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 & 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

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Behavior: Capability Statements

The following artifacts define the specific capabilities that different types of systems are expected to have in order to comply with this implementation guide. Systems conforming to this implementation guide are expected to declare conformance to one or more of the following capability statements.

Advanced Vulcan ePI Server Capability Statement
Simple Vulcan ePI Server Capability Statement

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

AdministrableProductDefinition (ePI)

AdministrableProductDefinition (ePI)

Binary - ePI

This profile represents the constraints applied to the Binary resource used in the ePI FHIR Implementation Guide. It enforces usage of contained base64 data.

Bundle - ePI Type 1

This profile represents the constraints applied to the Bundle resource used in the Electronic Product Information (ePI) FHIR Implementation Guide.

Bundle - ePI Type 2

This profile represents the constraints applied to the Bundle resource used in the ePI Type 2 (Structured Data) FHIR Implementation Guide.

Bundle - ePI Type 3

This profile represents the constraints applied to the Bundle resource used in the ePI Type 3 (Clinical/Knowledge) FHIR Implementation Guide.

ClinicalUseDefinition Contraindication (ePI)

ClinicalUseDefinition Contraindication (ePI) - Profile for Contraindication

ClinicalUseDefinition Indication (ePI)

ClinicalUseDefinition Indication (ePI) - Profile for Indication

ClinicalUseDefinition Interaction (ePI)

ClinicalUseDefinition Interaction (ePI) - Profile for Interaction

ClinicalUseDefinition Undesirable Effect (ePI)

ClinicalUseDefinition Undesirable Effect (ePI) - Profile for Undesirable Effect

ClinicalUseDefinition Warning (ePI)

ClinicalUseDefinition Warning (ePI) - Profile for Warning

Composition - ePI Type 1

This profile represents the constraints applied to the Composition resource used in the Electronic Product Information (ePI) FHIR Implementation Guide.

Ingredient (ePI)

Ingredient (ePI)

List (ePI)

List (ePI) - ported from Business Friendly ePI Outline

ManufacturedItemDefinition (ePI)

ManufacturedItemDefinition (ePI)

MedicationKnowledge (ePI)

MedicationKnowledge (ePI) - ported from Business Friendly ePI Outline

MedicinalProductDefinition (ePI)

MedicinalProductDefinition (ePI) - ported from MedicinalProductDefinitionUvEpi

Organization (ePI)

Organization (ePI) - ported from OrganizationUvEpi

PackagedProductDefinition (ePI)

PackagedProductDefinition (ePI)

RegulatedAuthorization (ePI)

RegulatedAuthorization (ePI)

SubstanceDefinition (ePI)

SubstanceDefinition (ePI)

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

Administrable Pharmaceutical Dose Form

Administrable Pharmaceutical Dose Form

Color of the product

Color of the product

Dose Form

The dose form for a single part product, or combined form of a multiple part product

Flavor of the product

Flavor of the product

ISO Country two letter code

ISO Country two letter code

ISO language two letter code

ISO language two letter code

Ingredient Role

Ingredient Role; e.g.,active, excipient

Manufactured Dose Form

Manufactured Dose Form

MedDRA Terms for clinical diseases and symptoms

MedDRA Terms for clinical diseases and symptoms

Route Of Administration

Route Of Administration

Section Codes

Section Codes

Shape of the product

Shape of the product

Substances

Substances

Units of Presentation

Units of Presentation

WHO ATC

World Health Organization Anatomical Therapeutic Chemical (ATC) classification system

ePI document types

ePI document types

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

eMedicinal Product Information Code System

eMedicinal Product Information Code System. Coded concepts defined for ePI use only.

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

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bundle-epi-type1-example
bundle-epi-type1-example-morphine
bundle-epi-type2-example
bundle-epi-type2-example-acetaminophen
bundle-epi-type2-example-aprokam
bundle-epi-type2-example-morphine
bundle-epi-type2-example-wondermox
bundle-epi-type3-example-aprokam
bundle-epi-type3-example-morphine
bundle-epi-type3-example-wonderdrug
bundle-epi-type3-example-wondermox
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da8e3290-e187-4ee7-860f-1397221a20ea