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

Table of Contents

Page standards status: Informative
.. 0 Table of Contents
... 1 Home
... 2 Build List of ePIs
... 3 Overview
... 4 Build ePI Type 1
... 5 Build ePI Type 2
... 6 Build ePI Type 3
... 7 Build ePI Type 4
... 8 FHIR Servers
... 9 Getting Started
... 10 Technical Style Guide
... 11 Style Sheets
... 12 Tracked Changes
... 13 Version Control
... 14 Terminology
... 15 Downloads
... 16 Credits
... 17 Artifacts Summary
.... 17.1 AdministrableProductDefinition (ePI)
.... 17.2 binary (ePI)
.... 17.3 Bundle - ePI Type 1
.... 17.4 Bundle - ePI Type 2
.... 17.5 Bundle - ePI Type 3
.... 17.6 ClinicalUseDefinition Contraindication (ePI)
.... 17.7 ClinicalUseDefinition Indication (ePI)
.... 17.8 ClinicalUseDefinition Interaction (ePI)
.... 17.9 ClinicalUseDefinition Undesirable Effect (ePI)
.... 17.10 ClinicalUseDefinition Warning (ePI)
.... 17.11 Composition - ePI Type 1 to 4
.... 17.12 Ingredient (ePI)
.... 17.13 List (ePI)
.... 17.14 ManufacturedItemDefinition (ePI)
.... 17.15 MedicationKnowledge (ePI)
.... 17.16 MedicinalProductDefinition (ePI)
.... 17.17 Organization (ePI)
.... 17.18 PackagedProductDefinition (ePI)
.... 17.19 RegulatedAuthorization (ePI)
.... 17.20 SubstanceDefinition (ePI)
.... 17.21 Authorisation Type
.... 17.22 Jurisdiction
.... 17.23 Language
.... 17.24 Medicine Domain
.... 17.25 Procedure Number
.... 17.26 Regulatory Agency
.... 17.27 Version Number
.... 17.28 Administrable Pharmaceutical Dose Form
.... 17.29 Color of the product
.... 17.30 Dose Form
.... 17.31 ePI document types
.... 17.32 ePI List Entry Flag ValueSet
.... 17.33 ePI List Type ValueSet
.... 17.34 Flavor of the product
.... 17.35 Ingredient Role
.... 17.36 ISO Country two letter code
.... 17.37 ISO language two letter code
.... 17.38 Manufactured Dose Form
.... 17.39 MedDRA Terms for clinical diseases and symptoms
.... 17.40 Patient Characteristic Type (ePI)
.... 17.41 Route Of Administration
.... 17.42 Section Codes
.... 17.43 Shape of the product
.... 17.44 Substances
.... 17.45 Units of Presentation
.... 17.46 WHO ATC
.... 17.47 Benefit and Risk Relationship
.... 17.48 eMedicinal Product Information Code System
.... 17.49 ePI List Entry Flag CodeSystem
.... 17.50 ePI List Type CodeSystem
.... 17.51 AdministrableProductDefinition - WonderDrug 500 mg
.... 17.52 AdministrableProductDefinition - WonderDrug 500 mg Carton
.... 17.53 ASEAN Cross-Jurisdictional ePI Tracking List Example
.... 17.54 Bundle - ePI Type 1 Paracetamol Example
.... 17.55 Bundle - ePI Type 2 Paracetamol Example
.... 17.56 Bundle - ePI Type 2 WonderDrug Blister in Carton Example
.... 17.57 Bundle - ePI Type 3 WonderDrug Example
.... 17.58 ClinicalUseDefinition - Contraindication Hepatic Failure
.... 17.59 ClinicalUseDefinition - Contraindication Paracetamol
.... 17.60 ClinicalUseDefinition - Indication Fever
.... 17.61 ClinicalUseDefinition - Indication Pain
.... 17.62 ClinicalUseDefinition - Interaction Other
.... 17.63 ClinicalUseDefinition - Interaction Warfarin
.... 17.64 Composition - ePI Type 3 WonderDrug SMPC
.... 17.65 Composition - Paracetamol 500 mg tablets
.... 17.66 Composition - Type 2 Paracetamol
.... 17.67 Composition - Type 2 WonderDrug Blister in Carton
.... 17.68 Ingredient - Lactose monohydrate
.... 17.69 Ingredient - Magnesium stearate
.... 17.70 Ingredient - Maize starch
.... 17.71 Ingredient - Paracetamol
.... 17.72 Ingredient - Paracetamol 500mg
.... 17.73 Ingredient - Pregelatinised starch
.... 17.74 List Example
.... 17.75 ManufacturedItemDefinition - WonderDrug 500 mg
.... 17.76 ManufacturedItemDefinition - WonderDrug 500 mg Carton
.... 17.77 MedicationKnowledge - WonderDrug
.... 17.78 MedicinalProductDefinition - WonderDrug 100 mg tablets
.... 17.79 MedicinalProductDefinition - WonderDrug 200 mg tablets
.... 17.80 MedicinalProductDefinition - WonderDrug 500 mg tablets Type 2
.... 17.81 MedicinalProductDefinition - WonderDrug 500 mg tablets Type 2 Carton
.... 17.82 MedicinalProductDefinition - WonderDrug 500 mg tablets Type 3
.... 17.83 Organization - Acme Pharma Inc.
.... 17.84 Organization - WonderPharma Inc.
.... 17.85 PackagedProductDefinition - WonderDrug 500 mg
.... 17.86 PackagedProductDefinition - WonderDrug 500 mg Carton
.... 17.87 RegulatedAuthorization - WonderDrug 500 mg
.... 17.88 RegulatedAuthorization - WonderDrug 500 mg Carton