EMA: Updates in the Product Lifecycle Management (PLM) Portal

Recommendation

17/18 September 2024

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New and revised guidance documents and materials relating to ePI (electronic Product Information) are now available on the EMA website under the heading "What's New in PLM?" in the PLM Portal (Product Lifecycle Management Portal).

These include the items listed below:

• "ePI registration guide":
  A guide that provides ePI (electronic Product Information) pilot participants with guidance on how to register on the ePI platform.
  
• "ePI procedural guidance":
  A guide describing the timelines for ePI processes for applicants of the ePI pilot phase.
  
• "ePI user guide for applicants":
  A guideline describing the preparation, handling and submission of ePIs as part of the authorisation and publication process. 
  
• "ePI videos" to support users with the functionalities of the PLM portal for ePI":
  A current a video tour explains the PLM website and its sections for ePI. Further videos will also be made available here in the future.
  
• "ePI Frequently Asked Questions (FAQ) document":
  The Q&A document answers frequently asked questions from pilot participants related to ePI. 
  
• "list of ePI known issues":
  This list shows all already known errors/problems of the ePI sections of the PLM Portal and gives suggestions for respective workarounds. No input is required for these items in the Service Desk, as they are already known.

The information on ePI in the PLM Portal is continuously updated and can be viewed on the EMA website.