The Medicines (Advertising Amendments) Regulations 2005

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (the 2001 Directive) and Directive 2004/24/EC of the European Parliament and Council of 31 March 2004 as regards traditional herbal medicinal products, in so far as those Directives relate to advertising. In particular, they implement paragraphs (51), (62), (64), (65), (66), (67), (68), (71) and (84) of Article 1 of Directive 2004/27/EC and Article 1(2) of Directive 2004/24/EC.

These Regulations amend the Medicines (Advertising) Regulations 1994 (the principal Regulations) by removing the prohibition on advertising medicinal products for certain diseases (regulations 5 & 14), by removing the prohibition on mentioning the grant of a marketing authorization in an advertisement for a medicinal product (regulation 6), by changing the wording of the provision relating to hospitality at promotional events for medicinal products (regulation 11) and by allowing certain alternatives to using the name of the product in advertisements on promotional aids (regulations 7 & 10).

The principal Regulations have also been amended so as to apply to products with an authorization under Article 126a of the 2001 Directive (regulation 2; see definition of “marketing authorization”), a traditional herbal registration (regulations 2, 3, 4, 12, 15 & 16) or a certificate of registration for homoeopathic medicinal products (regulations 2, 4, 9, 15 & 16), or the respective authorization or registration holder as appropriate.

These Regulations also update the references to Community legislation, in particular inserting references to Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency which replaces Council Regulation (EEC) No. 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for Evaluation of Medicinal Products.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business and Transposition Notes for the implementation of Directives 2004/27/EC and 2004/24/EC are available from the Medicines and Healthcare products Regulatory Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Copies have been placed in the libraries of both Houses of Parliament.