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

Technical Details · Code Systems

Controlled Terminology

Standardized code systems make drug label information precise and machine-readable — enabling global interoperability with EHRs, ePrescribing apps, and regulatory systems.

Why Controlled Terminology Matters
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Interoperability First

Standardized code systems allow ePI data to be consistently understood and processed by Electronic Health Records (EHRs), ePrescribing apps, and regulatory platforms — without manual translation between jurisdictions.

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Clinical Precision

SNOMED CT, ICD, and MedDRA are used for indications, contraindications, and adverse reactions — ensuring clinical content is universally interpreted by medical software globally.

Key Terminologies Used in ePI
LOINC
Logical Observation Identifiers

Document and section codes — SmPC headings, PIL headings, and standard section identifiers across jurisdictions.

e.g. SmPC section code: 34067-9
UCUM
Unified Code for Units of Measure

Standardized units of measure for dosages and quantities — ensures "mg", "mL", and "IU" are unambiguous across systems.

e.g. dose unit: mg, mL, IU
ISO 639-1
Language Codes

Two-letter language codes used to identify the language of an ePI document and its individual sections.

e.g. "en", "fr", "de", "ja"
ISO 3166-1
Country / Jurisdiction Codes

Two-letter alpha-2 country codes used to identify the regulatory jurisdiction an ePI is authorized in.

e.g. "US", "JP", "DE", "GB"
EDQM
European Directorate for the Quality of Medicines

Codes for dose forms, routes of administration, packaging materials, and units of presentation in European regulatory submissions.

e.g. dose form: 10219999 (tablet)
MedDRA
Medical Dictionary for Regulatory Activities

Adverse event and safety reporting codes — the international standard for coding clinical data in regulatory submissions worldwide.

e.g. adverse event: 10028813 (nausea)
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International Harmonization

By using EDQM and SNOMED CT, a single ePI Type 2 or Type 3 document can be understood and processed by healthcare systems in multiple jurisdictions with minimal adaptation — reducing duplication and supporting global regulatory convergence.

✅ Supported by Type 2 & Type 3 ePI
Full Technical Specification
For a full list of supported terminologies, code system URLs, and technical constraints — see the Artifacts Summary.
View Artifacts Summary →