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 of This Tab

The "How to Build ePI Type 1 to 4" tab offers detailed guidance, examples, and best practices for creating ePI resources for each type. It covers:

• FHIR Resource Usage: How to use FHIR resources like Composition, Medication, and Bundle to structure ePI data.
• Profiling: Applying the ePI IG profiles to ensure conformance with regulatory requirements.
• Examples: Sample FHIR instances for each ePI type to illustrate implementation.
• Tooling: Guidance on using tools like the FHIR IG Publisher to validate and publish ePI resources.
• Interoperability: Ensuring ePI data aligns with global standards and regional regulations.

​Recommend first reading the ePI components page to understand what resources make up an ePI, and the use cases to select the appropriate use case and ePI type to suit your needs.

Who Should Use This Tab?

This tab is intended for:

• Developers building ePI systems or applications.
• Regulators defining ePI requirements for medicinal product submissions.
• Pharmaceutical companies creating compliant ePI for their products.
• Healthcare IT professionals integrating ePI into electronic health record (EHR) systems.

Getting Started

To begin, explore the sub-sections linked below for each ePI type.

• Type 1: Narrative Only
  Reproduces the local health authority's DOCX or PDF-based template. Which includes all human-readable narrative (e.g., paragraphs, tables, bullets, images), section headings, sub-section headings, and document metadata (e.g., Document title, original date of approval, last date of modification, version, language).
  Learn how to build ePI Type 1

• Type 2: Narrative with Structured Product Data
  Includes structured data about the product (e.g., medication name, ingredients, dosage forms, market authorization holder). This type supports partial machine processing while prioritizing the narrative.
  Learn how to build ePI Type 2

• Type 3: Narrative with Structured Clinical Data
  Includes structured clinical data (e.g., indications, contraindications, warnings, undesireable effects). This type enables machine-readable clinical information for personalization, advanced search, and analytics.
  Learn how to build ePI Type 3)

• Type 4: Fully Structured
  Supports full machine processing and prioritizes structure over narrative (e.g., structured dose instructions, structured adverse event tables). Still includes narrative but the narrative is now a child of a structured component. This type is optimized for machine-to-machine exchange and advanced personalization (e.g., autogenerate an ePI for a specific individual or patient profile grouping).
  Learn how to build ePI Type 4)