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-additional-info-extension | Version: 1.1.6 | |||
Active as of 2024-09-22 | 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):
Usage info
Usage:
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
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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" | |
value[x] | 0..1 | markdown | Value of extension | |
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
Snapshot View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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" | |
value[x] | 0..1 | markdown | Value of extension | |
Documentation for this format |
Other representations of profile: CSV, Excel, Schematron
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() |