Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference | Version: 2.0.0 | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: LiteralCodeableReference | ||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.62 | ||||
An abstract profile to ensure the reference portion of a codeable reference is used, and that the reference is a literal reference to some resource in a bundle
Usages:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  CodeableReference |
0..* | CodeableReference | This is an abstract profile. Reference to a resource or a concept | |
  reference |
SΣ | 1..1 | LiteralReference() {b} | Reference to a resource (by instance) |
| 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()) |
This structure is derived from CodeableReference
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| CodeableReference |
CodeableReference | This is an abstract profile. | ||
| reference |
S | 1..1 | LiteralReference() {b} | Reference to a resource (by instance) |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| CodeableReference |
0..* | CodeableReference | This is an abstract profile. Reference to a resource or a concept | |
  id |
0..1 | id | Unique id for inter-element referencing | |
 extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
 concept |
Σ | 0..1 | CodeableConcept | Reference to a concept (by class) |
| reference |
SΣ | 1..1 | LiteralReference() {b} | Reference to a resource (by instance) |
| 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() |
This structure is derived from CodeableReference
Summary
Mandatory: 1 element
Must-Support: 1 element
Structures
This structure refers to these other structures:
Maturity: 2
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| CodeableReference |
0..* | CodeableReference | This is an abstract profile. Reference to a resource or a concept | |
| reference |
SΣ | 1..1 | LiteralReference() {b} | Reference to a resource (by instance) |
| 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()) |
Differential View
This structure is derived from CodeableReference
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| CodeableReference |
CodeableReference | This is an abstract profile. | ||
| reference |
S | 1..1 | LiteralReference() {b} | Reference to a resource (by instance) |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| CodeableReference |
0..* | CodeableReference | This is an abstract profile. Reference to a resource or a concept | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| concept |
Σ | 0..1 | CodeableConcept | Reference to a concept (by class) |
| reference |
SΣ | 1..1 | LiteralReference() {b} | Reference to a resource (by instance) |
| 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() |
This structure is derived from CodeableReference
Summary
Mandatory: 1 element
Must-Support: 1 element
Structures
This structure refers to these other structures:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0 based on FHIR 5.0.0. Generated 2025-06-19
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