The Medicines (Medicated Animal Feeding Stuffs) Regulations 1989

Restrictions on incorporation of medicinal products in animal feeding stuffs

3.—(1) No person shall, in the course of a business carried on by him, incorporate a medicinal product of any description in an animal feeding stuff unless–

(a) there is a valid product licence or animal test certificate relating to the incorporation of that medicinal product (whether held by him or another person) and, subject to paragraph (2) below–

(i) where the medicinal product is incorporated at a rate below 2 kilograms per tonne, his name is entered in Part A of the Register in respect of the premises where the medicinal product is incorporated, or

(ii) in any other case, his name is entered in Part A or Part B of the Register in respect of the premises where the medicinal product is incorporated; and

(b) the medicinal product is incorporated–

(i) in accordance with provisions relating to the incorporation of the medicinal product in animal feeding stuffs contained in a product licence or animal test certificate (whether held by him or another person), or

(ii) in accordance with a veterinary written direction; or

(c) his name is entered in the Register and he–

(i) intends to export the animal feeding stuff in accordance with a written export order;

(ii) stores such animal feeding stuff in a part of a building separate from the storage of any other animal feeding stuff; and

(iii) keeps, for a period of at least 2 years from the date of the sale or supply, a record of–

(aa) the name and address of the purchaser;

(bb) the written export order; and

(cc) the name, identification and quantity of the animal feeding stuff.

(2) The requirement for this name to be entered in the Register, specified in paragraph (1)(a)(i) or (ii) above, shall not apply–

(a) to a fish farmer;

(b) to a person incorporating a medicinal product in accordance with a veterinary written direction where–

(i) a veterinary surgeon or veterinary practitioner has reason to believe it necessary to authorise a derogation from that paragraph on grounds of immediate danger to the health of animals under his care and the veterinary written direction authorises such derogation on those grounds, and

(ii) the person incorporating the medicinal product sends a copy of the veterinary written direction to the Society or the Department within 28 days of incorporation; or

(c) to a person operating mobile mixing equipment if–

(i) his name is entered in the Register in respect of the premises where his mobile equipment is normally kept, and

(ii) in a case where his name is entered in Part B of the Register, the medicinal product is incorporated in the animal feeding stuff at a rate of at least 2 kilograms per tonne.