Europe – European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

This integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the post-authorisation guidance for access to the hyperlinked information.

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

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.

It will be updated regularly to reflect new developments, to include guidance on further postauthorisation procedures and to reflect the implementation of the new European legislation. Revised topics will be marked by “New” or “Rev” upon publication…