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Updated on: 1 July 2024

 

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

 

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)



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