FHIR Implementation Guide for ePI - Now Live
The European Medicines Regulatory Network has published a FHIR Implementation Guide. The guide offers technical details on the FHIR standard, enabling medicine information providers to create harmonised ePI according to the EU ePI Common Standard. Harmonised ePI will help deliver up-to-date medicines information to patients and healthcare professionals across Europe in an accessible electronic format.
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date: 22/07/2024
The published Implementation Guide presents an exhaustive overview of the FHIR resources which can be used to create ePI - electronic Product Information - according to the EU ePI Common Standard. Companies and providers can refer to the Implementation Guide to prepare for future submission of ePI to EU regulators.
ePI refers to the authorised, statutory product information for medicines adapted for handling in an electronic format for dissemination via the web, e-platforms and in print. Generally, product information includes the summary of product characteristics, package leaflet and labelling.
The EU ePI Common Standard has been adopted by the European Medicines Regulatory Network. It is based on FHIR - https://www.hl7.org/fhir/overview.htmlFast Healthcare Interoperability Resources, an international set of guidelines for exchanging electronic healthcare data.
This Guide contributes to the European Medicines Regulatory Network commitment to deliver medicines information to patients and healthcare professionals in a harmonised electronic format, accessible to all.
ePI refers to the authorised, statutory product information for medicines adapted for handling in an electronic format for dissemination via the web, e-platforms and in print. Generally, product information includes the summary of product characteristics, package leaflet and labelling.
The EU ePI Common Standard has been adopted by the European Medicines Regulatory Network. It is based on FHIR - https://www.hl7.org/fhir/overview.htmlFast Healthcare Interoperability Resources, an international set of guidelines for exchanging electronic healthcare data.
This Guide contributes to the European Medicines Regulatory Network commitment to deliver medicines information to patients and healthcare professionals in a harmonised electronic format, accessible to all.