Current issue of “RMS NEWS” New
Slot matrix for procedures with AT as RMS. To present the availability of slots for new applications with Austria as RMS even more transparently, the slots for chemical medicinal products will now be broken down by application type. Applications under Article 10(1), 10(3) or Article 10c of Directive 2001/83/EC are listed under the category “CHEM A”; applications under Article 10a, 10b or Article 8(3) of Directive 2001/83/EC are listed under “CHEM B”. This change is intended to help applicants plan their slot requests more accurately and efficiently in the future.
- RECENT COMMITTEE NEWS
CMDh Guidance on the application of the new Variation Regulation. The CMDh has adopted updates to several guidance documents and templates in relation to variation procedures, to align them with the new EC guidelines on the details of the different variation categories and the conduct of the procedures.
The new European Commission guidelines and the correspondingly updated CMDh guidance documents have been applicable since 15 January 2026.
Recommendation to applicants to use the RMS validation checklist before submitting a DCP. To support applicants in preparing and submitting compliant new marketing authorisation applications in a DCP, and to reduce validation issues due to missing documentation, it is strongly recommended to use the RMS Validation Checklist for self‑assessment prior to dossier submission.
The CMDh Best Practice Guide on the compilation of the dossier for new applications submitted in Mutual Recognition & Decentralised procedures has been updated accordingly and now also includes information on the requirement to provide bridging data in Article 10a applications.
Update of Public Assessment Report templates. Following the publication of the updated template for the DCP D70 Assessment Reports, it is now possible for the RMS to prepare the PAR based on the final Assessment Report. The updated template is available on the CMDh website.
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
