Article describes how to validate FHIR files against the EU ePI Common Standard on a user's local machine

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

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

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

Frequently Asked Questions (FAQs) document on electronic Product Information

Description of ePI processes within regulatory procedure timeframes for applicants participating in the ePI pilot.

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

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

Videos about creating and managing ePI in the PLM portal