Posted Thu, 03 Nov 2022 21:33:42 GMT by Kristiina Puusaari

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 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.

Posted Thu, 03 Nov 2022 21:38:49 GMT by Kristiina Puusaari
The following upcoming events are available to help users to get familiar with the new form and the new PLM Portal:
Upcoming events:

  • Human Variations web based eAF Form training session: 8th November 2022 (10:00-11:30)
  • Q&A clinics:
    • 15th November 2022 (11:00-11:30)
    • 22nd November 2022 (11:00-11:30)
    • 29th November 2022 (11:00-11:30)
Please register using the links available on the eSubmission website and/or the EMA corporate website.
Posted Fri, 04 Nov 2022 16:01:18 GMT by Paolo Tomasi EMA
Well done Kristiina and team!