The Medicines (Medicated Animal Feeding Stuffs) (No. 2) Regulations 1992

Restrictions on placing on the market final medicated feeding stuff containing medicinal products

8.—(1) The requirements of this regulation shall not apply to any person who, in the course of a business carried on by him, places on the market any final medicated feeding stuff in which a medicinal product has been incorporated, other than a prescription only medicinal product, provided that that feeding stuff is packed in pack sizes of 5 kg or less and is intended for retail sale to the keepers of pets or companion animals.

(2) No person shall, in the course of a business carried on by him, place on the market any final medicated feeding stuff in which a medicinal product has been incorporated unless his name is—

(a) entered in the Register of Merchants kept pursuant to article 8(1) of the Medicines (Veterinary Drugs) (Pharmacy and Merchants' List) Order 1992 in respect of each premises on which such final medicated feeding stuff is sold or stored as a Category I or Category II merchant; or

(b) entered in Part A or Part B of the Register of Manufacturers kept pursuant to regulation 3(1) in respect of each premises on which such final medicated feeding stuff is sold or stored

and the conditions contained in paragraphs (3) to (8) below are complied with.

(3) No person shall, in the course of a business carried on by him, place on the market or sell or supply any final medicated feeding stuff in which a medicinal product has been incorporated except to a person—

(a) whose name is entered in the Register of Merchants (as aforesaid) as a Category I or Category II merchant;

(b) whose name is entered in Part A or Part B of the Register of Manufacturers (as aforesaid); or

(c) whom the seller knows, or has reasonable cause to believe, to be a person who has 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 part of his business activities.

(4) No person shall, in the course of a business carried on by him, place on the market any final medicated feeding stuff in which a medicinal product has been incorporated except—

(a) in the container in which it was made up for sale or disposal by the manufacturer;

(b) in a container which has not been opened since the feeding stuff was made up for sale or disposal in it; and

(c) on premises which are occupied by, and under the control of, the seller at the time of sale or disposal.

(5) No final medicated feeding stuff in which a medicinal product has been incorporated shall be sold by retail by self-service methods.

(6) In respect of the placing on the market of any final medicated feeding stuff in which a medicinal product has been incorporated the seller shall make a record of the sale containing particulars of—

(a) the date on which the feeding stuff was sold;

(b) the name, identification and quantity of the feeding stuff sold; and

(c) the name and address of the person to whom the feeding stuff was sold;

and shall keep such a record for a period of 3 years from the date of the sale.

(7) No person shall, in the course of a business carried on by him, place on the market any final medicated feeding stuff in which a medicinal product has been incorporated unless that feeding stuff has been manufactured in accordance with the provisions of these Regulations pursuant to Council Directive 90/167/EEC.

(8) In paragraph (2) above, “premises” includes a stall of a permanent nature situated at a market or an agricultural showground.