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

FHIR Servers

Page standards status: Informative

Technical Details · FHIR R5

The Engine for Global Drug Data

Architecture, technical capabilities, and operational requirements for a FHIR-based ePI Repository — the single source of truth for digital drug labels.

Repository Architecture
⚙️
FHIR Server

The core engine for storing Bundle, Composition, and all related product resources on a FHIR R5-compliant platform.

🌐
API Layer

Standard RESTful endpoints for searching and retrieval, e.g. GET /Bundle?subject.identifier=...

📥
Ingestion Engine

Handles the upload and automatic validation of new ePI versions against profiles defined in this Implementation Guide.

🛡️
Security Layer

Manages granular access control — particularly for internal or pre-submission repositories used by pharmaceutical companies.

Recommended Resource Interactions
Resource Category FHIR Resources Supported Interactions
Document BundleComposition read vread search history
Product MedicinalProductDefinitionPackagedProductDefinitionManufacturedItemDefinition readsearch
Authorization RegulatedAuthorization readsearch
Entities OrganizationIngredientSubstanceDefinition readsearch
Clinical ClinicalUseDefinitionMedicationKnowledge readsearch
Supporting BinaryList read
Key Search Parameters
1
Document Search
identifierFind a specific document version
statusFilter by active or archived
subjectLink to MedicinalProductDefinition
dateDate range for authorization or update
GET /Bundle?subject.identifier=...
2
Product Search
nameSearch by medicinal product name
identifierSearch by GTIN or National Product Number
typeFilter by product type
GET /MedicinalProductDefinition?name:contains=Paracetamol
3
Substance & Ingredient Search
codeFind by chemical code (SNOMED CT, UNII)
forFind ingredients linked to a product
GET /SubstanceDefinition?code=...
4
Clinical Search
subjectIndications or contraindications for a product
typeFilter by indication, contraindication, interaction
GET /ClinicalUseDefinition?type=contraindication
Technical Constraints & Operations
📋 Server Requirements
SHOULD
Profile Validation — The server should validate all incoming resources against the ePI profiles defined in this Implementation Guide.
MUST
Format Support — The server must support both JSON and XML representations.
SHOULD
Content Negotiation — Support the _format parameter and Accept headers so clients can request specific data formats.
Deployment Options
Open Source
Self-Hosted

Maximum control over data residency, custom profiles, and security policies. Requires DevOps expertise to deploy and maintain.

Examples: HAPI FHIR, LinuxForHealth
Managed Cloud
Cloud-Native

Scalability and regulatory compliance out-of-the-box. Lower operational overhead — ideal for initiatives requiring rapid onboarding.

Examples: AWS HealthLake, Google Cloud Healthcare API, Azure Health Data Services
Transactional Workflows — APIX IG

This guide defines the content structure of ePI. For the full transactional framework — submitting, versioning, and exchanging ePIs across systems — refer to the APIX Implementation Guide.

View the APIX IG →
Vendor Neutrality: This Implementation Guide does not endorse specific software vendors or cloud providers. All technical requirements are based on the global HL7 FHIR R5 standard.