thochi / eu-epi-common-standard

Information on the EU Common Standard for electronic product information (ePI).

ePI for EU medicines

What is ePI?

EU Common Standard for electronic product information (ePI) is authorised, statutory product information for EU medicines (the summary of product characteristics [SmPC, intended for healthcare professionals], labelling [outer and inner packaging information] and package leaflet [PL, for patients / consumers]) in a semi-structured format created using the EU Common Standard. ePI is adapted for electronic handling and allows dissemination via the web, e-platforms and print.

EU ePI Common Standard

The EU ePI Common Standard refers to the technical features of ePI agreed by regulators and stakeholders. The documentation for the draft EU ePI Common Standard was the subject of workshops and a public consultation. The EU ePI Common Standard has been adopted in September 2021 by the EU Network Data Board on behalf of the European Medicines Regulatory Network.

The EU ePI Common Standard consists of:

• ePI API Specification (PDF) and the associated ePI API service list (Excel), available here;
• A FHIR XML template based on the Quality Review of Documents (QRD) template for human medicines, available here.

An instance of an ePI sample message is provided in XML and HTML, along with a sample XSL transformation, available here.

EMA, national competent authorities and the European Commission are conducting an electronic product information (ePI) pilot project to pilot use of the EU ePI Common Standard in regulatory procedures. This project is funded by EU4Health.

Contact

For further information or clarifications please contact [email protected].

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