Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan United States of America flag

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-ballot 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

Extension: Specification Status

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension Version: 2.0.0-ballot
Active as of 2024-12-04 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):

  • Element ID PlanDefinition

Usage info

Usage:

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

Summary

Simple Extension of type CodeableConcept: A classification of the regulatory status of the specification.

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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)

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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"

doco Documentation for this format

This structure is derived from Extension

Summary

Simple Extension of type CodeableConcept: A classification of the regulatory status of the specification.

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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)

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.value[x]requiredPqcmcSpecificationStatusTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()