Medicines Labelling and Leaflet Directive

HC Deb 12 December 1997 vol 302 cc736-7W

Mr. Austin

To ask the Secretary of State for Health what plans he has to implement the EU medicines labelling and leaflet directive. [19805]

Ms. Jowell

The European Union Directive 92/27/EEC on the labelling of medicines for human use and on package inserts was implemented into United Kingdom legislation by means of:

• The Medicines (Labelling) Amendment Regulation SI 1992 No. 3273.
• The Medicines (Leaflets) Amendment Regulations SI 1992 No. 3274.
• The Medicines for Human Use (Marketing Authorisations Etc.) Regulations SI 1994 No. 3274.

By 31 December 1998 all medicines on the UK market will have labelling and patient information leaflets approved meeting the requirements of the European Directive. The Medicines for Human Use (Marketing Authorisations Etc.) Regulation 1994 require any person who supplies a medicinal product to ensure that it is accompanied by the relevant statutory information.