Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Extension: Specification Type

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension Version: 1.0.0-ballot
Active as of 2024-04-08 Computable Name: SpecificationTypeExtension
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.21

A classification of specification related to the kind of the entity it is referencing.

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 specification related to the kind of the entity it is referencing.

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Specification Type
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension"
... value[x] S 1..1 CodeableConcept Specification Type
Binding: Specification Type Terminology (required)

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Specification Type
... 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-type-extension"

doco Documentation for this format

This structure is derived from Extension

Summary

Simple Extension of type CodeableConcept: A classification of specification related to the kind of the entity it is referencing.

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Specification Type
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension"
... value[x] S 1..1 CodeableConcept Specification Type
Binding: Specification Type Terminology (required)

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Specification Type
... 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-type-extension"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.value[x]requiredPqcmcSpecificationTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-type-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()