Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot International flag

This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR v5.0.0-ballot. . For a full list of available versions, see the Directory of published versions

Table of Contents

...0 Table of Contents
...1 Introduction
...2 Background
...3 Core ePI Profile
...4 Semantic Annotation
...5 Steps to create a Core FHIR ePI
...6 Capability
...7 General Technical Conformance Requirements
...8 Appendix
...9 Downloads
....10 Artifacts Summary
....10.1 epi-server
....10.2 AdministrableProductDefinition (ePI)
....10.3 Bundle - ePI
....10.4 ClinicalUseDefinition Contraindication (ePI)
....10.5 ClinicalUseDefinition Indication (ePI)
....10.6 ClinicalUseDefinition Interaction (ePI)
....10.7 ClinicalUseDefinition Undesirable Effect (ePI)
....10.8 ClinicalUseDefinition Warning (ePI)
....10.9 Composition (ePI)
....10.10 Ingredient (ePI)
....10.11 ManufacturedItemDefinition (ePI)
....10.12 MedicinalProductDefinition (ePI)
....10.13 Organization (ePI)
....10.14 PackagedProductDefinition (ePI)
....10.15 RegulatedAuthorization (ePI)
....10.16 SubstanceDefinition (ePI)
....10.17 Additional Monitoring Indicator
....10.18 AdministrableProductDefinition identifier systems
....10.19 WHO ATC
....10.20 Authorization Status
....10.21 Case System Identifiers
....10.22 ISO Country two letter code
....10.23 Data Carrier Identifiers
....10.24 ePI document types
....10.25 The topic of this list
....10.26 General Status used across ePI resources
....10.27 Legal Status for the Supply
....10.28 ManufacturedItemDefinition identifier systems
....10.29 Marketing Status
....10.30 MedicinalProductDefinition identifier systems
....10.31 Medicinal Product Type
....10.32 MedDRA Terms for clinical diseases and symptoms
....10.33 Non-proprietary Name of the active ingredient(s)
....10.34 Type of operation
....10.35 Organization identifier systems
....10.36 Type of organization
....10.37 Package Material
....10.38 High level Pack Type
....10.39 PackagedProductDefinition identifier systems
....10.40 Part Type
....10.41 Pediatric Use Indicator
....10.42 Combined Pharmaceutical Dose Form
....10.43 Pharmaceutical Dose Form of the medicinal product
....10.44 Product Confidentiality
....10.45 Product Name Part Type
....10.46 Color of the product
....10.47 Flavor of the product
....10.48 Score on the product
....10.49 Shape of the product
....10.50 Surface form of the product
....10.51 Proprietary Name of the medicinal product
....10.52 Type of Regulated Authorization
....10.53 Regulated Authorization Type identifier systems
....10.54 Regulatory Activity Type
....10.55 Ingredient Role; e.g., inactive, active base, active moiety
....10.56 Route Of Administration
....10.57 Pack Type
....10.58 Section Codes
....10.59 Shelf Life Type
....10.60 Special Precautions For Storage
....10.61 Strength of the medicinal product name
....10.62 Substances
....10.63 Units of Measure
....10.64 Units of Presentation
....10.65 eMedicinal Product Information Code System
....10.66 Organization Management Services CodeSystem
....10.67 Products Management Services CodeSystem
....10.68 Referentials Management Services CodeSystem
....10.69 Substances Management Services CodeSystem
....10.70 Ingredient-excipient Silicon dioxide
....10.71 Ingredient-excipient Hypromellose
....10.72 Ingredient-excipient Microcrystalline cellulose
....10.73 Regulated Authorization for cava 75 mg tablets
....10.74 Manufactured item cava 75 mg tabelt
....10.75 cava 75mg tablet administrable product
....10.76 indication
....10.77 Irbesartan – Example of Ingredient with basis for strength
....10.78 Ingredient-excipient Lactose Monohydrate
....10.79 Medicinal Product cava 75 mg tablet in blister pack of 28 tablets
....10.80 contraindication
....10.81 Ingredient-excipient carnauba wax
....10.82 Ingredient-excipient Titanium Dioxide
....10.83 warninghypotension
....10.84 ePI document Bundle for cava 75 mg Package Leaflet
....10.85 Ingredient-excipient Macrogol 3000
....10.86 Acme Inc. as Marketing Authorization Holder
....10.87 substanceirbesartan
....10.88 interactionmethotrexate
....10.89 Composition for cava 75 mg Package Leaflet
....10.90 Packaging Blister x28 75 mg tablets
....10.91 Ingredient-excipient Magnesium stearate
....10.92 interactiongrapefruitjuice
....10.93 Ingredient-excipient Croscarmellose sodium
....10.94 undesirableEffectanemia