CMDh: Update of Q&As on Renewals
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Recommendation
17/18 September 2024
With updates on the CEP 2.0!
The CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) updated the Q&A document on the topic of "Renewals" in March 2023 and published it on the HMA (Heads of Medicines Agencies) website in April in the CMDh - Questions & Answers section.
The first revision of the CMDh Questions & Answers Renewals document now contains 6 questions and their respective answers. The second question and the corresponding answer text have been completely revised and the following questions have been newly included:
- 2. Under which circumstances can a "standard" renewal application be submitted, with only the cover letter and renewals eAF without annexes?
- 3. Can variation applications be submitted in parallel with the renewal procedure?
- 4. In the eAF, should I tick the box for "shortened renewal" and specify a reason for shortened renewal when submitting my standard renewal application?
- 5. After MRP/RUP, when the MA in the RMS (and "old CMS" if applicable) has already been granted unlimited validity, but renewal is necessary in the (new) CMS, can a standard renewal application be submitted?
- 6. Can changes to the product information and/or RMP be proposed within
the renewal application?
You will find the Q&A Document "CMDh Questions & Answers Renewals" including the updates on the HMA website.
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