english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2011 Recap > Simplified examination of variations? Yes, but first re-evaluate old authorisations (10/2011)

Advancing healthcare policy

Advancing healthcare policy in Europe: a chronological recap of actions

A recap of actions in 2011
Simplified examination of variations to the terms of purely national marketing authorisations? Yes, but first re-evaluate "old national marketing authorisations"! (October 2011)

• Response to the public consultation on the "review of Commission Regulation (EC) No 1234/2008" concerning the examination of variations to the terms of purely national marketing authorisations .

Summary
Prescrire is taking advantage of its contribution to a technical consultation [concerning the review of a Regulation intended to simplify the examination of purely national marketing authorisation variations] to draw the attention of the European Medicines Agency (EMA ) and of the national competent authorities to the urgent need to organise a systematic re-assessment of all old national marketing authorisations, to prevent scandals similar to the benfluorex (Mediator°) scandal in France from occurring in other countries of the European Union.

> Download the EC Public Consultation Paper (pdf, 38 Ko)

> Download Prescrire's response dated 20 October 2011 (pdf, in English, 156 Ko)

> Download Prescrire's response in French (pdf, in French, 153 Ko)

©Prescrire 20 October 2011