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News

Previous DADI news can be found here

17-11-2022

Updated PLM Portal Guide to eAF (DADI) Registration is now available

An updated version of the Portal (eAF) guide to registration is now available. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. This update includes further details on the use of Multi Factor Authentication (MFA).

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.

For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal. Please share any questions with us via eSubProgofficer@ema.europa.eu.

04-11-2022

Web-based Human Variations eAF (DADI) now live on the new Product Lifecycle Management Portal

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

As a reminder: the use of the new web-based form is optional. This release will not trigger a transition period towards mandatory use. The formal transition period will start when nationally authorised products (NAPs) and features supporting use cases covered 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 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.

The following upcoming events and resources are available to help users get familiar with the new form and the new PLM Portal:
  • Upcoming events:
  • Training videos:
  • Useful resources:


  • Please share any questions with us at eSubProgofficer@ema.europa.eu.

    PLM Portal eAF (DADI) documentation:
    DADI webinars:

    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

    CESSP Previous News


     

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