New directive on Community Code relating to medicinal products for human use

A new Commission Directive 2003/63/EC has been issued, which amends Directive 2001/83/EC on the Community code relating to medicinal products for human use. The new Directive is applicable from 1 July 2003 and Member States must implement its provisions nationally by 31 October 2003 at the latest.

The new Directive replaces Annex I of Directive 2001/83/EC with a new, expanded Annex I, providing details of the supporting dossier required to be supplied with applications for marketing authorisations. This amendment takes into account the desire to implement the use of the Common Technical Document without delay and introduces standardised marketing authorisation dossier requirements.

In addition, specific rules are introduced relating to dossiers supporting applications for marketing authorisations for plasma-derived medicinal products, vaccines for human use, herbal medicinal products, gene therapy medicinal products and cell therapy medicinal products.

Plasma-derived medicinal products are biological medicinal products, the manufacture of which is based on human plasma as a starting material. To take account of the fact that the same plasma material is used in most cases for several medicinal products and as a result that a substantial part of the marketing authorisation dossier may be common to a great number of other dossiers for totally different plasma-derived products, a new system is established aimed at simplifying procedures.

The concept of a Plasma Master File (PMF) is introduced to allow the pooling of national expertise and a single evaluation coordinated by the European Agency for the Evaluation of Medicinal Products (EMEA). The PMF is expected to be a stand-alone document, by which harmonised control of relevant information on starting materials could be achieved. The PMF system would comprise a two step assessment, firstly the Community level PMF assessment, resulting in a certificate of compliance with Community legislation, and secondly, an assessment of the finished plasma-derived medicinal product, which would remain the task of the relevant competent authority.

A similar system is introduced for vaccines, where the same antigen may be common to several medicinal products. In order to simplify the existing system a new system based on a vaccine antigen master file (VAMF) will be introduced. The operation of the VAMF system mirrors the PMF system.

Specific, detailed rules are also laid down in respect of the contents of the supporting dossiers for herbal medicinal products and for advanced therapy (gene and cell therapy) medicinal products.

For further information on the content and implications of the new Directive, please contact:

Zelda Pickup
CMS Cameron McKenna
T: +44 (0) 207 367 2043
zelda.pickup@cms-cmck.com

Natalie Wood
CMS Cameron McKenna
T: +44 (0) 207 367 2523
natalie.wood@cms-cmck.com