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: section: short: Level 1 section heading for the whole EPI index: 12 elements: section: type: BackboneElement short: Nested sub-section headings for level 2 index: 13 elements: code: index: 14 elements: coding: index: 15 elements: system: {index: 16} code: {index: 17} required: [system, code] required: [coding] section: type: BackboneElement short: Nested sub-section headings for level 3. index: 18 elements: code: index: 19 elements: coding: index: 20 elements: system: {index: 21} code: {index: 22} 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: 23 elements: code: index: 24 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 25 code: pattern: {type: Code, value: '200000029894'} index: 26 required: [system, code] section: {index: 27} 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: 28 elements: title: {index: 29} code: index: 30 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 31 code: pattern: {type: Code, value: localized-sections} index: 32 required: [system, code] section: index: 33 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: 34 elements: title: {index: 35} code: index: 36 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 37 code: pattern: {type: Code, value: general-notification} index: 38 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: 39 elements: title: {index: 40} code: index: 41 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 42 code: pattern: {type: Code, value: education-material} index: 43 required: [system, code] section: index: 44 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: 45 elements: title: {index: 46} code: index: 47 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 48 code: pattern: {type: Code, value: subsection} index: 49 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: 50 elements: title: {index: 51} code: index: 52 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 53 code: pattern: {type: Code, value: additional-chapter} index: 54 required: [system, code] section: index: 55 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: 56 elements: title: {index: 57} code: index: 58 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 59 code: pattern: {type: Code, value: subsection} index: 60 required: [system, code] required: [title, code] required: [title, code] required: [section, title, code] type: short: Type of EPI document is Product Information Leaflet (PIL) index: 6 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/100000155531'} index: 7 code: pattern: {type: Code, value: '100000155538'} index: 8 required: [system, code] title: {short: Name of the ePIl, index: 11} 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: 10 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 status: short: Document status — fixed to 'final' pattern: {type: Code, value: final} index: 5 identifier: {short: Unique ID for each individual ePIl version, index: 3} version: {short: Semantic version of the ePIL document, index: 4} subject: type: Reference short: Product(s) the ePIL is about refers: ['http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition', 'http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition'] index: 9 package_version: 0.7.0 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: 0.7.0 required: [extension, section, subject]