CMDh: Update of Q&As on Renewals

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

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.