Current issue of “RMS NEWS” New
- RECENT COMMITTEE NEWS
Guidance on the application of the new Variation Regulation. Following the revision of the new Variation Regulation, which has been in force since 1 January 2025, the European Commission (EC) has now published the final version of the EC guidelines on the details of the classification of variations and on the implementation of the procedures. The guidelines will apply from 15 January 2026.
To facilitate the transition for Type IA variations, all Type IA changes implemented in 2025 should be submitted in an annual update in December 2025 or before 15 January 2026. Only in cases where individual Type IA variations are implemented after the annual update has been submitted, will they be accepted as individual notifications.
Within the next months, the CMDh will publish updates to several guidance documents and templates related to variations to bring them into line with the new European Commission guidelines. Further information on the application of the revised Variation Framework can be found on the CMDh website.
The BASG will also address the topic of ‘New Variation Regulation and Classification Guideline 2025’ during a so-called BASG discussion on 16 October 2025. Further information and registration details can be found in the AGES event calendar at this link.
Template for request for RMS in DCP updated. The CMDh has added a footnote clarifying that, in case of bioequivalence studies, the applicant should check whether the relevant site is already included in the OMS database or should apply for its inclusion as early as possible before submitting the application.
The updated template can be found on the CMDh website and the BASG website.
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
