Data Model Libraries
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    MedicinalProductAuthorization Class

    The regulatory authorization of a medicinal product.

    FHIR Specification

    • Short: The regulatory authorization of a medicinal product
    • Definition: The regulatory authorization of a medicinal product.
    • FHIR Version: 4.0.1

    Hierarchy (View Summary)

    Implements

    Index

    Constructors

    Properties

    Methods

    parse getIdentifier setIdentifier addIdentifier hasIdentifier getSubject setSubject hasSubject getCountry setCountry addCountry hasCountry getJurisdiction setJurisdiction addJurisdiction hasJurisdiction getStatus setStatus hasStatus getStatusDateElement setStatusDateElement hasStatusDateElement getStatusDate setStatusDate hasStatusDate getRestoreDateElement setRestoreDateElement hasRestoreDateElement getRestoreDate setRestoreDate hasRestoreDate getValidityPeriod setValidityPeriod hasValidityPeriod getDataExclusivityPeriod setDataExclusivityPeriod hasDataExclusivityPeriod getDateOfFirstAuthorizationElement setDateOfFirstAuthorizationElement hasDateOfFirstAuthorizationElement getDateOfFirstAuthorization setDateOfFirstAuthorization hasDateOfFirstAuthorization getInternationalBirthDateElement setInternationalBirthDateElement hasInternationalBirthDateElement getInternationalBirthDate setInternationalBirthDate hasInternationalBirthDate getLegalBasis setLegalBasis hasLegalBasis getJurisdictionalAuthorization setJurisdictionalAuthorization addJurisdictionalAuthorization hasJurisdictionalAuthorization getHolder setHolder hasHolder getRegulator setRegulator hasRegulator getProcedure setProcedure hasProcedure fhirType isEmpty copy toJSON getText setText hasText getContained setContained addContained hasContained getExtension setExtension hasExtension getExtensionByUrl addExtension removeExtension getModifierExtension setModifierExtension hasModifierExtension getModifierExtensionByUrl addModifierExtension removeModifierExtension resourceType getIdElement setIdElement hasIdElement getId setId hasId getMeta setMeta hasMeta getImplicitRulesElement setImplicitRulesElement hasImplicitRulesElement getImplicitRules setImplicitRules hasImplicitRules getLanguageElement setLanguageElement hasLanguageElement getLanguage setLanguage hasLanguage isResource isRequiredFieldsEmpty isDataType isComplexDataType isPrimitive isBooleanPrimitive isStringPrimitive isNumberPrimitive isBigIntPrimitive isDateTimePrimitive copyValues initIdentifier initCountry initJurisdiction initJurisdictionalAuthorization

    Constructors

    Properties

    identifier?: Identifier[]

    MedicinalProductAuthorization.identifier Element

    FHIR Specification

    • Short: Business identifier for the marketing authorization, as assigned by a regulator
    • Definition: Business identifier for the marketing authorization, as assigned by a regulator.
    • FHIR Type: Identifier
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    subject?: Reference

    MedicinalProductAuthorization.subject Element

    FHIR Specification

    country?: CodeableConcept[]

    MedicinalProductAuthorization.country Element

    FHIR Specification

    • Short: The country in which the marketing authorization has been granted
    • Definition: The country in which the marketing authorization has been granted.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    jurisdiction?: CodeableConcept[]

    MedicinalProductAuthorization.jurisdiction Element

    FHIR Specification

    • Short: Jurisdiction within a country
    • Definition: Jurisdiction within a country.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true

    MedicinalProductAuthorization.status Element

    FHIR Specification

    • Short: The status of the marketing authorization
    • Definition: The status of the marketing authorization.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    statusDate?: DateTimeType

    MedicinalProductAuthorization.statusDate Element

    FHIR Specification

    • Short: The date at which the given status has become applicable
    • Definition: The date at which the given status has become applicable.
    • FHIR Type: dateTime
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    restoreDate?: DateTimeType

    MedicinalProductAuthorization.restoreDate Element

    FHIR Specification

    • Short: The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
    • Definition: The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored.
    • FHIR Type: dateTime
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    validityPeriod?: Period

    MedicinalProductAuthorization.validityPeriod Element

    FHIR Specification

    • Short: The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format
    • Definition: The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.
    • FHIR Type: Period
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    dataExclusivityPeriod?: Period

    MedicinalProductAuthorization.dataExclusivityPeriod Element

    FHIR Specification

    • Short: A period of time after authorization before generic product applicatiosn can be submitted
    • Definition: A period of time after authorization before generic product applicatiosn can be submitted.
    • FHIR Type: Period
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    dateOfFirstAuthorization?: DateTimeType

    MedicinalProductAuthorization.dateOfFirstAuthorization Element

    FHIR Specification

    • Short: The date when the first authorization was granted by a Medicines Regulatory Agency
    • Definition: The date when the first authorization was granted by a Medicines Regulatory Agency.
    • FHIR Type: dateTime
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    internationalBirthDate?: DateTimeType

    MedicinalProductAuthorization.internationalBirthDate Element

    FHIR Specification

    • Short: Date of first marketing authorization for a company's new medicinal product in any country in the World
    • Definition: Date of first marketing authorization for a company's new medicinal product in any country in the World.
    • FHIR Type: dateTime
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    legalBasis?: CodeableConcept

    MedicinalProductAuthorization.legalBasis Element

    FHIR Specification

    • Short: The legal framework against which this authorization is granted
    • Definition: The legal framework against which this authorization is granted.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true

    MedicinalProductAuthorization.jurisdictionalAuthorization Element

    FHIR Specification

    • Short: Authorization in areas within a country
    • Definition: Authorization in areas within a country.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    holder?: Reference

    MedicinalProductAuthorization.holder Element

    FHIR Specification

    regulator?: Reference

    MedicinalProductAuthorization.regulator Element

    FHIR Specification

    MedicinalProductAuthorization.procedure Element

    FHIR Specification

    • Short: The regulatory procedure for granting or amending a marketing authorization
    • Definition: The regulatory procedure for granting or amending a marketing authorization.
    • FHIR Type: BackboneElement
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true

    Methods

    • Assigns the provided value to the text property.

      Parameters

      Returns this

      this

    • Returns boolean

      true if the text property exists and has a value; false otherwise

    • Assigns the provided Resource array value to the contained property.

      Parameters

      • value: undefined | IResource[]

        the contained array value

      Returns this

      this

    • Returns boolean

      true if the contained property exists and has a value; false otherwise

    • Assigns the provided array of Extension values to the extension property.

      Parameters

      • extension: undefined | IExtension[]

        array of Extensions

      Returns this

      this

    • Determines if the extension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url; false otherwise

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the extension property exists and has any values.

      AssertionError for invalid url

    • Adds the provided Extension to the extension property array.

      Parameters

      • extension: undefined | IExtension

        the Extension value to add to the extension property array

      Returns this

      this

    • Removes the Extension having the provided url from the extension property array.

      Parameters

      • url: string

        the url that identifies a specific Extension to remove

      Returns void

      AssertionError for invalid url

    • Determines if the modifierExtension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the modifierExtension property exists and has any values.

      AssertionError for invalid url

    • Assigns the provided PrimitiveType value to the id property.

      Parameters

      • element: undefined | IdType

        the id value

      Returns this

      this

    • Returns undefined | string

      the id property value as a primitive value

    • Assigns the provided primitive value to the id property.

      Parameters

      • value: undefined | string

        the id value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the id property exists and has a value; false otherwise

    • Assigns the provided value to the meta property.

      Parameters

      • value: undefined | Meta

        the meta value

      Returns this

      this

    • Returns boolean

      true if the meta property exists and has a value; false otherwise

    • Assigns the provided primitive value to the implicitRules property.

      Parameters

      • value: undefined | string

        the implicitRules value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns undefined | string

      the language property value as a primitive value

    • Assigns the provided primitive value to the language property.

      Parameters

      • value: undefined | string

        the language value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the language property exists and has a value; false otherwise

    • Returns boolean

      true if and only if the data model has required fields (min cardinality > 0) and at least one of those required fields in the instance is empty; false otherwise

    • Returns boolean

      true if the instance is a FHIR complex or primitive datatype; false otherwise