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

Terminology

Page standards status: Informative

Controlled terminology ensures consistency, interoperability, and regulatory compliance across digital drug labels, supporting global harmonization of medicinal product information.

Introduction to Controlled Terminology

Standardized code systems allow drug label information to be precise and machine-readable. In the ePI IG, these terminologies facilitate integration with systems like Electronic Health Records (EHRs) and ePrescribing apps.

Clinical Precision: SNOMED CT, ICD, and MedDRA are used for indications, contraindications, and adverse reactions, ensuring that clinical content is universally understood by medical software globally.

Key Terminologies Used

Standard Usage in ePI
LOINC Document and section codes (e.g., SmPC, PIL headings)
UCUM Standardized units of measure for dosages
ISO 639-1 Two-letter language codes (e.g., "en", "fr")
ISO 3166-1 Two-letter country/jurisdiction codes (alpha-2, e.g., "US", "JP")
EDQM Dose forms, routes of administration, packaging, and unit of presentation
MedDRA Adverse event and safety reporting codes

International Harmonization

IMPORTANT

International Harmonization: By using EDQM and SNOMED CT, a single ePI Type 2 or 3 document can be understood and processed by healthcare systems in multiple jurisdictions with minimal adaptation.

For a full list of supported terminologies and technical constraints, refer to the Artifacts Summary.