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Pharmaceuticals

Variations 1 Year In

Thursday, May 7, 2026
08:30 - 09:30 WEST
Location: Auditorium 3
Description Since the revision of the EU Variation Regulation became applicable on 1 January 2025, marketing authorisation holders and regulators have gained one year of practical experience with the updated framework. During this time, sponsors have navigated new classification principles, procedural adaptations, and evolving expectations in variation submissions across the EU.

In parallel, the European Commission has adopted and published the final version of the Guidelines on the details of the various categories of variations and the operation of procedures, which will apply from 15 January 2026. These guidelines further clarify classification, documentation requirements, grouping possibilities, and procedural handling. In addition, the revised variation fee structure introduces changes to how variations are grouped and charged.

This session will reflect on lessons learned during the first year of implementation, highlight practical challenges and regulatory trends, and prepare participants for the application of the new EC Guidelines and the revised fee framework.

Learning Objectives:

  • Assess the practical impact of the revised Variation Regulation after one year of implementation, including common challenges and emerging regulatory expectations.
  • Interpret key changes introduced by the new EC Guidelines (applicable from 15 January 2026), including updated classification principles and procedural clarifications.
  • Understand the revised variation fee structure and grouping rules, and incorporate these changes into regulatory lifecycle management strategies.