Explanatory note

These Regulations, made under powers contained in section 2(2) of the European Communities Act 1972, deal with matters related to the implementation of Council Directive 92/28/EEC (OJ No. L113, 30.4.92, p.13) (“the Advertising Directive”). The Advertising Directive, which was implemented principally by the Medicines (Advertising) Regulations 1994 (S.I. 1994/1932), provides that advertising of a relevant medicinal product must be based on the provisions of that product’s summary of product characteristics. Requirements for the contents of summaries of product characteristics are set out in Article 4a of Directive 65/65/EEC (OJ No. L22, 9.2.65, p.369/65; relevant amending Directives are 83/570/EEC (OJ No. L332, 28.11.83, p.1) and 89/341/EEC (OJ No. L142, 25.05.89, p.11)). The Advertising Directive also sets out the circumstances in which summaries of product characteristics are to be made available to health professionals. These provisions differ from those contained in the Medicines Act 1968.

Regulation 2 adds subsection (7) to section 96 of the Medicines Act 1968 (which deals with advertisements and representations directed to practitioners), so that that section does not apply in relation to any medicinal product governed by the provisions of the Medicines (Advertising) Regulations 1994 and which is required to have a summary of product characteristics.