The Controlled Drugs (Substances Useful for Manufacture) (Intra–Community Trade) Regulations 1993

5.—(1) No operator shall manufacture or place on the market any of the scheduled substances specified in Category 1 of Schedule 1 below without a licence to do so granted by the Secretary of State in accordance with regulation 6(1) below.

(2) An operator who holds a licence granted under paragraph (1) above shall not supply any of the substances there referred to, except to any of the following persons–

(a) another operator holding such a licence;

(b) an operator who requires any such substance for the manufacture of a medicinal product and in respect of whom a licence is in force to manufacture that product under section 8(2) of the Medicines Act 1968(1);

(c) a pharmacist or a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968;

(d) a person who is in charge of a laboratory, the recognised activities of which consist in, or include, the conduct of scientific education or research, and which is attached to a university or a hospital in the United Kingdom or to any other institution approved for the purpose by the Secretary of State;

(e) any other person who has been authorised by the Secretary of State to be supplied with such a substance for the purposes of the manufacture of non– medicinal products or other special purposes; or

(f) any other person permitted by a member State other than the United Kingdom to be supplied with, possess or handle such substances in accordance with Article 4(3) of Council Directive 92/109/EEC(2).

(3) An operator involved in the manufacture or placing on the market of scheduled substances listed in Category 2 of Schedule 1 below shall register with the Secretary of State the addresses of the premises from which he manufactures or trades in such substances and shall notify him in writing of any change of address.

(4) In this regulation–

“medicinal product” has the meaning assigned to it by section 130(3) of the Medicines Act 1968, and “non–medicinal products” shall be construed accordingly; and

“pharmacist” has the meaning assigned to it by section 132(1)(4) of that Act.

(1)

1968 c. 67.

(2)

OJ No. L370, 19.12.92, p.76, as amended by Commission Directive 93/46/EEC (OJ No. L159, 1.7.93. p.134).

(3)

Section 130 was amended by sections 13(2) and 16 of, and paragraph 3 of Schedule 1 and Schedule 2 to, the Animal Health and Welfare Act 1984 (c. 40).

(4)

The definition in section 132(1) was amended by paragraph 7 of Schedule 5 to the Pharmacy (Northern Ireland) Order 1976 (S.I. 1976/1213 (N.I. 22)).