Pharma Review 2001
 Section Overview
The most recent review of EU pharmaceutical legislation
was completed in spring 2004, and entered into effect in November
2005. This section of the EGA website makes available the final versions
of the legislative texts from the Official Journal of the European Communities, along
with a series of documents analysing the results in terms of generic medicines.
Results of the Pharma Review
a) Legislative Texts:
Directive 2004/27/EC
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
• Adopted Strasbourg, 31 March 2004
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.
• Adopted Strasbourg, 31 March 2004
b) Reviews and Analyses:
Main Outcomes of the Pharma Review
Status of key issues in table format for the generic medicines industry followig the compromise between the Council and the European Parliament
An EGA Working Document
• December 2003
Data Exclusivity in the Pharma Review
A discussion of the new legal framework for data exclusivity: harmonisation of data exclusivity periods and addition of new periods of data exclusivity.
EGA Web Page on Data Exclusivity
• December 2003
European
Revisions Offer New Freedoms to Generics
Article in “Generics Bulletin” outlining the key provisions in the revised EU pharmaceutical legislation and their potential impact on generic medicines.
• Generics Bulletin - 16 January 2004 (with permission)
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