SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI United States of America flag

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 0.2.1 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 Organziation-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 VersionNumber
.... 8.58 DualSubmissionProvenance
.... 8.59 SPLDocumentDate
.... 8.60 SPLDocumentReference
.... 8.61 AidarexPharmaceuticals
.... 8.62 Allopurinol100Tablets
.... 8.63 Allopurinol30Tablets
.... 8.64 Allopurinol60Tablets
.... 8.65 Allopurinol90Tablets
.... 8.66 Allopurinol<br/>Tablets USP<br/>Revised: February 2015<br/>Rx only        <br/>
.... 8.67 AllopurinolIngredientDefinition
.... 8.68 AllopurinolMarketing
.... 8.69 AllopurinolTablet
.... 8.70 AllopurinolTabletLabelBundle
.... 8.71 AllopurinolUSPActiveIngredient
.... 8.72 AllopurinolUSPDefinition
.... 8.73 AllopurinolUSPIngredient1
.... 8.74 AllopurinolUSPIngredient2
.... 8.75 AllopurinolUSPIngredient3
.... 8.76 AllopurinolUSPIngredient4
.... 8.77 AllopurinolUSPIngredient5
.... 8.78 AllopurinolUSPIngredient6
.... 8.79 Enbrel010Definition
.... 8.80 Enbrel010Marketing
.... 8.81 Enbrel010Package
.... 8.82 Enbrel021Definition
.... 8.83 Enbrel021Marketing
.... 8.84 Enbrel021Package
.... 8.85 Enbrel032Definition
.... 8.86 Enbrel032Marketing
.... 8.87 Enbrel032Package
.... 8.88 Enbrel044Definition
.... 8.89 Enbrel044Marketing
.... 8.90 Enbrel044Package
.... 8.91 Enbrel055Definition
.... 8.92 Enbrel055Marketing
.... 8.93 Enbrel055Package
.... 8.94 Enbrel25mgSolution
.... 8.95 Enbrel25mgSolutionActiveIngredient
.... 8.96 Enbrel25mgSolutionIngredient1
.... 8.97 Enbrel25mgSolutionIngredient2
.... 8.98 Enbrel25mgSolutionIngredient3
.... 8.99 Enbrel425Definition
.... 8.100 Enbrel425Marketing
.... 8.101 Enbrel425Package
.... 8.102 Enbrel425Part1Definition
.... 8.103 Enbrel425Part1Marketing
.... 8.104 Enbrel425Part1Package
.... 8.105 Enbrel425Part2Definition
.... 8.106 Enbrel425Part2Marketing
.... 8.107 Enbrel425Part2Package
.... 8.108 Enbrel435Definition
.... 8.109 Enbrel435Marketing
.... 8.110 Enbrel435Package
.... 8.111 Enbrel445Definition
.... 8.112 Enbrel445Marketing
.... 8.113 Enbrel445Package
.... 8.114 Enbrel446Definition
.... 8.115 Enbrel446Marketing
.... 8.116 Enbrel446Package
.... 8.117 Enbrel455Definition
.... 8.118 Enbrel455Marketing
.... 8.119 Enbrel455Package
.... 8.120 Enbrel456Definition
.... 8.121 Enbrel456Marketing
.... 8.122 Enbrel456Package
.... 8.123 Enbrel50mgSolution
.... 8.124 Enbrel50mgSolutionActiveIngredient
.... 8.125 Enbrel50mgSolutionIngredient1
.... 8.126 Enbrel50mgSolutionIngredient2
.... 8.127 Enbrel50mgSolutionIngredient3
.... 8.128 EnbrelIngredientDefinition
.... 8.129 EnbrelPowder
.... 8.130 EnbrelPowderActiveIngredient
.... 8.131 EnbrelPowderIngredient1
.... 8.132 EnbrelPowderIngredient2
.... 8.133 EnbrelPowderIngredient3
.... 8.134 EnbrelSterileSolution
.... 8.135 EnbrelSterileSolutionIngredient1
.... 8.136 EnbrelSterileSolutionIngredient2
.... 8.137 EnbrelSyringeLabelBundle
.... 8.138 ImmunexCorporation
.... 8.139 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
.... 8.140 LantusActiveIngredient
.... 8.141 LantusIngredient1
.... 8.142 LantusIngredient2
.... 8.143 LantusIngredient3
.... 8.144 LantusIngredient4
.... 8.145 LantusIngredient5
.... 8.146 LantusIngredient6
.... 8.147 LantusIngredient7
.... 8.148 LantusIngredientDefinition
.... 8.149 LantusInjectionLabelBundle
.... 8.150 LantusSolution
.... 8.151 LantusSyringeDefinition
.... 8.152 LantusSyringeMarketing
.... 8.153 LantusSyringePackage
.... 8.154 LantusVialDefinition
.... 8.155 LantusVialMarketing
.... 8.156 LantusVialPackage
.... 8.157 SanofiAventisDeutschland
.... 8.158 SanofiAventisSRL
.... 8.159 SanofiAventisUS
.... 8.160 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
.... 8.161 ProvenanceActivitySearchParameter
.... 8.162 All NDC Products
.... 8.163 Business Operation Qualifiers
.... 8.164 Establishment Business Operations
.... 8.165 GDUFA Facility Business Operation Qualifiers
.... 8.166 GDUFA Facility Business Operations
.... 8.167 Generic Facility Message Types
.... 8.168 Labeler Business Operations
.... 8.169 Organzation Submission Message Types
.... 8.170 Registrant Organization Types
.... 8.171 SPL Color
.... 8.172 SPL Combo Product Type
.... 8.173 SPL Document Codes
.... 8.174 SPL Dose Form
.... 8.175 SPL Flavor
.... 8.176 SPL Marketing Categories
.... 8.177 SPL Marketing Statuses ValueSet
.... 8.178 SPL Operation Type
.... 8.179 SPL Package Types
.... 8.180 SPL Product Characteristic Types ValueSet
.... 8.181 SPL Route of Administration
.... 8.182 SPL Section Codes
.... 8.183 SPL Shape
.... 8.184 SPL Special Measures
.... 8.185 Top-Level Organization Types
.... 8.186 FHIR Specific SPL Message Types
.... 8.187 Medicinal Product Name Types CodeSystem
.... 8.188 Organization Relationship Types
.... 8.189 SPL Marketing Statuses CodeSystem
.... 8.190 SPL Organization Types
.... 8.191 SPL Product Characteristic Types CodeSystem
.... 8.192 EnbrelKit
.... 8.193 ExampleEstablishment
.... 8.194 ExampleEstablishmentAffiliation
.... 8.195 ExampleEstablishmentFHIRtoSPLProvenance
.... 8.196 ExampleEstablishmentOperation
.... 8.197 ExampleEstablishmentRegistrant
.... 8.198 ExampleEstablishmentRegistration
.... 8.199 ExampleEstablishmentSPLtoFHIRProvenance
.... 8.200 ExampleGDUFAFacility
.... 8.201 ExampleGDUFAFacilityAffiliation
.... 8.202 ExampleGDUFAFacilityIdentification
.... 8.203 ExampleGDUFAFacilityInactivation
.... 8.204 ExampleGDUFAFacilityOperation
.... 8.205 ExampleGDUFARegistrant
.... 8.206 ExampleImporter
.... 8.207 ExampleImporterAffiliation
.... 8.208 ExampleLabelerFHIRtoSPLProvenance
.... 8.209 ExampleLabelerSPLtoFHIRProvenance
.... 8.210 ExampleSPLDocumentReference
.... 8.211 IdentifiedLabelerOrganization
.... 8.212 SampleEstablishmentInactivationBundle
.... 8.213 SampleEstablishmentInactivationMessage
.... 8.214 SampleEstablishmentRegistrationMessage
.... 8.215 SampleGDUFAFacilityIdentificationMessage
.... 8.216 SampleGDUFAFacilityInactivationMessage
.... 8.217 SampleIdentifiedEstablishment
.... 8.218 SampleIdentifiedEstablishmentRegistrant
.... 8.219 SampleIdentifiedGDUFAFacility
.... 8.220 SampleIdentifiedGDUFARegistrant
.... 8.221 SampleLabelerBusinessOperation
.... 8.222 SampleLabelerCodeRequestBundle
.... 8.223 SampleLabelerCodeRequestMessage
.... 8.224 SampleLabelerInactivationBundle
.... 8.225 SampleLabelerInactivationMessage
.... 8.226 SampleLabelerOrganization
.... 8.227 SampleLabelerUSAgent
.... 8.228 SampleLabelerUSAgentAffiliation
.... 8.229 SampleOutOfBusinessNotificationBundle
.... 8.230 SamplOutOfBusinessMessage