SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
Page standards status: Trial-use | Maturity Level: 1 |
Definitions for the ProductSubmissionDocumentLogicalModel logical model.
Guidance on how to interpret the contents of this table can be found here
0. ProductSubmissionDocument | |
Definition | A document that contains information about a product being submitted for approval to the FDA. |
Short | Product Submission Document Logical Model |
Logical Model | Instances of this logical model are not marked to be the target of a Reference |
2. ProductSubmissionDocument.identifier | |
Definition | A unique identifier of this specific Product Submission document. |
Short | Document Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
4. ProductSubmissionDocument.splVersion | |
Definition | A date reference to the SPL version being used for this document. |
Short | Document SPL Version |
Control | 1..1 |
Type | date |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
6. ProductSubmissionDocument.submissionIdentifier | |
Definition | A unique identifier of the submission that remains constant across all versions/revisions of this document. |
Short | Submission Identifier |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
8. ProductSubmissionDocument.versionNumber | |
Definition | An integer that provides a sequence to the versions of the submission document. |
Short | Document Version Number |
Control | 1..1 |
Type | positiveInt |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
10. ProductSubmissionDocument.type | |
Definition | A LOINC code that provides inforamtion on the Product Submission type. |
Short | Document Type |
Control | 1..1 |
Type | CodeableConcept |
12. ProductSubmissionDocument.title | |
Definition | The title for the document. |
Short | Document Title |
Control | 0..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
14. ProductSubmissionDocument.labeler | |
Definition | Information about the labeler organization that authored the document. |
Short | Product Labeler |
Control | 1..1 |
Type | BackboneElement |
16. ProductSubmissionDocument.labeler.dunsNumber | |
Definition | The Duns & Broadstreet number for the labeler organization. |
Short | Product Labeler DUNS Number |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
18. ProductSubmissionDocument.labeler.name | |
Definition | The name of the labeler organization. |
Short | Product Labeler Name |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
20. ProductSubmissionDocument.labeler.registrant | |
Definition | Information about the registrant organization associated with the labeler. |
Short | Product Labeler Registrant |
Control | 0..1 |
Type | BackboneElement |
22. ProductSubmissionDocument.labeler.registrant.dunsNumber | |
Definition | The Duns & Broadstreet number for the registrant organization. |
Short | Registrant DUNS Number |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
24. ProductSubmissionDocument.labeler.registrant.name | |
Definition | The name of the registrant organization. |
Short | Registrant Name |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
26. ProductSubmissionDocument.labeler.registrant.establishment | |
Definition | Information about the establishment organization associated with active or new marketed products. |
Short | Product Establishment |
Control | 1..* |
Type | BackboneElement |
28. ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber | |
Definition | The Duns & Broadstreet number for the establishment organization. |
Short | Establishment DUNS Number |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
30. ProductSubmissionDocument.labeler.registrant.establishment.name | |
Definition | The name of the establishment organization. |
Short | Establishment Name |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
32. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation | |
Definition | Various business operations that the Establishment organization performs. |
Short | Establishment Business Operations |
Control | 1..* |
Type | BackboneElement |
34. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code | |
Definition | A code representing the specific business operation that the Establishment organization can perform. |
Short | Business Operation Type |
Control | 1..1 |
Type | CodeableConcept |
36. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC | |
Definition | The NDC code of the specific product that this business operation is about. |
Short | Business Operation Product NDC |
Control | 0..1 |
Type | CodeableConcept |
38. ProductSubmissionDocument.relatedDocument | |
Definition | Reference to other documents that contain relevant information about this product submission. |
Short | Reference to Related Document |
Control | 0..* |
Type | BackboneElement |
40. ProductSubmissionDocument.relatedDocument.identifier | |
Definition | A unique identifier of this related document. |
Short | Related Document Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
42. ProductSubmissionDocument.relatedDocument.submissionIdentifier | |
Definition | A unique identifier of the submission of this related document. |
Short | Related Document Submission Identifier |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
44. ProductSubmissionDocument.relatedDocument.versionNumber | |
Definition | An integer that provides a sequence to the versions of the related document. |
Short | Related Document Version Number |
Control | 1..1 |
Type | positiveInt |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
46. ProductSubmissionDocument.section | |
Definition | A logical grouping of Product Submission information. |
Short | Document Sections |
Control | 1..* |
Type | BackboneElement |
48. ProductSubmissionDocument.section.identifier | |
Definition | An identifier for this section that can be used to reference it in the document. |
Short | Section Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
50. ProductSubmissionDocument.section.effectiveTime | |
Definition | The date when this section was authored. |
Short | Section Effective Time |
Control | 1..1 |
Type | date |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
52. ProductSubmissionDocument.section.type | |
Definition | A code that identifies the content conveyed in this section. |
Short | Section Type |
Control | 1..1 |
Type | CodeableConcept |
54. ProductSubmissionDocument.section.title | |
Definition | A header for the content contained in this section. |
Short | Section Title |
Control | 0..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
56. ProductSubmissionDocument.section.text | |
Definition | The human readable content of this section. |
Short | Section Text |
Control | 0..1 |
Type | xhtml |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
58. ProductSubmissionDocument.section.highlights | |
Definition | Content that is not a complete rendering of the information in this section. |
Short | Section Text Highlights |
Control | 0..1 |
Type | xhtml |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
60. ProductSubmissionDocument.section.image | |
Definition | References to images that are used in the human readable content of this section. |
Short | Section Images |
Control | 0..* |
Type | BackboneElement |
62. ProductSubmissionDocument.section.image.name | |
Definition | Title of the image. |
Short | Image Title |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
64. ProductSubmissionDocument.section.image.reference | |
Definition | Reference, either local or remote, to the image data. |
Short | Image Reference |
Control | 1..1 |
Type | url |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
66. ProductSubmissionDocument.section.product | |
Definition | The complete definition of a medication being submitted in this document. |
Short | Section Product Information |
Control | 0..* |
Type | http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel |
68. ProductSubmissionDocument.section.subsection | |
Definition | subsection |
Short | subsection |
Control | 0..* |
Type | Seettp://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel#ProductSubmissionDocument.section |
Guidance on how to interpret the contents of this table can be found here
0. ProductSubmissionDocument | |
Definition | A document that contains information about a product being submitted for approval to the FDA. Base definition for all elements in a resource. |
Short | Product Submission Document Logical ModelBase for all elements |
Control | 0..* |
Is Modifier | false |
Logical Model | Instances of this logical model are not marked to be the target of a Reference |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
2. ProductSubmissionDocument.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
4. ProductSubmissionDocument.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
6. ProductSubmissionDocument.identifier | |
Definition | A unique identifier of this specific Product Submission document. |
Short | Document Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
8. ProductSubmissionDocument.splVersion | |
Definition | A date reference to the SPL version being used for this document. |
Short | Document SPL Version |
Control | 1..1 |
Type | date |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
10. ProductSubmissionDocument.submissionIdentifier | |
Definition | A unique identifier of the submission that remains constant across all versions/revisions of this document. |
Short | Submission Identifier |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
12. ProductSubmissionDocument.versionNumber | |
Definition | An integer that provides a sequence to the versions of the submission document. |
Short | Document Version Number |
Control | 1..1 |
Type | positiveInt |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
14. ProductSubmissionDocument.type | |
Definition | A LOINC code that provides inforamtion on the Product Submission type. |
Short | Document Type |
Control | 1..1 |
Type | CodeableConcept |
16. ProductSubmissionDocument.title | |
Definition | The title for the document. |
Short | Document Title |
Control | 0..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
18. ProductSubmissionDocument.labeler | |
Definition | Information about the labeler organization that authored the document. |
Short | Product Labeler |
Control | 1..1 |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
20. ProductSubmissionDocument.labeler.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | idstring |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
22. ProductSubmissionDocument.labeler.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.labeler.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
24. ProductSubmissionDocument.labeler.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
26. ProductSubmissionDocument.labeler.dunsNumber | |
Definition | The Duns & Broadstreet number for the labeler organization. |
Short | Product Labeler DUNS Number |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
28. ProductSubmissionDocument.labeler.name | |
Definition | The name of the labeler organization. |
Short | Product Labeler Name |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
30. ProductSubmissionDocument.labeler.registrant | |
Definition | Information about the registrant organization associated with the labeler. |
Short | Product Labeler Registrant |
Control | 0..1 |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
32. ProductSubmissionDocument.labeler.registrant.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | idstring |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
34. ProductSubmissionDocument.labeler.registrant.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.labeler.registrant.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
36. ProductSubmissionDocument.labeler.registrant.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
38. ProductSubmissionDocument.labeler.registrant.dunsNumber | |
Definition | The Duns & Broadstreet number for the registrant organization. |
Short | Registrant DUNS Number |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
40. ProductSubmissionDocument.labeler.registrant.name | |
Definition | The name of the registrant organization. |
Short | Registrant Name |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
42. ProductSubmissionDocument.labeler.registrant.establishment | |
Definition | Information about the establishment organization associated with active or new marketed products. |
Short | Product Establishment |
Control | 1..* |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
44. ProductSubmissionDocument.labeler.registrant.establishment.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | idstring |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
46. ProductSubmissionDocument.labeler.registrant.establishment.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.labeler.registrant.establishment.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
48. ProductSubmissionDocument.labeler.registrant.establishment.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
50. ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber | |
Definition | The Duns & Broadstreet number for the establishment organization. |
Short | Establishment DUNS Number |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
52. ProductSubmissionDocument.labeler.registrant.establishment.name | |
Definition | The name of the establishment organization. |
Short | Establishment Name |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
54. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation | |
Definition | Various business operations that the Establishment organization performs. |
Short | Establishment Business Operations |
Control | 1..* |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
56. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | idstring |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
58. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
60. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
62. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code | |
Definition | A code representing the specific business operation that the Establishment organization can perform. |
Short | Business Operation Type |
Control | 1..1 |
Type | CodeableConcept |
64. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC | |
Definition | The NDC code of the specific product that this business operation is about. |
Short | Business Operation Product NDC |
Control | 0..1 |
Type | CodeableConcept |
66. ProductSubmissionDocument.relatedDocument | |
Definition | Reference to other documents that contain relevant information about this product submission. |
Short | Reference to Related Document |
Control | 0..* |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
68. ProductSubmissionDocument.relatedDocument.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | idstring |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
70. ProductSubmissionDocument.relatedDocument.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.relatedDocument.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
72. ProductSubmissionDocument.relatedDocument.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
74. ProductSubmissionDocument.relatedDocument.identifier | |
Definition | A unique identifier of this related document. |
Short | Related Document Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
76. ProductSubmissionDocument.relatedDocument.submissionIdentifier | |
Definition | A unique identifier of the submission of this related document. |
Short | Related Document Submission Identifier |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
78. ProductSubmissionDocument.relatedDocument.versionNumber | |
Definition | An integer that provides a sequence to the versions of the related document. |
Short | Related Document Version Number |
Control | 1..1 |
Type | positiveInt |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
80. ProductSubmissionDocument.section | |
Definition | A logical grouping of Product Submission information. |
Short | Document Sections |
Control | 1..* |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
82. ProductSubmissionDocument.section.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | idstring |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
84. ProductSubmissionDocument.section.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.section.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
86. ProductSubmissionDocument.section.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
88. ProductSubmissionDocument.section.identifier | |
Definition | An identifier for this section that can be used to reference it in the document. |
Short | Section Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
90. ProductSubmissionDocument.section.effectiveTime | |
Definition | The date when this section was authored. |
Short | Section Effective Time |
Control | 1..1 |
Type | date |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
92. ProductSubmissionDocument.section.type | |
Definition | A code that identifies the content conveyed in this section. |
Short | Section Type |
Control | 1..1 |
Type | CodeableConcept |
94. ProductSubmissionDocument.section.title | |
Definition | A header for the content contained in this section. |
Short | Section Title |
Control | 0..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
96. ProductSubmissionDocument.section.text | |
Definition | The human readable content of this section. |
Short | Section Text |
Control | 0..1 |
Type | xhtml |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
98. ProductSubmissionDocument.section.highlights | |
Definition | Content that is not a complete rendering of the information in this section. |
Short | Section Text Highlights |
Control | 0..1 |
Type | xhtml |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
100. ProductSubmissionDocument.section.image | |
Definition | References to images that are used in the human readable content of this section. |
Short | Section Images |
Control | 0..* |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
102. ProductSubmissionDocument.section.image.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | idstring |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
104. ProductSubmissionDocument.section.image.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.section.image.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
106. ProductSubmissionDocument.section.image.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
108. ProductSubmissionDocument.section.image.name | |
Definition | Title of the image. |
Short | Image Title |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
110. ProductSubmissionDocument.section.image.reference | |
Definition | Reference, either local or remote, to the image data. |
Short | Image Reference |
Control | 1..1 |
Type | url |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
112. ProductSubmissionDocument.section.product | |
Definition | The complete definition of a medication being submitted in this document. |
Short | Section Product Information |
Control | 0..* |
Type | http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel |
114. ProductSubmissionDocument.section.subsection | |
Definition | subsection |
Short | subsection |
Control | 0..* |
Type | Seettp://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel#ProductSubmissionDocument.section |
Guidance on how to interpret the contents of this table can be found here
0. ProductSubmissionDocument | |
Definition | A document that contains information about a product being submitted for approval to the FDA. |
Short | Product Submission Document Logical Model |
Control | 0..* |
Is Modifier | false |
Logical Model | Instances of this logical model are not marked to be the target of a Reference |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
2. ProductSubmissionDocument.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
4. ProductSubmissionDocument.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
6. ProductSubmissionDocument.identifier | |
Definition | A unique identifier of this specific Product Submission document. |
Short | Document Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
8. ProductSubmissionDocument.splVersion | |
Definition | A date reference to the SPL version being used for this document. |
Short | Document SPL Version |
Control | 1..1 |
Type | date |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
10. ProductSubmissionDocument.submissionIdentifier | |
Definition | A unique identifier of the submission that remains constant across all versions/revisions of this document. |
Short | Submission Identifier |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
12. ProductSubmissionDocument.versionNumber | |
Definition | An integer that provides a sequence to the versions of the submission document. |
Short | Document Version Number |
Control | 1..1 |
Type | positiveInt |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
14. ProductSubmissionDocument.type | |
Definition | A LOINC code that provides inforamtion on the Product Submission type. |
Short | Document Type |
Control | 1..1 |
Type | CodeableConcept |
16. ProductSubmissionDocument.title | |
Definition | The title for the document. |
Short | Document Title |
Control | 0..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
18. ProductSubmissionDocument.labeler | |
Definition | Information about the labeler organization that authored the document. |
Short | Product Labeler |
Control | 1..1 |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
20. ProductSubmissionDocument.labeler.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
22. ProductSubmissionDocument.labeler.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.labeler.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
24. ProductSubmissionDocument.labeler.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
26. ProductSubmissionDocument.labeler.dunsNumber | |
Definition | The Duns & Broadstreet number for the labeler organization. |
Short | Product Labeler DUNS Number |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
28. ProductSubmissionDocument.labeler.name | |
Definition | The name of the labeler organization. |
Short | Product Labeler Name |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
30. ProductSubmissionDocument.labeler.registrant | |
Definition | Information about the registrant organization associated with the labeler. |
Short | Product Labeler Registrant |
Control | 0..1 |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
32. ProductSubmissionDocument.labeler.registrant.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
34. ProductSubmissionDocument.labeler.registrant.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.labeler.registrant.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
36. ProductSubmissionDocument.labeler.registrant.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
38. ProductSubmissionDocument.labeler.registrant.dunsNumber | |
Definition | The Duns & Broadstreet number for the registrant organization. |
Short | Registrant DUNS Number |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
40. ProductSubmissionDocument.labeler.registrant.name | |
Definition | The name of the registrant organization. |
Short | Registrant Name |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
42. ProductSubmissionDocument.labeler.registrant.establishment | |
Definition | Information about the establishment organization associated with active or new marketed products. |
Short | Product Establishment |
Control | 1..* |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
44. ProductSubmissionDocument.labeler.registrant.establishment.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
46. ProductSubmissionDocument.labeler.registrant.establishment.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.labeler.registrant.establishment.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
48. ProductSubmissionDocument.labeler.registrant.establishment.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
50. ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber | |
Definition | The Duns & Broadstreet number for the establishment organization. |
Short | Establishment DUNS Number |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
52. ProductSubmissionDocument.labeler.registrant.establishment.name | |
Definition | The name of the establishment organization. |
Short | Establishment Name |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
54. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation | |
Definition | Various business operations that the Establishment organization performs. |
Short | Establishment Business Operations |
Control | 1..* |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
56. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
58. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
60. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
62. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code | |
Definition | A code representing the specific business operation that the Establishment organization can perform. |
Short | Business Operation Type |
Control | 1..1 |
Type | CodeableConcept |
64. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC | |
Definition | The NDC code of the specific product that this business operation is about. |
Short | Business Operation Product NDC |
Control | 0..1 |
Type | CodeableConcept |
66. ProductSubmissionDocument.relatedDocument | |
Definition | Reference to other documents that contain relevant information about this product submission. |
Short | Reference to Related Document |
Control | 0..* |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
68. ProductSubmissionDocument.relatedDocument.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
70. ProductSubmissionDocument.relatedDocument.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.relatedDocument.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
72. ProductSubmissionDocument.relatedDocument.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
74. ProductSubmissionDocument.relatedDocument.identifier | |
Definition | A unique identifier of this related document. |
Short | Related Document Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
76. ProductSubmissionDocument.relatedDocument.submissionIdentifier | |
Definition | A unique identifier of the submission of this related document. |
Short | Related Document Submission Identifier |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
78. ProductSubmissionDocument.relatedDocument.versionNumber | |
Definition | An integer that provides a sequence to the versions of the related document. |
Short | Related Document Version Number |
Control | 1..1 |
Type | positiveInt |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
80. ProductSubmissionDocument.section | |
Definition | A logical grouping of Product Submission information. |
Short | Document Sections |
Control | 1..* |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
82. ProductSubmissionDocument.section.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
84. ProductSubmissionDocument.section.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.section.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
86. ProductSubmissionDocument.section.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
88. ProductSubmissionDocument.section.identifier | |
Definition | An identifier for this section that can be used to reference it in the document. |
Short | Section Identifier |
Note | This is a business identifier, not a resource identifier (see discussion) |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
90. ProductSubmissionDocument.section.effectiveTime | |
Definition | The date when this section was authored. |
Short | Section Effective Time |
Control | 1..1 |
Type | date |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
92. ProductSubmissionDocument.section.type | |
Definition | A code that identifies the content conveyed in this section. |
Short | Section Type |
Control | 1..1 |
Type | CodeableConcept |
94. ProductSubmissionDocument.section.title | |
Definition | A header for the content contained in this section. |
Short | Section Title |
Control | 0..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
96. ProductSubmissionDocument.section.text | |
Definition | The human readable content of this section. |
Short | Section Text |
Control | 0..1 |
Type | xhtml |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
98. ProductSubmissionDocument.section.highlights | |
Definition | Content that is not a complete rendering of the information in this section. |
Short | Section Text Highlights |
Control | 0..1 |
Type | xhtml |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
100. ProductSubmissionDocument.section.image | |
Definition | References to images that are used in the human readable content of this section. |
Short | Section Images |
Control | 0..* |
Type | BackboneElement |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
102. ProductSubmissionDocument.section.image.id | |
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
Short | Unique id for inter-element referencing |
Control | 0..1 This element is affected by the following invariants: ele-1 |
Type | id |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
104. ProductSubmissionDocument.section.image.extension | |
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. |
Short | Additional content defined by implementations |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | false |
Summary | false |
Alternate Names | extensions, user content |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
Slicing | This element introduces a set of slices on ProductSubmissionDocument.section.image.extension . The slices areUnordered and Open, and can be differentiated using the following discriminators: |
106. ProductSubmissionDocument.section.image.modifierExtension | |
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. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
Short | Extensions that cannot be ignored even if unrecognized |
Comments | 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. |
Control | 0..* |
Type | Extension |
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
Summary | true |
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. |
Alternate Names | extensions, user content, modifiers |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) )ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists() ) |
108. ProductSubmissionDocument.section.image.name | |
Definition | Title of the image. |
Short | Image Title |
Control | 1..1 |
Type | string |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
110. ProductSubmissionDocument.section.image.reference | |
Definition | Reference, either local or remote, to the image data. |
Short | Image Reference |
Control | 1..1 |
Type | url |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
112. ProductSubmissionDocument.section.product | |
Definition | The complete definition of a medication being submitted in this document. |
Short | Section Product Information |
Control | 0..* |
Type | http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel |
114. ProductSubmissionDocument.section.subsection | |
Definition | subsection |
Short | subsection |
Control | 0..* |
Type | Seettp://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel#ProductSubmissionDocument.section |