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
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. |
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. |
OrganizationMessage |
An abstract profile that indicates what type of request is being made. |
OutOfBusinessMessage |
A profile of an Establishment Registration 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
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. |
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 |
USAgentAffiliation |
A profile that associates an organization to its US Agent. |
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. |
VersionNumber |
Adding a version number to documents. |
Artifacts needed for tracking dual submissions of SPL documents and FHIR Bundles
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 |
SPLDocumentDate |
Adding a SPL creation date to the document reference. |
SPLDocumentReference |
A profile that represents the SPL document that was either created by or was the source for the Organization FHIR Bundle. |
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 the properties by which a RESTful server can be searched. They can also be used for sorting and including related resources.
ProvenanceActivitySearchParameter |
A search parameter to allow searching for Provenance records by activity type. |
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 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. |
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. |
SamplOutOfBusinessMessage |
An example of a message header for an Out of Business notification |
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 |
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. |
SampleLabelerUSAgent |
An example of a US Agent Organization. |
SampleLabelerUSAgentAffiliation |
An example of the linkage between a Labeler and a US Agent |
SampleOutOfBusinessNotificationBundle |
An example of a Bundle containing a set of Establishment resources to inactivate. |