Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Influence of the EU-enlargement on the procedures for granting marketing authorisations for medicinal products in a single European market ***

Dr. Christian Witt (Abschlußjahr: 2002)

The purpose of the present work is to analyse the impact of the enlargement of the European Union (EU) on the procedures for granting marketing authorisations for medicinal products. Based on an overview on the existing rules within the EU and in the countries taking part in the Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries (CADREAC), the centralized procedure, the mutual recognition procedure and the national procedures are investigated regarding open legal issues for the accession of the proposed ten new member states.

The results for the centralized procedure demonstrate that harmonisation of the marketing authorisations granted before accession with the products coming from the relevant simplified procedure in the CADREAC states after accession has not yet been regulated. The differences in the summary of product characteristics and production sites as well as the impact of ten new languages on the licensing / authorisation of tradenames respectively labeling texts seem to need further clarification.

The amplification of the participants in the mutual recognition procedure will not decrease the problems already existing in this field. Concerning enlargement, impending legal issues are outlined considering the implementation of European decisions in the accessing countries coming from the different kinds of referral procedures. Moreover, in the competition of national regulatory authorities each will have to find her own position of provided scientific competence and organisation of the legal body.

The analysis of national procedures revealed, that the upgrade of dossiers, protection rights, legal status of medicinal products are important topics on the way to an accession to the EU. Further issues to be ruled in the future are registration procedures for certain kinds of products (e.g. herbal medicinal products, etc.). Besides the procedures for marketing authorisations, the harmonisation or recognition of decision on licensing products are outlined using the example of parallel trade.

Conclusively, the realization of a single European market, a fast access of patients to safe and innovative medicines and the consistency of procedures still require some legal guidance, although great efforts have been made so far for the integration of the new EU member states.

Pages: 35