The Medicines (Advertising) Regulations 1994

Explanatory Note

(This note is not part of the Regulations)

These Regulations, made under powers contained in the Medicines Act 1968 and in the European Communities Act 1972, implement parts of Council Directive 92/28/EEC (OJ No. L113, 0.4.1992, p.13) (“the Advertising Directive”) concerning the advertising of medicinal products for human use and parts of Council Directive 92/73/EEC (OJ No. L297, 13.10.1992, p.8) (“the Homoeopathics Directive”) concerning homoeopathic medicinal products for human use. The Regulations relate only to medicinal products for human use: see the definition of “relevant medicinal product” in regulation 2(1).

The Regulations cover homoeopathic products marketed under a certificate of registration, implementing article 6(3) of the Homoeopathics Directive, but not those marketed under a product licence of right.

For the purposes of these Regulations, “advertisement” has the same meaning as in section 92 of the Medicines Act 1968, with certain modifications to take account of article 1(3) and (4) of the Advertising Directive, and includes a representation (regulation 2(2)).

Regulation 3 creates the new offence of advertising a medicinal product in respect of which there is no product licence (except a homoeopathic product marketed under a certificate of registration).

Regulation 4 places the holder of a product licence under a duty to monitor information received about products which he promotes, provide adequate training for medical sales representatives, provide particulars of advertisements to the licensing authority on request and ensure that any decisions taken by the licensing authority regarding advertisements are complied with. These provisions implements articles 8(1) and 13 of the Advertising Directive.

Part III of the Regulations concerns advertising of medicinal products to the general public. Regulation 6 prohibits advertisements for medicinal products for the treatment, prevention or diagnosis of certain diseases specified in Schedule 1, implementing article 3(2) of the Advertising Directive. Article 3(1) of the Directive is implemented by regulations 7 (prohibition of advertisements for medicinal products on prescription only) and 8 (prohibition of advertisements relating to certain medicinal products). Regulation 9 implements article 5 of the Advertising Directive, prohibiting various forms of misleading advertisements, and regulation 10 implements article 4, specifying the form and content of advertisements (except in relation to name-only advertisements on promotional aids). Regulation 11 provides for an exemption from certain of the requirements of the Regulations for advertisements which are part of an approved vaccination campaign (article 3(4) of the Advertising Directive), and regulation 12 prohibits the supply of medicinal products to the general public (article 3(6) of that Directive).

Part IV of the Regulations concerns advertising of medicinal products to health professionals. Regulations 14 and 15 implement article 6(1) of the Advertising Directive, providing that advertisements to health professionals, including audio-visual advertisements, shall contain essential information compatible with the summary of product characteristics (see the definition in regulation 2(1)) together with the particulars specified in Schedule 2. Regulation 16 applies the requirements of article 6(1) also to abbreviated advertisements, which must include the particulars specified in Schedule 3 to the Regulations. The provisions of regulations 14, 15 and 16 do not apply to name-only advertisements on promotional aids (regulation 17).

Article 7 of the Advertising Directive (requirements for written material accompanying promotions) is implemented by regulation 18. Implementing article 11 of the Advertising Directive, regulation 19 and Schedule 4 regulate the provision of free samples to persons qualified to prescribe medicinal products.

Regulation 20 regulates the promotion of medicinal products by medical sales representatives and implements article8(2) and (3) of the Advertising Directive. Regulation 21 regulates the provision of inducements and hospitality in relation to medicinal products, implementing articles 9 and 10 of that Directive.

Regulation 22 and Schedule 5 implement articles 6(3) (second indent) and 7(2) of the Homoeopathics Directive, specifying the particulars which advertisements for homoeopathic medicinal products marketed under a certificate of registration may contain.

Regulation 23 provides that breach of any of the provisions of the Regulations there specified is a criminal offence, and specifies penalties.

Part VII deals with revocations, amendments and transitional provisions. The Medicines (Advertising to Medical and Dental Practitioners) Regulations 1978 are revoked, and the Medicines (Labelling and Advertising to the Public) Regulations 1978 are amended so that those Regulations do not apply to an advertisement or representation for a medicinal product covered by these Regulations (regulation 24).

Regulation 25 contains a transitional provision exempting from the requirements of Parts III and IV of the Regulations advertisements for which a contract has already been made and which cannot be altered without incurring a financial penalty.

Implementation of the Advertising Directive is completed by the Medicines (Monitoring of Advertising) Regulations 1994, which implement article 12 (monitoring of advertising). Implementation of the remaining articles of the Homoeopathics Directive is completed by four sets of Regulations: the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994, the Medicines Act 1968 (Amendment) (No. 2) Regulations 1994, the Medicines (Labelling and Leaflets) Amendment Regulations 1994, and the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1994.