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Posted 01 December 2009

Regulatory Advice

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has relatively recently updated the way in which it handles new applications for Certification of Suitability to the Monograph of the European Pharmacopoeia (CEP). Beginning September of 2008, EDQM decided to apply the procedure for managing the certification scheme described in the Resolution AP CSP (07) 1 in a more rigorous fashion to ensure that official timelines are met. The evaluation of new dossiers is now handled in two phases.

 

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