On 15 January 2026, the new Variation Guidelines (including updated variation classifications) came into force. All variations submitted after this date should follow the new guideline. If, unexpectedly, a MAH identifies one or more Type IA variations that were implemented before 15 January 2026 but not submitted by that date, the delayed Type IA variations should be submitted promptly and without any further delay as an “early annual update”, using the old eAF and in accordance with the previous (2013) classification guideline. The MAH should ensure that all Type IA variations that were implemented before 15 January 2026 are included in this submission.
Further guidance on the application of the revised variations framework can be found on the CMDh webpage.
