The Medicines (Medicated Animal Feeding Stuffs) Regulations 1992

Explanatory Note

(This note is not part of the Regulations)

These Regulations replace the Medicines (Medicated Animal Feeding Stuffs) Regula tions 1989 as amended in 1990.

These Regulations, pursuant to Council Directive 90/167/EEC (laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community, OJ No. L 92, 7.4.90, p.42) introduce controls in respect of the holding for sale or disposal in any other form whatever to third parties, whether or not for consideration, of any medicated animal feedingstuffs which include, for the first time, final medicated feeding stuffs.

The powers in section 2(2) of the European Communities Act 1972, are used to give effect to the provisions specified below—

(a) the definition of placing on the market (article 2 of the Directive) and withdrawal period (regulation 2(1));

(b) the incorporation in an animal feeding stuff of a prescription only medicinal product must be done only in accordance with a veterinary written direction and then only in specified circumstances (regulation 4(4) and article 8.1 of the Directive);

(c) the incorporation in an animal feeding stuff of any medicinal product (in accordance with a veterinary written direction) must be in accordance with specified requirements as to daily dosages and non-use of the same antibiotic or coccidiostat (regulation 4(5) and article 4.1 of the Directive);

(d) a person who incorporates a medicinal product in an animal feeding stuff must store the feed only on premises in respect of which he is registered (regulation 5 and article 4.1(a) of the Directive);

(e) any prescription only medicine incorporated in an animal feeding stuff which is placed on the market or imported, must have been manufactured in accordance with the provisions of these Regulations pursuant to article 4 of the Directive (regulation 6(3) and (5)); any importation of animal feeding stuff incorporating a medicinal product from another member State must be accompanied by a certificate in the prescribed form (regulation 6(6), Schedule 1 and article 10.3 of the Directive);

(f) merchants must not place on the market any final medicated feeding stuff containing a medicinal product unless they are registered in the Register of Merchants or the Register of Manufacturers, nor sell otherwise than to specified persons (regulation 8 and article 9.1 of the Directive);

(g) medicated animal feeding stuffs incorporating a prescription only medicine can be used only if they have been manufactured in accordance with the provisions of these Regulations pursuant to the Directive (regulation 9 and article 7 of the Directive);

(h) packages or containers of medicated feeding stuffs must not be re-used (regulation 10 and article 5.1 of the Directive);

(i) the stock farmer or holder of food-producing animals which are fed with medicated feeding stuffs, must observe the withdrawal period (regulation 11 and article 8.3 of the Directive);

(j) the form of the veterinary written direction is amended (regulation 7, Schedule 2 and article 8.1(a) of the Directive).

Under the Medicines Act 1968 provision is made for the Code of Practice for registered manufacturers to be updated (regulation 6(7)). The Code of Practice is a priced publication and is available from MAFF Publications, London SE99 7TP.