Artifacts Summary

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

Contents:

Structures: Resource Profiles
Structures: Extension Definitions
Terminology: Value Sets
Terminology: Code Systems
Example: Example Instances

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

Structures: Resource Profiles

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

AdministrableProductDefinition (ePI)

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 to 4

This profile represents the constraints applied to the Composition resource used in the Electronic Product Information (ePI) FHIR Implementation Guide. This profile applies to all ePI Types (1, 2, 3, and 4).

Ingredient (ePI)

List (ePI)

List (ePI) - ported from Business Friendly ePI Outline

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)

RegulatedAuthorization (ePI)

SubstanceDefinition (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.

Structures: Extension Definitions

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

Authorisation Type

Authorisation type for this list

Jurisdiction

Jurisdiction for this list

Language

Language of the document referenced in this entry

Medicine Domain

Medicine domain for this list

Procedure Number

Procedure number for this list

Regulatory Agency

The organization describing the regulator that authorized the ePIs in the list.

Version Number

Version number for this list

Terminology: Value Sets

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

Administrable Pharmaceutical Dose Form

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

ISO Country two letter code

ISO language two letter code

Ingredient Role

Ingredient Role; e.g.,active, excipient

Manufactured Dose Form

MedDRA Terms for clinical diseases and symptoms

Patient Characteristic Type (ePI)

A terminology defining types of patient characteristics (e.g., age, weight, broad demographic categories) for use in dosing and clinical use definitions.

Route Of Administration

Section Codes

Shape of the product

Substances

Units of Presentation

WHO ATC

World Health Organization Anatomical Therapeutic Chemical (ATC) classification system

ePI List Entry Flag ValueSet

Values to classify the component type or lifecycle status of an ePI list entry.

ePI List Type ValueSet

Values to classify the usecase/type of an ePI list.

ePI document types

Terminology: Code Systems

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

Benefit and Risk Relationship

eMedicinal Product Information Code System

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

ePI List Entry Flag CodeSystem

Codes to classify the component type or lifecycle status of an ePI list entry.

ePI List Type CodeSystem

Codes to classify the usecase/type of an ePI list.

Example: Example Instances

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

ASEAN Cross-Jurisdictional ePI Tracking List Example

An example of a List resource conforming to the List-uv-epi profile, specifically tracking ePIs across the 10 ASEAN member states using UUID references.

AdministrableProductDefinition - WonderDrug 500 mg

AdministrableProductDefinition - WonderDrug 500 mg Carton

Bundle - ePI Type 1 Paracetamol Example

Bundle - ePI Type 2 Paracetamol Example

Bundle - ePI Type 2 WonderDrug Blister in Carton Example

Bundle - ePI Type 2 WonderDrug 500 mg Blister in Carton Example

Bundle - ePI Type 3 WonderDrug Example

ClinicalUseDefinition - Contraindication Hepatic Failure

ClinicalUseDefinition - Contraindication Paracetamol

ClinicalUseDefinition - Indication Fever

ClinicalUseDefinition - Indication Pain

ClinicalUseDefinition - Interaction Other