Purpose and Context
The European Medicines Regulatory Network ePI Implementation Guide describes how the HL7 FHIR standard is used to generate ePI according to the EU ePI Common Standard. Publication of the Guide is intended to provide transparency to stakeholders, including the pharmaceutical industry, on future requirements for ePI to be submitted to EU regulators.
Content of the Implementation Guide
The Implementation Guide presents the FHIR resources used to create an ePI according the EU ePI Common Standard, which has been adopted by the European Medicines Regulatory Network to enable provision of harmonised ePI across the EU.
The Guide contains information on the following resources:
- Profiles for Bundle, List, Composition and Regulated Authorization
- Details of extensions Authorization type, Image reference and Version number
Important Note: The Guide is intended as a preview only, and does not yet constitute a formal version. On the go-live implementation of ePI for regulatory procedures, a formal version will be published with versioning in place. The guide is subject to change as development of core functionality of ePI creation and management tooling is ongoing.
European Medicines Regulatory Network ePI Implementation Guide: link