Human MAA eAF v1.28.0.0 – timeline for implementation
Versions 1.28.0.0 of the interactive PDF electronic application form (eAF) for human marketing authorisation application are available on the eAF website, together with the associated release notes.
- Industry must use the updated eAFs, Version 1.28.0.0, for any new CAP MAA application submitted to EMA from 28 July 2026.
- The forms can be used for new MAA applications submitted to the NCAs for NP, MPR, DCP and SRP procedures from 1st September 2026.
- It will be mandatory to use the updated forms for all new MAA submissions to the NCAs from 1 January 2027.
- Applicants are reminded that the version of the form should not be changed during an ongoing procedure.
You can better view the timelines at the link below.
Source: eSubmission