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

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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
IG Standards status: Trial-use Active as of 2026-04-03 Computable Name: EpiIG

Drug labels — SmPCs, Package Leaflets, and Product Monographs — are among the most critical documents in healthcare, yet today they are locked in static PDFs and fragmented regional formats that are difficult to exchange, search, or automatically process. The ePI (Electronic Product Information) Implementation Guide defines how to transform these documents into structured, machine-readable HL7 FHIR R5 resources that regulators, industry, and digital health systems can use interoperably — globally.

Why ePI?

Moving from static documents to structured FHIR data creates transformative benefits across the healthcare ecosystem:

  • One Global Standard: A single FHIR-based model replacing fragmented country-specific XML and PDF formats. Build once, adapt for any jurisdiction.
  • Advanced Digital Capabilities: Enable structured search, auto-generate comparison tables, support drug shortage management, and streamline pack artwork generation.
  • Digital Health Interoperability: Seamless integration with ePrescription, Electronic Medical Records (EMR), allergen checking, and automated regulatory reporting.

Background

The Fragmentation Problem: Currently, regions use a mix of SPL, custom XML, or static PDFs. This fragmentation delays safety updates and hinders the global exchange of critical medical data. ePI addresses this by defining a common technical standard that supports existing local regulatory templates and requirements — it does not replace national regulations or regional labeling rules. Each jurisdiction continues to govern its own content requirements; ePI simply provides a shared, interoperable format for exchanging that information.

FHIR: The Engine of ePI

FHIR (Fast Healthcare Interoperability Resources) provides the technical foundation using modern web technologies like XML, JSON, and RESTful APIs.

Concept Description ePI Implementation
Structured Data Resources organize label content into discrete, queryable fields Composition structures the label section headings and narrative content (E.g., text, images, tables)
Interoperability Common FHIR-based format enables seamless exchange with national and international healthcare systems ePI data can be consumed directly by any FHIR-enabled system (e.g., national medicines databases, EMRs, ePrescribing platforms) without custom integration
Standardization Common data model reduces custom integration work Base ePI Profile harmonizes structures across regions
Flexibility Adaptable to regional regulatory requirements Local regulatory requirements (e.g., EU/FDA/PMDA) are supported by region-specific profiles built on the common base

Global Harmonization

ePI and FHIR promote international alignment by providing a unified technical standard. A single ePI document, built on the Base ePI Profile, can be adapted for multiple jurisdictions, reducing redundancy. Efforts like the HL7 Vulcan Accelerator are ensuring that global regulators align on these standards and improve access to medicinal product information.

Scope

In-Scope: All medicinal drug products for human use — including Healthcare Professional labels (e.g., SmPC), Patient labels (e.g., PIL), Instructions for Use (IFU), and pack artwork.

Out of Scope (Temporary): Medical devices, Veterinary Drugs, and Natural Health Products. These will be addressed in future phases.

ePI Maturity & Use Cases

ePI is organized into four Types based on technical maturity and data depth — so organizations can adopt incrementally, starting where they are and evolving toward fully computable data.

Type Core FHIR Resources Primary Value & Use Cases
Type 1 Bundle, Composition, Binary Digital Reproduction: A faithful digital version of the approved labeling (SmPC, PIL, carton). Acceptable as a legal document of record.
Type 2
RECOMMENDED STARTING POINT 		MedicinalProductDefinition, RegulatedAuthorization, Organization, PackagedProductDefinition, ManufacturedItemDefinition, AdministrableProductDefinition, Ingredient, Substance Product Identification: Enables accurate lookup in hospital systems and national medicine databases. Supports Drug Shortage management (therapeutic alternatives), Allergen/Excipient Safety (e.g., lactose, gluten), and Digital Interoperability (ePrescribing).
Type 3 ClinicalUseDefinition, MedicationKnowledge Clinical Guidance: Structured indications, contraindications, and dosing. Enables Interaction Alerts (Drug-Drug, Drug-Food) in EMRs and clinical apps.
Type 4 All resources used in Types 1 to 3 Digital-First Components: Links Composition sections to structured resources to enable full support for personalization and batch-specific label variations.