Current issue of “RMS NEWS”
- IMPORTANT INFORMATION
Processing times of DCPs, MRPs, RUPs. Due to the large number of applications, there are currently delays in their processing. This may affect the duration of the validation phase, procedure starts and, if relevant, re-starts. We are trying to coordinate the situation in your interest as best as possible and to restore the usual processing times.
We ask for your understanding for the resulting delays and thank you for your patience.
- RECENT COMMITTEE NEWS
Request Form for MRP/RUP. The CMDh has revised the MRP/RUP application form for medicinal products for human use. More information has been included in the request form based on the Assessment Report template to support the completion of the updated Assessment Report, which should avoid duplication of work.
As with the previous form, applicants are advised to pay attention to national adaptations by the respective national competent authorities. The request form will be published on the CMDh website for transparency, but MAHs should contact their respective RMS to discuss updating the AR for the MRP/RUP process and use the RMS's nationally adapted request form, if applicable.
It is recommended to use the new request form for applications submitted on or after September 1, 2022, but it may be used on a voluntary basis prior to that date.
Update Q&A on Variations. The CMDh agreed to update the Questions & Answers on Variations and the Examples for acceptable and not acceptable groupings for MRP/DCP products. It is clarified that a Type II variation to update the dossier in preparation of an RUP/MRP or prior to submission of a duplicate application, may include new or updated documentation for the medical device confirming compliance with relevant general safety and performance requirements set out in the MDR (EU) 2017/745. Furthermore, references relevant only to veterinary medicinal products have been removed.
Update CMDh Guidance Documents - "Automated" Art. 29(1) referral. The CMDh agreed to update the following documents: "Best Practice Guide for Decentralised and Mutual Recognition Procedures", "Decentralised procedure member states' standard operating procedure", and "Disagreement in Procedures - Referral to CMDh". The updates describe the process by which an "automated" Art. 29(1) referral - in the event of a late change in the RMS position from "non-approvable" to "approvable" after Day 205 of a DCP procedure - is triggered by the RMS.
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties