EMA – Revision of the EMA post-authorisation procedural advice for users of the centralised procedure

The EMA published its last version of the post-authorisation procedural advice for users of the centralised procedure. This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. More information on post-authorisation on the EMA Website.