Since 1 January 2025 the new Variation Regulation is applicable. It’s one of the most significant updates in EU lifecycle management in years. The European Commission (EC) has recently adopted and published the final version of the EC guideline on the details of the various variation categories and operation of the procedures. This guideline applies from 15 January 2026.
Here’s what is important for regulatory teams and lifecycle management:
Key changes in processing
- New framework & transition
- Regulation effective 1 Jan 2025; new EC Variations Guidelines apply from 15 Jan 2026.
- Until then, continue using the current guidelines and existing electronic application forms (eAF).
- Risk-based classification
- Type IA, IB and II remain, but criteria are more clearly linked to risk.
- PACMPs (Post-Approval Change Management Protocol) lifecycle management documents are emphasized to pre-agree change strategies.
- Type IA Annual Update
- Type IA variations not requiring immediate notification (IAIN) should now be bundled into one annual submission.
- This annual cycle is based on the first implementation date.
- Expanded worksharing
- Identical variations across multiple MA’s (marketing authorisation) can be submitted together.
- Mandatory for same-MAH (MA holder) products; optional across different MAHs.
- Supergrouping
- Multiple type IA variations across different MA’s under the same MAH can now be grouped in a single submission, reducing duplication and improving efficiency.
Content-specific Changes
The types of variations remain largely the same, i.e. quality, safety/efficacy and administrative changes. However, there are some changes from a content perspective:
- Condition clarifications
- More explicit criteria for Type IA, IB, II based on risk to product quality, safety, or efficacy.
- For biologicals, some changes previously Type II may now be considered IB or IA if low risk.
- Documentation updates:
- Explicit requirements for risk justification for IB and II, and for some IA changes.
- Reference to PACMPs or lifecycle documents where relevant.
- Annual IA updates must include all bundled changes in one submission, with clear implementation dates.
- Special cases:
- Vaccines (e.g., influenza, COVID) have specific rules for annual updates and worksharing.
- Emergency or safety-driven updates can follow accelerated cycles outside the annual update.
How is your organization preparing for these changes? Our team at Starodub specializes in guiding pharma companies through regulatory transitions like this one. Let’s navigate the new Variations Regulation together and contact us at [email protected] for more information.
