http://hl7.org/fhir/StructureDefinition/MedicinalProduct|4.0.1

description: Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).
derivation: specialization
name: MedicinalProduct
type: MedicinalProduct
elements:
  additionalMonitoringIndicator: {short: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, isSummary: true, index: 5}
  manufacturingBusinessOperation:
    short: An operation applied to the product, for manufacturing or adminsitrative purpose
    array: true
    isSummary: true
    index: 26
    elements:
      operationType: {short: The type of manufacturing operation, isSummary: true, index: 27}
      authorisationReferenceNumber: {short: Regulatory authorization reference number, isSummary: true, index: 28}
      effectiveDate: {short: Regulatory authorization date, isSummary: true, index: 29}
      confidentialityIndicator: {short: To indicate if this proces is commercially confidential, isSummary: true, index: 30}
      manufacturer: {short: The manufacturer or establishment associated with the process, array: true, isSummary: true, index: 31}
      regulator: {short: A regulator which oversees the operation, isSummary: true, index: 32}
  combinedPharmaceuticalDoseForm: {short: 'The dose form for a single part product, or combined form of a multiple part product', isSummary: true, index: 3}
  clinicalTrial: {short: Clinical trials or studies that this product is involved in, array: true, isSummary: true, index: 15}
  productClassification: {short: Allows the product to be classified by various systems, array: true, isSummary: true, index: 8}
  name:
    min: 1
    short: The product's name, including full name and possibly coded parts
    array: true
    isSummary: true
    index: 16
    elements:
      productName: {short: The full product name, isSummary: true, index: 17}
      namePart:
        short: Coding words or phrases of the name
        array: true
        isSummary: true
        index: 18
        elements:
          part: {short: A fragment of a product name, isSummary: true, index: 19}
          type: {short: Idenifying type for this part of the name (e.g. strength part), isSummary: true, index: 20}
        required: [part, type]
      countryLanguage:
        short: Country where the name applies
        array: true
        isSummary: true
        index: 21
        elements:
          country: {short: Country code for where this name applies, isSummary: true, index: 22}
          jurisdiction: {short: Jurisdiction code for where this name applies, isSummary: true, index: 23}
          language: {short: Language code for this name, isSummary: true, index: 24}
        required: [country, language]
    required: [productName]
  masterFile: {short: A master file for to the medicinal product (e.g. Pharmacovigilance System Master File), array: true, isSummary: true, index: 13}
  pharmaceuticalProduct: {short: Pharmaceutical aspects of product, array: true, isSummary: true, index: 10}
  type: {short: 'Regulatory type, e.g. Investigational or Authorized', isSummary: true, index: 1}
  marketingStatus: {short: 'Marketing status of the medicinal product, in contrast to marketing authorizaton', array: true, isSummary: true, index: 9}
  specialMeasures: {short: Whether the Medicinal Product is subject to special measures for regulatory reasons, array: true, isSummary: true, index: 6}
  specialDesignation:
    short: Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
    array: true
    isSummary: true
    index: 33
    elements:
      identifier: {short: 'Identifier for the designation, or procedure number', array: true, isSummary: true, index: 34}
      type: {short: 'The type of special designation, e.g. orphan drug, minor use', isSummary: true, index: 35}
      intendedUse: {short: 'The intended use of the product, e.g. prevention, treatment', isSummary: true, index: 36}
      indication:
        short: Condition for which the medicinal use applies
        choices: []
        isSummary: true
        index: 38
      status: {short: 'For example granted, pending, expired or withdrawn', isSummary: true, index: 39}
      date: {short: Date when the designation was granted, isSummary: true, index: 40}
      species: {short: Animal species for which this applies, isSummary: true, index: 41}
  packagedMedicinalProduct: {short: Package representation for the product, array: true, isSummary: true, index: 11}
  identifier: {short: Business identifier for this product. Could be an MPID, array: true, isSummary: true, index: 0}
  crossReference: {short: 'Reference to another product, e.g. for linking authorised to investigational product', array: true, isSummary: true, index: 25}
  attachedDocument: {short: 'Supporting documentation, typically for regulatory submission', array: true, isSummary: true, index: 12}
  domain: {short: If this medicine applies to human or veterinary uses, isSummary: true, index: 2}
  legalStatusOfSupply: {short: The legal status of supply of the medicinal product as classified by the regulator, isSummary: true, index: 4}
  paediatricUseIndicator: {short: If authorised for use in children, isSummary: true, index: 7}
  contact: {short: 'A product specific contact, person (in a role), or an organization', array: true, isSummary: true, index: 14}
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/MedicinalProduct
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 4.0.1
required: [name]