| Package | hl7.fhir.us.spl |
| Type | StructureDefinition |
| Id | ProductSubmissionDocumentLogicalModel |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/us/spl/https://build.fhir.org/ig/HL7/fhir-spl/StructureDefinition-ProductSubmissionDocumentLogicalModel.html |
| URL | http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel |
| Version | 0.2.8 |
| Status | active |
| Date | 2025-07-07T15:17:39+00:00 |
| Name | ProductSubmissionDocumentLogicalModel |
| Title | Product Submission Document Logical Model |
| Realm | us |
| Authority | hl7 |
| Description | A document that contains information about a product being submitted for approval to the FDA. |
| Type | http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel |
| Kind | logical |
No resources found
| StructureDefinition | |
| SubmittedMedicationLogicalModel | Submitted Medication Logical Model |
Note: links and images are rebased to the (stated) source
Generated Narrative: StructureDefinition ProductSubmissionDocumentLogicalModel
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ProductSubmissionDocumentLogicalModel | 0..* | Element | Elements defined in Ancestors:@id, extension Product Submission Document Logical Model | |
  identifier | 1..1 | string | Document Identifier | |
| splVersion | 1..1 | date | Document SPL Version | |
| submissionIdentifier | 1..1 | string | Submission Identifier | |
| versionNumber | 1..1 | positiveInt | Document Version Number | |
 type | 1..1 | CodeableConcept | Document Type | |
| title | 0..1 | string | Document Title | |
| labeler | 1..1 | BackboneElement | Product Labeler | |
 dunsNumber | 1..1 | string | Product Labeler DUNS Number | |
| name | 1..1 | string | Product Labeler Name | |
 registrant | 0..1 | BackboneElement | Product Labeler Registrant | |
 dunsNumber | 1..1 | string | Registrant DUNS Number | |
| name | 1..1 | string | Registrant Name | |
| establishment | 1..* | BackboneElement | Product Establishment | |
| dunsNumber | 1..1 | string | Establishment DUNS Number | |
| name | 1..1 | string | Establishment Name | |
| businessOperation | 1..* | BackboneElement | Establishment Business Operations | |
| code | 1..1 | CodeableConcept | Business Operation Type | |
| productNDC | 0..1 | CodeableConcept | Business Operation Product NDC | |
| relatedDocument | 0..* | BackboneElement | Reference to Related Document | |
| identifier | 1..1 | string | Related Document Identifier | |
| submissionIdentifier | 1..1 | string | Related Document Submission Identifier | |
| versionNumber | 1..1 | positiveInt | Related Document Version Number | |
| section | 1..* | BackboneElement | Document Sections | |
| identifier | 1..1 | string | Section Identifier | |
| effectiveTime | 1..1 | date | Section Effective Time | |
| type | 1..1 | CodeableConcept | Section Type | |
| title | 0..1 | string | Section Title | |
| text | 0..1 | xhtml | Section Text | |
| highlights | 0..1 | xhtml | Section Text Highlights | |
| image | 0..* | BackboneElement | Section Images | |
| name | 1..1 | string | Image Title | |
| reference | 1..1 | url | Image Reference | |
 product | 0..* | SubmittedMedicationLogicalModel | Section Product Information | |
| subsection | 0..* | See section | subsection | |
| Documentation for this format | ||||
FHIR{
"resourceType": "StructureDefinition",
"id": "ProductSubmissionDocumentLogicalModel",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 1,
"_valueInteger": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"
}
]
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use",
"_valueCode": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"
}
]
}
}
],
"url": "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel",
"version": "0.2.8",
"name": "ProductSubmissionDocumentLogicalModel",
"title": "Product Submission Document Logical Model",
"status": "active",
"date": "2025-07-07T15:17:39+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"contact": [
{
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim"
}
]
}
],
"description": "A document that contains information about a product being submitted for approval to the FDA.",
"jurisdiction": [
{
"coding": [
{
"system": "urn:iso:std:iso:3166",
"code": "US",
"display": "United States of America"
}
]
}
],
"fhirVersion": "5.0.0",
"mapping": [
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
}
],
"kind": "logical",
"abstract": false,
"type": "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Element",
"derivation": "specialization",
"snapshot": {
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "5.0.0"
}
],
"element": [
{
"id": "ProductSubmissionDocumentLogicalModel",
"path": "ProductSubmissionDocumentLogicalModel",
"short": "Product Submission Document Logical Model",
"definition": "A document that contains information about a product being submitted for approval to the FDA.",
"min": 0,
"max": "*",
"base": {
"path": "Element",
"min": 0,
"max": "*"
},
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.id",
"path": "ProductSubmissionDocumentLogicalModel.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.extension",
"path": "ProductSubmissionDocumentLogicalModel.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.identifier",
"path": "ProductSubmissionDocumentLogicalModel.identifier",
"short": "Document Identifier",
"definition": "A unique identifier of this specific Product Submission document.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.identifier",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.splVersion",
"path": "ProductSubmissionDocumentLogicalModel.splVersion",
"short": "Document SPL Version",
"definition": "A date reference to the SPL version being used for this document.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.splVersion",
"min": 1,
"max": "1"
},
"type": [
{
"code": "date"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.submissionIdentifier",
"path": "ProductSubmissionDocumentLogicalModel.submissionIdentifier",
"short": "Submission Identifier",
"definition": "A unique identifier of the submission that remains constant across all versions/revisions of this document.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.submissionIdentifier",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.versionNumber",
"path": "ProductSubmissionDocumentLogicalModel.versionNumber",
"short": "Document Version Number",
"definition": "An integer that provides a sequence to the versions of the submission document.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.versionNumber",
"min": 1,
"max": "1"
},
"type": [
{
"code": "positiveInt"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.type",
"path": "ProductSubmissionDocumentLogicalModel.type",
"short": "Document Type",
"definition": "A LOINC code that provides inforamtion on the Product Submission type.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.type",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.title",
"path": "ProductSubmissionDocumentLogicalModel.title",
"short": "Document Title",
"definition": "The title for the document.",
"min": 0,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.title",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler",
"path": "ProductSubmissionDocumentLogicalModel.labeler",
"short": "Product Labeler",
"definition": "Information about the labeler organization that authored the document.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler",
"min": 1,
"max": "1"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.id",
"path": "ProductSubmissionDocumentLogicalModel.labeler.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.extension",
"path": "ProductSubmissionDocumentLogicalModel.labeler.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.modifierExtension",
"path": "ProductSubmissionDocumentLogicalModel.labeler.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.dunsNumber",
"path": "ProductSubmissionDocumentLogicalModel.labeler.dunsNumber",
"short": "Product Labeler DUNS Number",
"definition": "The Duns & Broadstreet number for the labeler organization.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.dunsNumber",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.name",
"path": "ProductSubmissionDocumentLogicalModel.labeler.name",
"short": "Product Labeler Name",
"definition": "The name of the labeler organization.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.name",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant",
"short": "Product Labeler Registrant",
"definition": "Information about the registrant organization associated with the labeler.",
"min": 0,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant",
"min": 0,
"max": "1"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.id",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.extension",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.modifierExtension",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.dunsNumber",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.dunsNumber",
"short": "Registrant DUNS Number",
"definition": "The Duns & Broadstreet number for the registrant organization.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.dunsNumber",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.name",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.name",
"short": "Registrant Name",
"definition": "The name of the registrant organization.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.name",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment",
"short": "Product Establishment",
"definition": "Information about the establishment organization associated with active or new marketed products.",
"min": 1,
"max": "*",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment",
"min": 1,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.id",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.extension",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.modifierExtension",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.dunsNumber",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.dunsNumber",
"short": "Establishment DUNS Number",
"definition": "The Duns & Broadstreet number for the establishment organization.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.dunsNumber",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.name",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.name",
"short": "Establishment Name",
"definition": "The name of the establishment organization.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.name",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation",
"short": "Establishment Business Operations",
"definition": "Various business operations that the Establishment organization performs.",
"min": 1,
"max": "*",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation",
"min": 1,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.id",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.extension",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.modifierExtension",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.code",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.code",
"short": "Business Operation Type",
"definition": "A code representing the specific business operation that the Establishment organization can perform.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.code",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.productNDC",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.productNDC",
"short": "Business Operation Product NDC",
"definition": "The NDC code of the specific product that this business operation is about.",
"min": 0,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.productNDC",
"min": 0,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument",
"short": "Reference to Related Document",
"definition": "Reference to other documents that contain relevant information about this product submission.",
"min": 0,
"max": "*",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument",
"min": 0,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument.id",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument.extension",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument.modifierExtension",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument.identifier",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.identifier",
"short": "Related Document Identifier",
"definition": "A unique identifier of this related document.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.identifier",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument.submissionIdentifier",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.submissionIdentifier",
"short": "Related Document Submission Identifier",
"definition": "A unique identifier of the submission of this related document.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.submissionIdentifier",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument.versionNumber",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.versionNumber",
"short": "Related Document Version Number",
"definition": "An integer that provides a sequence to the versions of the related document.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.versionNumber",
"min": 1,
"max": "1"
},
"type": [
{
"code": "positiveInt"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section",
"path": "ProductSubmissionDocumentLogicalModel.section",
"short": "Document Sections",
"definition": "A logical grouping of Product Submission information.",
"min": 1,
"max": "*",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section",
"min": 1,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.id",
"path": "ProductSubmissionDocumentLogicalModel.section.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.extension",
"path": "ProductSubmissionDocumentLogicalModel.section.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.modifierExtension",
"path": "ProductSubmissionDocumentLogicalModel.section.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.identifier",
"path": "ProductSubmissionDocumentLogicalModel.section.identifier",
"short": "Section Identifier",
"definition": "An identifier for this section that can be used to reference it in the document.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.identifier",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.effectiveTime",
"path": "ProductSubmissionDocumentLogicalModel.section.effectiveTime",
"short": "Section Effective Time",
"definition": "The date when this section was authored.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.effectiveTime",
"min": 1,
"max": "1"
},
"type": [
{
"code": "date"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.type",
"path": "ProductSubmissionDocumentLogicalModel.section.type",
"short": "Section Type",
"definition": "A code that identifies the content conveyed in this section.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.type",
"min": 1,
"max": "1"
},
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.title",
"path": "ProductSubmissionDocumentLogicalModel.section.title",
"short": "Section Title",
"definition": "A header for the content contained in this section.",
"min": 0,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.title",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.text",
"path": "ProductSubmissionDocumentLogicalModel.section.text",
"short": "Section Text",
"definition": "The human readable content of this section.",
"min": 0,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.text",
"min": 0,
"max": "1"
},
"type": [
{
"code": "xhtml"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.highlights",
"path": "ProductSubmissionDocumentLogicalModel.section.highlights",
"short": "Section Text Highlights",
"definition": "Content that is not a complete rendering of the information in this section.",
"min": 0,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.highlights",
"min": 0,
"max": "1"
},
"type": [
{
"code": "xhtml"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.image",
"path": "ProductSubmissionDocumentLogicalModel.section.image",
"short": "Section Images",
"definition": "References to images that are used in the human readable content of this section.",
"min": 0,
"max": "*",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.image",
"min": 0,
"max": "*"
},
"type": [
{
"code": "BackboneElement"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.image.id",
"path": "ProductSubmissionDocumentLogicalModel.section.image.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"condition": [
"ele-1"
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.image.extension",
"path": "ProductSubmissionDocumentLogicalModel.section.image.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"alias": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.image.modifierExtension",
"path": "ProductSubmissionDocumentLogicalModel.section.image.modifierExtension",
"short": "Extensions that cannot be ignored even if unrecognized",
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"alias": [
"extensions",
"user content",
"modifiers"
],
"min": 0,
"max": "*",
"base": {
"path": "BackboneElement.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.image.name",
"path": "ProductSubmissionDocumentLogicalModel.section.image.name",
"short": "Image Title",
"definition": "Title of the image.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.image.name",
"min": 1,
"max": "1"
},
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.image.reference",
"path": "ProductSubmissionDocumentLogicalModel.section.image.reference",
"short": "Image Reference",
"definition": "Reference, either local or remote, to the image data.",
"min": 1,
"max": "1",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.image.reference",
"min": 1,
"max": "1"
},
"type": [
{
"code": "url"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.product",
"path": "ProductSubmissionDocumentLogicalModel.section.product",
"short": "Section Product Information",
"definition": "The complete definition of a medication being submitted in this document.",
"min": 0,
"max": "*",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.product",
"min": 0,
"max": "*"
},
"type": [
{
"code": "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.subsection",
"path": "ProductSubmissionDocumentLogicalModel.section.subsection",
"short": "subsection",
"definition": "subsection",
"min": 0,
"max": "*",
"base": {
"path": "ProductSubmissionDocumentLogicalModel.section.subsection",
"min": 0,
"max": "*"
},
"contentReference": "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel#ProductSubmissionDocumentLogicalModel.section",
"type": [
{
"code": "BackboneElement"
}
]
}
]
},
"differential": {
"element": [
{
"id": "ProductSubmissionDocumentLogicalModel",
"path": "ProductSubmissionDocumentLogicalModel",
"short": "Product Submission Document Logical Model",
"definition": "A document that contains information about a product being submitted for approval to the FDA."
},
{
"id": "ProductSubmissionDocumentLogicalModel.identifier",
"path": "ProductSubmissionDocumentLogicalModel.identifier",
"short": "Document Identifier",
"definition": "A unique identifier of this specific Product Submission document.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.splVersion",
"path": "ProductSubmissionDocumentLogicalModel.splVersion",
"short": "Document SPL Version",
"definition": "A date reference to the SPL version being used for this document.",
"min": 1,
"max": "1",
"type": [
{
"code": "date"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.submissionIdentifier",
"path": "ProductSubmissionDocumentLogicalModel.submissionIdentifier",
"short": "Submission Identifier",
"definition": "A unique identifier of the submission that remains constant across all versions/revisions of this document.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.versionNumber",
"path": "ProductSubmissionDocumentLogicalModel.versionNumber",
"short": "Document Version Number",
"definition": "An integer that provides a sequence to the versions of the submission document.",
"min": 1,
"max": "1",
"type": [
{
"code": "positiveInt"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.type",
"path": "ProductSubmissionDocumentLogicalModel.type",
"short": "Document Type",
"definition": "A LOINC code that provides inforamtion on the Product Submission type.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.title",
"path": "ProductSubmissionDocumentLogicalModel.title",
"short": "Document Title",
"definition": "The title for the document.",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler",
"path": "ProductSubmissionDocumentLogicalModel.labeler",
"short": "Product Labeler",
"definition": "Information about the labeler organization that authored the document.",
"min": 1,
"max": "1",
"type": [
{
"code": "BackboneElement"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.dunsNumber",
"path": "ProductSubmissionDocumentLogicalModel.labeler.dunsNumber",
"short": "Product Labeler DUNS Number",
"definition": "The Duns & Broadstreet number for the labeler organization.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.name",
"path": "ProductSubmissionDocumentLogicalModel.labeler.name",
"short": "Product Labeler Name",
"definition": "The name of the labeler organization.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant",
"short": "Product Labeler Registrant",
"definition": "Information about the registrant organization associated with the labeler.",
"min": 0,
"max": "1",
"type": [
{
"code": "BackboneElement"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.dunsNumber",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.dunsNumber",
"short": "Registrant DUNS Number",
"definition": "The Duns & Broadstreet number for the registrant organization.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.name",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.name",
"short": "Registrant Name",
"definition": "The name of the registrant organization.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment",
"short": "Product Establishment",
"definition": "Information about the establishment organization associated with active or new marketed products.",
"min": 1,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.dunsNumber",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.dunsNumber",
"short": "Establishment DUNS Number",
"definition": "The Duns & Broadstreet number for the establishment organization.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.name",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.name",
"short": "Establishment Name",
"definition": "The name of the establishment organization.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation",
"short": "Establishment Business Operations",
"definition": "Various business operations that the Establishment organization performs.",
"min": 1,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.code",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.code",
"short": "Business Operation Type",
"definition": "A code representing the specific business operation that the Establishment organization can perform.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.productNDC",
"path": "ProductSubmissionDocumentLogicalModel.labeler.registrant.establishment.businessOperation.productNDC",
"short": "Business Operation Product NDC",
"definition": "The NDC code of the specific product that this business operation is about.",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument",
"short": "Reference to Related Document",
"definition": "Reference to other documents that contain relevant information about this product submission.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument.identifier",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.identifier",
"short": "Related Document Identifier",
"definition": "A unique identifier of this related document.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument.submissionIdentifier",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.submissionIdentifier",
"short": "Related Document Submission Identifier",
"definition": "A unique identifier of the submission of this related document.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.relatedDocument.versionNumber",
"path": "ProductSubmissionDocumentLogicalModel.relatedDocument.versionNumber",
"short": "Related Document Version Number",
"definition": "An integer that provides a sequence to the versions of the related document.",
"min": 1,
"max": "1",
"type": [
{
"code": "positiveInt"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section",
"path": "ProductSubmissionDocumentLogicalModel.section",
"short": "Document Sections",
"definition": "A logical grouping of Product Submission information.",
"min": 1,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.identifier",
"path": "ProductSubmissionDocumentLogicalModel.section.identifier",
"short": "Section Identifier",
"definition": "An identifier for this section that can be used to reference it in the document.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.effectiveTime",
"path": "ProductSubmissionDocumentLogicalModel.section.effectiveTime",
"short": "Section Effective Time",
"definition": "The date when this section was authored.",
"min": 1,
"max": "1",
"type": [
{
"code": "date"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.type",
"path": "ProductSubmissionDocumentLogicalModel.section.type",
"short": "Section Type",
"definition": "A code that identifies the content conveyed in this section.",
"min": 1,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.title",
"path": "ProductSubmissionDocumentLogicalModel.section.title",
"short": "Section Title",
"definition": "A header for the content contained in this section.",
"min": 0,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.text",
"path": "ProductSubmissionDocumentLogicalModel.section.text",
"short": "Section Text",
"definition": "The human readable content of this section.",
"min": 0,
"max": "1",
"type": [
{
"code": "xhtml"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.highlights",
"path": "ProductSubmissionDocumentLogicalModel.section.highlights",
"short": "Section Text Highlights",
"definition": "Content that is not a complete rendering of the information in this section.",
"min": 0,
"max": "1",
"type": [
{
"code": "xhtml"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.image",
"path": "ProductSubmissionDocumentLogicalModel.section.image",
"short": "Section Images",
"definition": "References to images that are used in the human readable content of this section.",
"min": 0,
"max": "*",
"type": [
{
"code": "BackboneElement"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.image.name",
"path": "ProductSubmissionDocumentLogicalModel.section.image.name",
"short": "Image Title",
"definition": "Title of the image.",
"min": 1,
"max": "1",
"type": [
{
"code": "string"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.image.reference",
"path": "ProductSubmissionDocumentLogicalModel.section.image.reference",
"short": "Image Reference",
"definition": "Reference, either local or remote, to the image data.",
"min": 1,
"max": "1",
"type": [
{
"code": "url"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.product",
"path": "ProductSubmissionDocumentLogicalModel.section.product",
"short": "Section Product Information",
"definition": "The complete definition of a medication being submitted in this document.",
"min": 0,
"max": "*",
"type": [
{
"code": "http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel"
}
]
},
{
"id": "ProductSubmissionDocumentLogicalModel.section.subsection",
"path": "ProductSubmissionDocumentLogicalModel.section.subsection",
"short": "subsection",
"definition": "subsection",
"min": 0,
"max": "*",
"contentReference": "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel#ProductSubmissionDocumentLogicalModel.section",
"type": [
{
"code": "BackboneElement"
}
]
}
]
}
}