Current issue of “RMS NEWS” New
- RECENT COMMITTEE NEWS
Update Procedural Advice on Repeat-Use. The CMDh approved an update of the guidance document “Procedural Advice on Repeat-Use”. The most important change is the alignment with the updated guidance on renewal procedures. The updated document can be found on the CMDh website.
Update Q&A 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 to the common questions and answers on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations. It has been updated that - if a declaration of conformity is not available from the manufacturer of the medical device - in certain cases (for class I medical devices - except Is and Im) the marketing authorisation holder's declaration of compliance with the relevant general safety and performance requirements (GSPRs) of MDR Annex I, can be accepted. The updated document has been published on the EMA website.
Update CMDh SOP on decision-making process for new active substance status or extension of marketing protection/data exclusivity. The CMDh has updated the “CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity” and it has been included in the document that decisions on an additional year of market protection/data exclusivity for new therapeutic indications will be published in a separate document (in addition to the CMDh Minutes). It has also been added how the start of the non-cumulative period of one year of data exclusivity for a new therapeutic indication should be calculated. The updated document can be found on the CMDh website.
Update Assessment Report Templates. The CMDh agreed to update all assessment report templates published on the CMDh website and remove the “Names of the assessors” section; this is also in line with the centralised procedure. The name/contact details of the RMS contact person remain included.
MRP/DCP statistics for 2024. The CMDh has presented its annual statistics on DC/MR procedures for 2024 according to the CTS database. In 2024, Austria as RMS was again in 7th place for finalised marketing authorisation procedures for human medicinal products and 9th place for started marketing authorisation procedures! Thank you very much for your trust - we look forward to continuing to be your competent and reliable partner in marketing authorisation procedures at European level!
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
