Please note that, due to system limitations and pending future improvements, the web-based eAF cannot currently be used for submissions to the National Competent Authorities. However, the web eAF is fully functional for the submission of variations of CAPs, including EMA-led worksharing variations of non-CAPs.
In order to familiarise with the new functionality of web-based eAFs for Human non-CAP variation procedures, the eAF team provided a dedicated training session on 17 October 2024. The recording will soon be available at the event page.
Additionally, the eAF team will provide:

• a Q&A clinic on web-based eAFs for Human non-CAP variation procedures on 25 October 2024 10:00 – 10:30 (CEST). Register here. You can start already now to leave your questions on Slido using the access code # QANONCAPS.
• a Training and Q&A Clinic for Human Variation eAF new fixes/functionalities on 8 November 2024 10:00-11:00 (CET). Register here.
• A Q&A Clinic on eAF variations on 14 November 2024 10:00 – 10:30 (CET). Register here.

• Register as an eAF user in the PLM Portal following the registration process and log into the eAF for familiarisation and testing purposes;
• Follow EMA announcements to be informed of the date when web-based eAF can be submitted to the NCAs. This is currently expected to start in January 2025;

• Continue to submit the interactive PDF eAFs to the NCAs for non-EMA led procedures;
• Gather user feedback related to non-CAP variations within your organisations (MAHs and industry organisations) and to provide this consolidated feedback to EMA via plm.valuestream@ema.europa.eu.

• Follow EMA announcements to be informed of the date when they will start receiving web-based eAF submissions.

• Forward any non-CAP variations related user feedback from MAHs to EMA via plm.valuestream@ema.europa.eu.
• Join upcoming information session on the go-live of the web-based eAF for non-CAPs to take place in November 2024.