PackagesCanonicalsLogsProblems
    Packages
    hl7.fhir.uv.emedicinal@product-info-1.0.0-ballot
    http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi
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]