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

The EMA has released a guidance document on the post-authorisation 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.

European Medicines Agency


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