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Europe: EMA preps for EU common standard on electronic product information

2021/06/11  EMA

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.

EMA, national competent authorities and the European Commission are conducting an electronic product information (ePI) set-up project to develop an EU Common Standard for ePI.

An EU Common Standard for ePI refers to the technical features of ePI to be agreed by regulators and stakeholders. The documentation for the draft EU Common Standard is currently the subject of an open public consultation.

To facilitate stakeholder consultation, EMA is hosting half-day virtual workshops designed to inform on the standard and explore its future use. Feedback from the workshops will contribute to ensuring that the adopted Common Standard meets the needs of its future users, confirming they can access, view and disseminate product information in electronic format, ePI.

The consultation is being carried out on the following documents:

  • ePI API Specification (PDF) and the associated ePI API service list (Excel);
  • A FHIR XML template based on the Quality Review of Documents (QRD) template for human medicines.
  • An instance of an ePI sample message is provided in XML and HTML, along with a sample XSL transformation.

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