Current issue of “RMS NEWS”
- RECENT COMMITTEE NEWS
Applicant's response - new template and updated guidance. The CMDh has created a new template for applicant's responses during DC procedures. The new template allows the applicant to submit responses to clinical, non-clinical, quality, and Module 1 questions in a common document or as separate documents per module.
The CMDh Guidance document "Applicant's response document in MRP and DCP for MAAs" has also been updated to reflect the use of the document. Use of the template will become mandatory for all pending responses, including already ongoing procedures, as of April 1, 2022, but may have been used on a voluntary basis prior to that date.
Update the RMS Validation Checklist for DCP. The RMS Validation Checklist for DCP has been revised by the CMDh to reflect the medical devices and companion diagnostics section updated in the application form, and to include the latest information on Brexit as per Commission Notice 2021/C 524/02.
Update CMDh procedural advice on changing the Reference Member State. The CMDh agreed to update the Procedural advice document "CMDh procedural advice on changing the Reference Member States" on changing the RMS. Examples where a change of the RMS may be required have been updated and information on the new procedure numbers in the new RMS has been clarified. The updated document will be published on the CMDh website at this link.
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)