Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Overview

Page standards status: Informative

The Build ePI section provides the technical implementation guidance, resource mapping, and step-by-step instructions required to create valid ePI documents. It also describes how to set up an ePI Repository to manage a catalog of authorized labels.

ePI is not a single resource but a collection of interlinked FHIR resources. Depending on the ePI Type (Maturity Level) being implemented, different resources are required to capture the necessary narrative and structured data.

Core ePI Resources

The table below identifies the primary FHIR resources used across the four ePI types and their specific roles in the labeling lifecycle.

Resource Role in ePI Context
Bundle The 1:1 container for a single ePI document (e.g., an SmPC or PIL).
Composition The backbone of the document, organizing headings and narrative (XHTML) sections.
Binary Stores media (SVG/PNG/JPEG) embedded within the ePI as Base64 objects.
List Used for cross-document navigation, history tracking, and grouping translated versions.
MedicinalProductDefinition Captures high-level product identity, including the name and marketing status.
RegulatedAuthorization Details approval dates, license numbers, and legal status.
ManufacturedItemDefinition Describes the physical form of the product (e.g., tablet, vial).
AdministrableProductDefinition Specifies the product in its final administrable state (e.g., solution).
Ingredient Defines active substances and excipients with clinical-grade precision.
SubstanceDefinition The technical chemical definition of the active or inactive ingredients.
ClinicalUseDefinition Structures indications, contraindications, and interaction alerts.

Select Your Implementation Path

Implementation guidance is organized by the depth of structured data required:

  • Type 1: Narrative Reproduction
    • Focus: Digitizing the official label template (SmPC/PIL/Artwork).
    • Key Features: HTML5/XHTML narrative, embedded images, and document metadata.
  • Type 2: Product Identification
    • Focus: Structured supply chain and search capabilities.
    • Key Features: Type 1 + structured ingredients, form, packaging, and authorization.
  • Type 3: Clinical Guidance
    • Focus: Clinical decision support.
    • Key Features: Type 2 + structured indications, contraindications, and warnings.
  • Type 4: Digital-First Components
    • Focus: Advanced automation and personalization.
    • Key Features: Fully granular, computable components designed for dynamic assembly.