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ePI Bundle (FHIR Resource)

An ePI Bundle is the FHIR container resource used to group the Composition and other related resources to reproduce the local label template in a semi-structured format.

Structure​

The ePI Bundle contains:

  • Composition: Core resource with narrative text and metadata
  • Organization: Manufacturer and regulatory authority information
  • MedicinalProductDefinition: Product identification
  • AdministrableProductDefinition: Dosage forms
  • Ingredient: Active substances
  • ClinicalUseDefinition: Indications, contraindications, warnings

Composition Resource​

The Composition is the central resource containing:

  • Narrative text: HTML content with PIL sections
  • Sections: Structured division of content
  • Extensions: Including HtmlElementLink for annotations
  • Metadata: Language, status, date

FHIR Standard​

Follows the FHIR ePI Implementation Guide:

  • Bundle type: document
  • First entry: Composition resource
  • Referenced resources included

Usage in FOSPS​

ePI Bundles are: