Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use International flag

Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 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

.. 0 Table of Contents
... 1 Home
... 2 Use Case
... 3 Steps to create ePI Type 1
... 4 Steps to create ePI Type 2
... 5 Steps to create ePI Type 3
... 6 Best Practice
... 7 Downloads
... 8 Credits
... 9 Artifacts Summary
.... 9.1 Advanced Vulcan ePI Server Capability Statement
.... 9.2 Simple Vulcan ePI Server Capability Statement
.... 9.3 AdministrableProductDefinition (ePI)
.... 9.4 Bundle - ePI
.... 9.5 ClinicalUseDefinition Contraindication (ePI)
.... 9.6 ClinicalUseDefinition Indication (ePI)
.... 9.7 ClinicalUseDefinition Interaction (ePI)
.... 9.8 ClinicalUseDefinition Undesirable Effect (ePI)
.... 9.9 ClinicalUseDefinition Warning (ePI)
.... 9.10 Composition (ePI)
.... 9.11 Ingredient (ePI)
.... 9.12 ManufacturedItemDefinition (ePI)
.... 9.13 MedicinalProductDefinition (ePI)
.... 9.14 Organization (ePI)
.... 9.15 PackagedProductDefinition (ePI)
.... 9.16 RegulatedAuthorization (ePI)
.... 9.17 SubstanceDefinition (ePI)
.... 9.18 Administrable Pharmaceutical Dose Form
.... 9.19 Color of the product
.... 9.20 Dose Form
.... 9.21 ePI document types
.... 9.22 Flavor of the product
.... 9.23 Ingredient Role
.... 9.24 ISO Country two letter code
.... 9.25 ISO language two letter code
.... 9.26 Manufactured Dose Form
.... 9.27 MedDRA Terms for clinical diseases and symptoms
.... 9.28 Route Of Administration
.... 9.29 Section Codes
.... 9.30 Shape of the product
.... 9.31 Substances
.... 9.32 Units of Presentation
.... 9.33 WHO ATC
.... 9.34 eMedicinal Product Information Code System
.... 9.35 Administrable Product for DrugX 75 mg tablets
.... 9.36 Clinical Use - Contraindication
.... 9.37 Clinical Use - Indication
.... 9.38 Clinical Use - Interaction
.... 9.39 Clinical Use - Undesirable Effect
.... 9.40 Clinical Use - Warning
.... 9.41 ePI Bundle Type 1 - DrugX Package Insert
.... 9.42 ePI Bundle Type 2 - DrugX Package Insert
.... 9.43 ePI Bundle Type 3 - DrugX Package Insert
.... 9.44 Ingredient - acetaminophen
.... 9.45 Ingredient - Carnauba wax
.... 9.46 Ingredient - Croscarmellose sodium
.... 9.47 Ingredient - Hypromellose
.... 9.48 Ingredient - Lactose Monohydrate
.... 9.49 Ingredient - Macrogol 3000
.... 9.50 Ingredient - Magnesium stearate
.... 9.51 Ingredient - Microcrystalline cellulose
.... 9.52 Ingredient - Silicon dioxide
.... 9.53 Ingredient - Titanium Dioxide
.... 9.54 Manufactured Item - 75 mg tablet
.... 9.55 Medicinal Product DrugX 75 tablet in a blister of x28 tablets
.... 9.56 Organization - Acme Inc.
.... 9.57 Package Leaflet with a medicinal product
.... 9.58 Package Leaflet without a medicinal product
.... 9.59 Packaging - Blister
.... 9.60 Regulated Authorization for the 75 mg tablet
.... 9.61 Substance - acetaminophen