FHIR Fundamentals for ePI Success

Europe’s adoption of HL7 FHIR for electronic Product Information (ePI) marks a decisive move toward structured content authoring and scientific assessment across the European network. Under the EU ePI Common Standard, all medicinal product information—SmPCs, package leaflets, and labeling annexes—must conform to defined FHIR profiles before being shared with patients and healthcare professionals.  
  
That change is more than a format swap. Moving from document-based files to structured content requires rigorous validation against profile constraints, terminology bindings, mandatory element cardinality, and alignment with SPOR master data domains. In practice, product information authored in one form must reliably withstand automated interrogation in another; the gap between those forms directly determines an organization’s regulatory and operational exposure. This white paper explains the implications and practical steps to compliance.

Authors:

- Anjana Pindoria-Rettenberger, EXTEDO
- Kenneth Gutiérrez, Docuvera