Non-CAPs data available in the PLM Portal web based eAF from 14th October 2024
The EMA is pleased to announce that, as of the 14 October 2024, non-Centrally Authorised Products* (non-CAPs) data will be available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal.
date: 03/10/2024
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 is providing a dedicated training session on 17 October 2024 10:00 – 11:30 (CEST). During this event, access and navigation of web-based eAF for non-CAPs will be showcased. We would highly recommend all relevant Industry stakeholders to participate to this training: Register here
Key actions for Marketing Authorisation Holders:
Please be reminded that:
Best regards,
On behalf of the PMS Team
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)
Key actions for Marketing Authorisation Holders:
- Register as an eAF user in the PLM Portal following the registration process and log into the eAF for familiarisation and testing purposes;
- Join upcoming training session;
- 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.
Please be reminded that:
- External testing of the eAF User Acceptance Testing (UAT) is not foreseen for 2024
- No transition towards mandatory use of the Human variations web-based eAF will start before a UAT takes place
Best regards,
On behalf of the PMS Team
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)