Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use World

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

Table of Contents

Page standards status: Informative
.. 0 Table of Contents
... 1 Home
... 2 Build List of ePIs
... 3 Overview
... 4 Type 1 Digital Label
... 5 Type 2 Product Identification
... 6 Type 3 Clinical Information
... 7 Type 4 Dynamic Digital Label
... 8 Dosing and Population Model
... 9 FHIR Servers
... 10 Getting Started
... 11 Technical Style Guide
... 12 Templates
... 13 Tracked Changes
... 14 Version Control
... 15 Terminology
... 16 Downloads
... 17 Credits
... 18 Artifacts Summary
.... 18.1 AdministrableProductDefinition (ePI)
.... 18.2 binary (ePI)
.... 18.3 Bundle - ePI Type 1
.... 18.4 Bundle - ePI Type 2
.... 18.5 Bundle - ePI Type 3
.... 18.6 ClinicalUseDefinition Contraindication (ePI)
.... 18.7 ClinicalUseDefinition Indication (ePI)
.... 18.8 ClinicalUseDefinition Interaction (ePI)
.... 18.9 ClinicalUseDefinition Undesirable Effect (ePI)
.... 18.10 ClinicalUseDefinition Warning (ePI)
.... 18.11 Composition - ePI Type 1 to 4
.... 18.12 Group (ePI)
.... 18.13 Ingredient (ePI)
.... 18.14 List (ePI)
.... 18.15 ManufacturedItemDefinition (ePI)
.... 18.16 MedicationKnowledge (ePI)
.... 18.17 MedicinalProductDefinition (ePI)
.... 18.18 Organization (ePI)
.... 18.19 PackagedProductDefinition (ePI)
.... 18.20 RegulatedAuthorization (ePI)
.... 18.21 SubstanceDefinition (ePI)
.... 18.22 Authorisation Type
.... 18.23 Jurisdiction
.... 18.24 Language
.... 18.25 Medicine Domain
.... 18.26 Procedure Number
.... 18.27 Regulatory Agency
.... 18.28 Version Number
.... 18.29 Administrable Pharmaceutical Dose Form
.... 18.30 Color of the product
.... 18.31 Dose Form
.... 18.32 ePI document types
.... 18.33 ePI List Entry Flag ValueSet
.... 18.34 ePI List Type ValueSet
.... 18.35 Flavor of the product
.... 18.36 Group Characteristic Type (ePI)
.... 18.37 Group Hepatic Function Value (ePI)
.... 18.38 Group Immune Status Value (ePI)
.... 18.39 Group Lifestyle Value (ePI)
.... 18.40 Group Race Value (ePI)
.... 18.41 Group Sex Value (ePI)
.... 18.42 Ingredient Role
.... 18.43 ISO Country two letter code
.... 18.44 ISO language two letter code
.... 18.45 Manufactured Dose Form
.... 18.46 MedDRA Terms for clinical diseases and symptoms
.... 18.47 Route Of Administration
.... 18.48 Section Codes
.... 18.49 Shape of the product
.... 18.50 Substances
.... 18.51 Units of Presentation
.... 18.52 WHO ATC
.... 18.53 Benefit and Risk Relationship
.... 18.54 eMedicinal Product Information Code System
.... 18.55 ePI List Entry Flag CodeSystem
.... 18.56 ePI List Type CodeSystem
.... 18.57 Group Characteristic Type Code System (ePI)
.... 18.58 AdministrableProductDefinition - WonderDrug 500 mg
.... 18.59 AdministrableProductDefinition - WonderDrug 500 mg Carton
.... 18.60 ASEAN Cross-Jurisdictional ePI Tracking List Example
.... 18.61 Bundle - ePI Type 1 Paracetamol Example
.... 18.62 Bundle - ePI Type 2 Paracetamol Example
.... 18.63 Bundle - ePI Type 2 WonderDrug Blister in Carton Example
.... 18.64 Bundle - ePI Type 3 Diflucan Example
.... 18.65 Bundle - ePI Type 3 WonderDrug Example
.... 18.66 ClinicalUseDefinition - Contraindication Hepatic Failure
.... 18.67 ClinicalUseDefinition - Contraindication Paracetamol
.... 18.68 ClinicalUseDefinition - Indication Fever
.... 18.69 ClinicalUseDefinition - Indication Invasive Candidiasis
.... 18.70 ClinicalUseDefinition - Indication Oropharyngeal Candidiasis
.... 18.71 ClinicalUseDefinition - Indication Pain
.... 18.72 ClinicalUseDefinition - Interaction Other
.... 18.73 ClinicalUseDefinition - Interaction Warfarin
.... 18.74 ClinicalUseDefinition - Warning Renal Dose Adjustment
.... 18.75 Composition - Diflucan SmPC
.... 18.76 Composition - ePI Type 3 WonderDrug SMPC
.... 18.77 Composition - Paracetamol 500 mg tablets
.... 18.78 Composition - Type 2 Paracetamol
.... 18.79 Composition - Type 2 WonderDrug Blister in Carton
.... 18.80 ePI Type 1 Template
.... 18.81 ePI Type 2 Template
.... 18.82 ePI Type 3 Template
.... 18.83 Group - Adult Men
.... 18.84 Group - Adult Women
.... 18.85 Group - Adults
.... 18.86 Group - Children
.... 18.87 Group - Renal impairment (CrCl ≤ 50 mL/min)
.... 18.88 Ingredient - Lactose monohydrate
.... 18.89 Ingredient - Magnesium stearate
.... 18.90 Ingredient - Maize starch
.... 18.91 Ingredient - Paracetamol
.... 18.92 Ingredient - Paracetamol 500mg
.... 18.93 Ingredient - Pregelatinised starch
.... 18.94 List Example
.... 18.95 ManufacturedItemDefinition - WonderDrug 500 mg
.... 18.96 ManufacturedItemDefinition - WonderDrug 500 mg Carton
.... 18.97 MedicationKnowledge - Diflucan
.... 18.98 MedicationKnowledge - WonderDrug
.... 18.99 MedicinalProductDefinition - Diflucan 150 mg capsule
.... 18.100 MedicinalProductDefinition - WonderDrug 100 mg tablets
.... 18.101 MedicinalProductDefinition - WonderDrug 200 mg tablets
.... 18.102 MedicinalProductDefinition - WonderDrug 500 mg tablets Type 2
.... 18.103 MedicinalProductDefinition - WonderDrug 500 mg tablets Type 2 Carton
.... 18.104 MedicinalProductDefinition - WonderDrug 500 mg tablets Type 3
.... 18.105 Organization - Acme Pharma Inc.
.... 18.106 Organization - Diflucan MAH
.... 18.107 Organization - WonderPharma Inc.
.... 18.108 PackagedProductDefinition - WonderDrug 500 mg
.... 18.109 PackagedProductDefinition - WonderDrug 500 mg Carton
.... 18.110 RegulatedAuthorization - WonderDrug 500 mg
.... 18.111 RegulatedAuthorization - WonderDrug 500 mg Carton