French National Competent Authority states that it will comply with the European Comission decision rearding Diane 35

May 31, 2013 | By Márcio Barra

France’s health regulator, the National Agency for the Safety of Drugs and Health Products (ANSM), announced yesterday that it would comply with the European Commission if it ruled that Bayer acne pill Diane 35 and its generic versions were safe to use in some cases. Sales of Diane would keep on hold until the final ruling, it said.

The European Commission’s decision is expected to arrive in the coming weeks, following EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) decision back in May, and Thursday’s endorsement of the decision by the The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

For more on this story, please go here, here, here and here.



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