Current issue of “RMS NEWS”
- RECENT COMMITTEE NEWS
Update Renewal Documents. Following the update of the „Best practice guide on the processing of renewals in the mutual recognition and decentralised procedures“ by the CMDh, the following guidance documents have now also been updated accordingly with regard to the new simplified standard renewal procedure.
- CMDh procedural advice on common grounds seen for delaying D0 renewals
- Member State agreement upon conditions under which the RMS can start renewals
- Recommendations on informed consent applications in MRP and DCP
- Template for request for MRP/RUP
- Template for end of renewal procedure
- Questions & Answers on renewals
- End of Procedure in MRP/R
The updated documents have been published on the CMDh-Website.
EMA COVID-19 Status. The EMA and the European medicines regulatory network are lifting their respective COVID-19 business continuity measures after successfully managing the unprecedented operational challenges of the pandemic.
While the temporary measures put in place to manage the COVID-19 pandemic are no longer required, resourcing across the European medicines regulatory network remains a major challenge. CMDh will therefore continue to work closely with the EMA and the Heads of Medicines Agencies from the Member State to identify and implement sustainable solutions.
Update RMS request form for DCP. The CMDh has agreed on an update of the RMS request form for DC procedures. The use of the form will become mandatory as of 1 September 2023, but it can already be used before that date on a voluntary basis. The updated request form will be published here on the website of the CMDh.
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)