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The EDQM has revised the “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs”:
- to include the requirements of the revised EU guideline on “Stability testing for applications for variations to a marketing authorisation” (EMA/CHMP/CVMP/QWP/441071/2011 Rev 2).
- to describe the types of revision to be submitted when a CEP for a starting material is used in an application for another CEP (cf.PA/PH/CEP (14) 06).
The revised document has an implementation date of 1st October 2014
Please find below the link for the revised guidelines,