description: Abstract base profile for Product Information Leaflet (PIL) documents. Defines the two root sections (QRD + Localized Sections), MAH extension, and shared metadata. Cannot be used directly — use eAAPI or eCAPI child profiles. package_name: acs.ig.epi.pl.deu derivation: constraint name: DEU_ePIL_Composition abstract: true type: Composition elements: extension: index: 0 slicing: rules: open ordered: false discriminator: - {path: url, type: value} min: 1 slices: mahOrganization: match: {url: null} schema: {type: Extension, short: Marketing Authorisation Holder (MAH), url: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-MAH-Organization', index: 1} min: 1 max: 1 deviceImage: match: {url: null} schema: {type: Extension, short: Device image for header display, url: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Device-Image', index: 2} min: 0 max: 1 identifier: {short: Unique ID for each individual ePIl version, index: 3} version: {short: Semantic version of the ePIL document, index: 4} type: short: Type of EPI document is Product Information Leaflet (PIL) index: 5 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/100000155531'} index: 6 code: pattern: {type: Code, value: '100000155538'} index: 7 required: [system, code] author: type: Reference short: Author of the ePIL document mustSupport: true refers: ['http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Organization'] index: 8 title: {short: Name of the ePIl, index: 9} section: short: Level 1 section heading for the whole EPI index: 10 elements: section: type: BackboneElement short: Nested sub-section headings for level 2 index: 11 elements: code: index: 12 elements: coding: index: 13 elements: system: {index: 14} code: {index: 15} required: [system, code] required: [coding] section: type: BackboneElement short: Nested sub-section headings for level 3. index: 16 elements: code: index: 17 elements: coding: index: 18 elements: system: {index: 19} code: {index: 20} required: [system, code] required: [coding] required: [code] required: [code] required: [section] slicing: rules: closed ordered: true discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: 1 slices: QRD-200000029894-PACKUNGSBEILAGE: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029894'} schema: _required: true index: 21 elements: code: index: 22 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 23 code: pattern: {type: Code, value: '200000029894'} index: 24 required: [system, code] section: {index: 25} required: [section, code] ACS-localized-sections: match: code: coding: {system: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem', code: localized-sections} schema: index: 26 elements: title: {index: 27} code: index: 28 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 29 code: pattern: {type: Code, value: localized-sections} index: 30 required: [system, code] section: index: 31 slicing: rules: closed ordered: false discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: 1 slices: ACS-general-notification: match: code: coding: {system: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem', code: general-notification} schema: type: BackboneElement index: 32 elements: title: {index: 33} code: index: 34 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 35 code: pattern: {type: Code, value: general-notification} index: 36 required: [system, code] required: [title, code] ACS-education-material: match: code: coding: {system: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem', code: education-material} schema: type: BackboneElement index: 37 elements: title: {index: 38} code: index: 39 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 40 code: pattern: {type: Code, value: education-material} index: 41 required: [system, code] section: index: 42 slicing: rules: closed ordered: false discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: null slices: ACS-generic-subsection: match: code: coding: {system: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem', code: subsection} schema: type: BackboneElement array: true index: 43 elements: title: {index: 44} code: index: 45 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 46 code: pattern: {type: Code, value: subsection} index: 47 required: [system, code] required: [title, code] required: [title, code] ACS-additional-chapter: match: code: coding: {system: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem', code: additional-chapter} schema: type: BackboneElement array: true index: 48 elements: title: {index: 49} code: index: 50 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 51 code: pattern: {type: Code, value: additional-chapter} index: 52 required: [system, code] section: index: 53 slicing: rules: closed ordered: false discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: null slices: ACS-generic-subsection: match: code: coding: {system: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem', code: subsection} schema: type: BackboneElement array: true index: 54 elements: title: {index: 55} code: index: 56 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 57 code: pattern: {type: Code, value: subsection} index: 58 required: [system, code] required: [title, code] required: [title, code] required: [section, title, code] package_version: 0.5.0 extensions: mahOrganization: {url: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-MAH-Organization', min: 1, max: 1, type: Extension, short: Marketing Authorisation Holder (MAH), index: 1} deviceImage: {url: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Device-Image', min: 0, max: 1, type: Extension, short: Device image for header display, index: 2} class: profile kind: resource url: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Composition base: http://hl7.org/fhir/StructureDefinition/Composition version: 0.5.0 required: [extension, section]