description: This profile extends DEU_ePIL_Composition with detailed QRD validation rules and diGItal project-specific chapter extensions. It provides strict validation for EMA chapters 1-6 plus extensible additional chapters. package_name: acs.ig.epi.pl.deu derivation: constraint name: DEU_ePIL_Extended_QRD_template_de type: Composition elements: language: pattern: {type: Code, value: de} index: 0 section: index: 1 slicing: rules: closed ordered: true discriminator: - {path: code.coding.code, type: value} min: null slices: QRD-200000029894-PACKUNGSBEILAGE: match: code: coding: {code: '200000029894'} schema: _required: true index: 2 elements: title: {index: 3} code: elements: coding: elements: code: pattern: {type: Code, value: '200000029894'} index: 4 section: array: true min: 6 index: 5 slicing: rules: closed ordered: true discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: 6 slices: QRD-200000029895-1--Was-ist-X-und-wofür-wird-es-angewendet: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029895'} schema: _required: true index: 6 elements: title: {index: 7} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 8 code: pattern: {type: Code, value: '200000029895'} index: 9 section: index: 10 slicing: rules: closed ordered: false discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: null slices: QRD-200000029895-Blanksubsections: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000044346'} schema: array: true index: 11 elements: title: {index: 12} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 13 code: pattern: {type: Code, value: '200000044346'} index: 14 required: [title] required: [title] QRD-200000029896-2--Was-sollten-Sie-vor-der-Einnahme-Anwendung-von-X-beachten: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029896'} schema: _required: true index: 15 elements: title: {index: 16} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 17 code: pattern: {type: Code, value: '200000029896'} index: 18 section: array: true min: 5 index: 19 slicing: rules: closed ordered: false discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: 5 slices: QRD-200000029903-Verkehrstüchtigkeit-und-Fähigkeit-zum-Bedienen-von-Maschinen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029903'} schema: _required: true index: 48 elements: title: {index: 49} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 50 code: pattern: {type: Code, value: '200000029903'} index: 51 required: [title] QRD-200000029899-Kinder-und-Jugendliche: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029899'} schema: index: 32 elements: title: {index: 33} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 34 code: pattern: {type: Code, value: '200000029899'} index: 35 required: [title] QRD-200000029902-Schwangerschaft---Stillzeit-und-Fortpflanzungsfähigkeit: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029902'} schema: _required: true index: 44 elements: title: {index: 45} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 46 code: pattern: {type: Code, value: '200000029902'} index: 47 required: [title] QRD-200000029896-Blanksubsections: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000044346'} schema: array: true index: 20 elements: title: {index: 21} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 22 code: pattern: {type: Code, value: '200000044346'} index: 23 required: [title] QRD-200000029898-Warnhinweise-und-Vorsichtsmaßnahmen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029898'} schema: _required: true index: 28 elements: title: {index: 29} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 30 code: pattern: {type: Code, value: '200000029898'} index: 31 required: [title] QRD-200000029897-Nehmen-wenden-Sie-X-nicht-an-ein: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029897'} schema: _required: true index: 24 elements: title: {index: 25} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 26 code: pattern: {type: Code, value: '200000029897'} index: 27 required: [title] QRD-200000029904-X-enthält-benennen-Sie-den-sonstigen-Bestandteil: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029904'} schema: index: 52 elements: title: {index: 53} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 54 code: pattern: {type: Code, value: '200000029904'} index: 55 required: [title] QRD-200000029900-Einnahme-Anwendung-von-X-zusammen-mit-anderen-Arzneimitteln: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029900'} schema: _required: true index: 36 elements: title: {index: 37} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 38 code: pattern: {type: Code, value: '200000029900'} index: 39 required: [title] QRD-200000029901-X-zusammen-mit-Nahrungsmitteln---Getränken-und-Alkohol: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029901'} schema: index: 40 elements: title: {index: 41} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 42 code: pattern: {type: Code, value: '200000029901'} index: 43 required: [title] required: [title] QRD-200000029905-3--Wie-ist-X-einzunehmen-anzuwenden: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029905'} schema: _required: true index: 56 elements: title: {index: 57} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 58 code: pattern: {type: Code, value: '200000029905'} index: 59 section: index: 60 slicing: rules: closed ordered: false discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: null slices: QRD-200000029905-Blanksubsections: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000044346'} schema: array: true index: 61 elements: title: {index: 62} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 63 code: pattern: {type: Code, value: '200000044346'} index: 64 required: [title] QRD-200000029906-Anwendung-bei-Kindern-und-Jugendlichen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029906'} schema: index: 65 elements: title: {index: 66} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 67 code: pattern: {type: Code, value: '200000029906'} index: 68 required: [title] QRD-200000029907-Wenn-Sie-eine-größere-Menge-von-X-eingenommen-angewendet-haben--als-Sie-sollten: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029907'} schema: index: 69 elements: title: {index: 70} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 71 code: pattern: {type: Code, value: '200000029907'} index: 72 required: [title] QRD-200000029908-Wenn-Sie-die-Einnahme-Anwendung-von-X-vergessen-haben: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029908'} schema: index: 73 elements: title: {index: 74} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 75 code: pattern: {type: Code, value: '200000029908'} index: 76 required: [title] QRD-200000029909-Wenn-Sie-die-Einnahme-Anwendung-von-X-abbrechen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029909'} schema: index: 77 elements: title: {index: 78} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 79 code: pattern: {type: Code, value: '200000029909'} index: 80 required: [title] required: [title] QRD-200000029910-4--Welche-Nebenwirkungen-sind-möglich: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029910'} schema: _required: true index: 81 elements: title: {index: 82} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 83 code: pattern: {type: Code, value: '200000029910'} index: 84 section: index: 85 slicing: rules: closed ordered: false discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: null slices: QRD-200000029910-Blanksubsections: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000044346'} schema: array: true index: 86 elements: title: {index: 87} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 88 code: pattern: {type: Code, value: '200000044346'} index: 89 required: [title] QRD-200000029911-Zusätzliche-Nebenwirkungen-bei-Kindern-und-Jugendlichen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029911'} schema: index: 90 elements: title: {index: 91} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 92 code: pattern: {type: Code, value: '200000029911'} index: 93 required: [title] QRD-200000029912-Meldung-von-Nebenwirkungen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029912'} schema: index: 94 elements: title: {index: 95} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 96 code: pattern: {type: Code, value: '200000029912'} index: 97 required: [title] required: [title] QRD-200000029913-5--Wie-ist-X-aufzubewahren: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029913'} schema: _required: true index: 98 elements: title: {index: 99} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 100 code: pattern: {type: Code, value: '200000029913'} index: 101 section: index: 102 slicing: rules: closed ordered: false discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: null slices: QRD-200000029913-Blanksubsections: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000044346'} schema: array: true index: 103 elements: title: {index: 104} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 105 code: pattern: {type: Code, value: '200000044346'} index: 106 required: [title] required: [title] QRD-200000029914-6--Inhalt-der-Packung-und-weitere-Informationen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029914'} schema: _required: true index: 107 elements: title: {index: 108} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 109 code: pattern: {type: Code, value: '200000029914'} index: 110 section: array: true min: 4 index: 111 slicing: rules: closed ordered: false discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: 4 slices: QRD-200000029914-Blanksubsections: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000044346'} schema: array: true index: 112 elements: title: {index: 113} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 114 code: pattern: {type: Code, value: '200000044346'} index: 115 required: [title] QRD-200000029915-Was-X-enthält: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029915'} schema: _required: true index: 116 elements: title: {index: 117} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 118 code: pattern: {type: Code, value: '200000029915'} index: 119 required: [title] QRD-200000029916-Wie-X-aussieht-und-Inhalt-der-Packung: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029916'} schema: _required: true index: 120 elements: title: {index: 121} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 122 code: pattern: {type: Code, value: '200000029916'} index: 123 required: [title] QRD-200000029917-Pharmazeutischer-Unternehmer-und-Hersteller: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029917'} schema: _required: true index: 124 elements: title: {index: 125} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 126 code: pattern: {type: Code, value: '200000029917'} index: 127 required: [title] QRD-200000029919-Diese-Packungsbeilage-wurde-zuletzt-überarbeitet-im-MM-JJJJ-Monat-JJJJ-: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029919'} schema: _required: true index: 128 elements: title: {index: 129} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 130 code: pattern: {type: Code, value: '200000029919'} index: 131 required: [title] QRD-200000029920-Weitere-Informationsquellen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029920'} schema: index: 132 elements: title: {index: 133} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 134 code: pattern: {type: Code, value: '200000029920'} index: 135 required: [title] QRD-200000029921-Die-folgenden-Informationen-sind-für-medizinisches-Fachpersonal-bestimmt: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029921'} schema: index: 136 elements: title: {index: 137} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 138 code: pattern: {type: Code, value: '200000029921'} index: 139 required: [title] required: [title] ACS-usage-instructions: match: code: coding: {system: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem', code: usage-instructions} schema: index: 140 elements: title: {index: 141} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 142 code: pattern: {type: Code, value: usage-instructions} index: 143 section: index: 144 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: array: true index: 145 elements: title: {index: 146} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 147 code: pattern: {type: Code, value: subsection} index: 148 required: [title] required: [title] 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: array: true index: 149 elements: title: {index: 150} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 151 code: pattern: {type: Code, value: additional-chapter} index: 152 section: index: 153 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: array: true index: 154 elements: title: {index: 155} code: elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 156 code: pattern: {type: Code, value: subsection} index: 157 required: [title] required: [title] required: [title] package_version: 0.3.0 class: profile kind: resource url: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Extended-QRD-template-de base: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Composition version: 0.3.0