The Medicines (Advertising) Amendment Regulations 2004

Explanatory Note

(This note is not part of the Regulations)

These Regulations further amend the Medicines (Advertising) Regulations 1994 which implemented parts of Council Directive 92/28/EEC (OJ No. L113, 30.4.92, p.13) 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92/73/EEC (OJ No. L297, 13.10.1992, p.8) concerning homeopathic medicinal products for human use; both of which are now repealed and re-enacted by Directive 2001/83/EC (OJ No. L311, 28.11.2001, p.67) (see Title VIII in relation to advertising).

The Regulations amend regulation 6 and Schedule 1, which implemented article 3(2) of Council Directive 92/28/EEC (see now Article 88(2) of Directive 2001/83/EC). They remove the prohibition on advertising to the public medicinal products for the treatment, prevention or diagnosis of bone, cardiovascular, endocrine, psychiatric and joint, rheumatic and collagen diseases, genetic disorders, diseases of the liver, biliary system and pancreas, serious disorders of the eye and ear, serious gastrointestinal, neurological and muscular, renal and respiratory diseases, and serious skin disorders.

The prohibition on advertising medicinal products for chronic insomnia, diabetes and other metabolic diseases, malignant diseases, serious infectious diseases and sexually transmitted diseases remains.

A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Medicines and Healthcare products Regulatory Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.