EMA - Q&A - post-authorisation procedural advice for users of the centralised procedure

17th February 2021

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

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