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Updated on: 01 July 2025

 

Purpose and Context
 

EMA is pleased to announce the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) has gone live on 4th November 2022, on the new 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.

This document lists and briefly describes the new features and fixed issues included in the release of the PLM Portal FHIR XML only. For the Release notes related to the eAF, please visit the guidance on 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 FHIR XML only.
For the Release notes related to the eAF, please visit the guidance on the PLM Portal. 
The most recent release appears first.
The components mentioned in this document are:
 

ComponentShort 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 exported PDF

 

FHIR Package:

The latest FHIR mapping (starting with version 2.2.3) can be found here: PLM Portal eAF FHIR Package (Mapping) 2.2.3, and it can be read together with the package: PLM Portal eAF FHIR XML Package 2.0.0/2.1.0

 


For additional information on the PLM portal:

 

 

Version 2.2.3 (Release date: 30/06/2025)

 

Version 2.2.2 (Release date: 13/05/2025)

 

Version 2.2.1 (Release date: 14/02/2025)

 

Version 2.2.0 (Release date: 07/01/2025)

 

Version 2.1.1 (Release date: 09/12/2024)

 

Version 2.1.0 (Release date: 28/10/2024)

 

Version 2.0.1 (Release date: 28/06/2024)

 

Version 2.0.0 (Announcement date: 31/01/2024 - Release date: 14/06/2024)

 

Version 1.2.0 (Release date: 21/11/2023)

 

Version 1.1.2 (Release date: 10/02/2023)

 

Version 1.0.2 (Release date: 16/11/2022)

 

Version 1.0.0 (Release date: 04/11/2022)