The Medicines Act 1968 (Amendment) (No. 2) Regulations 1994

Section 7 of the Act — dealings with medicinal products

3.—(1) Section 7(1) (general provisions as to dealing with medicinal products) is amended as follows.

(2) After subsection (2), there is inserted—

“(2A) The restrictions imposed by subsection (2) of this section shall not apply where the medicinal product concerned is a homoeopathic medicinal product in respect of which a certificate of registration has been granted.

(2B) In relation to a homoeopathic medicinal product to which the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(2) apply but in respect of which no certificate of registration has been granted, the references in subsection (2) of this section to the activities of sale or supply and of procuring the sale or supply respectively shall be taken to include references to any activity which amounts to placing such a product on the market within the meaning of Council Directive 92/73/EEC(3) of 22 September 1992.”.

(3) In subsection (6A)—

(a) at the end of paragraph (a) there is inserted “or”; and

(b) paragraph (c) and “, or” immediately preceding it are omitted.

(4) In subsection (7), before the definition of “proprietary medicinal product” there is inserted—

““certificate of registration” means a certificate granted under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;

“homoeopathic medicinal product” means any medicinal product (which may contain a number of principles) prepared from products, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State;”.

(1)

Subsection (5) of section 7 was amended by regulation 2(2) of the Medicines (Medicines Act 1968 Amendment) Regulations 1977 (S.I. 1977/1050) and regulation 3 of (N.I.) S.R. 1977 No. 170, regulation 2(2) of S.I. 1983/1724 and regulation 2 of S.I. 1992/604 (which also inserted subsections (6A) and (6B)).

(2)

S.I. 1994/105.

(3)

OJ No. L 297, 13.10.92, p. 8.