Questions and Answers on how to use a CEP in the context of a Marketing Authorisation Application or a Marketing Authorisation Variation

This document aims to clarify existing guidance as a compilation of required data to be submitted in a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV) when a CEP is referred to in the MA dossier.

Current version

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)

Reference Number: EMA/CHMP/CVMP/QWP/5/2024