CMDh Report – January 2025 Meeting
The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the meeting held on 28-30 January 2025.
Among the items reported, the following may be noted:
TEMPLATE FOR REQUEST FOR RMS IN DCP
The CMDh agreed an update of the template for request for RMS in DCP. The document has been updated to include a field for the bioequivalence study number (as applicable) and a footnote to add the definition of the European Reference Medicinal Product. The declaration that no other Member State has agreed to become RMS for the procedure has been changed to a tick box and extended to pending requests.
PROCEDURAL ADVICE ON REPEAT-USE
The CMDh agreed an update of the Procedural Advice on Repeat-Use. The main change is to align the guidance with the updated Best Practice Guide on Renewals. Other minor changes, in line with the experience gained, have been included.
Procedural Advice on Repeat Use (tracked)
QUESTIONS AND ANSWERS ON THE IMPLEMENTATION OF THE REGULATIONS ON MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES (REGULATIONS (EU) 2017/745 AND (EU) 2017/746)
The CMDh together with the EMA has agreed an update of the joint EMA/CMDh Q&As on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746). The document has been updated to state that, when a Declaration of Conformity is not available, in certain cases (for class I (excluding Is and Im) medical devices), a MAH’s statement of compliance with the relevant general safety and performance requirements (GSPRs) of the MDR Annex I can be acceptable.
EMA/CMDh Q&As on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746) (tracked)
CMDH BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN MRP (CHAPTER 3 AND 6)
The CMDh agreed an update of Chapter 3 (Type IA Minor Variations (Notifications)) and Chapter 6 ((Super-)Grouped Applications) of the Best Practice Guides for the Submission and Processing of Variations in MRP.
Chapter 3 (tracked)
Chapter 6 (tracked)
CMDH POSITIONS FOLLOWING PSUSA PROCEDURES FOR NATIONALLY AUTHORISED PRODUCTS ONLY*
The CMDh, having considered the PSURs on the basis of the PRAC recommendations and the PRAC assessment reports, agreed by consensus on the variation of the marketing authorisations of medicinal products containing the following active substances: aciclovir.
The minutes of the CMDh meeting held on 10-11 December 2024 have also been published and can be accessed here.
