Vulcan ePI FHIR Implementation Guide
0.1.0 - CI Build

Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

Table of Contents

..0 Table of Contents
...1 Introduction
...2 Background
...3 Core ePI Profile
...4 Terminology
...5 Steps to create a Core FHIR ePI
...6 Capability
...7 General Technical Conformance Requirements
...8 Appendix
...9 Annex I - EU/EMA FHIR ePI Profile
...10 Annex II - US/FDA FHIR ePI Profile
...11 Annex III - Japan/PMDA FHIR ePI Profile
...12 Artifacts Summary
....12.1 calculate
....12.2 AdministrableProductDefinition (ePI)
....12.3 Bundle - ePI
....12.4 ClinicalUseDefinition Contraindication (ePI)
....12.5 ClinicalUseDefinition Indication (ePI)
....12.6 ClinicalUseDefinition Interaction (ePI)
....12.7 ClinicalUseDefinition Undesirable Effect (ePI)
....12.8 ClinicalUseDefinition Warning (ePI)
....12.9 Composition (ePI)
....12.10 Ingredient (ePI)
....12.11 List - ePI
....12.12 ManufacturedItemDefinition (ePI)
....12.13 MedicinalProductDefinition (ePI)
....12.14 Organization (ePI)
....12.15 PackagedProductDefinition (ePI)
....12.16 RegulatedAuthorization (ePI)
....12.17 SubstanceDefinition (ePI)
....12.18 AdministrableProductDefinition identifier systems
....12.19 ePI document types
....12.20 ManufacturedItemDefinition identifier systems
....12.21 MedicinalProductDefinition identifier systems
....12.22 Organization identifier systems
....12.23 PackagedProductDefinition identifier systems
....12.24 RegulatedAuthorization identifier systems
....12.25 Gravitate Health Project Code System
....12.26 Organization Management Services CodeSystem
....12.27 Products Management Services CodeSystem
....12.28 Referentials Management Services CodeSystem
....12.29 Substances Management Services CodeSystem
....12.30 EMA example-sections-pl
....12.31 EMA example-sections-smpc
....12.32 0c81c330-cf57-45c2-9ca2-559aea4c8060
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....12.37 363cbf4a-9c4d-442a-af67-b72a1225ca28
....12.38 39151aef-f61a-40cb-86fc-d0e556fa07ef
....12.39 Vulcan Monuril FHIR Package Insert
....12.40 56b3b73e-dba0-4447-b8cd-1e24ed637017
....12.41 5a574ff2-f3e6-4aaa-8d3c-27e6ab343533
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....12.61 cfsb1639762372321
....12.62 cfsb1639762372322
....12.63 cfsb1639762372323
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....12.66 cfsb1639764389612
....12.67 cfsb1639991356428
....12.68 cfsb1650904258324
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....12.81 cfsb1651230330246
....12.82 cfsb1651231019151
....12.83 cfsb1651234995610
....12.84 Vulcan Dovato FHIR Package Insert EMA
....12.85 Vulcan Dovato FHIR Package Insert EMA ESP
....12.86 db5e392b-e7b2-47dc-829c-ee5182986dca
....12.87 f1b25777-da7a-4a35-98af-ab18d3246d54
....12.88 Vulcan FHIR USA Patient Package Insert Test - Aromasin (exemestane) Tablets 25 mg
....12.89 f35c1543-e4e2-4215-b91c-f092b1fb9655