Current issue of “RMS NEWS”
NEWSTICKER 31.03.2024
- RECENT COMMITTEE NEWS
CMDh Best Practice Guide on Multilingual Packaging. The CMDh agreed to update the best practice guide for multilingual packaging. Guidance was added on how to create an "EU full/reduced harmonised labelling text" in RUP and Line Extension procedures; guidance on how to change the MS cluster if the "EU reduced harmonised text" is already approved; and guidance on how an already approved "EU reduced harmonised text" is to be changed. The updated document has been published on the CMDh website at this link.
MRP/DCP statistics for 2023. The CMDh has presented its annual statistics on DC/MR procedures for 2023 according to the CTS database. In 2023, Austria as RMS was in 7th place for finalised procedures for human medicinal products! Thank you very much for your trust - we look forward to continuing to be your competent and reliable partner in marketing authorization procedures at European level!
Procedural Advice on Zero Day MR procedures. The CMDh agreed on a new procedural advice on Zero Day MR procedures. The Zero Day procedure is a mutual recognition procedure with a shortened timetable that can be initiated in exceptional cases to mitigate shortages or problems with access to critical medicinal products with the agreement of the Member States concerned. The Procedural Advice contains information on the preparations prior to the initiation of the procedure, the requirements for the dossier and the respective procedural steps and will be published on the CMDh website under this link.
On the BASG website you will find information on the requirements for day 0 repeat use procedures with Austria as RMS.
IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
