Package | hl7.fhir.us.spl |
Type | ImplementationGuide |
Id | hl7.fhir.us.spl |
FHIR Version | R5 |
Source | http://hl7.org/fhir/us/spl/https://build.fhir.org/ig/HL7/fhir-spl/index.html |
URL | http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl |
Version | 0.2.8 |
Status | active |
Date | 2025-07-07T15:17:39+00:00 |
Name | FHIR_SPL |
Title | SPL Mapping FHIR R5 Implementation Guide |
Realm | us |
Authority | hl7 |
Description | A guide that provides mapping from the FDA SPL Documents to FHIR Resources and operations. |
No resources found
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Note: links and images are rebased to the (stated) source
Generated Narrative: ImplementationGuide hl7.fhir.us.spl
The official URL for this implementation guide is:
http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl
A guide that provides mapping from the FDA SPL Documents to FHIR Resources and operations.
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"extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MedicinalProductDefinition" } ], "reference": { "reference": "MedicinalProductDefinition/Enbrel425Part1Definition" }, "name": "Enbrel425Part1Definition", "description": "Structured information for the Enbrel 425 Part 1", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "RegulatedAuthorization" } ], "reference": { "reference": "RegulatedAuthorization/Enbrel425Part1Marketing" }, "name": "Enbrel425Part1Marketing", "description": "Marketing information for Enbrel 425 Part 1", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": 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"valueString": "RegulatedAuthorization" } ], "reference": { "reference": "RegulatedAuthorization/Enbrel425Part2Marketing" }, "name": "Enbrel425Part2Marketing", "description": "Marketing information for Enbrel 425 Part 2", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "PackagedProductDefinition" } ], "reference": { "reference": "PackagedProductDefinition/Enbrel425Part2Package" }, "name": "Enbrel425Part2Package", "description": "1 syringe of sterile bacteriostatic water", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MedicinalProductDefinition" } ], "reference": { "reference": "MedicinalProductDefinition/Enbrel435Definition" }, "name": "Enbrel435Definition", "description": "Structured information for the Enbrel 435 Label", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "RegulatedAuthorization" } ], "reference": { "reference": "RegulatedAuthorization/Enbrel435Marketing" }, "name": "Enbrel435Marketing", "description": "Marketing information for Enbrel 435", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "PackagedProductDefinition" } ], "reference": { "reference": "PackagedProductDefinition/Enbrel435Package" }, "name": "Enbrel435Package", "description": "4 1mL Syringes of Enbrel", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MedicinalProductDefinition" } ], "reference": { "reference": "MedicinalProductDefinition/Enbrel445Definition" }, "name": "Enbrel445Definition", "description": "Structured information for the Enbrel 445 Label", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "RegulatedAuthorization" } ], "reference": { "reference": "RegulatedAuthorization/Enbrel445Marketing" }, "name": "Enbrel445Marketing", "description": "Marketing information for Enbrel 445", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "PackagedProductDefinition" } ], "reference": { "reference": "PackagedProductDefinition/Enbrel445Package" }, "name": "Enbrel445Package", "description": "4 1mL autoinjectors of Enbrel", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MedicinalProductDefinition" } ], "reference": { "reference": "MedicinalProductDefinition/Enbrel446Definition" }, "name": "Enbrel446Definition", "description": "Structured information for the Enbrel 446 Label", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "RegulatedAuthorization" } ], "reference": { "reference": "RegulatedAuthorization/Enbrel446Marketing" }, "name": "Enbrel446Marketing", "description": "Marketing information for Enbrel 446", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "PackagedProductDefinition" } ], "reference": { "reference": "PackagedProductDefinition/Enbrel446Package" }, "name": "Enbrel446Package", "description": "4 1mL autoinjectors of Enbrel", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MedicinalProductDefinition" } ], "reference": { "reference": "MedicinalProductDefinition/Enbrel455Definition" }, "name": "Enbrel455Definition", "description": "Structured information for the Enbrel 455 Label", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "RegulatedAuthorization" } ], "reference": { "reference": "RegulatedAuthorization/Enbrel455Marketing" }, "name": "Enbrel455Marketing", "description": "Marketing information for Enbrel 455", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "PackagedProductDefinition" } ], "reference": { "reference": "PackagedProductDefinition/Enbrel455Package" }, "name": "Enbrel455Package", "description": "4 0.5mL syringes of Enbrel", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MedicinalProductDefinition" } ], "reference": { "reference": "MedicinalProductDefinition/Enbrel456Definition" }, "name": "Enbrel456Definition", "description": "Structured information for the Enbrel 456 Label", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "RegulatedAuthorization" } ], "reference": { "reference": "RegulatedAuthorization/Enbrel456Marketing" }, "name": "Enbrel456Marketing", "description": "Marketing information for Enbrel 456", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "PackagedProductDefinition" } ], "reference": { "reference": "PackagedProductDefinition/Enbrel456Package" }, "name": "Enbrel456Package", "description": "4 1mL cartridges of Enbrel", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ManufacturedItemDefinition" } ], "reference": { "reference": "ManufacturedItemDefinition/Enbrel50mgSolution" }, "name": "Enbrel50mgSolution", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/Enbrel50mgSolutionActiveIngredient" }, "name": "Enbrel50mgSolutionActiveIngredient", "description": "Active Ingredient Strength for Enbrel", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/Enbrel50mgSolutionIngredient1" }, "name": "Enbrel50mgSolutionIngredient1", "description": "Inactive Ingredient #1 for Enbrel Solution", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/Enbrel50mgSolutionIngredient2" }, "name": "Enbrel50mgSolutionIngredient2", "description": "Inactive Ingredient #2 for Enbrel Solution", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/Enbrel50mgSolutionIngredient3" }, "name": "Enbrel50mgSolutionIngredient3", "description": "Inactive Ingredient #3 for Enbrel Solution", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "SubstanceDefinition" } ], "reference": { "reference": "SubstanceDefinition/EnbrelIngredientDefinition" }, "name": "EnbrelIngredientDefinition", "description": "Active Ingredient Information for Enbrel", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedIngredientDefinition" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ManufacturedItemDefinition" } ], "reference": { "reference": "ManufacturedItemDefinition/EnbrelKit" }, "name": "EnbrelKit", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ManufacturedItemDefinition" } ], "reference": { "reference": "ManufacturedItemDefinition/EnbrelPowder" }, "name": "EnbrelPowder", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/EnbrelPowderActiveIngredient" }, "name": "EnbrelPowderActiveIngredient", "description": "Active Ingredient Strength for Enbrel Powder", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/EnbrelPowderIngredient1" }, "name": "EnbrelPowderIngredient1", "description": "Inactive Ingredient #1 for Enbrel Powder", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/EnbrelPowderIngredient2" }, "name": "EnbrelPowderIngredient2", "description": "Inactive Ingredient #2 for Enbrel Powder", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/EnbrelPowderIngredient3" }, "name": "EnbrelPowderIngredient3", "description": "Inactive Ingredient #3 for Enbrel Powder", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ManufacturedItemDefinition" } ], "reference": { "reference": "ManufacturedItemDefinition/EnbrelSterileSolution" }, "name": "EnbrelSterileSolution", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/EnbrelSterileSolutionIngredient1" }, "name": "EnbrelSterileSolutionIngredient1", "description": "Inactive Ingredient #1 for Enbrel Sterile Solution", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/EnbrelSterileSolutionIngredient2" }, "name": "EnbrelSterileSolutionIngredient2", "description": "Inactive Ingredient #2 for Enbrel Sterile Solution", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/EnbrelSyringeLabelBundle" }, "name": "EnbrelSyringeLabelBundle", "description": "A bundle containing all of the information for the Enbrel Label", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionBundle" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-establishmentBusinessOperations" }, "name": "Establishment Business Operations", "description": "The set of business operations that can be specified for an establishment.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:logical" } ], "reference": { "reference": "StructureDefinition/EstablishmentRegistrationLogicalModel" }, "name": "Establishment Registration Logical Model", "description": "An operation to register Establishment organizations.", "isExample": false, "groupingId": "LogicalModel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/EstablishmentAffiliation" }, "name": "EstablishmentAffiliation", "description": "A profile that associates an registrant to the establishments it is registering.", "isExample": false, "groupingId": "EstablishmentRegistration" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/EstablishmentBusinessOperation" }, "name": "EstablishmentBusinessOperation", "description": "A profile that associates an establishment to the set of business operations that it can perform.", "isExample": false, "groupingId": "EstablishmentRegistration" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/EstablishmentInactivationBundle" }, "name": "EstablishmentInactivationBundle", "description": "A profile that represents the Bundle that contains all of the resources for an Establishment Inactivation Request.", "isExample": false, "groupingId": "OperationBundles" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/EstablishmentInactivationMessage" }, "name": "EstablishmentInactivationMessage", "description": "A profile of an Establishment Inactivation message", "isExample": false, "groupingId": "OperationMessages" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/EstablishmentOrganization" }, "name": "EstablishmentOrganization", "description": "A profile for the data elements required to identify an organization that is registered as an Establishment.", "isExample": false, "groupingId": "EstablishmentRegistration" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/EstablishmentRegistrantOrganization" }, "name": "EstablishmentRegistrantOrganization", "description": "A specialization of the RegistrantOrganization profile that fixes the type to EstablishmentRegistrant", "isExample": false, "groupingId": "EstablishmentRegistration" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/EstablishmentRegistrationBundle" }, "name": "EstablishmentRegistrationBundle", "description": "A profile that represents the Bundle that contains all of the resources for an Estabishment Registration Request.", "isExample": false, "groupingId": "OperationBundles" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/EstablishmentRegistrationMessage" }, "name": "EstablishmentRegistrationMessage", "description": "A profile of an Establishment Registration message", "isExample": false, "groupingId": "OperationMessages" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/EstablishmentUSAgentAffiliation" }, "name": "EstablishmentUSAgentAffiliation", "description": "A profile that associates an establishment to its US Agent.", "isExample": false, "groupingId": "GeneralOrganization" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/ExampleEstablishment" }, "name": "ExampleEstablishment", "description": "An example of an Establishment Organization.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentOrganization" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "OrganizationAffiliation" } ], "reference": { "reference": "OrganizationAffiliation/ExampleEstablishmentAffiliation" }, "name": "ExampleEstablishmentAffiliation", "description": "An example of an affiliation between a registrant and an establishment.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentAffiliation" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Provenance" } ], "reference": { "reference": "Provenance/ExampleEstablishmentFHIRtoSPLProvenance" }, "name": "ExampleEstablishmentFHIRtoSPLProvenance", "description": "A Provenance record that associates a set of FHIR Registrant and Establishment Organizations with a generated SPL document.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/DualSubmissionProvenance" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "HealthcareService" } ], "reference": { "reference": "HealthcareService/ExampleEstablishmentOperation" }, "name": "ExampleEstablishmentOperation", "description": "An example of a Establishment's business operations.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentBusinessOperation" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/ExampleEstablishmentRegistrant" }, "name": "ExampleEstablishmentRegistrant", "description": "An example of a Registrant Organization.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentRegistrantOrganization" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/ExampleEstablishmentRegistration" }, "name": "ExampleEstablishmentRegistration", "description": "An example of a Bundle containing a set of Establishment Registration resources to register.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentRegistrationBundle" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Provenance" } ], "reference": { "reference": "Provenance/ExampleEstablishmentSPLtoFHIRProvenance" }, "name": "ExampleEstablishmentSPLtoFHIRProvenance", "description": "A Provenance record that associates a set of FHIR Registrant and Establishment Organizations with a submitted SPL document.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/DualSubmissionProvenance" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "OrganizationAffiliation" } ], "reference": { "reference": "OrganizationAffiliation/ExampleEstablishmentUSAgentAffiliation" }, "name": "ExampleEstablishmentUSAgentAffiliation", "description": "An example of the linkage between an Establishment and a US Agent", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentUSAgentAffiliation" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/ExampleGDUFAFacility" }, "name": "ExampleGDUFAFacility", "description": "An example of an GDUFA Facility Organization.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityOrganization" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "OrganizationAffiliation" } ], "reference": { "reference": "OrganizationAffiliation/ExampleGDUFAFacilityAffiliation" }, "name": "ExampleGDUFAFacilityAffiliation", "description": "An example of an affiliation between a registrant and a GDUFA facility.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityAffiliation" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/ExampleGDUFAFacilityIdentification" }, "name": "ExampleGDUFAFacilityIdentification", "description": "An example of a Bundle containing a set of GDUFA Facility resources to identify.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityIdentificationBundle" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/ExampleGDUFAFacilityInactivation" }, "name": "ExampleGDUFAFacilityInactivation", "description": "An example of a Bundle containing a set of GDUFA Facility resources to inactivate.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityInactivationBundle" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "HealthcareService" } ], "reference": { "reference": "HealthcareService/ExampleGDUFAFacilityOperation" }, "name": "ExampleGDUFAFacilityOperation", "description": "An example of a GDUFA Facility's business operations.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityBusinessOperation" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/ExampleGDUFARegistrant" }, "name": "ExampleGDUFARegistrant", "description": "An example of a Registrant Organization.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/GDUFARegistrantOrganization" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/ExampleImporter" }, "name": "ExampleImporter", "description": "An example of an Importer Organization.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/ImporterOrganization" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "OrganizationAffiliation" } ], "reference": { "reference": "OrganizationAffiliation/ExampleImporterAffiliation" }, "name": "ExampleImporterAffiliation", "description": "An example of the linkage between an Establishment and an Importer", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/ImporterAffiliation" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Provenance" } ], "reference": { "reference": "Provenance/ExampleLabelerFHIRtoSPLProvenance" }, "name": "ExampleLabelerFHIRtoSPLProvenance", "description": "A Provenance record that associates a set of FHIR Labeler Organizations with a generated SPL document.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/DualSubmissionProvenance" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Provenance" } ], "reference": { "reference": "Provenance/ExampleLabelerSPLtoFHIRProvenance" }, "name": "ExampleLabelerSPLtoFHIRProvenance", "description": "A Provenance record that associates a set of FHIR Labeler Organizations with a submitted SPL document.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/DualSubmissionProvenance" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "DocumentReference" } ], "reference": { "reference": "DocumentReference/ExampleSPLDocumentReference" }, "name": "ExampleSPLDocumentReference", "description": "An example of an SPL document that will be attached to a FHIR Provenance.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SPLDocumentReference" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "CodeSystem" } ], "reference": { "reference": "CodeSystem/codesystem-fhirMessageTypes" }, "name": "FHIR Specific SPL Message Types", "description": "Codes that are unique to the FHIR organization submissions, i.e. these are not current SPL submission types.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-gdufaFacilityBusinessOperationQualifiers" }, "name": "GDUFA Facility Business Operation Qualifiers", "description": "Codes that give further information about a GUDFA facility's business operation.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-gdufaFacilityBusinessOperations" }, "name": "GDUFA Facility Business Operations", "description": "The set of business operations that can be specified for a GDUFA facility.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:logical" } ], "reference": { "reference": "StructureDefinition/GDUFAFacilityIdentificationLogicalModel" }, "name": "GDUFA Facility Identification Logical Model", "description": "An operation to provide details about a GDUFA Facility.", "isExample": false, "groupingId": "LogicalModel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/GDUFAFacilityAffiliation" }, "name": "GDUFAFacilityAffiliation", "description": "A profile that associates a GDUFA facility to its registrant.", "isExample": false, "groupingId": "GDUFAFacility" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/GDUFAFacilityBusinessOperation" }, "name": "GDUFAFacilityBusinessOperation", "description": "A profile that associates an establishment to the set of business operations that it can perform.", "isExample": false, "groupingId": "GDUFAFacility" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/GDUFAFacilityIdentificationBundle" }, "name": "GDUFAFacilityIdentificationBundle", "description": "A profile that represents the Bundle that contains all of the resources for a GDUFA Facility Identification Request.", "isExample": false, "groupingId": "OperationBundles" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/GDUFAFacilityIdentificationMessage" }, "name": "GDUFAFacilityIdentificationMessage", "description": "A profile of a GDUFA Facility Identification message", "isExample": false, "groupingId": "OperationMessages" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/GDUFAFacilityInactivationBundle" }, "name": "GDUFAFacilityInactivationBundle", "description": "A profile that represents the Bundle that contains all of the resources for an GDUFA Facility Inactivation Request.", "isExample": false, "groupingId": "OperationBundles" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/GDUFAFacilityInactivationMessage" }, "name": "GDUFAFacilityInactivationMessage", "description": "A profile of an GDUFA Facility Inactivation message", "isExample": false, "groupingId": "OperationMessages" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/GDUFAFacilityOrganization" }, "name": "GDUFAFacilityOrganization", "description": "A profile for the data elements required to identify an organization that is identified as a GDUFA Facility.", "isExample": false, "groupingId": "GDUFAFacility" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/GDUFARegistrantOrganization" }, "name": "GDUFARegistrantOrganization", "description": "A specialization of the RegistrantOrganization profile that fixes the type to GDUFARegistrant.", "isExample": false, "groupingId": "GDUFAFacility" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-genericFacilityMessageTypes" }, "name": "Generic Facility Message Types", "description": "The set of message types that are allowed as a Generic User Fee Facility submission.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/IdentifiedEstablishment" }, "name": "IdentifiedEstablishment", "description": "A profile for an identified establishment.", "isExample": false, "groupingId": "EstablishmentRegistration" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/IdentifiedEstablishmentRegistrant" }, "name": "IdentifiedEstablishmentRegistrant", "description": "A profile for an identified establishment registrant.", "isExample": false, "groupingId": "EstablishmentRegistration" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/IdentifiedGDUFAFacility" }, "name": "IdentifiedGDUFAFacility", "description": "A profile for an identified GDUFA facility.", "isExample": false, "groupingId": "GDUFAFacility" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/IdentifiedGDUFARegistrant" }, "name": "IdentifiedGDUFARegistrant", "description": "A profile for an identified GDUFA facility registrant.", "isExample": false, "groupingId": "GDUFAFacility" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/IdentifiedLabeler" }, "name": "IdentifiedLabeler", "description": "A profile for an identified labeler.", "isExample": false, "groupingId": "LabelerRequest" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/IdentifiedLabelerOrganization" }, "name": "IdentifiedLabelerOrganization", "description": "A sample Labeler organizaiton that just has the DUNS number and name.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedLabeler" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource:abstract" } ], "reference": { "reference": "StructureDefinition/IdentifiedOrganization" }, "name": "IdentifiedOrganization", "description": "A profile on Organization that specifies a name and an identifier used to identify rather than specify the organization.", "isExample": false, "groupingId": "GeneralOrganization" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/ImmunexCorporation" }, "name": "ImmunexCorporation", "description": "Immunex Corporation - labeller for Enbrel", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedLabeler" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/ImporterAffiliation" }, "name": "ImporterAffiliation", "description": "A profile that associates an organization to its import organization.", "isExample": false, "groupingId": "GeneralOrganization" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/ImporterOrganization" }, "name": "ImporterOrganization", "description": "A profile for the data elements required for an organization fulfilling the role of an importer for another organization.", "isExample": false, "groupingId": "GeneralOrganization" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-labelerBusinessOperations" }, "name": "Labeler Business Operations", "description": "The set of business operations that can be specified for a labelling facility.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/LabelerBusinessOperation" }, "name": "LabelerBusinessOperation", "description": "A profile that associates a Labeler to the set of business operations that it can perform.", "isExample": false, "groupingId": "LabelerRequest" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/LabelerCodeRequestBundle" }, "name": "LabelerCodeRequestBundle", "description": "A profile that represents the Bundle that contains all of the resources for a Labeler NDC Code Request.", "isExample": false, "groupingId": "OperationBundles" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/LabelerCodeRequestMessage" }, "name": "LabelerCodeRequestMessage", "description": "An example of a message header for a Labeler Code Request", "isExample": false, "groupingId": "OperationMessages" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/LabelerInactivationBundle" }, "name": "LabelerInactivationBundle", "description": "A profile that represents the Bundle that contains all of the resources for a Labeler Inactivation.", "isExample": false, "groupingId": "OperationBundles" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/LabelerInactivationMessage" }, "name": "LabelerInactivationMessage", "description": "A profile for the Labeler Inactivation Message.", "isExample": false, "groupingId": "OperationMessages" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/LabelerOrganization" }, "name": "LabelerOrganization", "description": "A profile for the data elements required to identify a NDC Labeler organization.", "isExample": false, "groupingId": "LabelerRequest" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/LabelerUSAgentAffiliation" }, "name": "LabelerUSAgentAffiliation", "description": "A profile that associates a labeler to its US Agent.", "isExample": false, "groupingId": "GeneralOrganization" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/LantusActiveIngredient" }, "name": "LantusActiveIngredient", "description": "Active Ingredient Strength for Lantus", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/LantusIngredient1" }, "name": "LantusIngredient1", "description": "Inactive Ingredient #1 for Lantus", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/LantusIngredient2" }, "name": "LantusIngredient2", "description": "Inactive Ingredient #2 for Lantus", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/LantusIngredient3" }, "name": "LantusIngredient3", "description": "Inactive Ingredient #3 for Lantus", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/LantusIngredient4" }, "name": "LantusIngredient4", "description": "Inactive Ingredient #4 for Lantus", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/LantusIngredient5" }, "name": "LantusIngredient5", "description": "Inactive Ingredient #5 for Lantus", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/LantusIngredient6" }, "name": "LantusIngredient6", "description": "Inactive Ingredient #6 for Lantus", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Ingredient" } ], "reference": { "reference": "Ingredient/LantusIngredient7" }, "name": "LantusIngredient7", "description": "Inactive Ingredient #7 for Lantus", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "SubstanceDefinition" } ], "reference": { "reference": "SubstanceDefinition/LantusIngredientDefinition" }, "name": "LantusIngredientDefinition", "description": "Active Ingredient Information for Lantus", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedIngredientDefinition" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/LantusInjectionLabelBundle" }, "name": "LantusInjectionLabelBundle", "description": "A bundle containing all of the information for the Lantus Injection Label", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionBundle" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ManufacturedItemDefinition" } ], "reference": { "reference": "ManufacturedItemDefinition/LantusSolution" }, "name": "LantusSolution", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MedicinalProductDefinition" } ], "reference": { "reference": "MedicinalProductDefinition/LantusSyringeDefinition" }, "name": "LantusSyringeDefinition", "description": "Structured information for the Lantus Syringe product", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "RegulatedAuthorization" } ], "reference": { "reference": "RegulatedAuthorization/LantusSyringeMarketing" }, "name": "LantusSyringeMarketing", "description": "Marketing information for Lantus Syringe", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "PackagedProductDefinition" } ], "reference": { "reference": "PackagedProductDefinition/LantusSyringePackage" }, "name": "LantusSyringePackage", "description": "Lantus Syringe Packaging", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MedicinalProductDefinition" } ], "reference": { "reference": "MedicinalProductDefinition/LantusVialDefinition" }, "name": "LantusVialDefinition", "description": "Structured information for the Lantus Vial product", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "RegulatedAuthorization" } ], "reference": { "reference": "RegulatedAuthorization/LantusVialMarketing" }, "name": "LantusVialMarketing", "description": "Marketing information for Lantus Vial", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "PackagedProductDefinition" } ], "reference": { "reference": "PackagedProductDefinition/LantusVialPackage" }, "name": "LantusVialPackage", "description": "Lantus Vial Packaging", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:extension" } ], "reference": { "reference": "StructureDefinition/itemMarketingStatusDates" }, "name": "Manufactured Item Marketing Status Date Range", "description": "Used to indicate the date range of the marketing status of a manufactured item. This is being added in R5.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "CodeSystem" } ], "reference": { "reference": "CodeSystem/codesystem-submittedMedicinalProductNameTypes" }, "name": "Medicinal Product Name Types CodeSystem", "description": "Codes that types of names for a medicinal product.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:logical" } ], "reference": { "reference": "StructureDefinition/LabelerCodeRequestLogicalModel" }, "name": "NDC Labeler Code Request Logical Model", "description": "An operation to request a NDC Labeler code for a registrant or private Labeler organization.", "isExample": false, "groupingId": "LogicalModel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/NoChangeNotificationBundle" }, "name": "NoChangeNotificationBundle", "description": "A profile that represents the Bundle that contains all of the resources for a No Change Notifcation.", "isExample": false, "groupingId": "OperationBundles" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/NoChangeNotificationMessage" }, "name": "NoChangeNotificationMessage", "description": "A profile of an No Change Notification message", "isExample": false, "groupingId": "OperationMessages" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "CodeSystem" } ], "reference": { "reference": "CodeSystem/codesystem-organizationContactType" }, "name": "Organization Contact Type", "description": "A code that will distinguish the organizations's address from the contact party information.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "CodeSystem" } ], "reference": { "reference": "CodeSystem/codesystem-organizationAffiliationCodes" }, "name": "Organization Relationship Types", "description": "Codes that identify the relationship between two organizations.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-organizationSubmissionMessageTypes" }, "name": "Organization Submission Message Types", "description": "The set of message types that are allowed as a FHIR organization submission.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource:abstract" } ], "reference": { "reference": "StructureDefinition/OrganizationBundle" }, "name": "OrganizationBundle", "description": "A profile that provides the minimum set of information about a Bundle using for Organization messages.", "isExample": false, "groupingId": "OperationBundles" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource:abstract" } ], "reference": { "reference": "StructureDefinition/OrganizationMessage" }, "name": "OrganizationMessage", "description": "An abstract profile that indicates what type of request is being made.", "isExample": false, "groupingId": "OperationMessages" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/OutOfBusinessBundle" }, "name": "OutOfBusinessBundle", "description": "A profile that represents the Bundle that contains all of the resources for an Out of Business Notifcation.", "isExample": false, "groupingId": "OperationBundles" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/OutOfBusinessMessage" }, "name": "OutOfBusinessMessage", "description": "A profile of an Out of Business message", "isExample": false, "groupingId": "OperationMessages" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:extension" } ], "reference": { "reference": "StructureDefinition/packageInstanceOf" }, "name": "Packaged Product Reference", "description": "A reference to a packaged product that is represented in a packaging element.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:logical" } ], "reference": { "reference": "StructureDefinition/ProductSubmissionDocumentLogicalModel" }, "name": "Product Submission Document Logical Model", "description": "A document that contains information about a product being submitted for approval to the FDA.", "isExample": false, "groupingId": "LogicalModel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/ProductSubmissionBundle" }, "name": "ProductSubmissionBundle", "description": "A profile that represents the Bundle that contains the Product Submission document.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/ProductSubmissionDocument" }, "name": "ProductSubmissionDocument", "description": "A profile that represents a document that is required for Product Submission to the FDA.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-registrantOrganizationTypes" }, "name": "Registrant Organization Types", "description": "Codes that are specifically used for Registration Organizations.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource:abstract" } ], "reference": { "reference": "StructureDefinition/RegistrantOrganization" }, "name": "RegistrantOrganization", "description": "A profile for the data elements required to identify an organization that registers organizations and facilities.", "isExample": false, "groupingId": "GeneralOrganization" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/SampleEstablishmentInactivationBundle" }, "name": "SampleEstablishmentInactivationBundle", "description": "An example of a Bundle containing a set of Establishment resources to inactivate.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentInactivationBundle" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MessageHeader" } ], "reference": { "reference": "MessageHeader/SampleEstablishmentInactivationMessage" }, "name": "SampleEstablishmentInactivationMessage", "description": "An example of a message header for a Establishment Inactivation", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentInactivationMessage" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MessageHeader" } ], "reference": { "reference": "MessageHeader/SampleEstablishmentRegistrationMessage" }, "name": "SampleEstablishmentRegistrationMessage", "description": "An example of an Establishment Registration message", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentRegistrationMessage" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MessageHeader" } ], "reference": { "reference": "MessageHeader/SampleGDUFAFacilityIdentificationMessage" }, "name": "SampleGDUFAFacilityIdentificationMessage", "description": "An example of a GDUFA Facility Identification message", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityIdentificationMessage" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MessageHeader" } ], "reference": { "reference": "MessageHeader/SampleGDUFAFacilityInactivationMessage" }, "name": "SampleGDUFAFacilityInactivationMessage", "description": "An example of a GDUFA Facility Identification message", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityInactivationMessage" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MessageHeader" } ], "reference": { "reference": "MessageHeader/SampleGDUFAOutOfBusinessMessage" }, "name": "SampleGDUFAOutOfBusinessMessage", "description": "An example of a message header for an Out of Business notification", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/OutOfBusinessMessage" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/SampleGDUFAOutOfBusinessNotificationBundle" }, "name": "SampleGDUFAOutOfBusinessNotificationBundle", "description": "An example of a Bundle containing a set of Establishment resources to inactivate.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/OutOfBusinessBundle" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/SampleIdentifiedEstablishment" }, "name": "SampleIdentifiedEstablishment", "description": "A sample Establishment organizaiton that just has the DUNS number and name.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/SampleIdentifiedEstablishmentRegistrant" }, "name": "SampleIdentifiedEstablishmentRegistrant", "description": "A sample Establishment Registrant organization that just has the DUNS number and name.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishmentRegistrant" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/SampleIdentifiedGDUFAFacility" }, "name": "SampleIdentifiedGDUFAFacility", "description": "An example of an Identified GDUFA Facility Organization.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedGDUFAFacility" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/SampleIdentifiedGDUFARegistrant" }, "name": "SampleIdentifiedGDUFARegistrant", "description": "An example of a Identified Registrant Organization.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedGDUFARegistrant" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "HealthcareService" } ], "reference": { "reference": "HealthcareService/SampleLabelerBusinessOperation" }, "name": "SampleLabelerBusinessOperation", "description": "An example of a Labeler's business operations.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/LabelerBusinessOperation" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/SampleLabelerCodeRequestBundle" }, "name": "SampleLabelerCodeRequestBundle", "description": "An example of a Bundle containing a Labeler Code Request resource to register.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/LabelerCodeRequestBundle" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MessageHeader" } ], "reference": { "reference": "MessageHeader/SampleLabelerCodeRequestMessage" }, "name": "SampleLabelerCodeRequestMessage", "description": "An example of a message header for a Labeler Code Request", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/LabelerCodeRequestMessage" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/SampleLabelerInactivationBundle" }, "name": "SampleLabelerInactivationBundle", "description": "An example of a Bundle containing a Labeler Code Request resource to inactivate.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/LabelerInactivationBundle" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MessageHeader" } ], "reference": { "reference": "MessageHeader/SampleLabelerInactivationMessage" }, "name": "SampleLabelerInactivationMessage", "description": "An example of a message header for a Labeler Inactivation", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/LabelerInactivationMessage" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/SampleLabelerOrganization" }, "name": "SampleLabelerOrganization", "description": "An example of a Labeler Organization.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/LabelerOrganization" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "OrganizationAffiliation" } ], "reference": { "reference": "OrganizationAffiliation/SampleLabelerUSAgentAffiliation" }, "name": "SampleLabelerUSAgentAffiliation", "description": "An example of the linkage between a Labeler and a US Agent", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/LabelerUSAgentAffiliation" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/SampleNoChangeNotificationBundle" }, "name": "SampleNoChangeNotificationBundle", "description": "An example of a Bundle containing a set of Establishment resources to indicate no change required.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/NoChangeNotificationBundle" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MessageHeader" } ], "reference": { "reference": "MessageHeader/SampleNoChangeNotificationMessage" }, "name": "SampleNoChangeNotificationMessage", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/NoChangeNotificationMessage" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "MessageHeader" } ], "reference": { "reference": "MessageHeader/SampleOutOfBusinessMessage" }, "name": "SampleOutOfBusinessMessage", "description": "An example of a message header for an Out of Business notification", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/OutOfBusinessMessage" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/SampleOutOfBusinessNotificationBundle" }, "name": "SampleOutOfBusinessNotificationBundle", "description": "An example of a Bundle containing a set of Establishment resources to inactivate.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/OutOfBusinessBundle" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/SampleUSAgent" }, "name": "SampleUSAgent", "description": "An example of a US Agent Organization.", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/USAgentOrganization" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/SanofiAventisDeutschland" }, "name": "SanofiAventisDeutschland", "description": "Sanifo-Aventis Deutschland - establishment for Lantus Injection", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/SanofiAventisSRL" }, "name": "SanofiAventisSRL", "description": "Sanifo-Aventis SRL - establishment for Lantus Injection", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Organization" } ], "reference": { "reference": "Organization/SanofiAventisUS" }, "name": "SanofiAventisUS", "description": "Sanifo-Aventis US - labeller for Lantus Injection", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedLabeler" ], "groupingId": "LantusLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:extension" } ], "reference": { "reference": "StructureDefinition/sectionEffectiveTime" }, "name": "SectionEffectiveTime", "description": "Providing an effective time for a section.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:extension" } ], "reference": { "reference": "StructureDefinition/sectionLinkId" }, "name": "SectionLinkId", "description": "Provide the ID that is using for linking between sections. NOTE: This will also be contained in the section text as a link.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splColor" }, "name": "SPL Color", "description": "Codes from NCI Thesaurus for SPL Color (C54453 Subset)", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splComboProductType" }, "name": "SPL Combo Product Type", "description": "Codes from NCI Thesaurus for SPL Combo Product Type (C102833 Subset)", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/splDocumentCodes" }, "name": "SPL Document Codes", "description": "Document Codes for SPL Product Submission documents", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splDoseForm" }, "name": "SPL Dose Form", "description": "Codes from NCI Thesaurus for SPL Dose Form (C54456 Subset)", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splFlavor" }, "name": "SPL Flavor", "description": "Codes from NCI Thesaurus for SPL Flavor (C73339 Subset)", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splMarketingCategories" }, "name": "SPL Marketing Categories", "description": "Codes from NCI Thesaurus for SPL Marketing Categories (C43164 Subset)", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "CodeSystem" } ], "reference": { "reference": "CodeSystem/codesystem-splMarketingStatuses" }, "name": "SPL Marketing Statuses CodeSystem", "description": "Marketing Status Status Codes", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splMarketingStatuses" }, "name": "SPL Marketing Statuses ValueSet", "description": "Marketing Status Status Codes", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splOperationType" }, "name": "SPL Operation Type", "description": "Codes from NCI Thesaurus for SPL Operation Type (C73600 Subset)", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "CodeSystem" } ], "reference": { "reference": "CodeSystem/codesystem-organizationTypes" }, "name": "SPL Organization Types", "description": "Codes that identify the types of organizations involved in a SPL submission.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splPackageTypes" }, "name": "SPL Package Types", "description": "Codes from NCI Thesaurus for SPL Package Types (C43164 Subset)", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "CodeSystem" } ], "reference": { "reference": "CodeSystem/codesystem-characteristicTypes" }, "name": "SPL Product Characteristic Types CodeSystem", "description": "Codes that were specified in the SPL guide for characteristic types.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-SubmittedMedicinalProductCharacteristicCodes" }, "name": "SPL Product Characteristic Types ValueSet", "description": "Codes that identify the types of characteristics allowed for Submitted Medicinal Product.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splRouteOfAdministration" }, "name": "SPL Route of Administration", "description": "Codes from NCI Thesaurus for SPL Route of Administration (C54455 Subset)", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/splSectionCodes" }, "name": "SPL Section Codes", "description": "Section Codes for SPL Product Submission documents", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splShape" }, "name": "SPL Shape", "description": "Codes from NCI Thesaurus for SPL Shape (C54454 Subset)", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "ValueSet" } ], "reference": { "reference": "ValueSet/valueset-splSpecialMeasures" }, "name": "SPL Special Measures", "description": "Codes from NCI Thesaurus for SPL Special Measures (C54459 Subset)", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:complex-type" } ], "reference": { "reference": "StructureDefinition/SPLAddress" }, "name": "SPLAddress", "description": "SPL-specific Constraints on the Address datatype dealing with US addresses.", "isExample": false, "groupingId": "GeneralOrganization" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:complex-type" } ], "reference": { "reference": "StructureDefinition/SPLContactPoint" }, "name": "SPLContactPoint", "description": "SPL-specific Constraints on the ContactPoint dealing with proper formatting", "isExample": false, "groupingId": "GeneralOrganization" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:extension" } ], "reference": { "reference": "StructureDefinition/splDocumentDate" }, "name": "SPLDocumentDate", "description": "Adding a SPL creation date to the document reference.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/SPLDocumentReference" }, "name": "SPLDocumentReference", "description": "A profile that represents the SPL document that was either created by or was the source for the Organization FHIR Bundle.", "isExample": false }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:logical" } ], "reference": { "reference": "StructureDefinition/SubmittedMedicationLogicalModel" }, "name": "Submitted Medication Logical Model", "description": "Details about the Medication that is submitted to the FDA.", "isExample": false, "groupingId": "LogicalModel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/SubmittedIngredientDefinition" }, "name": "SubmittedIngredientDefinition", "description": "Used to represent an substance's active moiety.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/SubmittedManufacturedItem" }, "name": "SubmittedManufacturedItem", "description": "Details around the actual item, i.e tablet, solution, etc. that is packaged as part of the medicinal product.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/SubmittedMedicinalPackaging" }, "name": "SubmittedMedicinalPackaging", "description": "Details around the packaging of submitted medicinal products.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/SubmittedMedicinalProduct" }, "name": "SubmittedMedicinalProduct", "description": "A profile that allows for the submission of Medicinal Product information to the FDA.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/SubmittedMedicinalProductIngredient" }, "name": "SubmittedMedicinalProductIngredient", "description": "Details around the ingredients of a submitted medicinal product.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "StructureDefinition:resource" } ], "reference": { "reference": "StructureDefinition/SubmittedMedicinalProductMarketing" }, "name": "SubmittedMedicinalProductMarketing", "description": "Details around the marketing of a submitted medicinal product.", "isExample": false, "groupingId": "ProductSubmission" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Bundle" } ], "reference": { "reference": "Bundle/TestEstablishmentRegistration" }, "name": "TestEstablishmentRegistration", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/EstablishmentRegistrationBundle" ] }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Composition" } ], "reference": { "reference": "Composition/EnbrelSyringeLabelComposition" }, "name": "These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. <br/>\n <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", "description": "Header information for the Enbrel Syringe Labels", "isExample": true, "profile": [ "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument" ], "groupingId": "EnbrelLabel" }, { "extension": [ { "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information", "valueString": "Composition" } ], "reference": { "reference": "Composition/LantusInjectionLabelComposition" }, "name": "These highlights do not include all the information needed to use LANTUS safely and effectively. 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