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Post-authorisation

Question-and-answer (Q&A) document

EMA's post-authorisation procedural advice document provides a printable overview in Q&A format of EMA's position on issues typically addressed with marketing authorisation holders.

EMA regularly updates the Q&A to reflect new developments, additional guidance and the implementation of new European legislation. A track-changes version shows the latest updates. New or revised Q&As are labelled 'New' or 'Rev' respectively together with the relevant date.

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