| Name | Flags | Card. | Type |
Description & Constraints
|
|---|---|---|---|---|
ProductSubmissionDocument
|
Element |
Product Submission Document Logical Model This logical model cannot be the target of a reference |
||
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..* | SubmittedMedication |
Section Product Information |
|
|
subsection
|
0..* | See section |
subsection |
|
|
Documentation for this format
|
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