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 0.2.8 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 NoChangeNotificationBundle
.... 8.13 OrganizationBundle
.... 8.14 OutOfBusinessBundle
.... 8.15 EstablishmentInactivationMessage
.... 8.16 EstablishmentRegistrationMessage
.... 8.17 GDUFAFacilityIdentificationMessage
.... 8.18 GDUFAFacilityInactivationMessage
.... 8.19 LabelerCodeRequestMessage
.... 8.20 LabelerInactivationMessage
.... 8.21 NoChangeNotificationMessage
.... 8.22 OrganizationMessage
.... 8.23 OutOfBusinessMessage
.... 8.24 IdentifiedLabeler
.... 8.25 LabelerBusinessOperation
.... 8.26 LabelerOrganization
.... 8.27 EstablishmentAffiliation
.... 8.28 EstablishmentBusinessOperation
.... 8.29 EstablishmentOrganization
.... 8.30 EstablishmentRegistrantOrganization
.... 8.31 IdentifiedEstablishment
.... 8.32 IdentifiedEstablishmentRegistrant
.... 8.33 GDUFAFacilityAffiliation
.... 8.34 GDUFAFacilityBusinessOperation
.... 8.35 GDUFAFacilityOrganization
.... 8.36 GDUFARegistrantOrganization
.... 8.37 IdentifiedGDUFAFacility
.... 8.38 IdentifiedGDUFARegistrant
.... 8.39 EstablishmentUSAgentAffiliation
.... 8.40 IdentifiedOrganization
.... 8.41 ImporterAffiliation
.... 8.42 ImporterOrganization
.... 8.43 LabelerUSAgentAffiliation
.... 8.44 RegistrantOrganization
.... 8.45 SPLAddress
.... 8.46 SPLContactPoint
.... 8.47 USAgentOrganization
.... 8.48 Manufactured Item Marketing Status Date Range
.... 8.49 Packaged Product Reference
.... 8.50 ProductSubmissionBundle
.... 8.51 ProductSubmissionDocument
.... 8.52 SectionEffectiveTime
.... 8.53 SectionLinkId
.... 8.54 SubmittedIngredientDefinition
.... 8.55 SubmittedManufacturedItem
.... 8.56 SubmittedMedicinalPackaging
.... 8.57 SubmittedMedicinalProduct
.... 8.58 SubmittedMedicinalProductIngredient
.... 8.59 SubmittedMedicinalProductMarketing
.... 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 DualSubmissionProvenance
.... 8.161 SPLDocumentReference
.... 8.162 SPLDocumentDate
.... 8.163 All NDC Products
.... 8.164 Business Operation Qualifiers
.... 8.165 Establishment Business Operations
.... 8.166 GDUFA Facility Business Operation Qualifiers
.... 8.167 GDUFA Facility Business Operations
.... 8.168 Generic Facility Message Types
.... 8.169 Labeler Business Operations
.... 8.170 Organization Submission Message Types
.... 8.171 Registrant Organization Types
.... 8.172 SPL Color
.... 8.173 SPL Combo Product Type
.... 8.174 SPL Document Codes
.... 8.175 SPL Dose Form
.... 8.176 SPL Flavor
.... 8.177 SPL Marketing Categories
.... 8.178 SPL Marketing Statuses ValueSet
.... 8.179 SPL Operation Type
.... 8.180 SPL Package Types
.... 8.181 SPL Product Characteristic Types ValueSet
.... 8.182 SPL Route of Administration
.... 8.183 SPL Section Codes
.... 8.184 SPL Shape
.... 8.185 SPL Special Measures
.... 8.186 Top-Level Organization Types
.... 8.187 FHIR Specific SPL Message Types
.... 8.188 Medicinal Product Name Types CodeSystem
.... 8.189 Organization Contact Type
.... 8.190 Organization Relationship Types
.... 8.191 SPL Marketing Statuses CodeSystem
.... 8.192 SPL Organization Types
.... 8.193 SPL Product Characteristic Types CodeSystem
.... 8.194 EnbrelKit
.... 8.195 ExampleEstablishment
.... 8.196 ExampleEstablishmentAffiliation
.... 8.197 ExampleEstablishmentFHIRtoSPLProvenance
.... 8.198 ExampleEstablishmentOperation
.... 8.199 ExampleEstablishmentRegistrant
.... 8.200 ExampleEstablishmentRegistration
.... 8.201 ExampleEstablishmentSPLtoFHIRProvenance
.... 8.202 ExampleEstablishmentUSAgentAffiliation
.... 8.203 ExampleGDUFAFacility
.... 8.204 ExampleGDUFAFacilityAffiliation
.... 8.205 ExampleGDUFAFacilityIdentification
.... 8.206 ExampleGDUFAFacilityInactivation
.... 8.207 ExampleGDUFAFacilityOperation
.... 8.208 ExampleGDUFARegistrant
.... 8.209 ExampleImporter
.... 8.210 ExampleImporterAffiliation
.... 8.211 ExampleLabelerFHIRtoSPLProvenance
.... 8.212 ExampleLabelerSPLtoFHIRProvenance
.... 8.213 ExampleSPLDocumentReference
.... 8.214 IdentifiedLabelerOrganization
.... 8.215 SampleEstablishmentInactivationBundle
.... 8.216 SampleEstablishmentInactivationMessage
.... 8.217 SampleEstablishmentRegistrationMessage
.... 8.218 SampleGDUFAFacilityIdentificationMessage
.... 8.219 SampleGDUFAFacilityInactivationMessage
.... 8.220 SampleGDUFAOutOfBusinessMessage
.... 8.221 SampleGDUFAOutOfBusinessNotificationBundle
.... 8.222 SampleIdentifiedEstablishment
.... 8.223 SampleIdentifiedEstablishmentRegistrant
.... 8.224 SampleIdentifiedGDUFAFacility
.... 8.225 SampleIdentifiedGDUFARegistrant
.... 8.226 SampleLabelerBusinessOperation
.... 8.227 SampleLabelerCodeRequestBundle
.... 8.228 SampleLabelerCodeRequestMessage
.... 8.229 SampleLabelerInactivationBundle
.... 8.230 SampleLabelerInactivationMessage
.... 8.231 SampleLabelerOrganization
.... 8.232 SampleLabelerUSAgentAffiliation
.... 8.233 SampleNoChangeNotificationBundle
.... 8.234 SampleNoChangeNotificationMessage
.... 8.235 SampleOutOfBusinessMessage
.... 8.236 SampleOutOfBusinessNotificationBundle
.... 8.237 SampleUSAgent
.... 8.238 TestEstablishmentRegistration