3.2.1: About CMDh (ALT-O)
3.2.2: Statistics (ALT-S)
3.2.3: Press Releases (ALT-P)
3.2.4: Procedural Guidance (ALT-L)
3.2.5: CMDh-Referrals
3.2.6: Product Information (ALT-T)
3.2.7: Advice from CMDh
3.2.8: Templates
3.2.9: CMD subgroups / working groups (ALT-G)
3.2.10: Paediatric Regulation (ALT-N)
3.2.11: Questions & Answers (ALT-Q)
- 3.2.11.1: Applications for MA
- 3.2.11.2: CMDh Referrals
- 3.2.11.3: Variations
- 3.2.11.4: Post referral phase
- 3.2.11.5: PSURs & Renewals (ALT-W)
  - 3.2.11.5.1: PSURs
  - 3.2.11.5.2: Renewals
- 3.2.11.6: Product Information / Information on medicinal products
- 3.2.11.7: Generics & Usage Patents
- 3.2.11.8: Biologicals
- 3.2.11.9: Homeopathics
- 3.2.11.10: Advice from CMDh
- 3.2.11.11: EU-Enlargement
3.2.12: Contact Form
3.2.13: Contact Points
3.2.14: What's new history (ALT-Y)

Q&A on Renewals

Application for the renewal of a Marketing Authorisation

Question 1
Is it possible to apply for the renewal of a marketing authorisation granted via the Mutual Recognition Procedure or the Decentralised Procedure in the situation where not all of the Member States involved in the procedure have issued the national marketing authorisation?

The CMDh has agreed that it should be possible to apply for the renewal of a marketing authorisation granted via the MRP or DCP, in the situation where not all of the Member States involved in the procedure have issued a national marketing authorisation, in view of the legal requirement to apply for the renewal of a marketing authorisation at least six months before the expiry of the marketing authorisation.
However, if the national marketing authorisations have not been issued due to the lack of submission of high quality translation of the agreed SPC, PL and labelling after the end of the MRP or DCP, the renewal procedure will not be concluded until the respective national translations are provided.

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