http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|5.0.0

Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs, to support prescribing, adverse events management etc.).
description: Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs, to support prescribing, adverse events management etc.).
derivation: specialization
name: MedicinalProductDefinition
type: MedicinalProductDefinition
elements:
  description: {isModifier: false, short: General description of this product, mustSupport: false, isSummary: true, index: 6}
  additionalMonitoringIndicator:
    isModifier: false
    short: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
    mustSupport: false
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring'}
    isSummary: true
    index: 11
  comprisedOf: {isModifier: false, short: 'Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes', mustSupport: false, array: true, isSummary: true, index: 17}
  combinedPharmaceuticalDoseForm:
    isModifier: false
    short: The dose form for a single part product, or combined form of a multiple part product
    mustSupport: false
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/combined-dose-form'}
    isSummary: true
    index: 7
  clinicalTrial: {isModifier: false, short: Clinical trials or studies that this product is involved in, mustSupport: false, array: true, isSummary: true, index: 25}
  impurity:
    isModifier: false
    short: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/substance-codes'}
    isSummary: true
    index: 19
  indication: {isModifier: false, short: 'Description of indication(s) for this product, used when structured indications are not required', mustSupport: false, isSummary: true, index: 9}
  name:
    min: 1
    isModifier: false
    short: The product's name, including full name and possibly coded parts
    index: 27
    mustSupport: false
    array: true
    elements:
      productName: {isModifier: false, short: The full product name, mustSupport: false, isSummary: true, index: 28}
      type:
        isModifier: false
        short: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
        mustSupport: false
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-name-type'}
        isSummary: true
        index: 29
      part:
        isModifier: false
        short: Coding words or phrases of the name
        mustSupport: false
        array: true
        isSummary: true
        index: 30
        elements:
          part: {isModifier: false, short: A fragment of a product name, mustSupport: false, isSummary: true, index: 31}
          type:
            isModifier: false
            short: Identifying type for this part of the name (e.g. strength part)
            mustSupport: false
            binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type'}
            isSummary: true
            index: 32
        required: [part, type]
      usage:
        isModifier: false
        short: Country and jurisdiction where the name applies
        mustSupport: false
        array: true
        isSummary: true
        index: 33
        elements:
          country:
            isModifier: false
            short: Country code for where this name applies
            mustSupport: false
            binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/country'}
            isSummary: true
            index: 34
          jurisdiction:
            isModifier: false
            short: Jurisdiction code for where this name applies
            mustSupport: false
            binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/jurisdiction'}
            isSummary: true
            index: 35
          language:
            isModifier: false
            short: Language code for this name
            mustSupport: false
            binding: {strength: required, valueSet: 'http://hl7.org/fhir/ValueSet/all-languages|5.0.0'}
            isSummary: true
            index: 36
        required: [country, language]
    required: [productName]
    isSummary: true
  masterFile: {isModifier: false, short: A master file for the medicinal product (e.g. Pharmacovigilance System Master File), mustSupport: false, array: true, isSummary: true, index: 21}
  operation:
    isModifier: false
    short: A manufacturing or administrative process for the medicinal product
    mustSupport: false
    array: true
    isSummary: true
    index: 40
    elements:
      type: {isModifier: false, short: 'The type of manufacturing operation e.g. manufacturing itself, re-packaging', mustSupport: false, isSummary: true, index: 41}
      effectiveDate: {isModifier: false, short: Date range of applicability, mustSupport: false, isSummary: true, index: 42}
      organization: {isModifier: false, short: 'The organization responsible for the particular process, e.g. the manufacturer or importer', mustSupport: false, array: true, isSummary: true, index: 43}
      confidentialityIndicator:
        isModifier: false
        short: Specifies whether this process is considered proprietary or confidential
        mustSupport: false
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality'}
        isSummary: true
        index: 44
  type:
    isModifier: false
    short: Regulatory type, e.g. Investigational or Authorized
    mustSupport: false
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-type'}
    isSummary: true
    index: 1
  route:
    isModifier: false
    short: The path by which the product is taken into or makes contact with the body
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/route-codes'}
    isSummary: true
    index: 8
  pediatricUseIndicator:
    isModifier: false
    short: If authorised for use in children
    mustSupport: false
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use'}
    isSummary: true
    index: 13
  classification:
    isModifier: false
    short: Allows the product to be classified by various systems
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-classification'}
    isSummary: true
    index: 14
  characteristic:
    isModifier: false
    short: Key product features such as \"sugar free\", \"modified release\"
    mustSupport: false
    array: true
    isSummary: true
    index: 45
    elements:
      type:
        isModifier: false
        short: A code expressing the type of characteristic
        mustSupport: false
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/product-characteristic-codes'}
        isSummary: true
        index: 46
      value:
        isModifier: false
        short: A value for the characteristic
        mustSupport: false
        choices: []
        isSummary: true
        index: 48
    required: [type]
  marketingStatus: {isModifier: false, short: 'Marketing status of the medicinal product, in contrast to marketing authorization', mustSupport: false, array: true, isSummary: true, index: 15}
  specialMeasures:
    isModifier: false
    short: Whether the Medicinal Product is subject to special measures for regulatory reasons
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-special-measures'}
    isSummary: true
    index: 12
  ingredient:
    isModifier: false
    short: The ingredients of this medicinal product - when not detailed in other resources
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/substance-codes'}
    isSummary: true
    index: 18
  status:
    isModifier: true
    short: The status within the lifecycle of this product record
    mustSupport: false
    binding: {strength: preferred, valueSet: 'http://hl7.org/fhir/ValueSet/publication-status'}
    isModifierReason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
    isSummary: true
    index: 4
  packagedMedicinalProduct:
    isModifier: false
    short: Package type for the product
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-package-type'}
    isSummary: true
    index: 16
  code:
    isModifier: false
    short: A code that this product is known by, within some formal terminology
    mustSupport: false
    array: true
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medication-codes'}
    isSummary: true
    index: 26
  identifier: {isModifier: false, short: Business identifier for this product. Could be an MPID, mustSupport: false, array: true, isSummary: true, index: 0}
  statusDate: {isModifier: false, short: The date at which the given status became applicable, mustSupport: false, isSummary: true, index: 5}
  crossReference:
    isModifier: false
    short: Reference to another product, e.g. for linking authorised to investigational product
    mustSupport: false
    array: true
    isSummary: true
    index: 37
    elements:
      product: {isModifier: false, short: 'Reference to another product, e.g. for linking authorised to investigational product', mustSupport: false, isSummary: true, index: 38}
      type:
        isModifier: false
        short: The type of relationship, for instance branded to generic or virtual to actual product
        mustSupport: false
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type'}
        isSummary: true
        index: 39
    required: [product]
  attachedDocument: {isModifier: false, short: Additional documentation about the medicinal product, mustSupport: false, array: true, isSummary: true, index: 20}
  domain:
    isModifier: false
    short: If this medicine applies to human or veterinary uses
    mustSupport: false
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-domain'}
    isSummary: true
    index: 2
  legalStatusOfSupply:
    isModifier: false
    short: The legal status of supply of the medicinal product as classified by the regulator
    mustSupport: false
    binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/legal-status-of-supply'}
    isSummary: true
    index: 10
  version: {isModifier: false, short: A business identifier relating to a specific version of the product, mustSupport: false, isSummary: true, index: 3}
  contact:
    isModifier: false
    short: A product specific contact, person (in a role), or an organization
    mustSupport: false
    array: true
    isSummary: true
    index: 22
    elements:
      type:
        isModifier: false
        short: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
        mustSupport: false
        binding: {strength: example, valueSet: 'http://hl7.org/fhir/ValueSet/medicinal-product-contact-type'}
        isSummary: true
        index: 23
      contact: {isModifier: false, short: 'A product specific contact, person (in a role), or an organization', mustSupport: false, isSummary: true, index: 24}
    required: [contact]
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 5.0.0
required: [name]