Reminder – New variation classification in eAF
The updated Variation Regulation Classification Guideline has been made available in both the interactive pdf eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version.
Users are reminded to verify the accuracy and content of the selected scopes (including the conditions and documentation), before submitting the form to the relevant health authorities. In case of any discrepancies, a ticket should be raised Request RMS Service – Employee Center.
Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
You can view the slide deck here.
List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
You can view the list here.