Restrictions on placing on the market and importation of animal feeding stuffs in which medicinal products have been incorporated
6.—(1) No person shall, in the course of a business carried on by him, place on the market any animal feeding stuff in which a medicinal product, not being a prescription only medicine, has been incorporated unless the medicinal product was incorporated in accordance with regulation 4.
(2) No person shall, in the course of a business carried on by him, import any animal feeding stuff in which a medicinal product, not being a prescription only medicine, has been incorporated unless 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 the medicinal product was incorporated as mentioned in regulation 4(1)(a).
(3) Subject to paragraph (4) below, no person shall, in the course of a business carried on by him, place on the market any animal feeding stuff in which a prescription only medicine has been incorporated unless—
(a)(i)it has been manufactured in accordance with the provisions of these Regulations pursuant to Council Directive 90/167/EEC and then only if the medicinal product was incorporated in accordance with regulation 4(1)(a); and
(ii)subject to paragraph (4) below, 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 the animal feeding stuff is placed on the market or imported in accordance with a veterinary written direction;
or
(b)that person is satisfied that the placing on the market has been requested by a veterinary surgeon who, by reason of any emergency, is unable to furnish a veterinary written direction immediately but who has undertaken to furnish that person with a veterinary written direction within 72 hours.
(4) Paragraph (3)(a)(ii) above shall not apply where any animal feeding stuff in which a prescription only medicine has been incorporated as mentioned in regulation 4(1)(a) is sold or supplied to a person—
(a)whose name is entered in Part A of the Register and whom the seller or supplier knows, or has reasonable cause to believe, to be a person who does not have animals under his control for the purposes of, and in the course of carrying on a business, either as his sole business activity or as a part of his business activities unless for research or educational purposes only, or
(b)whose name is entered in the register kept by the Society (in the case of a person carrying on a business elsewhere than in Northern Ireland) or by the Department of Health (N.I.) (in the case of a person carrying on a business in Northern Ireland) under article 5(1) of the Medicines (Veterinary Drugs) (Pharmacy and Merchants' List) Order 1992(1) .
(5) No person shall, in the course of a business carried on by him, import any animal feeding stuff in which a prescription only medicine has been incorporated unless it has been manufactured in accordance with the provisions of Council Directive 90/167/EEC and then only if 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 the animal feeding stuff is placed on the market or imported in accordance with a veterinary written direction.
(6) No person shall import from a member State any animal feeding stuff in which a prescription only medicinal product has been incorporated unless that feeding stuff—
(a)has been manufactured in accordance with the provisions of Council Directive 90/167/EEC;
(b)has been manufactured with medicinal products authorised by the exporting member State and which have the same active ingredient as licensed medicinal products; and
(c)is accompanied by a certificate in the form, including the note thereto, set out in Schedule 1.
(7) Any person who intends to export to a member State any animal feeding stuff in which a medicinal product has been incorporated shall, where that Member State requires a certificate corresponding in form to that set out in Schedule 1, in the case of a person carrying on a business elsewhere than in Northern Ireland make an application in writing to the Society and, in the case of a person carrying on a business in Northern Ireland make an application in writing to the Department, for such a certificate and, in either case, not less than 72 hours before the date of exportation and upon payment of the appropriate fee.
S.I. 1992/33.