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 GuidePDF file (opens in new window) (549Kb).

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 Human Medicines Regulations 2012, SI 2012/1916 (external link)

The Human Medicines (Amendment No. 2) Regulations 2014, SI 2014/1878 (external link)

Contact for further information

Further advice can be obtained from The Advertising Unit, MHRA, 151 Buckingham Palace Road Victoria London, SW1W 9SZ. 

Page last modified: 01 October 2014