Explanatory note

These Regulations implement Article 12 of Council Directive 92/28/EEC (OJ No. L113, 30.4.92, p.13) (“the Directive”) concerning the advertising of medicinal products for human use by specifying procedures whereby persons or organisations may bring an advertisement which is inconsistent with the requirements of the Directive before an administrative authority competent either to decide on complaints or to institute civil proceedings in the High Court (or, in Scotland, the Court of Session).

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 Directive, and includes a representation (regulation 2(2)).

Regulation 2(6) provides that the Regulations apply to advertisements for medicinal products for human use to which Council Directive 65/65/EEC applies (OJ No. 22, 9.2.1965, p.369/65), and also to advertisements for homoeopathic medicinal products marketed under a certificate of registration (implementing article 6(3) of Council Directive 92/73/EEC (OJ No. L297, 13.10.1992, p.8)) (but not to advertisements for homoeopathic medicinal products marketed under a product licence of right).

Regulation 4 provides that it is the duty of the Health Ministers under the Medicines Act 1968 to consider complaints about advertisements for medicinal products for human use, except complaints to which regulations 5, 9 or 10 apply.

Where a complaint is made either that an advertisement is in breach of Part IV of the Medicines (Advertising) Regulations 1994 (advertising to health professionals), or that a non–broadcast advertisement is in breach of regulation 9 of those Regulations (prohibition of certain material in advertisements to the public), a self–regulatory body which deals with complaints about such advertisements, selected by the Health Ministers, may consider such complaint, if the complainant and the Health Ministers agree (regulation 5).

Regulation 6 provides that the Health Ministers may apply to the court for an injunction about a particular advertisement, to prevent its publication or further publication, and regulations 7 and 8 give details in relation to the granting of an injunction. If a final injunction is granted, the Health Ministers have power to require the publication of the decision and a corrective statement.

Regulations 9 and 10 provide that the Independent Television Commission, the Radio Authority or the Welsh Authority, as appropriate (statutory bodies given powers over advertisements by the Broadcasting Act 1990), has a duty to consider complaints that a broadcast advertisement may be in breach of regulation 9 of the Medicines (Advertising) Regulations 1994. Those bodies also have power under the Broadcasting Act 1990 to prevent transmission or further transmission of an advertisement (regulation 11).

These Regulations do not affect the availability of criminal proceedings where relevant in connection with the advertising of medicinal products for human use (regulation 3(2)).

The remaining parts of the Directive are implemented by the Medicines (Advertising) Regulations 1994, and these Regulations complete implementation of the Directive.