New variations guidelines: webinar for marketing authorisation holders (human)
EventHumanRegulatory and procedural guidance
- The original event time is:
- Tuesday, January 13, 2026 - 13:00 - 15:00 Amsterdam time (CET)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the NetherlandsLive broadcast
Event summary
Following the amendment of the Variation Regulation, applicable since 1 January 2025, the European Commission (EC) has adopted and published an updated version of the EC guidelines on the details of the various categories of variations and operation of the procedures (EC Variations Guidelines (2025)). The Guidelines apply from 15 January 2026.
To support stakeholders on the upcoming changes resulting from the EC Variations Guidelines (2025), the Agency is hosting this session.
The event is broadcast live. A video recording will be made available after the event.
Registration
Live broadcast - 13:00-15:00 (CEST)
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