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  1. Home
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  3. ePI guidance

ePI guidance

  • ePI Videos

    Videos about creating and managing ePI in the PLM portal

  • ePI Registration Guide

    Information on ePI roles in the PLM portal and how to request them

  • ePI User Guide for Applicants

    Instructions for ePI Applicant Managers and Contributors to navigate the authoring tool and create, prepare and submit ePI to regulators

  • ePI Frequently Asked Questions (FAQs)

    ePI Frequently Asked Questions (FAQs)

  • ePI Known Issues

    Details of all known issues in the PLM portal – ePI that the ePI team is aware of and workarounds where available.

  • ePI User Guide for Regulators

    Instructions for ePI Approvers and Publishers to navigate the tool and approve and publish ePI after they have been submitted by a pharmaceutical company

  • ePI FHIR Implementation Guide

    Preview of the FHIR Implementation Guide for ePI to enable creation of ePI according to the EU ePI Common Standard

  • ePI Style Guide

    This style guide aims to instruct applicants on how styling information is added for ePIs.

  • ePI QRD template lists

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