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 1.1.6 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/pq-specification-status-extension | Version: 1.1.6 | |||
Active as of 2024-09-22 | Computable Name: SpecificationStatusExtension | |||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.54 |
A classification of the regulatory status of the specification.
Context of Use
This extension may be used on the following element(s):
Usage info
Usage:
Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.
This structure is derived from Extension
This structure is derived from Extension
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | Specification Status | |
extension | 0..0 | |||
url | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension" | |
value[x] | S | 1..1 | CodeableConcept | Specification Stutus Binding: Specification Status Terminology (required) |
Documentation for this format |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | Specification Status | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension" | |
value[x] | S | 1..1 | CodeableConcept | Specification Stutus Binding: Specification Status Terminology (required) |
Documentation for this format |
This structure is derived from Extension
Differential View
This structure is derived from Extension
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | Specification Status | |
extension | 0..0 | |||
url | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension" | |
value[x] | S | 1..1 | CodeableConcept | Specification Stutus Binding: Specification Status Terminology (required) |
Documentation for this format |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | Specification Status | |
id | 0..1 | id | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension" | |
value[x] | S | 1..1 | CodeableConcept | Specification Stutus Binding: Specification Status Terminology (required) |
Documentation for this format |
Other representations of profile: CSV, Excel, Schematron
Path | Conformance | ValueSet | URI |
Extension.value[x] | required | PqcmcSpecificationStatusTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology from this IG |
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() |