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

Getting Started

Page standards status: Informative

Not sure where to start? Whether you're a regulator evaluating the standard, a vendor building an authoring tool, or a developer creating the FHIR resources — this page will point you in the right direction. Start with the path that best describes your role, then follow the steps that apply to you.

Choose Your Path

🏛️ Regulator / Business Analyst 🏭 Vendor / Implementer 👩‍💻 FHIR Developer
You want to understand what ePI is, what it enables, and how your organization should position itself.

  1. Read the Home page for context and benefits
  2. Review the ePI Types to identify the right starting point
  3. Review the ePI Structure overview
  4. Share the GitHub repository with your technical team
 You are building a system that creates, stores, or renders ePI documents.

  1. Review the ePI Types to select your target scope
  2. Review the rendered HTML examples below
  3. Examine the underlying FHIR JSON
  4. Review the provided stylesheets for rendering
  5. Set up a FHIR R5 server (e.g., HAPI FHIR) for storage and API exchange
 You are mapping, profiling, or validating FHIR resources for ePI.

  1. Review the ePI Structure overview
  2. Study the Profiles & Extensions in the Artifacts tab
  3. Examine the FHIR JSON examples
  4. Validate your Bundle using the Official FHIR Validator
  5. Reference the Technical Details page for implementation notes

Prerequisites

Before you start building, make sure you have the following in place:

Component Authoring Tool (Required) A structured authoring tool to create FHIR resources, supporting rich text, product metadata, and lifecycle management (versioning).

Style Sheets (Required) Converting raw FHIR JSON/XML into human-readable views requires CSS. Use the provided stylesheet in this IG as a foundation.

FHIR R5 Server (Recommended) A central storage system (e.g., HAPI FHIR, Google Cloud Healthcare API) for searching, versioning, and sharing ePI documents via standard APIs.

Required Skills

To successfully implement ePI, your team should have familiarity with the following:

Technical Staff Regulatory / Business Staff
FHIR R5 Core Specification National Regulatory Guidance on ePI
JSON & XML Editing Medicinal Product Metadata
RESTful APIs Controlled Terminology (SNOMED, MedDRA)
CSS & XSLT Structured Authoring Workflows

Example ePI Documents

See how raw FHIR data is transformed into a modern, user-friendly interface. The examples below use a 2-pane design with structured navigation:

Underlying FHIR JSON:

Validate & Build

Once you have reviewed the examples:

  1. Validate your ePI — Use the Official FHIR Validator with the ePI IG package to check for compliance with the profiles defined in this guide.
  2. Build your own — Use the provided examples as a template. Start with Type 2 if you are unsure — it offers the best balance of implementability and clinical value.