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

📋 New to ePI? Before building an ePI, reading this Vulcan ePI IG, your national regulator's ePI guidance, and select a structured authoring tool.

The Build ePI section provides step-by-step instructions for creating valid ePI documents at each maturity level, from a basic digital label (Type 1) through to structured clinical information (Type 3). It also describes how to set up an ePI Repository to manage a catalogue of authorised 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.
MedicationKnowledge Defines the authorized dosage and administration instructions.

Select Your Implementation Path

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

  • Type 1: Digital Label
    • Focus: Digitizing the official label template (SmPC/PIL/Artwork).
    • Key Features: Structured narrative text, structured tables, embedded images, and document metadata.
  • Type 2: Product Information
    • Focus: Structured product information for advanced search capabilities.
    • Key Features: Type 1 + structured ingredients, strength, organization, pharmaceutical dose form, packaging, and authorization.
  • Type 3: Clinical Information
    • Focus: structured Clinical information.
    • Key Features: Type 2 + structured indications, contraindications, and warnings.
  • Type 4: Dynamic Digital Label
    • Focus: Personalization and dynamic content generation.
    • Key Features: Direct links between specific sections of the text and their corresponding machine-readable FHIR resources.