description: The fields needed to represent the Substance Nomenclature and Structure to be included under the 3.2.S.1 heading of the eCTD. References Sponsor Organization. package_name: hl7.fhir.us.pq-cmc-fda derivation: constraint name: EctdComposition32S10 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.1, system: 'http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use', display: General Information} index: 2 author: type: Reference mustSupport: true refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization'] index: 3 title: {mustSupport: true, index: 4} section: mustSupport: true index: 5 elements: title: {mustSupport: true, index: 6} entry: type: Reference mustSupport: true refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure'] index: 7 required: [entry, title] package_version: 2.0.0-ballot class: profile kind: resource url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s10 base: http://hl7.org/fhir/StructureDefinition/Composition version: 2.0.0-ballot required: [section]