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.

Administrative changes were implemented in January 2026 to ensure alignment with the revised variations classification framework.

Current version

Questions and answers on 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 Rev.1