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

API Server Capabilities

This page defines the minimum technical capabilities recommended for a FHIR server hosting an ePI repository. These requirements ensure that authorized medicinal product information is accessible, searchable, and maintainable across different healthcare systems.

Recommended Resource Interactions

To support discovery, display, and clinical use of ePI, a repository SHOULD support the following interactions across core resources:

Resource Category	FHIR Resource(s)	Supported Interactions
Document	Bundle, Composition	read, vread, search, history
Product	MedicinalProductDefinition, PackagedProductDefinition, ManufacturedItemDefinition, AdministrableProductDefinition	read, search
Authorization	RegulatedAuthorization	read, search
Entities	Organization, Ingredient, SubstanceDefinition	read, search
Clinical	ClinicalUseDefinition, MedicationKnowledge	read, search
Supporting	Binary (Images), List (Histories)	read

Key Search Parameters by Resource

A high-performance ePI repository must allow clients to find medicinal information using various starting points:

1. Document Search (Bundle, Composition)

• identifier: Search for a specific document version.
• status: Filter by active or archived labels.
• subject: Find documents for a specific MedicinalProductDefinition.
• date: Search for labels updated or authorized in a date range.

2. Product Search (MedicinalProductDefinition)

• name: Search by medicinal product name (e.g., [base]/MedicinalProductDefinition?name:contains=Paracetamol).
• identifier: Search by GTIN or National Product Number.
• type: Filter by product type (e.g., Human Medicinal Product).

3. Substance & Ingredient Search (SubstanceDefinition, Ingredient)

• code: Find ingredients by chemical code (e.g., SNOMED CT or UNII).
• for: Find ingredients associated with a specific product.

4. Clinical Search (ClinicalUseDefinition)

• subject: Find indications or contraindications for a specific product.
• type: Filter by category (e.g., indication, contraindication, interaction).

Technical Constraints & Operations

1. Profile Validation: The server SHOULD validate all incoming resources against the ePI profiles defined in this Implementation Guide.
2. Format Support: The server MUST support both JSON and XML representations.
3. Content Negotiation: Support for _format parameter and Accept headers to allow clients to request specific data formats.

Submission & Maintenance (APIX IG)

For detailed technical guidance on how to submit, validate, and maintain ePI documents on a server (including lifecycle management operations), refer to the APIX Implementation Guide. While this IG focuses on the content structure of ePI, the APIX IG provides the transactional framework for exchanging that content between manufacturers and regulators.