Generic medicines, affordable solutions.

EGA Position Papers

Scientific|Regulatory

Intellectual Property

Pharma Review

Legislative Proposals

Science and Regulatory

Marketing Authorisation

a) New EU Pharmaceutical legislation:

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

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) Enlargement and Marketing Authorisation Procedure

Standard Operating Procedure on how to deal with simultaneous applications for marketing authorisation. This document was produced by the MRFG in order to facilitate and harmonise the practical application of Article 17 paragraph 2 of Directive 2001/83/EC by the competent national Authorities.
• Updated: May 2004

How to trigger the mutual recognition of marketing authorisation. This document was produced by the MRFG to facilitate and harmonise the practical application of Article 18 of Directive 2001/83/EC by the competent national Authorities.
• Updated: May 2004

Recommendations from the European Medicines Agency on how to deal with the Centralised Procedure at the time of Enlargement. Click on "Human Medicinal Products (Marketing Authorisation)" at this link to the EMEA Web site.

MRFG recommendation on how to deal with the Mutual Recognition Procedure at the time of Enlargement.
• April 2004

REPR Acquis Group Reflection Paper
• May 2003

EGA examines some practical aspects of the MRP and their impact on the activity of producers and Authorities during Enlargement.
• February 2004

c) Articles & Presentations:

Suzette Kox, EGA Senior Scientific & Regulatory Advisor
PowerPoint Presentation - Séminaire ARC
• 8-9 December 2003