description: Definition for a document bundle with the CMC eCTD SP4151 profiles.
package_name: hl7.fhir.us.pq-cmc-fda
derivation: constraint
name: CMCeCTDDocumentSP4151
type: Bundle
elements:
  identifier: {mustSupport: true, index: 0}
  type:
    short: document
    mustSupport: true
    pattern: {type: Code, value: document}
    index: 1
  timestamp: {mustSupport: true, index: 2}
  entry:
    mustSupport: true
    array: true
    min: 3
    index: 3
    elements:
      fullUrl: {mustSupport: true, index: 4}
      resource: {mustSupport: true, index: 5}
    required: [resource, fullUrl]
    slicing:
      rules: open
      description: The specific bundle entries that are needed for a Substance Characterisation document.
      discriminator:
      - {path: resource, type: profile}
      min: 3
      slices:
        Composition:
          match: {}
          schema:
            _required: true
            index: 6
            elements:
              resource: {type: Composition, index: 7}
        Organization:
          match: {}
          schema:
            array: true
            min: 1
            _required: true
            index: 8
            elements:
              resource: {type: Organization, index: 9}
        Specification:
          match: {}
          schema:
            _required: true
            index: 10
            elements:
              resource: {type: PlanDefinition, index: 11}
        RoutineSubstance:
          match: {}
          schema:
            index: 12
            elements:
              resource: {type: SubstanceDefinition, index: 13}
        RoutineProduct:
          match: {}
          schema:
            index: 14
            elements:
              resource: {type: MedicinalProductDefinition, index: 15}
        ExcipientRaw:
          match: {}
          schema:
            index: 16
            elements:
              resource: {type: SubstanceDefinition, index: 17}
package_version: 2.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151
base: http://hl7.org/fhir/StructureDefinition/Bundle
version: 2.0.0-ballot
required: [timestamp]