Amended EC rules on medicinal products

Regulation 726/2004, which replaces Regulation 2309/93, provides new rules for the Community procedure (Community wide marketing authorisation) of human and veterinary medicines and creates the name European Medicines Agency for the organization which reviews applications for central marketing authorizations. Several types of medicines must follow the central marketing authorization procedure, including these based on biotechnological processes (recombinant DNA, controlled expression of gene coding for certain proteins, hybridoma and monoclonal antibody method), and human medicines containing new active substances for certain indications, such as acquired immune deficiency syndrome, cancer, neurodegenerative disorder, diabetes; with additional indications as from 2008 and further indications to be adopted on the basis of qualified majority.

Directive 2001/83 on the Community code relating to medicinal products for human use is amended by Directive 2004/24 and by Directive 2004/27. Directive 2004/24 defines and introduces a simplified registration procedure for traditional herbal medicinal products containing, as active ingredient(s), exclusively one or more herbal substance(s) or preparation(s). The Directive contains a detailed list of conditions to be satisfied, including evidence of the product medicinal use since at least 30 years, including 15 years within the Community. The preparation and publication of Community herbal monographs is also introduced. The simplified registration procedure, designated as “traditional-use registration”, may in the future be extended to other categories of medicines.

Directive 2004/27 introduces more fundamental changes to EC human medicines rules, among others, especially with regard to rules on the abridged registration and the marketing of generic products, as defined, by reference to existing medicines already authorized on the market since at least ten years (the generic application may be submitted after eight years). Under the new rules, it will be sufficient that the reference medicine is authorized in any Member State. The ten year protection period may however be extended by one year, to a total of eleven years, if the reference medicine obtains an authorization covering a new indication bringing “a significant clinical benefit in comparison with existing therapies” within the first eight years of marketing authorisation. When the reference medicinal product is centrally approved, applicants for marketing authorization of a generic version are able, under certain conditions, to apply for a national marketing authorization.

Separately, Directive 2004/27 introduces significant changes, among others, to the mutual recognition and decentralized procedures for marketing authorization, to packaging and advertising rules, to pharmacovigilance rules for medicinal products. Also Directive 2004/27 provides for the simplification of registration rules and requirements applicable to homeopathic medicines.

Regulation 726/2004/EC entered into force on 20 May 2004. Directive 2004/24/EC and Directive 2004/27/EC entered into force on 30 April 2004 and should be implemented by the Member States by 30 October 2005.