Views:

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:
  • 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.
Key actions for NCAs to:
  • 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.
eAF guidance documents available to support your work on the PLM:
  • Guide for PLM Portal Registration - Document
  • Guide for PLM Portal eAF Navigation - Document

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
If you have any question please contact plm.valuestream@ema.europa.eu or post them via the PLM Portal Forum.
Best regards,
On behalf of the PMS Team

* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)