NEWS | QWP Questions and Answers: how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV)

The Certificate of suitability to the Monographs of the European Pharmacopoeia (CEP) procedure is widely used in EU for submission of pharmacopoeial active substance manufacturer data. Based on experience gained by National Competent Authorities (NCA) and the extensive use of CEPs in MAA/MAV, it has become apparent that some aspects of Marketing Authorisation Holders (MAH)/applicant responsibilities need to be elucidated.

MAHs are responsible for the quality, safety and efficacy of medicinal products they place on the market throughout their lifecycle. It is therefore expected that when a CEP is referred to in a dossier, the MAH/applicant has access to detailed information equivalent to the open part of an ASMF via suitable technical agreements.

The European Medicines Agency recently published a document that aims to clarify the additional information and supporting data that are not currently addressed in the existing guidance, as a compilation of required data to be submitted in a MAA or in certain MAVs when a CEP is referred to in the MA dossier.

Have a look at the complete document here:

QWP Questions and Answers (Q&A): how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV)

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