complies with the conditions set out therein: (a) immunological veterinary medicinal products to diagnose the state of immunity of animals; (b) hyper-immune serum; (c) inactivated immunological veterinary medicinal products, as referred to in Article 2(3) of Regulation (EU) 2019/6; (d) antimicrobials.
PART II RULES ON THE USE OF VACCINES FOR THE PREVENTION AND CONTROL OF CATEGORY A DISEASES IN ANIMALS CHAPTER 1
Preconditions Article 5 Preconditions for the use of vaccines for the prevention and control of category A diseases in terrestrial and aquatic animals 1.
The competent authority may decide on the use of vaccines in animals to prevent and control category A diseases, in accordance with Article 3(1), provided that: (a) it has carried out an assessment to support this decision considering at least the criteria set out in Part 1 of Annex II, in addition to the criteria provided for in Article 46(2) of Regulation (EU) 2016/429;