European Medicines Agency 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.

Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with the relevant date upon publication.