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Purpose and context

This user guide describes how to create, author and submit electronic Product Information (ePI) for regulatory approval and publication.

With an ePI Applicant role, you can access the PLM portal and manage ePI for your organisation.

Please visit the EMA Account Management page to login (or create an account first) and request an ePI Applicant role. ePI Applicant roles are currently only available to participants in the ePI pilot.

ePI Applicant roles and permissions are explained in the ePI registration guide.

Visibility of ePIs

An ePI Applicant Manager will only see the ePIs they have created or been invited to as a co-author. Similarly, an ePI Applicant Contributor will only see the ePIs they have been invited to as a co-author.

Please refer to 'Grants provided by user access roles' in the ePI registration guide.

Navigating ePI

There are two main entry points to managing ePI:

  • ePI list: use the dropdown option on the top banner to access your ePI list and edit an ePI that has already been created.
  • New ePI: use the dropdown option on the top banner (or the tile on the PLM Portal homepage or the '+ Create New ePI' button on the ePI list) to create an ePI either from a blank template or from an existing ePI. This option is visible to users with the ePI Applicant Manager role.

ePI Applicants view of PLM portal

Tooltips are available and can be viewed by hovering your mouse wherever you see this symbol: tooltip information button

 

Create ePI

 

ePI list

 

Editor

 

Preview ePI

 

Export ePI

 

Upload FHIR