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23 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.


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 small number of limitations still exists 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 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 new 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. One new feature launched on the PLM portal is a chatbot through which you can ask questions about the web-forms and get quick answers.

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 for them. The components currently used are:

Component

Short Description
 

PLM Portal

This component relates to the website, the UI (user interface)

Human Variations eAF

The business process where MAH’s create and edit their variation eAF (electronic application form) on the PLM Portal

PDF

The PDF that is available for download after the completion of an application

FHIR XML

The FHIR xml file attached to exported PDF


For additional information on the PLM portal see this:

 

 

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)