english.prescrire.org > Topics > Advancing healthcare policy > Simplified examination of variations? Yes, but first re-evaluate old authorisations (10/2011)
Advancing healthcare policy

Via its policy advocacy, Prescrire acts as a force for change in health policies, first and foremost in the interest of patients.
 

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

In its response to the public consultation on variations to the terms of national marketing authorisations, Prescrire draws attention 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. Read on...
 

• 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