MA Announces Implementation Timeline for Human eAF Version 1.28.0.0
The European Medicines Agency (EMA) has released Version 1.28.0.0 of the Human Marketing Authorisation Application (MAA) electronic Application Form (eAF), introducing important implementation milestones for regulatory submissions.
📅 Key Implementation Dates
28 July 2026: Mandatory for new centralised MAA submissions to EMA.
1 September 2026: Available for new national, Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and Subsequent Recognition Procedure (SRP) submissions.
1 January 2027: Mandatory for all new MAA submissions to National Competent Authorities (NCAs).
⚠️ Important Reminder: Applicants should not change the eAF version during an ongoing regulatory procedure.
🔗 Official guidance: https://esubmission.ema.europa.eu/eaf/
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