Advertising of medicines: The legislative framework

The principal European and UK legislation for the advertising and monitoring of medicines is contained in the following documents.  Further information and guidance is also given in the Blue Guide. (206Kb)

European legislation
› Council Directive 2001/83/EC - The Community Code relating to medicinal products for human use  (external link) - Title VIII of this Directive relates to advertising

› Council Directive 2004/27/EC – amending Directive 2001/83/EC (external link)

› Council Directive 2004/24/EC - The Traditional Herbal Medicinal Products Directive (external link)

› Council Directive 84/450/EEC – relating to the approximation of the laws, Regulations and administrative provisions of the Member States concerning Misleading Advertising

UK legislation
The Medicines Act 1968 – available from The Stationery Office.

› The Medicines (Advertising) Regulations 1994 - SI No. 1932 (external link)

› The Medicines (Monitoring of Advertising) Regulations 1994  - SI No. 1933 (external link)

› The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994  - SI No. 3144  (external link)

› The Medicines (Advertising) Amendment Regulations 1996  - SI No. 1552  (external link)

› The Medicines (Advertising and Monitoring of Advertising) (Amendment) Regulations 1999 - SI No. 267  (external link)

› The Medicines (Monitoring of Advertising) Amendment Regulations 1999 - SI No. 784 (external link)

› The Medicines (Codification Amendments Etc.) Regulations 2002 - SI No. 236 (external link)

› Communications Act 2003 (Amendment of the Medicines (Monitoring of Advertising) Regulations) Order 2003 - SI No 3093 (external link)

› The Medicines (Advertising) Amendment Regulations 2004 - SI No. 1480 (external link)

› The Medicines (Advertising Amendments) Regulations 2005 - SI No. 2787 (external link)

The most recent amendment to the Regulations (provided for by the Medicines (Advertising Amendments) Regulations 2005 (SI No. 2787 ) removes the prohibition on advertising medicinal products for certain diseases, removes the prohibition on mentioning the grant of a marketing authorisation in an advertisement and changes the provision relating to hospitality at events and scientific meetings where medicines are promoted. These Regulations also bring products with a traditional herbal registration under their scope.  Further infomation on traditional herbal medicnes is available in the Traditional Herbal Medicines Registration Scheme section:

› Traditional Herbal Medicines Registration Scheme

Copies of UK legislation can be ordered from The Stationery Office. (external link)

Contact for further information
Further advice can be obtained from The Advertising Unit, MHRA, 14-149, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.