Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)

The Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) has been developed by the EDQM (European Directorate for the Quality of Medicines) to ensure the quality of drugs for the protection of European public health.

This is a regulatory tool representing a great benefit not only for regulatory agencies, but also for manufacturing sites of medicinal products and their respective MA holders.

However, obtaining a CEP involves the submission to the EDQM of a series of documents, undergoing strict assessment and control procedures, aiming at identifying any deficiency, and potentially leading to requests of integrations from the authority. 

The technical team of the regulatory consultancy Di Renzo Regulatory Affairs provides clients with assistance in the submission of the ASMFs of APIs and dossiers of starting materials to the EDQM for the registration, renewal and variation of CEPs.

Foto di EmilianDanaila da Pixabay