SPL Mapping FHIR R5 Implementation Guide
0.2.5 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.5 - Build CI
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 0.2.5 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
| Official URL: http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel | Version: 0.2.5 | |||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: ProductSubmissionDocumentLogicalModel | ||
A document that contains information about a product being submitted for approval to the FDA.
The following UML diagram shows the data elements of a Product Submission Document. More details about the data elements can be found in the definition tables below.
A Product Submission is done as a Document with metadata about the document such as:
The body of the document is broken into sections (which can have sub-sections) where each section corresponds to a logical grouping of information about the product. Each section has the following information:
It also has human readable text (or a set of human readable highlights). One of the sections may also have detailed information about the submitted product.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ProductSubmissionDocumentLogicalModel |
0..* | Element | Elements defined in Ancestors:@id, extension Product Submission Document Logical Model ele-1: All FHIR elements must have a @value or children | |
  @id |
0..1 | string | Unique id for inter-element referencing | |
 extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| 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 ele-1: All FHIR elements must have a @value or children | |
 @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| dunsNumber |
1..1 | string | Product Labeler DUNS Number | |
| name |
1..1 | string | Product Labeler Name | |
 registrant |
0..1 | BackboneElement | Product Labeler Registrant ele-1: All FHIR elements must have a @value or children | |
 @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| dunsNumber |
1..1 | string | Registrant DUNS Number | |
| name |
1..1 | string | Registrant Name | |
| establishment |
1..* | BackboneElement | Product Establishment ele-1: All FHIR elements must have a @value or children | |
| @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| dunsNumber |
1..1 | string | Establishment DUNS Number | |
| name |
1..1 | string | Establishment Name | |
| businessOperation |
1..* | BackboneElement | Establishment Business Operations ele-1: All FHIR elements must have a @value or children | |
| @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| code |
1..1 | CodeableConcept | Business Operation Type | |
 productNDC |
0..1 | CodeableConcept | Business Operation Product NDC | |
| relatedDocument |
0..* | BackboneElement | Reference to Related Document ele-1: All FHIR elements must have a @value or children | |
| @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| 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 ele-1: All FHIR elements must have a @value or children | |
| @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| 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 ele-1: All FHIR elements must have a @value or children | |
| @id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| name |
1..1 | string | Image Title | |
| reference |
1..1 | url | Image Reference | |
 product |
0..* | SubmittedMedicationLogicalModel | Section Product Information | |
| subsection |
0..* | See section | subsection | |
| Documentation for this format | ||||
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.5 based on FHIR 5.0.0. Generated 2025-02-27
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