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Recital 57

Recital 57

(57)Article 6 of Directive 2001/82/EC provides that a veterinary medicinal product may not be the subject of a marketing authorisation for the purpose of administering it to one or more food-producing species unless the pharmacologically active substances which it contains are included in Annex I, II or III to Regulation (EEC) No 2377/90. The rules laid down in those Annexes are now set out in Commission Regulation (EU) No 37/2010 34 . However, by way of derogation a veterinary medicinal product containing pharmacologically active substances not included in Annex I, II or III to Regulation (EEC) No 2377/90 may be authorised for particular animals of the equidae family that have been declared, in accordance with Union animal health legislation as not being intended for slaughter for human consumption. Such veterinary medicinal products must neither include active substances that appear in Annex IV to Regulation (EEC) No 2377/90 nor be intended for use in the treatment of conditions, as detailed in the authorised Summary of Product Characteristics, for which a veterinary medicinal product is authorised for animals of the equidae family. Consequently, provisions should be made that an equine animal may be excluded from slaughter for human consumption on the discretion of the owner of the animal.

  1. 34 Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin ( OJ L 15, 20.1.2010, p. 1 ). ↩
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