European Medicines Agency Post-Authorization Procedural Advice for Users of the Centralized Procedure

20 June 2022 — EMA published updated Q&A guidance on extensions of marketing authorizations.

This guidance document addresses a number of questions which marketing authorization holders (MAHs) may have on post-authorization 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-authorization phase. The following sections were revised:

  • 3.21. Do I need to confirm the maintenance of my orphan designation when applying for a type II variation? Rev. Jun 2022
  • 4.7. Do I need to confirm the maintenance of my orphan designation when applying for an extension application? Rev. Jun 2022
  • 10.6. When, how and to whom shall I submit my annual re-assessment application? Rev. Jun 2022
  • 19.5. How to choose the implementation date? Rev. Jun 2022
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