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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 - 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 - 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 - Frequently Asked Questions (FAQs) Document
Frequently Asked Questions (FAQs) document on electronic Product Information
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ePI - Procedural Guide
Description of ePI processes within regulatory procedure timeframes for applicants participating in the ePI pilot.
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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 - Registration Guide
Information on ePI roles in the PLM portal and how to request them
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ePI - Videos
Videos about creating and managing ePI in the PLM portal