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 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

• Content
• Detailed Descriptions
• XML
• JSON

Extension: Additional Information

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension				Version: 2.0.0
Standards status: Trial-use			Maturity Level: 2	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:

• Use this Extension: Drug Product Batch Formula and Quality Specification
• Examples for this Extension: Bundle/SpecificationSubstanceBundle

Formal Views of Extension Content

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

 

Other representations of profile: CSV, Excel, Schematron

Constraints

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()