On 15 January 2026, the new Variation Guidelines, including updated variation classifications, entered into force. All variations submitted after this date must comply with the new guideline.
However, if a Marketing Authorisation Holder (MAH) identifies one or more Type IA variations that were implemented before 15 January 2026 but were not submitted by that date, specific transitional measures apply.
In such cases, the delayed Type IA variations should be submitted promptly and without any further delay as an “early annual update”, using:
- The old electronic Application Form (eAF), and
- The previous 2013 Variation Classification Guideline.
For full details, please refer to the official communication published by the Heads of Medicines Agencies (CMDh): Guidance on the application of the revised variations
framework
Need help? Contact us at: [email protected]
