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ePI Videos
Videos about creating and managing ePI in the PLM portal
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ePI Registration Guide
Information on ePI roles in the PLM portal and how to request them
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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
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ePI Frequently Asked Questions (FAQs) Document
Frequently Asked Questions (FAQs) document on electronic Product Information
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ePI Known Issues
Details of all known issues in the PLM portal – ePI that the ePI team is aware of and workarounds where available.
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ePI news
News articles and announcements related to the electronic Product Information (ePI)
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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
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[ePI] FHIR Implementation Guide for ePI
Preview of the FHIR Implementation Guide for ePI to enable creation of ePI according to the EU ePI Common Standard
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[ePI] How to validate ePI against the EU ePI Common Standard
Article describes how to validate FHIR files against the EU ePI Common Standard on a user's local machine
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ePI Style Guide
This style guide aims to instruct applicants on how styling information is added for ePIs.
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ePI QRD template lists
Quality Review of Documents template lists provide identifiers, term names, term translations, hierarchy and attributes
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