European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - ci-build
European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: http://ema.europa.eu/fhir/ImplementationGuide/EUePI | Version: 1.0.0 | |||
| Active as of 2025-03-11 | Computable Name: EUePIImplementationGuide | |||
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:
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.
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.
The Implementation Guide is a draft provided for preview purposes only. A formal, published version will be made available prior to implementation of ePI, and the content and location of this guide will change in the future.
Additional resources on FHIR and the EU Common Standard for Electronic Product Information (EPI).
EU ePI Common Standard specifications (GitHub)
Quality Review of Documents (QRD) Product-Information templates -human medicines
To facilitate the learning of the ePI FHIR resources described in this Implementation Guide, we provide few samples, containing validated examples of summary of product characteristics (SMPC), Annex II, labelling and package leaflet documents.
In addition to the validation of Bundle and Composition resources, EU electronic Product Information (ePI) Composition resources will also be checked for their level of compliance with published Quality Review of Documents (QRD) templates.
ePI documents have mandatory, non-mandatory and additional sections. Mandatory sections are required by the legislation and are defined in the QRD template. They cannot be moved or deleted. Non-mandatory sections are optional, however, their headings and position are defined in the QRD template. They cannot be re-ordered, but can be renamed where necessary. To check for compliance with QRD templates, please download and use the structure definition files included in the file below. File contain structure definition files for Centrally Authorised Products (CAP) and Nationally Authorised Products (NAP).