description: This profile represents the constraints from QRD rules applied to the Composition resource used in ePI. package_name: ema.qrdvalidation derivation: constraint name: EUQRD_CAP_template_new_Labeling_en type: Composition elements: language: pattern: {type: Code, value: en} index: 0 section: index: 1 slicing: rules: closed ordered: true discriminator: - {path: code, type: value} min: 1 slices: QRD-200000029861-LABELLING: match: code: coding: - {code: '200000029861'} schema: _required: true index: 2 elements: title: {index: 3} code: pattern: type: CodeableConcept value: coding: - {code: '200000029861'} index: 4 section: index: 5 slicing: rules: closed ordered: true discriminator: - {path: code, type: value} min: 1 slices: QRD-200000029862-PARTICULARS-TO-APPEAR-ON-THE-OUTER-PACKAGING-AND-THE-IMMEDIATE-PACKAGING-NATURE-TYPE: match: code: coding: - {code: '200000029862'} schema: type: BackboneElement _required: true index: 6 elements: title: {index: 7} code: pattern: type: CodeableConcept value: coding: - {code: '200000029862'} index: 8 section: array: true min: 18 index: 9 slicing: rules: closed ordered: true discriminator: - {path: code, type: value} min: 18 slices: QRD-200000029874-12--MARKETING-AUTHORISATION-NUMBERS: match: code: coding: - {code: '200000029874'} schema: type: BackboneElement _required: true index: 54 elements: title: {index: 55} code: pattern: type: CodeableConcept value: coding: - {code: '200000029874'} index: 56 section: {index: 57} required: [title, code] QRD-200000029878-16--INFORMATION-IN-BRAILLE: match: code: coding: - {code: '200000029878'} schema: type: BackboneElement _required: true index: 70 elements: title: {index: 71} code: pattern: type: CodeableConcept value: coding: - {code: '200000029878'} index: 72 section: {index: 73} required: [title, code] QRD-200000029880-18--UNIQUE-IDENTIFIER---HUMAN-READABLE-DATA: match: code: coding: - {code: '200000029880'} schema: type: BackboneElement _required: true index: 78 elements: title: {index: 79} code: pattern: type: CodeableConcept value: coding: - {code: '200000029880'} index: 80 section: {index: 81} required: [title, code] QRD-200000029864-2--STATEMENT-OF-ACTIVE-SUBSTANCES: match: code: coding: - {code: '200000029864'} schema: type: BackboneElement _required: true index: 14 elements: title: {index: 15} code: pattern: type: CodeableConcept value: coding: - {code: '200000029864'} index: 16 section: {index: 17} required: [title, code] QRD-200000029876-14--GENERAL-CLASSIFICATION-FOR-SUPPLY: match: code: coding: - {code: '200000029876'} schema: type: BackboneElement _required: true index: 62 elements: title: {index: 63} code: pattern: type: CodeableConcept value: coding: - {code: '200000029876'} index: 64 section: {index: 65} required: [title, code] ? QRD-200000029872-10--SPECIAL-PRECAUTIONS-FOR-DISPOSAL-OF-UNUSED-MEDICINAL-PRODUCTS-OR-WASTE-MATERIALS-DERIVED-FROM-SUCH-MEDICINAL-PRODUCTS--IF-APPROPRIATE : match: code: coding: - {code: '200000029872'} schema: type: BackboneElement _required: true index: 46 elements: title: {index: 47} code: pattern: type: CodeableConcept value: coding: - {code: '200000029872'} index: 48 section: {index: 49} required: [title, code] QRD-200000029865-3--LIST-OF-EXCIPIENTS: match: code: coding: - {code: '200000029865'} schema: type: BackboneElement _required: true index: 18 elements: title: {index: 19} code: pattern: type: CodeableConcept value: coding: - {code: '200000029865'} index: 20 section: {index: 21} required: [title, code] QRD-200000029879-17--UNIQUE-IDENTIFIER---2D-BARCODE: match: code: coding: - {code: '200000029879'} schema: type: BackboneElement _required: true index: 74 elements: title: {index: 75} code: pattern: type: CodeableConcept value: coding: - {code: '200000029879'} index: 76 section: {index: 77} required: [title, code] QRD-200000029875-13--BATCH-NUMBER--DONATION-AND-PRODUCT-CODES: match: code: coding: - {code: '200000029875'} schema: type: BackboneElement _required: true index: 58 elements: title: {index: 59} code: pattern: type: CodeableConcept value: coding: - {code: '200000029875'} index: 60 section: {index: 61} required: [title, code] QRD-200000029868-6--SPECIAL-WARNING-THAT-THE-MEDICINAL-PRODUCT-MUST-BE-STORED-OUT-OF-THE-SIGHT-AND-REACH-OF-CHILDREN: match: code: coding: - {code: '200000029868'} schema: type: BackboneElement _required: true index: 30 elements: title: {index: 31} code: pattern: type: CodeableConcept value: coding: - {code: '200000029868'} index: 32 section: {index: 33} required: [title, code] QRD-200000029873-11--NAME-AND-ADDRESS-OF-THE-MARKETING-AUTHORISATION-HOLDER: match: code: coding: - {code: '200000029873'} schema: type: BackboneElement _required: true index: 50 elements: title: {index: 51} code: pattern: type: CodeableConcept value: coding: - {code: '200000029873'} index: 52 section: {index: 53} required: [title, code] QRD-200000029870-8--EXPIRY-DATE: match: code: coding: - {code: '200000029870'} schema: type: BackboneElement _required: true index: 38 elements: title: {index: 39} code: pattern: type: CodeableConcept value: coding: - {code: '200000029870'} index: 40 section: {index: 41} required: [title, code] QRD-200000029877-15--INSTRUCTIONS-ON-USE: match: code: coding: - {code: '200000029877'} schema: type: BackboneElement _required: true index: 66 elements: title: {index: 67} code: pattern: type: CodeableConcept value: coding: - {code: '200000029877'} index: 68 section: {index: 69} required: [title, code] QRD-200000029867-5--METHOD-AND-ROUTES-OF-ADMINISTRATION: match: code: coding: - {code: '200000029867'} schema: type: BackboneElement _required: true index: 26 elements: title: {index: 27} code: pattern: type: CodeableConcept value: coding: - {code: '200000029867'} index: 28 section: {index: 29} required: [title, code] QRD-200000029863-1--NAME-OF-THE-MEDICINAL-PRODUCT: match: code: coding: - {code: '200000029863'} schema: type: BackboneElement _required: true index: 10 elements: title: {index: 11} code: pattern: type: CodeableConcept value: coding: - {code: '200000029863'} index: 12 section: {index: 13} required: [title, code] QRD-200000029871-9--SPECIAL-STORAGE-CONDITIONS: match: code: coding: - {code: '200000029871'} schema: type: BackboneElement _required: true index: 42 elements: title: {index: 43} code: pattern: type: CodeableConcept value: coding: - {code: '200000029871'} index: 44 section: {index: 45} required: [title, code] QRD-200000029869-7--OTHER-SPECIAL-WARNINGS--IF-NECESSARY: match: code: coding: - {code: '200000029869'} schema: type: BackboneElement _required: true index: 34 elements: title: {index: 35} code: pattern: type: CodeableConcept value: coding: - {code: '200000029869'} index: 36 section: {index: 37} required: [title, code] QRD-200000029866-4--PHARMACEUTICAL-FORM-AND-CONTENTS: match: code: coding: - {code: '200000029866'} schema: type: BackboneElement _required: true index: 22 elements: title: {index: 23} code: pattern: type: CodeableConcept value: coding: - {code: '200000029866'} index: 24 section: {index: 25} required: [title, code] required: [title, code] QRD-200000029881-MINIMUM-PARTICULARS-TO-APPEAR-ON-BLISTERS-OR-STRIPS-NATURE-TYPE: match: code: coding: - {code: '200000029881'} schema: type: BackboneElement index: 82 elements: title: {index: 83} code: pattern: type: CodeableConcept value: coding: - {code: '200000029881'} index: 84 section: array: true min: 5 index: 85 slicing: rules: closed ordered: true discriminator: - {path: code, type: value} min: 5 slices: QRD-200000029882-1--NAME-OF-THE-MEDICINAL-PRODUCT: match: code: coding: - {code: '200000029882'} schema: type: BackboneElement _required: true index: 86 elements: title: {index: 87} code: pattern: type: CodeableConcept value: coding: - {code: '200000029882'} index: 88 section: {index: 89} required: [title, code] QRD-200000029883-2--NAME-OF-THE-MARKETING-AUTHORISATION-HOLDER: match: code: coding: - {code: '200000029883'} schema: type: BackboneElement _required: true index: 90 elements: title: {index: 91} code: pattern: type: CodeableConcept value: coding: - {code: '200000029883'} index: 92 section: {index: 93} required: [title, code] QRD-200000029884-3--EXPIRY-DATE: match: code: coding: - {code: '200000029884'} schema: type: BackboneElement _required: true index: 94 elements: title: {index: 95} code: pattern: type: CodeableConcept value: coding: - {code: '200000029884'} index: 96 section: {index: 97} required: [title, code] QRD-200000029885-4--BATCH-NUMBER--DONATION-AND-PRODUCT-CODES: match: code: coding: - {code: '200000029885'} schema: type: BackboneElement _required: true index: 98 elements: title: {index: 99} code: pattern: type: CodeableConcept value: coding: - {code: '200000029885'} index: 100 section: {index: 101} required: [title, code] QRD-200000029886-5--OTHER: match: code: coding: - {code: '200000029886'} schema: type: BackboneElement _required: true index: 102 elements: title: {index: 103} code: pattern: type: CodeableConcept value: coding: - {code: '200000029886'} index: 104 section: {index: 105} required: [title, code] required: [title, code] QRD-200000029887-MINIMUM-PARTICULARS-TO-APPEAR-ON-SMALL-IMMEDIATE-PACKAGING-UNITS-NATURE-TYPE: match: code: coding: - {code: '200000029887'} schema: type: BackboneElement index: 106 elements: title: {index: 107} code: pattern: type: CodeableConcept value: coding: - {code: '200000029887'} index: 108 section: array: true min: 6 index: 109 slicing: rules: closed ordered: true discriminator: - {path: code, type: value} min: 6 slices: QRD-200000029888-1--NAME-OF-THE-MEDICINAL-PRODUCT-AND-ROUTES-OF-ADMINISTRATION: match: code: coding: - {code: '200000029888'} schema: type: BackboneElement _required: true index: 110 elements: title: {index: 111} code: pattern: type: CodeableConcept value: coding: - {code: '200000029888'} index: 112 section: {index: 113} required: [title, code] QRD-200000029889-2--METHOD-OF-ADMINISTRATION: match: code: coding: - {code: '200000029889'} schema: type: BackboneElement _required: true index: 114 elements: title: {index: 115} code: pattern: type: CodeableConcept value: coding: - {code: '200000029889'} index: 116 section: {index: 117} required: [title, code] QRD-200000029890-3--EXPIRY-DATE: match: code: coding: - {code: '200000029890'} schema: type: BackboneElement _required: true index: 118 elements: title: {index: 119} code: pattern: type: CodeableConcept value: coding: - {code: '200000029890'} index: 120 section: {index: 121} required: [title, code] QRD-200000029891-4--BATCH-NUMBER--DONATION-AND-PRODUCT-CODES: match: code: coding: - {code: '200000029891'} schema: type: BackboneElement _required: true index: 122 elements: title: {index: 123} code: pattern: type: CodeableConcept value: coding: - {code: '200000029891'} index: 124 section: {index: 125} required: [title, code] QRD-200000029892-5--CONTENTS-BY-WEIGHT--BY-VOLUME-OR-BY-UNIT: match: code: coding: - {code: '200000029892'} schema: type: BackboneElement _required: true index: 126 elements: title: {index: 127} code: pattern: type: CodeableConcept value: coding: - {code: '200000029892'} index: 128 section: {index: 129} required: [title, code] QRD-200000029893-6--OTHER: match: code: coding: - {code: '200000029893'} schema: type: BackboneElement _required: true index: 130 elements: title: {index: 131} code: pattern: type: CodeableConcept value: coding: - {code: '200000029893'} index: 132 section: {index: 133} required: [title, code] required: [title, code] required: [section, title, code] package_version: 0.0.6 class: profile kind: resource url: http://ema.europa.eu/fhir/StructureDefinition/EUQRD-CAP-template-new-Labeling-en base: http://hl7.org/fhir/StructureDefinition/Composition version: null required: [section]