description: Concrete input profile for QRD Template Revision 10.4 via eAAPI. Enforces EMA chapters 1-6 with 3-level section depth, plus ACS extensions for instructions-for-use and information-for-hcp. No change detection. package_name: acs.ig.epi.pl.deu derivation: constraint name: DEU_ePIL_QRD_10_4_de_eAAPI type: Composition elements: language: pattern: {type: Code, value: de} index: 0 section: index: 1 slicing: slices: QRD-200000029894-PACKUNGSBEILAGE: match: {} schema: index: 1 elements: title: {index: 2} section: array: true min: 6 index: 3 slicing: rules: closed ordered: true discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: 6 slices: QRD-200000029914-6--Inhalt-der-Packung-und-weitere-Informationen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029914'} schema: type: BackboneElement _required: true index: 129 elements: title: {index: 130} code: index: 131 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 132 code: pattern: {type: Code, value: '200000029914'} index: 133 required: [system, code] section: array: true min: 4 index: 134 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: type: BackboneElement array: true index: 135 elements: title: {index: 136} code: index: 137 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 138 code: pattern: {type: Code, value: '200000044346'} index: 139 required: [system, code] required: [title, code] QRD-200000029915-Was-X-enthält: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029915'} schema: type: BackboneElement _required: true index: 140 elements: title: {index: 141} code: index: 142 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 143 code: pattern: {type: Code, value: '200000029915'} index: 144 required: [system, code] required: [title, code] QRD-200000029916-Wie-X-aussieht-und-Inhalt-der-Packung: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029916'} schema: type: BackboneElement _required: true index: 145 elements: title: {index: 146} code: index: 147 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 148 code: pattern: {type: Code, value: '200000029916'} index: 149 required: [system, code] required: [title, code] QRD-200000029917-Pharmazeutischer-Unternehmer-und-Hersteller: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029917'} schema: type: BackboneElement _required: true index: 150 elements: title: {index: 151} code: index: 152 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 153 code: pattern: {type: Code, value: '200000029917'} index: 154 required: [system, code] required: [title, code] 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: type: BackboneElement _required: true index: 155 elements: title: {index: 156} code: index: 157 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 158 code: pattern: {type: Code, value: '200000029919'} index: 159 required: [system, code] required: [title, code] QRD-200000029920-Weitere-Informationsquellen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029920'} schema: type: BackboneElement index: 160 elements: title: {index: 161} code: index: 162 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 163 code: pattern: {type: Code, value: '200000029920'} index: 164 required: [system, code] required: [title, code] QRD-200000029921-Die-folgenden-Informationen-sind-für-medizinisches-Fachpersonal-bestimmt: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029921'} schema: type: BackboneElement index: 165 elements: title: {index: 166} code: index: 167 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 168 code: pattern: {type: Code, value: '200000029921'} index: 169 required: [system, code] required: [title, code] required: [title, code] QRD-200000029905-3--Wie-ist-X-einzunehmen-anzuwenden: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029905'} schema: type: BackboneElement _required: true index: 66 elements: title: {index: 67} code: index: 68 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 69 code: pattern: {type: Code, value: '200000029905'} index: 70 required: [system, code] section: index: 71 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: type: BackboneElement array: true index: 72 elements: title: {index: 73} code: index: 74 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 75 code: pattern: {type: Code, value: '200000044346'} index: 76 required: [system, code] required: [title, code] QRD-200000029906-Anwendung-bei-Kindern-und-Jugendlichen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029906'} schema: type: BackboneElement index: 77 elements: title: {index: 78} code: index: 79 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 80 code: pattern: {type: Code, value: '200000029906'} index: 81 required: [system, code] required: [title, code] 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: type: BackboneElement index: 82 elements: title: {index: 83} code: index: 84 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 85 code: pattern: {type: Code, value: '200000029907'} index: 86 required: [system, code] required: [title, code] 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: type: BackboneElement index: 87 elements: title: {index: 88} code: index: 89 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 90 code: pattern: {type: Code, value: '200000029908'} index: 91 required: [system, code] required: [title, code] QRD-200000029909-Wenn-Sie-die-Einnahme-Anwendung-von-X-abbrechen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029909'} schema: type: BackboneElement index: 92 elements: title: {index: 93} code: index: 94 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 95 code: pattern: {type: Code, value: '200000029909'} index: 96 required: [system, code] required: [title, code] required: [title, code] ACS-information-for-hcp: match: code: coding: {system: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem', code: information-for-hcp} schema: type: BackboneElement index: 181 elements: title: {index: 182} code: index: 183 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 184 code: pattern: {type: Code, value: information-for-hcp} index: 185 required: [system, code] section: index: 186 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: 187 elements: title: {index: 188} code: index: 189 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 190 code: pattern: {type: Code, value: subsection} index: 191 required: [system, code] required: [title, code] required: [title, code] 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: type: BackboneElement _required: true index: 15 elements: title: {index: 16} code: index: 17 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 18 code: pattern: {type: Code, value: '200000029896'} index: 19 required: [system, code] section: array: true min: 5 index: 20 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: type: BackboneElement _required: true index: 56 elements: title: {index: 57} code: index: 58 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 59 code: pattern: {type: Code, value: '200000029903'} index: 60 required: [system, code] required: [title, code] QRD-200000029899-Kinder-und-Jugendliche: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029899'} schema: type: BackboneElement index: 36 elements: title: {index: 37} code: index: 38 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 39 code: pattern: {type: Code, value: '200000029899'} index: 40 required: [system, code] required: [title, code] QRD-200000029902-Schwangerschaft---Stillzeit-und-Fortpflanzungsfähigkeit: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029902'} schema: type: BackboneElement _required: true index: 51 elements: title: {index: 52} code: index: 53 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 54 code: pattern: {type: Code, value: '200000029902'} index: 55 required: [system, code] required: [title, code] QRD-200000029896-Blanksubsections: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000044346'} schema: type: BackboneElement array: true index: 21 elements: title: {index: 22} code: index: 23 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 24 code: pattern: {type: Code, value: '200000044346'} index: 25 required: [system, code] required: [title, code] QRD-200000029898-Warnhinweise-und-Vorsichtsmaßnahmen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029898'} schema: type: BackboneElement _required: true index: 31 elements: title: {index: 32} code: index: 33 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 34 code: pattern: {type: Code, value: '200000029898'} index: 35 required: [system, code] required: [title, code] QRD-200000029897-Nehmen-wenden-Sie-X-nicht-an-ein: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029897'} schema: type: BackboneElement _required: true index: 26 elements: title: {index: 27} code: index: 28 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 29 code: pattern: {type: Code, value: '200000029897'} index: 30 required: [system, code] required: [title, code] QRD-200000029904-X-enthält-benennen-Sie-den-sonstigen-Bestandteil: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029904'} schema: type: BackboneElement index: 61 elements: title: {index: 62} code: index: 63 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 64 code: pattern: {type: Code, value: '200000029904'} index: 65 required: [system, code] required: [title, code] QRD-200000029900-Einnahme-Anwendung-von-X-zusammen-mit-anderen-Arzneimitteln: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029900'} schema: type: BackboneElement _required: true index: 41 elements: title: {index: 42} code: index: 43 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 44 code: pattern: {type: Code, value: '200000029900'} index: 45 required: [system, code] required: [title, code] QRD-200000029901-X-zusammen-mit-Nahrungsmitteln---Getränken-und-Alkohol: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029901'} schema: type: BackboneElement index: 46 elements: title: {index: 47} code: index: 48 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 49 code: pattern: {type: Code, value: '200000029901'} index: 50 required: [system, code] required: [title, code] required: [title, code] ACS-unclassified-approved-chapter: match: code: coding: {system: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem', code: unclassified-approved-chapter} schema: type: BackboneElement array: true index: 192 elements: title: {index: 193} code: index: 194 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 195 code: pattern: {type: Code, value: unclassified-approved-chapter} index: 196 required: [system, code] section: index: 197 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: 198 elements: title: {index: 199} code: index: 200 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 201 code: pattern: {type: Code, value: subsection} index: 202 required: [system, code] required: [title, code] required: [title, code] ACS-instructions-for-use: match: code: coding: {system: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem', code: instructions-for-use} schema: type: BackboneElement index: 170 elements: title: {index: 171} code: index: 172 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 173 code: pattern: {type: Code, value: instructions-for-use} index: 174 required: [system, code] section: index: 175 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: 176 elements: title: {index: 177} code: index: 178 elements: coding: elements: system: pattern: {type: Uri, value: 'http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Extended-Section-CodeSystem'} index: 179 code: pattern: {type: Code, value: subsection} index: 180 required: [system, code] required: [title, code] required: [title, code] QRD-200000029913-5--Wie-ist-X-aufzubewahren: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029913'} schema: type: BackboneElement _required: true index: 118 elements: title: {index: 119} code: index: 120 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 121 code: pattern: {type: Code, value: '200000029913'} index: 122 required: [system, code] section: index: 123 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: type: BackboneElement array: true index: 124 elements: title: {index: 125} code: index: 126 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 127 code: pattern: {type: Code, value: '200000044346'} index: 128 required: [system, code] required: [title, code] required: [title, code] 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: type: BackboneElement _required: true index: 4 elements: title: {index: 5} code: index: 6 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 7 code: pattern: {type: Code, value: '200000029895'} index: 8 required: [system, code] section: index: 9 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: type: BackboneElement array: true index: 10 elements: title: {index: 11} code: index: 12 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: [system, code] required: [title, code] required: [title, code] QRD-200000029910-4--Welche-Nebenwirkungen-sind-möglich: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029910'} schema: type: BackboneElement _required: true index: 97 elements: title: {index: 98} code: index: 99 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 100 code: pattern: {type: Code, value: '200000029910'} index: 101 required: [system, code] section: index: 102 slicing: rules: closed ordered: false discriminator: - {path: code.coding.system, type: value} - {path: code.coding.code, type: value} min: 1 slices: QRD-200000029910-Blanksubsections: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000044346'} schema: type: BackboneElement array: true index: 103 elements: title: {index: 104} code: index: 105 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 106 code: pattern: {type: Code, value: '200000044346'} index: 107 required: [system, code] required: [title, code] QRD-200000029911-Zusätzliche-Nebenwirkungen-bei-Kindern-und-Jugendlichen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029911'} schema: type: BackboneElement index: 108 elements: title: {index: 109} code: index: 110 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 111 code: pattern: {type: Code, value: '200000029911'} index: 112 required: [system, code] required: [title, code] QRD-200000029912-Meldung-von-Nebenwirkungen: match: code: coding: {system: 'http://ema.europa.eu/fhir/CodeSystem/200000029659', code: '200000029912'} schema: type: BackboneElement _required: true index: 113 elements: title: {index: 114} code: index: 115 elements: coding: elements: system: pattern: {type: Uri, value: 'http://ema.europa.eu/fhir/CodeSystem/200000029659'} index: 116 code: pattern: {type: Code, value: '200000029912'} index: 117 required: [system, code] required: [title, code] required: [section, title, code] required: [title] package_version: 0.7.0 class: profile kind: resource url: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Extended-QRD-10-4-template-de-eAAPI base: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Composition version: 0.7.0