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

Getting Started with ePI

Whether you are a Health Authority defining the rules, a Pharmaceutical company mapping your portfolio, or a Technology Vendor building an authoring platform — choose your path below.


Choose Your Path

🏢
Pharmaceutical Industry

You are responsible for converting existing drug labels into the ePI standard.

  1. Review the Interactive Showcases
  2. Read the Build Overview
  3. Select a structured authoring tool vendor
  4. Assess your internal ingredient data quality
🏛️
Health Authorities

You are defining digital interoperability strategies at a national or regional level.

  1. Review the Build List of ePIs guide
  2. Understand the Four ePI Types
  3. Establish national controlled terminologies
  4. Test with the Jurisdiction Showcases
💻
Technology Vendors

You are building FHIR editing tools, viewers, or server architectures.

  1. Study the FHIR Profiles
  2. Copy the CSS Style Sheets
  3. Review the Product Architecture mapping
  4. Validate with the HL7 Validator

The journey is incremental

You don't need to model complex clinical algorithms on day one. Start with Type 1 to digitize the paper layout, then add Type 2 product data for automated supply chain tracking.


Prerequisites

Required
Structured Authoring Tool

An ePI authoring tool to create FHIR resources, supporting rich text, product metadata, and versioning.

Required
Style Sheets

CSS to render FHIR JSON/XML as human-readable views. Use the provided stylesheet as your foundation.

Recommended
FHIR R5 Server

A central storage system (e.g., HAPI FHIR, Google Cloud Healthcare API) for searching, versioning, and sharing ePIs via the API.


Example ePI Documents

See how raw FHIR data is transformed into a modern, user-friendly interface.


Validate & Build

Once you have reviewed the examples:

  1. Validate your ePI — Use the Official FHIR Validator with the ePI IG package to check 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 value.