The expected start date of the strongly recommended use of the PLM Portal web-based eAF for submissions to the National Competent Authorities for non-Centralised Procedure (CAP) variations is now planned for February 2025.

 

Please note that the web-based eAF is already fully functional for the submission of variations for CAPs, including EMA-led worksharing variations containing non-CAPs.

Post-authorisation procedures submitted to the EMA will now be managed in IRIS. The transition will affect all CAPs and and non-CAPs where EMA acts as reference authority. e.g.

• Worksharings with both Non-CAPs and CAPs,
• Single assessments of PSURs which may exclusively pertain to NAPs
• Referrals
• PASS

 

To access the PLM Portal eAF all users are required to have:

▪ an active EMA user account, and,

▪ user access role(s) assigned to that account.

Registration needs to be done only once. For information on how to request an EMA account and how to an appropriate PLM Portal – eAF role (these are two separate actions), please consult the separate document – PLM Portal (eAF) guide to registration.pdf

This guide aims to support the users of the PLM Portal – eAF in completing the registration steps before accessing the platform. Most of these steps are independent from the PLM Portal – eAF and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).

Once access to PLM Portal eAF is available follow the Guide for PLM Portal eAF Navigation –

PLM Portal eAF guide to navigation – eAF user guide.pdf

This guide aims to support the users of the PLM Portal – eAF in navigating through the platform. More specifically, the guide has been produced to show users how to access the PLM Portal – eAF, as well as prepare application forms.

Please note that this guide is a living document which will be updated regularly. It describes some issues in the form functionality and aims to provide workaround solutions.

Supported Browsers

The PLM Portal – eAF can be accessed on any modern Web Browser, including but has only been tested with Google Chrome (latest version) and Edge (including the new, Chromium-based Edge). No official testing has been done using other browsers, such as Safari 12 and above, Firefox (latest version), Vivaldi, etc.

If you need assistance with any of the above, contact us.

Written by Nanda Naik.