description: Description of the packaged authorized medicinal product(s) associated to this ePI document. package_name: hl7.fhir.uv.emedicinal derivation: constraint name: MedicinalProductDefinitionUvEpi type: MedicinalProductDefinition elements: description: {short: General description of the medicinal product referred by the ePI, index: 8} additionalMonitoringIndicator: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/additionalMonitoringIndicator'} index: 13 combinedPharmaceuticalDoseForm: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/PharmaceuticalDoseForm'} index: 9 indication: {short: Narrative text of the authorized indication(s) for this product., index: 11} name: elements: productName: {short: The full name of this product, index: 19} type: pattern: type: CodeableConcept value: coding: - {code: '220000000001', system: 'https://spor.ema.europa.eu/rmswi/220000000000'} index: 20 part: index: 21 slicing: rules: open discriminator: - {path: type, type: pattern} min: null slices: ProprietaryNamePart: match: type: coding: - {code: '220000000002', system: 'https://spor.ema.europa.eu/rmswi/220000000000'} schema: array: true index: 22 elements: part: {short: brand name of this product, index: 23} type: pattern: type: CodeableConcept value: coding: - {code: '220000000002', system: 'https://spor.ema.europa.eu/rmswi/220000000000'} index: 24 Non-proprietaryNamePart: match: type: coding: - {code: '220000000003', system: 'https://spor.ema.europa.eu/rmswi/220000000000'} schema: array: true index: 25 elements: part: {short: International Non-proprietary Name (INN) of this product, index: 26} type: pattern: type: CodeableConcept value: coding: - {code: '220000000003', system: 'https://spor.ema.europa.eu/rmswi/220000000000'} index: 27 StrengthPart: match: type: coding: - {code: '220000000004', system: 'https://spor.ema.europa.eu/rmswi/220000000000'} schema: array: true index: 28 elements: part: {short: strength expressed as the quantity of active ingredient, index: 29} type: pattern: type: CodeableConcept value: coding: - {code: '220000000004', system: 'https://spor.ema.europa.eu/rmswi/220000000000'} index: 30 PharmaceuticalDoseFormPart: match: type: coding: - {code: '220000000005', system: 'https://spor.ema.europa.eu/rmswi/220000000000'} schema: array: true index: 31 elements: part: {short: Physical manifestation of a product as intended to be delivered to the patient., index: 32} type: pattern: type: CodeableConcept value: coding: - {code: '220000000005', system: 'https://spor.ema.europa.eu/rmswi/220000000000'} index: 33 usage: elements: country: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country'} index: 34 jurisdiction: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country'} index: 35 operation: elements: type: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/operationType'} index: 37 elements: concept: {index: 38} required: [concept] organization: type: Reference refers: ['http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi'] index: 39 type: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/medProductType'} index: 3 route: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration'} index: 10 pediatricUseIndicator: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/pediatricUseIndicator'} index: 14 classification: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification'} index: 15 marketingStatus: short: Marketing status of the medicinal product in contrast to marketing authorization index: 16 elements: status: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/marketingStatus'} index: 17 status: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/publication-status'} index: 6 packagedMedicinalProduct: short: High level package type for this product. E.g., sample pack binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/packageType'} index: 18 identifier: short: Unique identifier assigned to this medicinal product by the health authority. Could be the ISO IDMP Medicinal Product Identifier (MPID). index: 0 elements: system: binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/VsMedProductIdSystems'} index: 1 value: {index: 2} required: [value, system] statusDate: {short: The date at which this status became applicable., index: 7} crossReference: elements: type: binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type'} index: 36 domain: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-domain'} index: 4 legalStatusOfSupply: binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/legalStatusOfSupply'} index: 12 version: {short: Business version of this product, index: 5} package_version: product-info-1.0.0-ballot class: profile kind: resource url: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi base: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition version: 1.0.0-ballot required: [identifier]