eAF updates and related training sessions happening in Quarter 1 2025
The Human Variations electronic Application Form (eAF) has been updated with key redesigns and improvements. During the first quarter of 2025 EMA will host training sessions and Q&A clinics to introduce the changes to eAF Industry users.
date: [27/02/2025]
The Human Variations electronic Application Form (eAF) team is implementing important fixes and redesigns, including updated Present and Proposed and updated Proof of Payment sections. These key updates, together with the successful data cleansing exercise done in January 2025, will enable the use of the web-based eAF for all EU procedures: CAPs and non-CAPs.
These latest updates mean that the form will be ready for MRP/DCP and purely national variation applications in February 2025. After this launch, the web-based eAF will be open for first use for non-CAPs. The web based eAF is currently already recommended for use for CAPs.
These latest updates mean that the form will be ready for MRP/DCP and purely national variation applications in February 2025. After this launch, the web-based eAF will be open for first use for non-CAPs. The web based eAF is currently already recommended for use for CAPs.
Following the updates and enhancements of the electronic Application Form (eAF), the EMA will host two training sessions to introduce the new features.
The training sessions will focus on the Present and Proposed redesign, new variation regulation (CAPs and non-CAPs), updated Proof of Payment section and the new features such as the contact person multi-select for non-CAPs. The training session will take place on:
- 11 February 2025 (10.30-12.30 CET) - Event web-page;
- 27 February 2025 (10.30-12.30 CET) – Event web-page.
- 6 March 2025 (11.00-11.30 CET) – Event web-page;
- 13 March 2025 (11.30-12.00 CET) – Event web-page.
Please share any user feedback related to non-CAP variations from within your organisation (MAHs or industry organisations) and provide this consolidated feedback to EMA via plm.valuestream@ema.europa.eu.
Users should note that the interactive pdf eAF remains available for use for all variation procedures.