European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - release

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Official URL: http://ema.europa.eu/fhir/ImplementationGuide/EUePI Version: 1.0.0
Active as of 2026-09-17 Computable Name: EUePIImplementationGuide

Background

The European Medicines Agency (EMA) and its European medicines regulatory network partners, together with the European Commission (EC), are working to enable the use of electronic product information (ePI) for human medicines in the European Union (EU).

ePI refers to the authorised product information for medicines adapted for handling in electronic format and dissemination via the web, e-platforms and in print. ePI includes:

  • the summary of product characteristics (SmPC), intended for healthcare professionals,
  • Annex II (for centrally authorised products)
  • labelling, with outer and inner packaging information, and
  • the package leaflet, for patients and consumers.

ePI offers advantages such as improved accessibility, searchability and multilingual capabilities.

ePI can also integrate with electronic healthcare systems, enabling healthcare professionals and patients to access accurate and up-to-date product information more conveniently.

This documentation presents the FHIR resources used to create an ePI, as defined by the EU ePI Common Standard, which has been adopted by the EMRN to support the provision of harmonised electronic information on medicines within the EU.

EMRN

The European Medicines Regulatory Network comprises the closely coordinated regulatory network of national competent authorities in the Member States of the European Economic Area working together with the European Medicines Agency and the European Commission to regulate medicines in Europe.

ePI supporting material

The following resources support the creation, validation, and presentation of electronic Product Information (ePI) in accordance with the EU ePI Common Standard. They provide guidance on validating FHIR XML files, applying QRD-compliant styling, and using QRD template lists when creating ePI content.

How to Validate ePI Against the EU ePI Common Standard Guidance for validating ePI FHIR XML files against the EU ePI Common Standard locally on your machine using the HL7 FHIR Validator and the EMRN ePI FHIR profiles.

ePI QRD Template Lists QRD template lists containing identifiers, term names, translations, hierarchies, and attributes used for creating QRD-compliant ePI documents.

ePI Style Guide Guidance on applying styling and formatting to ePI content, including QRD styling conventions, XHTML requirements, and the correct use of escaped characters to ensure that special symbols are represented without breaking the XHTML, XML, or JSON structure of ePI documents. The guide also provides QRD CSS and XSLT resources for transforming and displaying ePI content to users.

Terms of Use

This Implementation Guide is published under the standard FHIR IG license. Use of this IG and its contents is subject to the terms described here: [https://www.hl7.org/fhir/license.html].

Disclaimer

This Implementation Guide is provided "as is" without warranty of any kind. No use of external IP (other than from the FHIR specification)