The Medicines Act 1968 (Amendment) Regulations 1994

• Citation: S.I. 1994/101
• Sections: 8

Section 1 Citation, commencement and interpretation

(1) These Regulations may be cited as the Medicines Act 1968 (Amendment) Regulations 1994 and shall come into force on 14th February 1994.

(2) In these Regulations “ the Act ” means the Medicines Act 1968 and a reference to a numbered section in these Regulations is a reference to the section of the Act which bears that number.

Section 2 Section 7 of the Act dealings with medicinal products

(1) Section 7 (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 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 of 22 September 1992.

(3) In subsection (6A), paragraph (c) and the word “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;

Section 3 Section 8 of the Act manufacture and wholesale dealing

(1) Section 8 (provisions as to manufacture and wholesale dealing) is amended as follows.

(2) In subsection (4), paragraph (b) and the word “or” immediately preceding it are omitted.

(3) In subsection (6), before “proprietary medicinal product” there is inserted “homoeopathic medicinal product,”.

Section 4 Section 24 of the Act duration and renewal of licence

In section 24 (duration and renewal of licence) —

(a) in subsection (1A) after “obligation” there is inserted “(other than an obligation under the 1992 Directive)”;

(b) in subsection (3)(c) after “this Act” there is inserted “and any Community obligation under the 1965 Directive or the 1992 Directive”; and

(c) after subsection (6) there is inserted—

(7) In this section “the 1992 Directive” means Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets.

Section 5 Section 28 of the Act suspension etc. of the licence

(1) Section 28 (general power to suspend, revoke or vary licences) is amended as follows.

(2) In subsection (3)—

(a) at the beginning there is inserted “Subject to subsection (3A) of this section”; and

(b) in paragraph (j) after “relates” there is inserted “(other than products to which Chapters II to V of the 1965 Directive apply)”.

(3) After subsection (3) there is inserted—

(3A) Where a product licence relates to a product to which Chapters II to V of the 1965 Directive apply, the power conferred by this section to suspend a licence shall be exercisable in relation to the licence on the ground that—

(a) any of the provisions contained in regulations made under section 85 (labelling and marking of containers and packages) or 86 (leaflets) of this Act, or

(b) section 86(4),

has to a material extent been contravened in relation to the product by the holder of the licence or by a person procured by him to manufacture or assemble the product.

(4) The amendments made by this regulation have effect only in relation to licences granted or renewed after the coming into force of these Regulations.

Section 6 Section 86 of the Act leaflets

(1) After section 86(3) (leaflets), there is inserted—

(4) No person shall, in the course of a business carried on by him, supply a product to which Chapters II to V of the Directive apply, unless—

(a) a leaflet enclosed in, or supplied with, the container or package of the product, or

(b) the container or package itself,

contains the particulars which a leaflet relating to the product is required by regulations under subsection (1) of this section to contain, and does so in the manner required by such regulations.

(2) The amendment made by this regulation has effect only in relation to licences granted or renewed after the coming into force of these Regulations.

Section 7 Section 91 of the Act penalties

In section 91(1) (offences under Part V etc.) , after “section 86(3)”, there is inserted “or (4)”.

Section 8 Section 132 of the Act interpretation

In section 132(1) (general interpretation), in the definition of “the 1965 Directive”, for “and 89/381/EEC (h);”there is substituted “, 89/381/EEC (h) and Article 9(1) of Council Directive 92/73/EEC ;” .