European Medicines Agency post-authorisation procedural advice for users of the centralised procedur
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 post-authorisation procedures and to reflect the implementation of the new European legislation. Revised topics will be marked by "New" or "Rev" upon publication.
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