Current issue of “RMS NEWS”
NEWSTICKER 30.06.2021
- AUSTRIA AS YOUR RMS
New RMS Flyer. Current figures and statistics on Austria as your RMS can be found in our new RMS flyer!
- RECENT COMMITTEE NEWS
Multilingual packing pilot. The CMDh would like to remind applicants of the Multilingual packaging pilot. The wish to participate in the pilot should be articulated in the cover letter of new submissions indicating the respective member state cluster(s). Further details on the pilot can be found in the May 2021 CMDh Press releases or the corresponding CMDh Best Practice Guide on Multilingual Packaging.
Statistics on MRPs, DCPs, Variations and Renewals. As of June 2021, the information published in the press releases on the procedures started or finalised will be changed. In the future, only the frequency of participation in started MRPs or DCPs of each member state will be published; the full information on started and finalised procedures will continue to be published every 6 months by the CMDh at this link.
Document Update. The CMDh, together with the EMA and EC, has revised the EMA/CMDh Q&As on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations and also added new Q&As. The revised version will be published on the CMDh website at this link. The template for requests for RMS in a DCP for medicinal products for human use has also been revised, in which applicants should in future also specify the intended indication(s) of the product and information on whether the ASMF is to be assessed in a worksharing procedure, if applicable. The revised version will be published on the CMDh website at this link.
IMPORTANT EVENT
***Save the date: BASG dialogue: Meet the Case Manager***
During this BASG meeting you will have the opportunity to meet your case managers for AT=RMS procedures personally and to ask questions.
Take the chance and register!
More information about the exciting program can be found on the AGES Academy website, where you can also register for the event. If you have any questions on one of the topics, we would ask you to send them in advance - please by 30.09.2021 at the latest - to lcm@ages.at. We will answer them anonymously in the presentations!
Please note that the talks will be in German.
When: 12.10.2021, 13:00-17:00
Where: Online via Zoom
Program/registration: Link
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
