SPL Mapping FHIR R5 Implementation Guide
0.2.8 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.8 - Build CI
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
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
Logical models that show the data elements for each use case
| Establishment Registration Logical Model |
An operation to register Establishment organizations. |
| GDUFA Facility Identification Logical Model |
An operation to provide details about a GDUFA Facility. |
| NDC Labeler Code Request Logical Model |
An operation to request a NDC Labeler code for a registrant or private Labeler organization. |
| Product Submission Document Logical Model |
A document that contains information about a product being submitted for approval to the FDA. |
| Submitted Medication Logical Model |
Details about the Medication that is submitted to the FDA. |
Bundle profiles that are used in the various use case operations
| EstablishmentInactivationBundle |
A profile that represents the Bundle that contains all of the resources for an Establishment Inactivation Request. |
| EstablishmentRegistrationBundle |
A profile that represents the Bundle that contains all of the resources for an Estabishment Registration Request. |
| GDUFAFacilityIdentificationBundle |
A profile that represents the Bundle that contains all of the resources for a GDUFA Facility Identification Request. |
| GDUFAFacilityInactivationBundle |
A profile that represents the Bundle that contains all of the resources for an GDUFA Facility Inactivation Request. |
| LabelerCodeRequestBundle |
A profile that represents the Bundle that contains all of the resources for a Labeler NDC Code Request. |
| LabelerInactivationBundle |
A profile that represents the Bundle that contains all of the resources for a Labeler Inactivation. |
| NoChangeNotificationBundle |
A profile that represents the Bundle that contains all of the resources for a No Change Notifcation. |
| OrganizationBundle |
A profile that provides the minimum set of information about a Bundle using for Organization messages. |
| OutOfBusinessBundle |
A profile that represents the Bundle that contains all of the resources for an Out of Business Notifcation. |
MessageHeader profiles that are used in the various use case operations
| EstablishmentInactivationMessage |
A profile of an Establishment Inactivation message |
| EstablishmentRegistrationMessage |
A profile of an Establishment Registration message |
| GDUFAFacilityIdentificationMessage |
A profile of a GDUFA Facility Identification message |
| GDUFAFacilityInactivationMessage |
A profile of an GDUFA Facility Inactivation message |
| LabelerCodeRequestMessage |
An example of a message header for a Labeler Code Request |
| LabelerInactivationMessage |
A profile for the Labeler Inactivation Message. |
| NoChangeNotificationMessage |
A profile of an No Change Notification message |
| OrganizationMessage |
An abstract profile that indicates what type of request is being made. |
| OutOfBusinessMessage |
A profile of an Out of Business message |
Artifacts associated with the Labeler Organization use cases
| IdentifiedLabeler |
A profile for an identified labeler. |
| LabelerBusinessOperation |
A profile that associates a Labeler to the set of business operations that it can perform. |
| LabelerOrganization |
A profile for the data elements required to identify a NDC Labeler organization. |
Artifacts associated with the Estabishment Organization use cases
| EstablishmentAffiliation |
A profile that associates an registrant to the establishments it is registering. |
| EstablishmentBusinessOperation |
A profile that associates an establishment to the set of business operations that it can perform. |
| EstablishmentOrganization |
A profile for the data elements required to identify an organization that is registered as an Establishment. |
| EstablishmentRegistrantOrganization |
A specialization of the RegistrantOrganization profile that fixes the type to EstablishmentRegistrant |
| IdentifiedEstablishment |
A profile for an identified establishment. |
| IdentifiedEstablishmentRegistrant |
A profile for an identified establishment registrant. |
Artifacts associated with the GDUFA Facility Identification use cases
| GDUFAFacilityAffiliation |
A profile that associates a GDUFA facility to its registrant. |
| GDUFAFacilityBusinessOperation |
A profile that associates an establishment to the set of business operations that it can perform. |
| GDUFAFacilityOrganization |
A profile for the data elements required to identify an organization that is identified as a GDUFA Facility. |
| GDUFARegistrantOrganization |
A specialization of the RegistrantOrganization profile that fixes the type to GDUFARegistrant. |
| IdentifiedGDUFAFacility |
A profile for an identified GDUFA facility. |
| IdentifiedGDUFARegistrant |
A profile for an identified GDUFA facility registrant. |
Artifacts that are used in any of the Organization use cases
| EstablishmentUSAgentAffiliation |
A profile that associates an establishment to its US Agent. |
| IdentifiedOrganization |
A profile on Organization that specifies a name and an identifier used to identify rather than specify the organization. |
| ImporterAffiliation |
A profile that associates an organization to its import organization. |
| ImporterOrganization |
A profile for the data elements required for an organization fulfilling the role of an importer for another organization. |
| LabelerUSAgentAffiliation |
A profile that associates a labeler to its US Agent. |
| RegistrantOrganization |
A profile for the data elements required to identify an organization that registers organizations and facilities. |
| SPLAddress |
SPL-specific Constraints on the Address datatype dealing with US addresses. |
| SPLContactPoint |
SPL-specific Constraints on the ContactPoint dealing with proper formatting |
| USAgentOrganization |
A profile for the data elements required for an organization fulfilling the role of a US Agent for another organization. |
Artifacts associated with the submission of a product document
| Manufactured Item Marketing Status Date Range |
Used to indicate the date range of the marketing status of a manufactured item. This is being added in R5. |
| Packaged Product Reference |
A reference to a packaged product that is represented in a packaging element. |
| ProductSubmissionBundle |
A profile that represents the Bundle that contains the Product Submission document. |
| ProductSubmissionDocument |
A profile that represents a document that is required for Product Submission to the FDA. |
| SectionEffectiveTime |
Providing an effective time for a section. |
| SectionLinkId |
Provide the ID that is using for linking between sections. NOTE: This will also be contained in the section text as a link. |
| SubmittedIngredientDefinition |
Used to represent an substance's active moiety. |
| SubmittedManufacturedItem |
Details around the actual item, i.e tablet, solution, etc. that is packaged as part of the medicinal product. |
| SubmittedMedicinalPackaging |
Details around the packaging of submitted medicinal products. |
| SubmittedMedicinalProduct |
A profile that allows for the submission of Medicinal Product information to the FDA. |
| SubmittedMedicinalProductIngredient |
Details around the ingredients of a submitted medicinal product. |
| SubmittedMedicinalProductMarketing |
Details around the marketing of a submitted medicinal product. |
Example Instances associated with the label for Allopurinol USP
| AidarexPharmaceuticals |
Aidarex Pharmaceuticals - labeller for Allopurinol Tablets USP |
| Allopurinol100Tablets |
100 Tablets Bottle of Allopurinol USP |
| Allopurinol30Tablets |
30 Tablets Bottle of Allopurinol USP |
| Allopurinol60Tablets |
60 Tablets Bottle of Allopurinol USP |
| Allopurinol90Tablets |
90 Tablets Bottle of Allopurinol USP |
| Allopurinol<br/>Tablets USP<br/>Revised: February 2015<br/>Rx only <br/> |
Header information for the Allopurinol Tablet USP Label |
| AllopurinolIngredientDefinition |
Active Ingredient Information for Allupurinol USP |
| AllopurinolMarketing |
Marketing information for Allopurinol USP |
| AllopurinolTablet | |
| AllopurinolTabletLabelBundle |
A bundle containing all of the information for the Allopurinol Tablet USP Label |
| AllopurinolUSPActiveIngredient |
Active Ingredient Strength for Allupurinol USP |
| AllopurinolUSPDefinition |
Structured information for the Allopurinol Tablet USP Label |
| AllopurinolUSPIngredient1 |
Inactive Ingredient #1 for Allopurinol USP |
| AllopurinolUSPIngredient2 |
Inactive Ingredient #2 for Allopurinol USP |
| AllopurinolUSPIngredient3 |
Inactive Ingredient #3 for Allopurinol USP |
| AllopurinolUSPIngredient4 |
Inactive Ingredient #4 for Allopurinol USP |
| AllopurinolUSPIngredient5 |
Inactive Ingredient #5 for Allopurinol USP |
| AllopurinolUSPIngredient6 |
Inactive Ingredient #6 for Allopurinol USP |
Example Instances associated with the label for Enbrel
| Enbrel010Definition |
Structured information for the Enbrel 010 Label |
| Enbrel010Marketing |
Marketing information for Enbrel 010 |
| Enbrel010Package |
4 0.5mL syringes of Enbrel |
| Enbrel021Definition |
Structured information for the Enbrel 021 Label |
| Enbrel021Marketing |
Marketing information for Enbrel 021 |
| Enbrel021Package |
4 1mL Syringes of Enbrel |
| Enbrel032Definition |
Structured information for the Enbrel 032 Label |
| Enbrel032Marketing |
Marketing information for Enbrel 032 |
| Enbrel032Package |
4 1mL autoinjectors of Enbrel |
| Enbrel044Definition |
Structured information for the Enbrel 044 Label |
| Enbrel044Marketing |
Marketing information for Enbrel 044 |
| Enbrel044Package |
4 1mL cartridges of Enbrel |
| Enbrel055Definition |
Structured information for the Enbrel 055 Label |
| Enbrel055Marketing |
Marketing information for Enbrel 055 |
| Enbrel055Package |
4 0.5mL syringes of Enbrel |
| Enbrel25mgSolution | |
| Enbrel25mgSolutionActiveIngredient |
Active Ingredient Strength for Enbrel |
| Enbrel25mgSolutionIngredient1 |
Inactive Ingredient #1 for Enbrel 25mg Solution |
| Enbrel25mgSolutionIngredient2 |
Inactive Ingredient #2 for Enbrel 25mg Solution |
| Enbrel25mgSolutionIngredient3 |
Inactive Ingredient #3 for Enbrel 25mg Solution |
| Enbrel425Definition |
Structured information for the Enbrel 425 Label |
| Enbrel425Marketing |
Marketing information for Enbrel 425 |
| Enbrel425Package |
4 25mg kits of Enbrel |
| Enbrel425Part1Definition |
Structured information for the Enbrel 425 Part 1 |
| Enbrel425Part1Marketing |
Marketing information for Enbrel 425 Part 1 |
| Enbrel425Part1Package |
1 vial of Enbrel powder |
| Enbrel425Part2Definition |
Structured information for the Enbrel 425 Part 2 |
| Enbrel425Part2Marketing |
Marketing information for Enbrel 425 Part 2 |
| Enbrel425Part2Package |
1 syringe of sterile bacteriostatic water |
| Enbrel435Definition |
Structured information for the Enbrel 435 Label |
| Enbrel435Marketing |
Marketing information for Enbrel 435 |
| Enbrel435Package |
4 1mL Syringes of Enbrel |
| Enbrel445Definition |
Structured information for the Enbrel 445 Label |
| Enbrel445Marketing |
Marketing information for Enbrel 445 |
| Enbrel445Package |
4 1mL autoinjectors of Enbrel |
| Enbrel446Definition |
Structured information for the Enbrel 446 Label |
| Enbrel446Marketing |
Marketing information for Enbrel 446 |
| Enbrel446Package |
4 1mL autoinjectors of Enbrel |
| Enbrel455Definition |
Structured information for the Enbrel 455 Label |
| Enbrel455Marketing |
Marketing information for Enbrel 455 |
| Enbrel455Package |
4 0.5mL syringes of Enbrel |
| Enbrel456Definition |
Structured information for the Enbrel 456 Label |
| Enbrel456Marketing |
Marketing information for Enbrel 456 |
| Enbrel456Package |
4 1mL cartridges of Enbrel |
| Enbrel50mgSolution | |
| Enbrel50mgSolutionActiveIngredient |
Active Ingredient Strength for Enbrel |
| Enbrel50mgSolutionIngredient1 |
Inactive Ingredient #1 for Enbrel Solution |
| Enbrel50mgSolutionIngredient2 |
Inactive Ingredient #2 for Enbrel Solution |
| Enbrel50mgSolutionIngredient3 |
Inactive Ingredient #3 for Enbrel Solution |
| EnbrelIngredientDefinition |
Active Ingredient Information for Enbrel |
| EnbrelPowder | |
| EnbrelPowderActiveIngredient |
Active Ingredient Strength for Enbrel Powder |
| EnbrelPowderIngredient1 |
Inactive Ingredient #1 for Enbrel Powder |
| EnbrelPowderIngredient2 |
Inactive Ingredient #2 for Enbrel Powder |
| EnbrelPowderIngredient3 |
Inactive Ingredient #3 for Enbrel Powder |
| EnbrelSterileSolution | |
| EnbrelSterileSolutionIngredient1 |
Inactive Ingredient #1 for Enbrel Sterile Solution |
| EnbrelSterileSolutionIngredient2 |
Inactive Ingredient #2 for Enbrel Sterile Solution |
| EnbrelSyringeLabelBundle |
A bundle containing all of the information for the Enbrel Label |
| ImmunexCorporation |
Immunex Corporation - labeller for Enbrel |
| 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 |
Header information for the Enbrel Syringe Labels |
Example Instances associated with the label for Lantus
| LantusActiveIngredient |
Active Ingredient Strength for Lantus |
| LantusIngredient1 |
Inactive Ingredient #1 for Lantus |
| LantusIngredient2 |
Inactive Ingredient #2 for Lantus |
| LantusIngredient3 |
Inactive Ingredient #3 for Lantus |
| LantusIngredient4 |
Inactive Ingredient #4 for Lantus |
| LantusIngredient5 |
Inactive Ingredient #5 for Lantus |
| LantusIngredient6 |
Inactive Ingredient #6 for Lantus |
| LantusIngredient7 |
Inactive Ingredient #7 for Lantus |
| LantusIngredientDefinition |
Active Ingredient Information for Lantus |
| LantusInjectionLabelBundle |
A bundle containing all of the information for the Lantus Injection Label |
| LantusSolution | |
| LantusSyringeDefinition |
Structured information for the Lantus Syringe product |
| LantusSyringeMarketing |
Marketing information for Lantus Syringe |
| LantusSyringePackage |
Lantus Syringe Packaging |
| LantusVialDefinition |
Structured information for the Lantus Vial product |
| LantusVialMarketing |
Marketing information for Lantus Vial |
| LantusVialPackage |
Lantus Vial Packaging |
| SanofiAventisDeutschland |
Sanifo-Aventis Deutschland - establishment for Lantus Injection |
| SanofiAventisSRL |
Sanifo-Aventis SRL - establishment for Lantus Injection |
| SanofiAventisUS |
Sanifo-Aventis US - labeller for Lantus Injection |
| 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 |
Header information for the Lantus Injection Label |
These define constraints on FHIR resources for systems conforming to this implementation guide.
| DualSubmissionProvenance |
A profile that links changes made to a FHIR system either via a converted SPL document or that are sent to a SPL system |
| SPLDocumentReference |
A profile that represents the SPL document that was either created by or was the source for the Organization FHIR Bundle. |
These define constraints on FHIR data types for systems conforming to this implementation guide.
| SPLDocumentDate |
Adding a SPL creation date to the document reference. |
These define sets of codes used by systems conforming to this implementation guide.
| All NDC Products |
A value set that is all of the NDC codesystem, i.e. all NDC products |
| Business Operation Qualifiers |
Codes that give further information about an organization's business operation. |
| Establishment Business Operations |
The set of business operations that can be specified for an establishment. |
| GDUFA Facility Business Operation Qualifiers |
Codes that give further information about a GUDFA facility's business operation. |
| GDUFA Facility Business Operations |
The set of business operations that can be specified for a GDUFA facility. |
| Generic Facility Message Types |
The set of message types that are allowed as a Generic User Fee Facility submission. |
| Labeler Business Operations |
The set of business operations that can be specified for a labelling facility. |
| Organization Submission Message Types |
The set of message types that are allowed as a FHIR organization submission. |
| Registrant Organization Types |
Codes that are specifically used for Registration Organizations. |
| SPL Color |
Codes from NCI Thesaurus for SPL Color (C54453 Subset) |
| SPL Combo Product Type |
Codes from NCI Thesaurus for SPL Combo Product Type (C102833 Subset) |
| SPL Document Codes |
Document Codes for SPL Product Submission documents |
| SPL Dose Form |
Codes from NCI Thesaurus for SPL Dose Form (C54456 Subset) |
| SPL Flavor |
Codes from NCI Thesaurus for SPL Flavor (C73339 Subset) |
| SPL Marketing Categories |
Codes from NCI Thesaurus for SPL Marketing Categories (C43164 Subset) |
| SPL Marketing Statuses ValueSet |
Marketing Status Status Codes |
| SPL Operation Type |
Codes from NCI Thesaurus for SPL Operation Type (C73600 Subset) |
| SPL Package Types |
Codes from NCI Thesaurus for SPL Package Types (C43164 Subset) |
| SPL Product Characteristic Types ValueSet |
Codes that identify the types of characteristics allowed for Submitted Medicinal Product. |
| SPL Route of Administration |
Codes from NCI Thesaurus for SPL Route of Administration (C54455 Subset) |
| SPL Section Codes |
Section Codes for SPL Product Submission documents |
| SPL Shape |
Codes from NCI Thesaurus for SPL Shape (C54454 Subset) |
| SPL Special Measures |
Codes from NCI Thesaurus for SPL Special Measures (C54459 Subset) |
| Top-Level Organization Types |
Codes that identify organizations that are considered top-level |
These define new code systems used by systems conforming to this implementation guide.
| FHIR Specific SPL Message Types |
Codes that are unique to the FHIR organization submissions, i.e. these are not current SPL submission types. |
| Medicinal Product Name Types CodeSystem |
Codes that types of names for a medicinal product. |
| Organization Contact Type |
A code that will distinguish the organizations's address from the contact party information. |
| Organization Relationship Types |
Codes that identify the relationship between two organizations. |
| SPL Marketing Statuses CodeSystem |
Marketing Status Status Codes |
| SPL Organization Types |
Codes that identify the types of organizations involved in a SPL submission. |
| SPL Product Characteristic Types CodeSystem |
Codes that were specified in the SPL guide for characteristic types. |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.
| EnbrelKit | |
| ExampleEstablishment |
An example of an Establishment Organization. |
| ExampleEstablishmentAffiliation |
An example of an affiliation between a registrant and an establishment. |
| ExampleEstablishmentFHIRtoSPLProvenance |
A Provenance record that associates a set of FHIR Registrant and Establishment Organizations with a generated SPL document. |
| ExampleEstablishmentOperation |
An example of a Establishment's business operations. |
| ExampleEstablishmentRegistrant |
An example of a Registrant Organization. |
| ExampleEstablishmentRegistration |
An example of a Bundle containing a set of Establishment Registration resources to register. |
| ExampleEstablishmentSPLtoFHIRProvenance |
A Provenance record that associates a set of FHIR Registrant and Establishment Organizations with a submitted SPL document. |
| ExampleEstablishmentUSAgentAffiliation |
An example of the linkage between an Establishment and a US Agent |
| ExampleGDUFAFacility |
An example of an GDUFA Facility Organization. |
| ExampleGDUFAFacilityAffiliation |
An example of an affiliation between a registrant and a GDUFA facility. |
| ExampleGDUFAFacilityIdentification |
An example of a Bundle containing a set of GDUFA Facility resources to identify. |
| ExampleGDUFAFacilityInactivation |
An example of a Bundle containing a set of GDUFA Facility resources to inactivate. |
| ExampleGDUFAFacilityOperation |
An example of a GDUFA Facility's business operations. |
| ExampleGDUFARegistrant |
An example of a Registrant Organization. |
| ExampleImporter |
An example of an Importer Organization. |
| ExampleImporterAffiliation |
An example of the linkage between an Establishment and an Importer |
| ExampleLabelerFHIRtoSPLProvenance |
A Provenance record that associates a set of FHIR Labeler Organizations with a generated SPL document. |
| ExampleLabelerSPLtoFHIRProvenance |
A Provenance record that associates a set of FHIR Labeler Organizations with a submitted SPL document. |
| ExampleSPLDocumentReference |
An example of an SPL document that will be attached to a FHIR Provenance. |
| IdentifiedLabelerOrganization |
A sample Labeler organizaiton that just has the DUNS number and name. |
| SampleEstablishmentInactivationBundle |
An example of a Bundle containing a set of Establishment resources to inactivate. |
| SampleEstablishmentInactivationMessage |
An example of a message header for a Establishment Inactivation |
| SampleEstablishmentRegistrationMessage |
An example of an Establishment Registration message |
| SampleGDUFAFacilityIdentificationMessage |
An example of a GDUFA Facility Identification message |
| SampleGDUFAFacilityInactivationMessage |
An example of a GDUFA Facility Identification message |
| SampleGDUFAOutOfBusinessMessage |
An example of a message header for an Out of Business notification |
| SampleGDUFAOutOfBusinessNotificationBundle |
An example of a Bundle containing a set of Establishment resources to inactivate. |
| SampleIdentifiedEstablishment |
A sample Establishment organizaiton that just has the DUNS number and name. |
| SampleIdentifiedEstablishmentRegistrant |
A sample Establishment Registrant organization that just has the DUNS number and name. |
| SampleIdentifiedGDUFAFacility |
An example of an Identified GDUFA Facility Organization. |
| SampleIdentifiedGDUFARegistrant |
An example of a Identified Registrant Organization. |
| SampleLabelerBusinessOperation |
An example of a Labeler's business operations. |
| SampleLabelerCodeRequestBundle |
An example of a Bundle containing a Labeler Code Request resource to register. |
| SampleLabelerCodeRequestMessage |
An example of a message header for a Labeler Code Request |
| SampleLabelerInactivationBundle |
An example of a Bundle containing a Labeler Code Request resource to inactivate. |
| SampleLabelerInactivationMessage |
An example of a message header for a Labeler Inactivation |
| SampleLabelerOrganization |
An example of a Labeler Organization. |
| SampleLabelerUSAgentAffiliation |
An example of the linkage between a Labeler and a US Agent |
| SampleNoChangeNotificationBundle |
An example of a Bundle containing a set of Establishment resources to indicate no change required. |
| SampleNoChangeNotificationMessage | |
| SampleOutOfBusinessMessage |
An example of a message header for an Out of Business notification |
| SampleOutOfBusinessNotificationBundle |
An example of a Bundle containing a set of Establishment resources to inactivate. |
| SampleUSAgent |
An example of a US Agent Organization. |
| TestEstablishmentRegistration |
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.8 based on FHIR 5.0.0. Generated 2025-07-25
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