Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Generics Medicines in the Centralised Procedure

Tünde Molnár (Abschlußjahr: 2007)

Language: English

For several years the generic industry has been the principal user of the Mutual Recognition Procedure in order to be able to place medicinal products on the market in the European Union. As the generic pharmaceutical industry is becoming a principle supplier of medicines in the EU, the need for quick access of high-quality generic medicines to EU markets through efficient and manageable way is undoubtful. The revised legislation has extended the scope of the centralised procedure to include also generic medicinal products, whereby beside the MRP/DCP, the centralised procedure has now become a tool of choice for the generic applicant as a route of registration in the European regulatory context. Nowadays, as the 10-year data protection period starts to expire for more and more centrally authorised medicines and the new Member States are extending their markets, generic registrations using this new route are expected to increase.

The centralised procedure aims both the provision of market protection for innovative products as well as the facilitation of generic competition through establishing a competitive balance between the branded and generic sectors. In line with these objectives an efficient and fair environment is created for the development of the EU generics industry.

This new regulatory pathway opens up numerous advances and opportunities that generic companies can benefit from. The present thesis describes the various aspects of the Centralised Procedure from the generic companies perspective, while reveals all the advantages and possible setbacks that the generic industry may face when using this new route of registration.
Additionally, the present thesis outlines the complexity of product information related issues in the context of the centralised procedure and points out some existing problems that generic applicants may face in this area. The requirements and current practicalities of handling product information from generics applicants perspective are also briefly outlined.

Finally, the thesis describes the principles and current proceedings regarding the publication of information on medicinal products, with particular focus on generics, in line with the objectives of the EU Transparency and Communication strategy.

Pages: 53