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: Additional Information

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension Version: 2.0.0-ballot
Active as of 2024-12-04 Computable Name: AditionalInformationExtension
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.14

Any additional information that that the submitter wishes to provide to the FDA that is not structured in the IG. The content of the information submitted via Additional Information may be analyzed at some point in the future, to identify candidate elements for structuring in future iterations of the IG.

Context of Use

This extension may be used on the following element(s):

  • Element ID ManufacturedItemDefinition.component.constituent
  • Element ID PlanDefinition
  • Element ID PlanDefinition.goal

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 markdown: Any additional information that that the submitter wishes to provide to the FDA that is not structured in the IG. The content of the information submitted via Additional Information may be analyzed at some point in the future, to identify candidate elements for structuring in future iterations of the IG.

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Additional Information
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension"
... value[x] 0..1 markdown Value of extension

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Additional Information
... 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-additional-info-extension"

doco Documentation for this format

This structure is derived from Extension

Summary

Simple Extension of type markdown: Any additional information that that the submitter wishes to provide to the FDA that is not structured in the IG. The content of the information submitted via Additional Information may be analyzed at some point in the future, to identify candidate elements for structuring in future iterations of the IG.

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Additional Information
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension"
... value[x] 0..1 markdown Value of extension

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Additional Information
... 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-additional-info-extension"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

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()