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29 April 2025

Purpose and context

Important notice 29 April 2025: a small number of products are affected by a synchronisation issue with PMS, and the forms where they are used cannot be exported and finalised. Once the products are added to the eAF, export the form, you should see the message “Data refresh cannot be completed. Aborting the operation. Please retry again.”. Please use the interactive PDF instead. The teams are working on fixing this issue, and a new message will be published once it is resolved.

EMA is pleased to announce that the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) has gone live on 4th November 2022, on the Product Lifecycle Management (PLM) portal. This is a big, first, milestone in the ongoing journey to improve the eAF and related processes. EMA has been collaborating with the UNICOM consortium to develop the human variation form and other new web-forms.

Following the release, users of the Human Variations eAF should expect continual work on improvements in the form of regular releases. These will be a mix of bug fixes, scheduled improvements, improvements based on user acceptance testing (UAT) feedback, or that may be identified by users after the release and new features, such as additional structured data fields.

Following a successful updated product load in April 2024, the use of the web-based eAF is now strongly recommended for all Centralised Procedure variation applications (where possible). Please note that a small number of limitations still exist in the system, however, the use of the web-based form should start becoming the first option, and the use of the interactive PDF should be only in cases where the use of the web-based form is not yet possible/feasible in the view of limitations.

The eAF team is pleased to announce that the PLM portal web-based eAFs can be used for all EU products and procedures starting from 11 February 2025. Please follow user guidance, the current release notes and EMA announcements in relation to any known technical limitations.

The formal transition period will start when nationally authorised products (NAPs) and features supporting all use cases covered by the interactive PDF eAF will be added to the form. The current interactive PDF eAF will remain available until the end of the transition period.

The PLM portal will, in due course, host all eAFs. In the future, it will also host the data input user interface for product management service (PMS) data and the interface to provide data for electronic Product Information (ePI). The PLM portal will develop over time to inform and support you in the use of these services.

This document lists and briefly describes the new features and fixed issues included in the release of the PLM portal. The most recent release appears first.

 

About this document 

This document lists and briefly describes the new features and fixed issues included in each release of the PLM portal. The most recent release appears first.

The known issues are categorised per component or business process of the system so that users can easily identify which issues are relevant to them. The components currently used are:

Component

Short description
PLM portalThis component relates to the website, the UI (User Interface)
Human Variations eAFThe business process where MAH’s create and edit their variation eAF (electronic application form) on the PLM portal
PDFThe PDF that is available for download after the completion of an application
FHIR XMLThe FHIR XML file attached to the exported PDF

 

For additional information on the PLM portal, see this:

 

 

Version: 1.2.0.3 (Release date 28/04/2025)

 

Version: 1.2.0.2 (Release date 31/03/2025)

 

Version: 1.2.0.1 (Release date 17/03/2025)

 

Version: 1.2.0.0 (Release date 06/03/2025)

 

Version: 1.1.1.4 (Release date 18/02/2025)

 

Version: 1.1.1.3 (Release date 03/02/2025)

 

Version: 1.1.1.2 (Release date 20/01/2025)

 

Version: 1.1.1.1 (Release date 07/01/2025)

 

Version: 1.1.1.0 (Release date 09/12/2024)

 

Version: 1.1.0.3 (Release date 25/11/2024)

 

Version: 1.1.0.2 (Release date 11/11/2024)

 

Version: 1.1.0.1 (Release date 28/10/2024)

 

Version: 1.1 (Release date 14/10/2024)

 

Version: 1.0.1.19 (Release date 18/09/2024)

 

Version: 1.0.1.18 (Release date 06/09/2024)

 

Version: 1.0.1.17 (Release date 27/08/2024)

 

Version: 1.0.1.16 (Release date 08/08/2024)

 

Version: 1.0.1.15 (Release date 22/07/2024)

 

Version: 1.0.1.14 (Release date 15/07/2024)

 

Version: 1.0.1.13 (Release date 13/05/2024)

 

Version: 1.0.1.13 (Release date 15/02/2024)

 

Version: 1.0.1.12 (Release date 27/11/2023)

 

Version: 1.0.1.11 (Release date 07/08/2023)

 

Version: 1.0.1.9 (Release date 13/06/2023)

 

Version: 1.0.1.8 (Release date 16/05/2023)

 

Version: 1.0.1.7 (Release date 17/04/2023)

 

Version: 1.0.1.6 (Release date 21/02/2023)

 

Version: 1.0.1.4 (Release date 23/01/2023)

 

Version: 1.0.1.3 (Release date 12/12/2022)

 

Version: 1.0.1.2 (Release date 28/11/2022)

 

Version: 1.0.1.1 (Release date 14/11/2022)

 

Version: 1.0.0.0 (Release date 04/11/2022)