description: The fields needed to represent the Substance Control of Materials to be included under the eCTD 3.2.S.2.3 heading. References Sponsor Organization and Drug Substance Materials.
package_name: hl7.fhir.us.pq-cmc-fda
derivation: constraint
name: EctdComposition32S23
type: Composition
elements:
  identifier: {mustSupport: true, index: 0}
  status:
    pattern: {type: Code, value: final}
    index: 1
  type:
    pattern:
      type: CodeableConcept
      value:
        coding:
        - {code: ich_3.2.s.2.3, system: 'http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use', display: Control of Materials}
    index: 2
  subject:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance']
    index: 3
  author:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization']
    index: 4
  title: {mustSupport: true, index: 5}
  section:
    mustSupport: true
    index: 6
    elements:
      entry:
        type: Reference
        mustSupport: true
        refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification']
        index: 7
    required: [entry]
package_version: 2.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23
base: http://hl7.org/fhir/StructureDefinition/Composition
version: 2.0.0-ballot
required: [section, subject]