The European Directorate for the Quality of Medicines & HealthCare has revised its guidance on the revision/renewal of certificates of suitability (CEPs), which guarantee that the quality of companies’ pharmaceutical substances comply with the relevant monographs of the European Pharmacopoeia. The system for revision/renewal of CEPs will change for all requests received from 1 March, in line with the new Variations Regulation (Regulation 1234/2008).
As such, the Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia monographs1 and the Procedures...
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