The European Commission's revised Variations Guidelines (published in the OJEU 22 September 2025) are now fully applicable. All variation applications to EMA must use the new classification system from 15 January 2026 onwards.
Key changes:
- New variation classification system — reclassification of many Type I and Type II variations;
- Mandatory use of updated variation application form version 1.28.0.0 (available on eSubmission portal);
- Greater use of Post-Approval Change Management Protocol (PACMP) for pre-agreed lifecycle changes;
- Introduction of the Product Lifecycle Management document (PLCM) to document agreed product changes;
- EMA and HMA published implementation guidance on 25 November 2025 to support MAHs. MHRA (UK) has aligned with this framework for UK submissions.
This is a major operational change for all MAHs holding CAPs — every variation workflow, classification decision, and submission strategy must reflect the new system. Post-implementation review period is ongoing; MAHs experiencing implementation issues should contact their EMA procedure manager.
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