18.12.2025
To the attention of marketing authorization holders
Considering that Regulation (CE) 2024/1701 amending Regulation (EC) no. 1234/2008 was published on 17 June 2024 and became applicable on 1 January 2025, and the New Guidelines on the details of the various categories of variation was published on 22 September 2025, the NAMMDR informs all MAHs that these Guidelines apply starting with 15 January 2026.
When submitting documentation supporting variations, the MAH should consider using the new form available at https://esubmission.ema.europa.eu/eaf/index.html
To support the implementation of the changes regarding variations, the EMA/CMDh has published various documents available to the MAHs via the following links:
https://www.ema.europa.eu/en/guidance-application-revised-variations-framework si https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation/revised-variations-framework.html
Moreover, the NAMMDR informs that the EMA will organize a virtual webinar on this topic on 13 January 2026 (13:00-15:00 CEST). (https://www.ema.europa.eu/en/events/new-variations-guidelines-webinar-marketing-authorisation-holders-human)