Explanatory note

These Regulations consolidate with amendments the Medicines (Medicated Animal Feeding Stuffs) Regulations 1985 and implement in part the provisions of Article 13 of Council Directive 70/524/EEC (OJ No. L270, 14.12.70, p. 1 (OJ/SE 1970 (III) p. 840)) concerning additives in feeding stuffs, as substituted by Article 1 of Council Directive 84/587/EEC (OJ No. L319, 8.12.84, p. 13). The relevant provisions of the Regulations which implement provisions in that Article are to be found in regulations 3(1)(a), 4(1)(a) and 6.

The Regulations continue to prohibit a person, in the course of a business carried on by him, from incorporating a medicinal product in an animal feeding stuff unless it is incorporated in accordance with a product licence, an animal test certificate or a veterinary written direction given by a veterinary surgeon or verterinary practitioner. Additionally, with effect from 1st July 1988 these Regulations generally require the person incorporating the medicinal product to be registered in Part A of a Register (“the Register”) kept by the person appointed as registrar under section 1 of the Pharmacy Act 1954 (c. 61) or by the Department of Agriculture for Northern Ireland in respect of the premises where the medicinal product is incorporated, if the medicinal product is incorporated at a rate below 2 kilograms per tonne. In any other case with effect from 1st July 1989 he must generally be registered in either Part A or Part B of the Register (regulations 1(2) and 3). The Regulations generally prohibit a person not registered in Part A of the Register from incorporating in an animal feeding stuff a medicinal product for which there is no product licence or animal test certificate relating to the incorporation of that product in an animal feeding stuff (regulation 3(3)). A person operating mobile mixing equipment may be registered in respect of the premises where that equipment is normally kept (regulation 3(2)(c)).

The Regulations continue to prohibit a person, in the course of a business carried on by him, from selling or supplying any animal feeding stuff in which a medicinal product, not being a prescription only medicine (that is to say a medicinal product which may be sold or supplied by retail only in accordance with a prescription given by a veterinary surgeon or veterinary practitioner), has been incorporated or from importing any such animal feeding stuff unless the medicinal product was incorporated in the animal feeding stuff in accordance with a product licence, an animal test certificate or a veterinary written direction. Additionally, these Regulations require that in the case of sale or supply all the other requirements of regulation 3 must have been complied with (regulation 4(1) and (2)).

The Regulations continue to prohibit a person, in the course of a business carried on by him, from selling or supplying any animal feeding stuff in which a prescription only medicine has been incorporated or from importing any such animal feeding stuff except in accordance with a veterinary written direction, subject to certain exceptions (regulation 4(3) and (4)).

The Regulations also—

Copies of the British Pharmacopoeia and British Pharmacopoeia (Veterinary) may be obtained from HMSO, and copies of the European Pharmacopoeia may be obtained from the Pharmaceutical Society of Great Britain.