SPL Mapping FHIR R5 Implementation Guide
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SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.5 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

Table of Contents

Page standards status: Informative
.. 0 Table of Contents
... 1 SPL Mapping Implementation Guide Home Page
... 2 Organization-Based Use Cases
... 3 Submit a Drug Label
... 4 How to Create a FHIR Drug Label
... 5 SPL / FHIR Transforms
... 6 Downloads
... 7 Credits
... 8 Artifacts Summary
.... 8.1 Establishment Registration Logical Model
.... 8.2 GDUFA Facility Identification Logical Model
.... 8.3 NDC Labeler Code Request Logical Model
.... 8.4 Product Submission Document Logical Model
.... 8.5 Submitted Medication Logical Model
.... 8.6 EstablishmentInactivationBundle
.... 8.7 EstablishmentRegistrationBundle
.... 8.8 GDUFAFacilityIdentificationBundle
.... 8.9 GDUFAFacilityInactivationBundle
.... 8.10 LabelerCodeRequestBundle
.... 8.11 LabelerInactivationBundle
.... 8.12 OrganizationBundle
.... 8.13 OutOfBusinessBundle
.... 8.14 EstablishmentInactivationMessage
.... 8.15 EstablishmentRegistrationMessage
.... 8.16 GDUFAFacilityIdentificationMessage
.... 8.17 GDUFAFacilityInactivationMessage
.... 8.18 LabelerCodeRequestMessage
.... 8.19 LabelerInactivationMessage
.... 8.20 OrganizationMessage
.... 8.21 OutOfBusinessMessage
.... 8.22 IdentifiedLabeler
.... 8.23 LabelerBusinessOperation
.... 8.24 LabelerOrganization
.... 8.25 EstablishmentAffiliation
.... 8.26 EstablishmentBusinessOperation
.... 8.27 EstablishmentOrganization
.... 8.28 EstablishmentRegistrantOrganization
.... 8.29 IdentifiedEstablishment
.... 8.30 IdentifiedEstablishmentRegistrant
.... 8.31 GDUFAFacilityAffiliation
.... 8.32 GDUFAFacilityBusinessOperation
.... 8.33 GDUFAFacilityOrganization
.... 8.34 GDUFARegistrantOrganization
.... 8.35 IdentifiedGDUFAFacility
.... 8.36 IdentifiedGDUFARegistrant
.... 8.37 IdentifiedOrganization
.... 8.38 ImporterAffiliation
.... 8.39 ImporterOrganization
.... 8.40 RegistrantOrganization
.... 8.41 SPLAddress
.... 8.42 SPLContactPoint
.... 8.43 USAgentAffiliation
.... 8.44 USAgentOrganization
.... 8.45 Manufactured Item Marketing Status Date Range
.... 8.46 Packaged Product Reference
.... 8.47 ProductSubmissionBundle
.... 8.48 ProductSubmissionDocument
.... 8.49 SectionEffectiveTime
.... 8.50 SectionLinkId
.... 8.51 SubmittedIngredientDefinition
.... 8.52 SubmittedManufacturedItem
.... 8.53 SubmittedMedicinalPackaging
.... 8.54 SubmittedMedicinalProduct
.... 8.55 SubmittedMedicinalProductIngredient
.... 8.56 SubmittedMedicinalProductMarketing
.... 8.57 DualSubmissionProvenance
.... 8.58 SPLDocumentDate
.... 8.59 SPLDocumentReference
.... 8.60 AidarexPharmaceuticals
.... 8.61 Allopurinol100Tablets
.... 8.62 Allopurinol30Tablets
.... 8.63 Allopurinol60Tablets
.... 8.64 Allopurinol90Tablets
.... 8.65 Allopurinol<br/>Tablets USP<br/>Revised: February 2015<br/>Rx only        <br/>
.... 8.66 AllopurinolIngredientDefinition
.... 8.67 AllopurinolMarketing
.... 8.68 AllopurinolTablet
.... 8.69 AllopurinolTabletLabelBundle
.... 8.70 AllopurinolUSPActiveIngredient
.... 8.71 AllopurinolUSPDefinition
.... 8.72 AllopurinolUSPIngredient1
.... 8.73 AllopurinolUSPIngredient2
.... 8.74 AllopurinolUSPIngredient3
.... 8.75 AllopurinolUSPIngredient4
.... 8.76 AllopurinolUSPIngredient5
.... 8.77 AllopurinolUSPIngredient6
.... 8.78 Enbrel010Definition
.... 8.79 Enbrel010Marketing
.... 8.80 Enbrel010Package
.... 8.81 Enbrel021Definition
.... 8.82 Enbrel021Marketing
.... 8.83 Enbrel021Package
.... 8.84 Enbrel032Definition
.... 8.85 Enbrel032Marketing
.... 8.86 Enbrel032Package
.... 8.87 Enbrel044Definition
.... 8.88 Enbrel044Marketing
.... 8.89 Enbrel044Package
.... 8.90 Enbrel055Definition
.... 8.91 Enbrel055Marketing
.... 8.92 Enbrel055Package
.... 8.93 Enbrel25mgSolution
.... 8.94 Enbrel25mgSolutionActiveIngredient
.... 8.95 Enbrel25mgSolutionIngredient1
.... 8.96 Enbrel25mgSolutionIngredient2
.... 8.97 Enbrel25mgSolutionIngredient3
.... 8.98 Enbrel425Definition
.... 8.99 Enbrel425Marketing
.... 8.100 Enbrel425Package
.... 8.101 Enbrel425Part1Definition
.... 8.102 Enbrel425Part1Marketing
.... 8.103 Enbrel425Part1Package
.... 8.104 Enbrel425Part2Definition
.... 8.105 Enbrel425Part2Marketing
.... 8.106 Enbrel425Part2Package
.... 8.107 Enbrel435Definition
.... 8.108 Enbrel435Marketing
.... 8.109 Enbrel435Package
.... 8.110 Enbrel445Definition
.... 8.111 Enbrel445Marketing
.... 8.112 Enbrel445Package
.... 8.113 Enbrel446Definition
.... 8.114 Enbrel446Marketing
.... 8.115 Enbrel446Package
.... 8.116 Enbrel455Definition
.... 8.117 Enbrel455Marketing
.... 8.118 Enbrel455Package
.... 8.119 Enbrel456Definition
.... 8.120 Enbrel456Marketing
.... 8.121 Enbrel456Package
.... 8.122 Enbrel50mgSolution
.... 8.123 Enbrel50mgSolutionActiveIngredient
.... 8.124 Enbrel50mgSolutionIngredient1
.... 8.125 Enbrel50mgSolutionIngredient2
.... 8.126 Enbrel50mgSolutionIngredient3
.... 8.127 EnbrelIngredientDefinition
.... 8.128 EnbrelPowder
.... 8.129 EnbrelPowderActiveIngredient
.... 8.130 EnbrelPowderIngredient1
.... 8.131 EnbrelPowderIngredient2
.... 8.132 EnbrelPowderIngredient3
.... 8.133 EnbrelSterileSolution
.... 8.134 EnbrelSterileSolutionIngredient1
.... 8.135 EnbrelSterileSolutionIngredient2
.... 8.136 EnbrelSyringeLabelBundle
.... 8.137 ImmunexCorporation
.... 8.138 These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. <br/> <br/>ENBREL<sup>®</sup> (etanercept) injection, for subcutaneous use <br/>ENBREL<sup>®</sup> (etanercept) for injection, for subcutaneous use <br/>Initial U.S. Approval: 1998
.... 8.139 LantusActiveIngredient
.... 8.140 LantusIngredient1
.... 8.141 LantusIngredient2
.... 8.142 LantusIngredient3
.... 8.143 LantusIngredient4
.... 8.144 LantusIngredient5
.... 8.145 LantusIngredient6
.... 8.146 LantusIngredient7
.... 8.147 LantusIngredientDefinition
.... 8.148 LantusInjectionLabelBundle
.... 8.149 LantusSolution
.... 8.150 LantusSyringeDefinition
.... 8.151 LantusSyringeMarketing
.... 8.152 LantusSyringePackage
.... 8.153 LantusVialDefinition
.... 8.154 LantusVialMarketing
.... 8.155 LantusVialPackage
.... 8.156 SanofiAventisDeutschland
.... 8.157 SanofiAventisSRL
.... 8.158 SanofiAventisUS
.... 8.159 These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/> <br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000
.... 8.160 All NDC Products
.... 8.161 Business Operation Qualifiers
.... 8.162 Establishment Business Operations
.... 8.163 GDUFA Facility Business Operation Qualifiers
.... 8.164 GDUFA Facility Business Operations
.... 8.165 Generic Facility Message Types
.... 8.166 Labeler Business Operations
.... 8.167 Organization Submission Message Types
.... 8.168 Registrant Organization Types
.... 8.169 SPL Color
.... 8.170 SPL Combo Product Type
.... 8.171 SPL Document Codes
.... 8.172 SPL Dose Form
.... 8.173 SPL Flavor
.... 8.174 SPL Marketing Categories
.... 8.175 SPL Marketing Statuses ValueSet
.... 8.176 SPL Operation Type
.... 8.177 SPL Package Types
.... 8.178 SPL Product Characteristic Types ValueSet
.... 8.179 SPL Route of Administration
.... 8.180 SPL Section Codes
.... 8.181 SPL Shape
.... 8.182 SPL Special Measures
.... 8.183 Top-Level Organization Types
.... 8.184 FHIR Specific SPL Message Types
.... 8.185 Medicinal Product Name Types CodeSystem
.... 8.186 Organization Contact Type
.... 8.187 Organization Relationship Types
.... 8.188 SPL Marketing Statuses CodeSystem
.... 8.189 SPL Organization Types
.... 8.190 SPL Product Characteristic Types CodeSystem
.... 8.191 EnbrelKit
.... 8.192 ExampleEstablishment
.... 8.193 ExampleEstablishmentAffiliation
.... 8.194 ExampleEstablishmentFHIRtoSPLProvenance
.... 8.195 ExampleEstablishmentOperation
.... 8.196 ExampleEstablishmentRegistrant
.... 8.197 ExampleEstablishmentRegistration
.... 8.198 ExampleEstablishmentSPLtoFHIRProvenance
.... 8.199 ExampleGDUFAFacility
.... 8.200 ExampleGDUFAFacilityAffiliation
.... 8.201 ExampleGDUFAFacilityIdentification
.... 8.202 ExampleGDUFAFacilityInactivation
.... 8.203 ExampleGDUFAFacilityOperation
.... 8.204 ExampleGDUFARegistrant
.... 8.205 ExampleImporter
.... 8.206 ExampleImporterAffiliation
.... 8.207 ExampleLabelerFHIRtoSPLProvenance
.... 8.208 ExampleLabelerSPLtoFHIRProvenance
.... 8.209 ExampleSPLDocumentReference
.... 8.210 IdentifiedLabelerOrganization
.... 8.211 SampleEstablishmentInactivationBundle
.... 8.212 SampleEstablishmentInactivationMessage
.... 8.213 SampleEstablishmentRegistrationMessage
.... 8.214 SampleGDUFAFacilityIdentificationMessage
.... 8.215 SampleGDUFAFacilityInactivationMessage
.... 8.216 SampleIdentifiedEstablishment
.... 8.217 SampleIdentifiedEstablishmentRegistrant
.... 8.218 SampleIdentifiedGDUFAFacility
.... 8.219 SampleIdentifiedGDUFARegistrant
.... 8.220 SampleLabelerBusinessOperation
.... 8.221 SampleLabelerCodeRequestBundle
.... 8.222 SampleLabelerCodeRequestMessage
.... 8.223 SampleLabelerInactivationBundle
.... 8.224 SampleLabelerInactivationMessage
.... 8.225 SampleLabelerOrganization
.... 8.226 SampleLabelerUSAgent
.... 8.227 SampleLabelerUSAgentAffiliation
.... 8.228 SampleOutOfBusinessNotificationBundle
.... 8.229 SamplOutOfBusinessMessage