European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Here, you can view the track changed (13 July 2026) and clean versions (5 October 2026) of the document with the above title. Responses to the following questions have been updated:
- 1.1. When shall I submit my Type IA/IAIN variation(s)?
- 3.8. How shall I present my application for a new or modified therapeutic indication?
- 3.11. How shall my Type II application be handled (timetable)?
- 3.13. Which post-opinion steps apply to my Type II variation and when can I implement the approved changes?
- 3.25. When will I get a PIP compliance statement?
- 4.12. How shall my Extension Application be handled (timetable)?
- 17.30. How shall I implement the outcome of a PSUSA procedure?
- 17.35. What fee should I pay and whom to contact if I have an issue related to the payment of fee and QPPV advice notes?
- 22.1. What is an Article 61(3) Notification?
- 22.3. When can I submit my 61(3) Notification?
Source: EMA
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Here, you can view the track changed (18 August 2026) and clean versions (5 October 2026) of the document with the above title. Responses to the following questions have been updated:
- 6.1.6. What are the protection periods for orphan medicinal products?
- 6.2.1. Extension of the ten-year period of marketing protection in the case of new therapeutic indications (8 + 2 +1)
Source: EMA