The EMA has updated its post-authorisation procedural advice for users of the centralised procedure.
The latest version of the Q & A advice document, Rev. 99 is dated 20 June 2022.
Here, you can view the track changed and clean versions of the document.
Answers to the following questions have been updated:
3. Type II variations
3.14. What fee do I have to pay for a type II variation?
3.21. Do I need to confirm the maintenance of my orphan designation when applying for a type II variation?
4. Extension of Marketing Authorisation
4.7. Do I need to confirm the maintenance of my orphan designation when applying for an extension application?
10 Annual re-assessment
10.6. When, how and to whom shall I submit my annual re-assessment application?
12 Annual renewal of conditional marketing authorisations
12.2. When shall I submit my annual renewal application?
19 Transfer of Marketing Authorisation
19.5. How to choose the implementation date?