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 & Regulation Work Group. 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

Purpose

This section provides guidance, examples, and best practices for creating ePI resources across all types. It covers FHIR resource usage, profiling, tooling, and interoperability.

Intended Audience: Developers, regulators, pharmaceutical companies, and healthcare IT professionals.

ePI Resources

ePI leverages 14 specific FHIR resources to support various labeling use cases. The table below outlines their roles.

Resource Purpose in ePI Context
List Organizes references to other resources, enabling navigation and advanced search.
Bundle Container for grouping resources. Essential for reproducing local label templates in Type 1.
Composition Core structure for label content (headings, text, images).
Binary Stores raw data like images or large text blocks for reproduction.
Organization Details the company (name, id, address) associated with the product.
Regulated Authorization Captures approval dates, license numbers, and holder details.
Medicinal Product Definition Regulatory details: name, route, marketing status.
Manufactured Item Definition Physical properties in primary packaging (strength, color, shape).
Administrable Product Definition Physical properties in final form for administration (e.g. reconstituted).
Ingredient Defines specific ingredients (active/excipient) and strength.
Substance Definition Detailed substance info, linked to Ingredients.
Packaged Product Definition Packaging layers, identifiers (GTIN/SKU), and quantity.
Clinical Use Definition Structured indications, contraindications, interactions, and warnings (Type 3/4).
Medication Knowledge Machine-readable dosing instructions (Type 3/4).

ePI Types (Building Instructions)

Select the ePI Type below to see specific build instructions: