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

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Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/ImplementationGuide/hl7.fhir.uv.emedicinal-product-info				Version: 1.1.0
				Computable Name: EpiIG

Electronic Product Information (ePI) is a HL7 FHIR R5 Implementation Guide that defines a global, open standard for structured, digital-first medicinal product information.

Why Implement ePI?

ePI replaces DOCX or PDF drug labels with fully structured, interoperable, and instantly distributable FHIR documents. The benefits are immediate and transformative:

Benefit	What it means for you
One global standard	A single FHIR-based standard built with open-source web standards that are widely supported and easy to implement – no need to develop or maintain custom XML standards per country.
Advanced Capabilities	Enable advanced search, auto-generate comparison tables or pack artwork, facilitate resolving drug shortages.
Digital Health Interoperability	Seamless integration with eHealth systems for ePrescription, eMedical Records, personalization, allergen checking, and regulatory reporting.
Future-proof and granular	Start with ePI Type 1 or 2 today and evolve to fully structured, personalized leaflets (Type 4) tomorrow without changing the underlying standard.

Four Maturity Levels – Choose Your Starting Point

Type	Description	Typical Use Cases
ePI Type 1	FHIR equivalent of authorized DOCX/PDF labels	Quick win for industry/regulators to replace existing labels
ePI Type 2 RECOMMENDED STARTING POINT	Adds structured medicinal product details	Advanced search, flag allergens, supply chain traceability, create online product label catalogue
ePI Type 3	Adds structured clinical details	Tracking indications, contraindications, interactions (drug:drug, drug:food, drug:device)
ePI Type 4	Digital-first, granular, computable components	Personalization, dynamically generated label content, and next-generation apps

Background

Drug labels (such as SmPCs, Product Monographs, and package leaflets) are frequently updated regulatory documents that provide essential information for healthcare professionals, patients, and product packaging.

They are frequently updated with new indications, safety warnings, or dosing changes. Today, however, most are distributed as DOCX or PDF files in fragmented, region-specific formats (e.g., US SPL, EU custom XML, or simple PDFs), which hinders interoperability, delays updates, and limits digital use in EHRs, ePrescribing systems, and patient apps.

Electronic Product Information (ePI) solves this by transforming drug labels into fully structured, machine-readable HL7 FHIR R5 documents. Using a common base, a single ePI can serve multiple jurisdictions while remaining adaptable to local regulatory requirements.

FHIR’s modern web-based approach paves the way for global harmonization of medicinal product information.

In-Scope

• Human medicinal drug products
• Healthcare professional label content (e.g., SMPC), patient label content (e.g., Pack Insert), pack artwork

Out of Scope

• Medical devices, Veterinary Drugs, Over the Counter Drugs, Natural Health Products