Version 1.28.0.0 of the Human Marketing Authorisation Application (MAA) electronic Application Form (eAF) is now available.
Industry stakeholders should take note of the upcoming implementation deadlines:
- From 28 July 2026: Mandatory for new centralised MAA submissions to EMA
- From 1 September 2026: Available for new national, MRP, DCP and SRP submissions
- From 1 January 2027: Mandatory for all new MAA submissions to National Competent Authorities (NCAs)
Applicants are also reminded not to change the eAF version during an ongoing regulatory procedure.
For full details, including the release notes and implementation timeline, visit the EMA eSubmission website: eAF news and implementation timeline.
Need help navigating the new Human eAF requirements or preparing your upcoming submissions? Our regulatory experts are here to support you: [email protected]
