CMDh Report from September 2024 Meeting
The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 17-18 September 2024.
ENVIRONMENTAL RISK ASSESSMENT (ERA) AND MUTUAL RECOGNITION/REPEAT-USE PROCEDURES
CMDh agreed an update of the request form for MRP/RUP. To facilitate the implementation of the updated ERA guideline, applicants are requested to confirm before the start of an MRP/RUP that the ERA provided in Module 1.6 is in line with the current version of the guideline. For MRP/RUP requests submitted until 31 March 2025, it is possible to provide a commitment to submit a variation within 3 months after end of MRP/RUP in case the ERA provided in Module 1.6 is not in line with the current version of the Guideline.
Q&A ON PHARMACOVIGILANCE
CMDh agreed an update of the Q&A on Pharmacovigilance Legislation. The Answer to Question 8 has been replaced by a reference to the Q&A 3.3. on variations which provides guidance on the variations to implement PI updates following PSUSAs. Question 10 has been revised to provide updated guidance on the extrapolation of the outcome of PSUSA to other products that were not within the scope of the single assessment (other fixed combinations/mono products) and for drug-drug interactions.
CMDH POSITIONS FOLLOWING PSUSA PROCEDURES FOR NATIONALLY AUTHORISED PRODUCTS ONLY
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 macrogol 3350 combinations (oral use).
In addition, the CMDh published the minutes of the CMDh meeting held on 23-24 July 2024.
