Last week, European Medicines Agency (EMA) updated the guidance document “European Medicines Agency post-authorisation procedural advice for users of the centralised procedure”.
This guidance document addresses a number of issues that marketing authorisation holders (MAHs) may have on post-approval procedures and provides an overview of the Agency’s position on issues, which are often addressed in evaluations or meetings with MAHs in the post-approval phase.
The Agency regularly updates this document to reflect new developments, to include guidance on further post-approval procedures and to reflect the implementation of the new European legislation.
Asphalion has extensive experience with Centralised Procedures (CP). If you are planning a CP for Marketing Authorisation Application (MAA) or about to initiate a post-authorisation procedure for products approved through CP and would like to have support, please contact us at firstname.lastname@example.org