New variations guidelines: webinar for marketing authorisation holders (human)

• Date:
  Tuesday, 13 January 2026 , 13:00 - 15:00 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live 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.

Video recording is made available after the event.

Documents

Agenda - New variations guidelines: webinar for marketing authorisation holders (human)

Presentation - New variations guidelines: webinar for marketing authorisation holders (human)

Video recording