| Package | hl7.fhir.us.spl |
| Type | ImplementationGuide |
| Id | Id |
| FHIR Version | R4B |
| 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 | 0.1.0 |
| Status | active |
| Date | 2024-07-22T19:21:23+00:00 |
| Name | FHIR_SPL |
| Title | SPL Mapping FHIR Implementation Guide |
| Experimental | False |
| Realm | us |
| Authority | hl7 |
| Description | A guide that provides mapping from the FDA SPL Documents to FHIR Resources and operations. |
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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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"valueString" : "Composition"
}
],
"reference" : {
"reference" : "Composition/AllopurinolTabletLabelComposition"
},
"name" : "Allopurinol<br/>Tablets USP<br/>Revised:�February 2015<br/>Rx only��������<br/>",
"description" : "Header information for the Allopurinol Tablet USP Label",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "SubstanceDefinition"
}
],
"reference" : {
"reference" : "SubstanceDefinition/AllopurinolIngredientDefinition"
},
"name" : "AllopurinolIngredientDefinition",
"description" : "Active Ingredient Information for Allupurinol USP",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedIngredientDefinition",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "RegulatedAuthorization"
}
],
"reference" : {
"reference" : "RegulatedAuthorization/AllopurinolMarketing"
},
"name" : "AllopurinolMarketing",
"description" : "Marketing information for Allopurinol USP",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ManufacturedItemDefinition"
}
],
"reference" : {
"reference" : "ManufacturedItemDefinition/AllopurinolTablet"
},
"name" : "AllopurinolTablet",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Bundle"
}
],
"reference" : {
"reference" : "Bundle/AllopurinolTabletLabelBundle"
},
"name" : "AllopurinolTabletLabelBundle",
"description" : "A bundle containing all of the information for the Allopurinol Tablet USP Label",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionBundle",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Ingredient"
}
],
"reference" : {
"reference" : "Ingredient/AllopurinolUSPActiveIngredient"
},
"name" : "AllopurinolUSPActiveIngredient",
"description" : "Active Ingredient Strength for Allupurinol USP",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicinalProductDefinition"
}
],
"reference" : {
"reference" : "MedicinalProductDefinition/AllopurinolUSPDefinition"
},
"name" : "AllopurinolUSPDefinition",
"description" : "Structured information for the Allopurinol Tablet USP Label",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Ingredient"
}
],
"reference" : {
"reference" : "Ingredient/AllopurinolUSPIngredient1"
},
"name" : "AllopurinolUSPIngredient1",
"description" : "Inactive Ingredient #1 for Allopurinol USP",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Ingredient"
}
],
"reference" : {
"reference" : "Ingredient/AllopurinolUSPIngredient2"
},
"name" : "AllopurinolUSPIngredient2",
"description" : "Inactive Ingredient #2 for Allopurinol USP",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Ingredient"
}
],
"reference" : {
"reference" : "Ingredient/AllopurinolUSPIngredient3"
},
"name" : "AllopurinolUSPIngredient3",
"description" : "Inactive Ingredient #3 for Allopurinol USP",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Ingredient"
}
],
"reference" : {
"reference" : "Ingredient/AllopurinolUSPIngredient4"
},
"name" : "AllopurinolUSPIngredient4",
"description" : "Inactive Ingredient #4 for Allopurinol USP",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Ingredient"
}
],
"reference" : {
"reference" : "Ingredient/AllopurinolUSPIngredient5"
},
"name" : "AllopurinolUSPIngredient5",
"description" : "Inactive Ingredient #5 for Allopurinol USP",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Ingredient"
}
],
"reference" : {
"reference" : "Ingredient/AllopurinolUSPIngredient6"
},
"name" : "AllopurinolUSPIngredient6",
"description" : "Inactive Ingredient #6 for Allopurinol USP",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient",
"groupingId" : "AllopurinolLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/valueset-businessOperationQualifiers"
},
"name" : "Business Operation Qualifiers",
"description" : "Codes that give further information about an organization's business operation.",
"exampleBoolean" : false
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/DualSubmissionProvenance"
},
"name" : "DualSubmissionProvenance",
"description" : "A profile that links changes made to a FHIR system either via a converted SPL document or that are sent to a SPL system",
"exampleBoolean" : false,
"groupingId" : "DualSubmission"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicinalProductDefinition"
}
],
"reference" : {
"reference" : "MedicinalProductDefinition/Enbrel010Definition"
},
"name" : "Enbrel010Definition",
"description" : "Structured information for the Enbrel 010 Label",
"exampleCanonical" : "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/Enbrel010Marketing"
},
"name" : "Enbrel010Marketing",
"description" : "Marketing information for Enbrel 010",
"exampleCanonical" : "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/Enbrel010Package"
},
"name" : "Enbrel010Package",
"description" : "4 0.5mL syringes of Enbrel",
"exampleCanonical" : "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/Enbrel021Definition"
},
"name" : "Enbrel021Definition",
"description" : "Structured information for the Enbrel 021 Label",
"exampleCanonical" : "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/Enbrel021Marketing"
},
"name" : "Enbrel021Marketing",
"description" : "Marketing information for Enbrel 021",
"exampleCanonical" : "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/Enbrel021Package"
},
"name" : "Enbrel021Package",
"description" : "4 1mL Syringes of Enbrel",
"exampleCanonical" : "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/Enbrel032Definition"
},
"name" : "Enbrel032Definition",
"description" : "Structured information for the Enbrel 032 Label",
"exampleCanonical" : "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/Enbrel032Marketing"
},
"name" : "Enbrel032Marketing",
"description" : "Marketing information for Enbrel 032",
"exampleCanonical" : "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/Enbrel032Package"
},
"name" : "Enbrel032Package",
"description" : "4 1mL autoinjectors of Enbrel",
"exampleCanonical" : "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/Enbrel044Definition"
},
"name" : "Enbrel044Definition",
"description" : "Structured information for the Enbrel 044 Label",
"exampleCanonical" : "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/Enbrel044Marketing"
},
"name" : "Enbrel044Marketing",
"description" : "Marketing information for Enbrel 044",
"exampleCanonical" : "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/Enbrel044Package"
},
"name" : "Enbrel044Package",
"description" : "4 1mL cartridges of Enbrel",
"exampleCanonical" : "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/Enbrel055Definition"
},
"name" : "Enbrel055Definition",
"description" : "Structured information for the Enbrel 055 Label",
"exampleCanonical" : "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/Enbrel055Marketing"
},
"name" : "Enbrel055Marketing",
"description" : "Marketing information for Enbrel 055",
"exampleCanonical" : "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/Enbrel055Package"
},
"name" : "Enbrel055Package",
"description" : "4 0.5mL syringes of Enbrel",
"exampleCanonical" : "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/Enbrel25mgSolution"
},
"name" : "Enbrel25mgSolution",
"exampleCanonical" : "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/Enbrel25mgSolutionActiveIngredient"
},
"name" : "Enbrel25mgSolutionActiveIngredient",
"description" : "Active Ingredient Strength for Enbrel",
"exampleCanonical" : "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/Enbrel25mgSolutionIngredient1"
},
"name" : "Enbrel25mgSolutionIngredient1",
"description" : "Inactive Ingredient #1 for Enbrel 25mg Solution",
"exampleCanonical" : "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/Enbrel25mgSolutionIngredient2"
},
"name" : "Enbrel25mgSolutionIngredient2",
"description" : "Inactive Ingredient #2 for Enbrel 25mg Solution",
"exampleCanonical" : "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/Enbrel25mgSolutionIngredient3"
},
"name" : "Enbrel25mgSolutionIngredient3",
"description" : "Inactive Ingredient #3 for Enbrel 25mg Solution",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductIngredient",
"groupingId" : "EnbrelLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicinalProductDefinition"
}
],
"reference" : {
"reference" : "MedicinalProductDefinition/Enbrel425Definition"
},
"name" : "Enbrel425Definition",
"description" : "Structured information for the Enbrel 425 Label",
"exampleCanonical" : "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/Enbrel425Marketing"
},
"name" : "Enbrel425Marketing",
"description" : "Marketing information for Enbrel 425",
"exampleCanonical" : "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/Enbrel425Package"
},
"name" : "Enbrel425Package",
"description" : "4 25mg kits of Enbrel",
"exampleCanonical" : "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/Enbrel425Part1Definition"
},
"name" : "Enbrel425Part1Definition",
"description" : "Structured information for the Enbrel 425 Part 1",
"exampleCanonical" : "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",
"exampleCanonical" : "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/Enbrel425Part1Package"
},
"name" : "Enbrel425Part1Package",
"description" : "1 vial of Enbrel powder",
"exampleCanonical" : "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/Enbrel425Part2Definition"
},
"name" : "Enbrel425Part2Definition",
"description" : "Structured information for the Enbrel 425 Part 2",
"exampleCanonical" : "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/Enbrel425Part2Marketing"
},
"name" : "Enbrel425Part2Marketing",
"description" : "Marketing information for Enbrel 425 Part 2",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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 Estabishment Inactivation Request.",
"exampleBoolean" : 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",
"exampleBoolean" : 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.",
"exampleBoolean" : 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",
"exampleBoolean" : 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.",
"exampleBoolean" : 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",
"exampleBoolean" : false,
"groupingId" : "OperationMessages"
},
{
"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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/DualSubmissionProvenance"
},
{
"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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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",
"exampleBoolean" : 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.",
"exampleBoolean" : 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",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleCanonical" : "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.",
"exampleBoolean" : 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",
"exampleCanonical" : "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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : false,
"groupingId" : "LabelerRequest"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Ingredient"
}
],
"reference" : {
"reference" : "Ingredient/LantusActiveIngredient"
},
"name" : "LantusActiveIngredient",
"description" : "Active Ingredient Strength for Lantus",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : false,
"groupingId" : "LogicalModel"
},
{
"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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : false,
"groupingId" : "OperationMessages"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/valueset-organizationSubmissionMessageTypes"
},
"name" : "Organzation Submission Message Types",
"description" : "The set of message types that are allowed as a FHIR organization submission.",
"exampleBoolean" : false
},
{
"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.",
"exampleBoolean" : 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 Establishment Registration message",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : false,
"groupingId" : "ProductSubmission"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "SearchParameter"
}
],
"reference" : {
"reference" : "SearchParameter/ProvenanceActivitySearchParameter"
},
"name" : "ProvenanceActivitySearchParameter",
"description" : "A search parameter to allow searching for Provenance records by activity type.",
"exampleBoolean" : false
},
{
"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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/GDUFAFacilityInactivationMessage"
},
{
"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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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.",
"exampleCanonical" : "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",
"exampleCanonical" : "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.",
"exampleCanonical" : "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",
"exampleCanonical" : "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.",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/LabelerOrganization"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Organization"
}
],
"reference" : {
"reference" : "Organization/SampleLabelerUSAgent"
},
"name" : "SampleLabelerUSAgent",
"description" : "An example of a US Agent Organization.",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/USAgentOrganization"
},
{
"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",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/USAgentAffiliation"
},
{
"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.",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/OutOfBusinessBundle"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MessageHeader"
}
],
"reference" : {
"reference" : "MessageHeader/SamplOutOfBusinessMessage"
},
"name" : "SamplOutOfBusinessMessage",
"description" : "An example of a message header for an Out of Business notification",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/OutOfBusinessMessage"
},
{
"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",
"exampleCanonical" : "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",
"exampleCanonical" : "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",
"exampleCanonical" : "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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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)",
"exampleBoolean" : 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)",
"exampleBoolean" : 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",
"exampleBoolean" : 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)",
"exampleBoolean" : 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)",
"exampleBoolean" : 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)",
"exampleBoolean" : 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",
"exampleBoolean" : 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",
"exampleBoolean" : 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)",
"exampleBoolean" : 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.",
"exampleBoolean" : 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)",
"exampleBoolean" : 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.",
"exampleBoolean" : false
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes"
},
"name" : "SPL Product Characteristic Types ValueSet",
"description" : "Codes that identify the types of characteristics allowed for Submitted Medicinal Product.",
"exampleBoolean" : 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)",
"exampleBoolean" : 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",
"exampleBoolean" : 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)",
"exampleBoolean" : 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)",
"exampleBoolean" : 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.",
"exampleBoolean" : 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",
"exampleBoolean" : 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.",
"exampleBoolean" : false,
"groupingId" : "DualSubmission"
},
{
"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.",
"exampleBoolean" : false,
"groupingId" : "DualSubmission"
},
{
"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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : 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.",
"exampleBoolean" : false,
"groupingId" : "ProductSubmission"
},
{
"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",
"exampleCanonical" : "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. See full prescribing information for LANTUS. <br/>\n <br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000",
"description" : "Header information for the Lantus Injection Label",
"exampleCanonical" : "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument",
"groupingId" : "LantusLabel"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ValueSet"
}
],
"reference" : {
"reference" : "ValueSet/valueset-topLevelOrganizationTypes"
},
"name" : "Top-Level Organization Types",
"description" : "Codes that identify organizations that are considered top-level",
"exampleBoolean" : false
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/USAgentAffiliation"
},
"name" : "USAgentAffiliation",
"description" : "A profile that associates an organization to its US Agent.",
"exampleBoolean" : false,
"groupingId" : "GeneralOrganization"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:resource"
}
],
"reference" : {
"reference" : "StructureDefinition/USAgentOrganization"
},
"name" : "USAgentOrganization",
"description" : "A profile for the data elements required for an organization fulfilling the role of a US Agent for another organization.",
"exampleBoolean" : false,
"groupingId" : "GeneralOrganization"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/versionNumber"
},
"name" : "VersionNumber",
"description" : "Adding a version number to documents.",
"exampleBoolean" : false,
"groupingId" : "ProductSubmission"
}
],
"page" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "informative"
}
],
"nameUrl" : "toc.html",
"title" : "Table of Contents",
"generation" : "html",
"page" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "informative"
}
],
"nameUrl" : "index.html",
"title" : "SPL Mapping Implementation Guide Home Page",
"generation" : "markdown"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "informative"
}
],
"nameUrl" : "organization.html",
"title" : "Organziation-Based Use Cases",
"generation" : "markdown"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "informative"
}
],
"nameUrl" : "druglabel.html",
"title" : "Submit a Drug Label",
"generation" : "markdown"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "informative"
}
],
"nameUrl" : "howtolabel.html",
"title" : "How to Create a FHIR Drug Label",
"generation" : "markdown"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "informative"
}
],
"nameUrl" : "transforms.html",
"title" : "SPL / FHIR Transforms",
"generation" : "markdown"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "informative"
}
],
"nameUrl" : "downloads.html",
"title" : "Downloads",
"generation" : "markdown"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "informative"
}
],
"nameUrl" : "credits.html",
"title" : "Credits",
"generation" : "markdown"
}
]
},
"parameter" : [
{
"code" : "path-resource",
"value" : "input/capabilities"
},
{
"code" : "path-resource",
"value" : "input/examples"
},
{
"code" : "path-resource",
"value" : "input/extensions"
},
{
"code" : "path-resource",
"value" : "input/models"
},
{
"code" : "path-resource",
"value" : "input/operations"
},
{
"code" : "path-resource",
"value" : "input/profiles"
},
{
"code" : "path-resource",
"value" : "input/resources"
},
{
"code" : "path-resource",
"value" : "input/vocabulary"
},
{
"code" : "path-resource",
"value" : "input/maps"
},
{
"code" : "path-resource",
"value" : "input/testing"
},
{
"code" : "path-resource",
"value" : "input/history"
},
{
"code" : "path-resource",
"value" : "fsh-generated/resources"
},
{
"code" : "path-pages",
"value" : "template/config"
},
{
"code" : "path-pages",
"value" : "input/images"
},
{
"code" : "path-tx-cache",
"value" : "input-cache/txcache"
}
]
}
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.