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11.8 Resource MedicinalProductAuthorization - Content

Biomedical Research and Regulation Work GroupMaturity Level: 0 Draft Compartments: Not linked to any defined compartments

The regulatory authorization of a medicinal product.

MedicinalProductAuthorization is a resource covering the Marketing Authorization of a Medicinal Product, from a regulatory point of view.

This resource is referenced by medicinalproduct

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductAuthorization ΣDDomainResourceThe regulatory authorization of a medicinal product
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..1IdentifierBusiness identifier for the marketing authorization, as assigned by a regulator
... country Σ1..*CodeableConceptThe country in which the marketing authorization has been granted
... legalStatusOfSupply Σ1..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
... status Σ1..1CodeableConceptThe status of the marketing authorization
... statusDate Σ1..1dateTimeThe date at which the given status has become applicable
... restoreDate Σ0..1dateTimeThe date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
... validityPeriod Σ1..1PeriodThe 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
... dataExclusivityPeriod Σ0..1PeriodA period of time after authorization before generic product applicatiosn can be submitted
... dateOfFirstAuthorization Σ0..1dateTimeThe date when the first authorization was granted by a Medicines Regulatory Agency
... internationalBirthDate Σ1..1dateTimeDate of first marketing authorization for a company's new medicinal product in any country in the World
... jurisdictionalAuthorization Σ0..*BackboneElementAuthorization in areas within a country
.... country Σ1..1CodeableConceptCountry of authorization
.... jurisdiction Σ0..1CodeableConceptJurisdiction within a country
.... number Σ0..1IdentifierThe assigned number for the marketing authorization
.... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply in a jurisdiction or region
... holder Σ1..1Reference(Organization)Marketing Authorization Holder
... regulator Σ1..1Reference(Organization)Medicines Regulatory Agency
... procedure Σ1..1BackboneElementThe regulatory procedure for granting or amending a marketing authorization
.... number Σ0..1IdentifierIdentifier for this procedure
.... type Σ1..1CodeableConceptType of procedure
.... date Σ0..1PeriodDate of procedure
.... application Σ0..*BackboneElementApplcations submitted to obtain a marketing authorization
..... number Σ1..1IdentifierA unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency
..... type Σ1..1CodeableConceptThe type of the application
..... date Σ1..1dateTimeDate that the application was made
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorizaton

doco Documentation for this format

UML Diagram (Legend)

MedicinalProductAuthorization (DomainResource)Business identifier for the marketing authorization, as assigned by a regulatoridentifier : Identifier [0..1]The country in which the marketing authorization has been grantedcountry : CodeableConcept [1..*]The legal status of supply of the medicinal product as classified by the regulatorlegalStatusOfSupply : CodeableConcept [1..1]The status of the marketing authorizationstatus : CodeableConcept [1..1]The date at which the given status has become applicablestatusDate : dateTime [1..1]The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restoredrestoreDate : dateTime [0..1]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 formatvalidityPeriod : Period [1..1]A period of time after authorization before generic product applicatiosn can be submitteddataExclusivityPeriod : Period [0..1]The date when the first authorization was granted by a Medicines Regulatory AgencydateOfFirstAuthorization : dateTime [0..1]Date of first marketing authorization for a company's new medicinal product in any country in the WorldinternationalBirthDate : dateTime [1..1]Marketing Authorization Holderholder : Reference [1..1] « Organization »Medicines Regulatory Agencyregulator : Reference [1..1] « Organization »Marketing status of the medicinal product, in contrast to marketing authorizatonmarketingStatus : MarketingStatus [0..*]JurisdictionalAuthorizationCountry of authorizationcountry : CodeableConcept [1..1]Jurisdiction within a countryjurisdiction : CodeableConcept [0..1]The assigned number for the marketing authorizationnumber : Identifier [0..1]The legal status of supply in a jurisdiction or regionlegalStatusOfSupply : CodeableConcept [0..1]ProcedureIdentifier for this procedurenumber : Identifier [0..1]Type of proceduretype : CodeableConcept [1..1]Date of proceduredate : Period [0..1]ApplicationA unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agencynumber : Identifier [1..1]The type of the applicationtype : CodeableConcept [1..1]Date that the application was madedate : dateTime [1..1]Authorization in areas within a countryjurisdictionalAuthorization[0..*]Applcations submitted to obtain a marketing authorizationapplication[0..*]The regulatory procedure for granting or amending a marketing authorizationprocedure[1..1]

XML Template

<MedicinalProductAuthorization xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..1 Identifier Business identifier for the marketing authorization, as assigned by a regulator --></identifier>
 <country><!-- 1..* CodeableConcept The country in which the marketing authorization has been granted --></country>
 <legalStatusOfSupply><!-- 1..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator --></legalStatusOfSupply>
 <status><!-- 1..1 CodeableConcept The status of the marketing authorization --></status>
 <statusDate value="[dateTime]"/><!-- 1..1 The date at which the given status has become applicable -->
 <restoreDate value="[dateTime]"/><!-- 0..1 The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored -->
 <validityPeriod><!-- 1..1 Period 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 --></validityPeriod>
 <dataExclusivityPeriod><!-- 0..1 Period A period of time after authorization before generic product applicatiosn can be submitted --></dataExclusivityPeriod>
 <dateOfFirstAuthorization value="[dateTime]"/><!-- 0..1 The date when the first authorization was granted by a Medicines Regulatory Agency -->
 <internationalBirthDate value="[dateTime]"/><!-- 1..1 Date of first marketing authorization for a company's new medicinal product in any country in the World -->
 <jurisdictionalAuthorization>  <!-- 0..* Authorization in areas within a country -->
  <country><!-- 1..1 CodeableConcept Country of authorization --></country>
  <jurisdiction><!-- 0..1 CodeableConcept Jurisdiction within a country --></jurisdiction>
  <number><!-- 0..1 Identifier The assigned number for the marketing authorization --></number>
  <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply in a jurisdiction or region --></legalStatusOfSupply>
 </jurisdictionalAuthorization>
 <holder><!-- 1..1 Reference(Organization) Marketing Authorization Holder --></holder>
 <regulator><!-- 1..1 Reference(Organization) Medicines Regulatory Agency --></regulator>
 <procedure>  <!-- 1..1 The regulatory procedure for granting or amending a marketing authorization -->
  <number><!-- 0..1 Identifier Identifier for this procedure --></number>
  <type><!-- 1..1 CodeableConcept Type of procedure --></type>
  <date><!-- 0..1 Period Date of procedure --></date>
  <application>  <!-- 0..* Applcations submitted to obtain a marketing authorization -->
   <number><!-- 1..1 Identifier A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency --></number>
   <type><!-- 1..1 CodeableConcept The type of the application --></type>
   <date value="[dateTime]"/><!-- 1..1 Date that the application was made -->
  </application>
 </procedure>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorizaton --></marketingStatus>
</MedicinalProductAuthorization>

JSON Template

{doco
  "resourceType" : "MedicinalProductAuthorization",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // Business identifier for the marketing authorization, as assigned by a regulator
  "country" : [{ CodeableConcept }], // R!  The country in which the marketing authorization has been granted
  "legalStatusOfSupply" : { CodeableConcept }, // R!  The legal status of supply of the medicinal product as classified by the regulator
  "status" : { CodeableConcept }, // R!  The status of the marketing authorization
  "statusDate" : "<dateTime>", // R!  The date at which the given status has become applicable
  "restoreDate" : "<dateTime>", // The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
  "validityPeriod" : { Period }, // R!  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
  "dataExclusivityPeriod" : { Period }, // A period of time after authorization before generic product applicatiosn can be submitted
  "dateOfFirstAuthorization" : "<dateTime>", // The date when the first authorization was granted by a Medicines Regulatory Agency
  "internationalBirthDate" : "<dateTime>", // R!  Date of first marketing authorization for a company's new medicinal product in any country in the World
  "jurisdictionalAuthorization" : [{ // Authorization in areas within a country
    "country" : { CodeableConcept }, // R!  Country of authorization
    "jurisdiction" : { CodeableConcept }, // Jurisdiction within a country
    "number" : { Identifier }, // The assigned number for the marketing authorization
    "legalStatusOfSupply" : { CodeableConcept } // The legal status of supply in a jurisdiction or region
  }],
  "holder" : { Reference(Organization) }, // R!  Marketing Authorization Holder
  "regulator" : { Reference(Organization) }, // R!  Medicines Regulatory Agency
  "procedure" : { // R!  The regulatory procedure for granting or amending a marketing authorization
    "number" : { Identifier }, // Identifier for this procedure
    "type" : { CodeableConcept }, // R!  Type of procedure
    "date" : { Period }, // Date of procedure
    "application" : [{ // Applcations submitted to obtain a marketing authorization
      "number" : { Identifier }, // R!  A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency
      "type" : { CodeableConcept }, // R!  The type of the application
      "date" : "<dateTime>" // R!  Date that the application was made
    }]
  },
  "marketingStatus" : [{ MarketingStatus }] // Marketing status of the medicinal product, in contrast to marketing authorizaton
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:MedicinalProductAuthorization;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:MedicinalProductAuthorization.identifier [ Identifier ]; # 0..1 Business identifier for the marketing authorization, as assigned by a regulator
  fhir:MedicinalProductAuthorization.country [ CodeableConcept ], ... ; # 1..* The country in which the marketing authorization has been granted
  fhir:MedicinalProductAuthorization.legalStatusOfSupply [ CodeableConcept ]; # 1..1 The legal status of supply of the medicinal product as classified by the regulator
  fhir:MedicinalProductAuthorization.status [ CodeableConcept ]; # 1..1 The status of the marketing authorization
  fhir:MedicinalProductAuthorization.statusDate [ dateTime ]; # 1..1 The date at which the given status has become applicable
  fhir:MedicinalProductAuthorization.restoreDate [ dateTime ]; # 0..1 The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
  fhir:MedicinalProductAuthorization.validityPeriod [ Period ]; # 1..1 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:MedicinalProductAuthorization.dataExclusivityPeriod [ Period ]; # 0..1 A period of time after authorization before generic product applicatiosn can be submitted
  fhir:MedicinalProductAuthorization.dateOfFirstAuthorization [ dateTime ]; # 0..1 The date when the first authorization was granted by a Medicines Regulatory Agency
  fhir:MedicinalProductAuthorization.internationalBirthDate [ dateTime ]; # 1..1 Date of first marketing authorization for a company's new medicinal product in any country in the World
  fhir:MedicinalProductAuthorization.jurisdictionalAuthorization [ # 0..* Authorization in areas within a country
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.country [ CodeableConcept ]; # 1..1 Country of authorization
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction [ CodeableConcept ]; # 0..1 Jurisdiction within a country
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.number [ Identifier ]; # 0..1 The assigned number for the marketing authorization
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply in a jurisdiction or region
  ], ...;
  fhir:MedicinalProductAuthorization.holder [ Reference(Organization) ]; # 1..1 Marketing Authorization Holder
  fhir:MedicinalProductAuthorization.regulator [ Reference(Organization) ]; # 1..1 Medicines Regulatory Agency
  fhir:MedicinalProductAuthorization.procedure [ # 1..1 The regulatory procedure for granting or amending a marketing authorization
    fhir:MedicinalProductAuthorization.procedure.number [ Identifier ]; # 0..1 Identifier for this procedure
    fhir:MedicinalProductAuthorization.procedure.type [ CodeableConcept ]; # 1..1 Type of procedure
    fhir:MedicinalProductAuthorization.procedure.date [ Period ]; # 0..1 Date of procedure
    fhir:MedicinalProductAuthorization.procedure.application [ # 0..* Applcations submitted to obtain a marketing authorization
      fhir:MedicinalProductAuthorization.procedure.application.number [ Identifier ]; # 1..1 A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency
      fhir:MedicinalProductAuthorization.procedure.application.type [ CodeableConcept ]; # 1..1 The type of the application
      fhir:MedicinalProductAuthorization.procedure.application.date [ dateTime ]; # 1..1 Date that the application was made
    ], ...;
  ];
  fhir:MedicinalProductAuthorization.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing status of the medicinal product, in contrast to marketing authorizaton
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductAuthorization ΣDDomainResourceThe regulatory authorization of a medicinal product
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..1IdentifierBusiness identifier for the marketing authorization, as assigned by a regulator
... country Σ1..*CodeableConceptThe country in which the marketing authorization has been granted
... legalStatusOfSupply Σ1..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
... status Σ1..1CodeableConceptThe status of the marketing authorization
... statusDate Σ1..1dateTimeThe date at which the given status has become applicable
... restoreDate Σ0..1dateTimeThe date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
... validityPeriod Σ1..1PeriodThe 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
... dataExclusivityPeriod Σ0..1PeriodA period of time after authorization before generic product applicatiosn can be submitted
... dateOfFirstAuthorization Σ0..1dateTimeThe date when the first authorization was granted by a Medicines Regulatory Agency
... internationalBirthDate Σ1..1dateTimeDate of first marketing authorization for a company's new medicinal product in any country in the World
... jurisdictionalAuthorization Σ0..*BackboneElementAuthorization in areas within a country
.... country Σ1..1CodeableConceptCountry of authorization
.... jurisdiction Σ0..1CodeableConceptJurisdiction within a country
.... number Σ0..1IdentifierThe assigned number for the marketing authorization
.... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply in a jurisdiction or region
... holder Σ1..1Reference(Organization)Marketing Authorization Holder
... regulator Σ1..1Reference(Organization)Medicines Regulatory Agency
... procedure Σ1..1BackboneElementThe regulatory procedure for granting or amending a marketing authorization
.... number Σ0..1IdentifierIdentifier for this procedure
.... type Σ1..1CodeableConceptType of procedure
.... date Σ0..1PeriodDate of procedure
.... application Σ0..*BackboneElementApplcations submitted to obtain a marketing authorization
..... number Σ1..1IdentifierA unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency
..... type Σ1..1CodeableConceptThe type of the application
..... date Σ1..1dateTimeDate that the application was made
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorizaton

doco Documentation for this format

UML Diagram (Legend)

MedicinalProductAuthorization (DomainResource)Business identifier for the marketing authorization, as assigned by a regulatoridentifier : Identifier [0..1]The country in which the marketing authorization has been grantedcountry : CodeableConcept [1..*]The legal status of supply of the medicinal product as classified by the regulatorlegalStatusOfSupply : CodeableConcept [1..1]The status of the marketing authorizationstatus : CodeableConcept [1..1]The date at which the given status has become applicablestatusDate : dateTime [1..1]The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restoredrestoreDate : dateTime [0..1]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 formatvalidityPeriod : Period [1..1]A period of time after authorization before generic product applicatiosn can be submitteddataExclusivityPeriod : Period [0..1]The date when the first authorization was granted by a Medicines Regulatory AgencydateOfFirstAuthorization : dateTime [0..1]Date of first marketing authorization for a company's new medicinal product in any country in the WorldinternationalBirthDate : dateTime [1..1]Marketing Authorization Holderholder : Reference [1..1] « Organization »Medicines Regulatory Agencyregulator : Reference [1..1] « Organization »Marketing status of the medicinal product, in contrast to marketing authorizatonmarketingStatus : MarketingStatus [0..*]JurisdictionalAuthorizationCountry of authorizationcountry : CodeableConcept [1..1]Jurisdiction within a countryjurisdiction : CodeableConcept [0..1]The assigned number for the marketing authorizationnumber : Identifier [0..1]The legal status of supply in a jurisdiction or regionlegalStatusOfSupply : CodeableConcept [0..1]ProcedureIdentifier for this procedurenumber : Identifier [0..1]Type of proceduretype : CodeableConcept [1..1]Date of proceduredate : Period [0..1]ApplicationA unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agencynumber : Identifier [1..1]The type of the applicationtype : CodeableConcept [1..1]Date that the application was madedate : dateTime [1..1]Authorization in areas within a countryjurisdictionalAuthorization[0..*]Applcations submitted to obtain a marketing authorizationapplication[0..*]The regulatory procedure for granting or amending a marketing authorizationprocedure[1..1]

XML Template

<MedicinalProductAuthorization xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..1 Identifier Business identifier for the marketing authorization, as assigned by a regulator --></identifier>
 <country><!-- 1..* CodeableConcept The country in which the marketing authorization has been granted --></country>
 <legalStatusOfSupply><!-- 1..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator --></legalStatusOfSupply>
 <status><!-- 1..1 CodeableConcept The status of the marketing authorization --></status>
 <statusDate value="[dateTime]"/><!-- 1..1 The date at which the given status has become applicable -->
 <restoreDate value="[dateTime]"/><!-- 0..1 The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored -->
 <validityPeriod><!-- 1..1 Period 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 --></validityPeriod>
 <dataExclusivityPeriod><!-- 0..1 Period A period of time after authorization before generic product applicatiosn can be submitted --></dataExclusivityPeriod>
 <dateOfFirstAuthorization value="[dateTime]"/><!-- 0..1 The date when the first authorization was granted by a Medicines Regulatory Agency -->
 <internationalBirthDate value="[dateTime]"/><!-- 1..1 Date of first marketing authorization for a company's new medicinal product in any country in the World -->
 <jurisdictionalAuthorization>  <!-- 0..* Authorization in areas within a country -->
  <country><!-- 1..1 CodeableConcept Country of authorization --></country>
  <jurisdiction><!-- 0..1 CodeableConcept Jurisdiction within a country --></jurisdiction>
  <number><!-- 0..1 Identifier The assigned number for the marketing authorization --></number>
  <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply in a jurisdiction or region --></legalStatusOfSupply>
 </jurisdictionalAuthorization>
 <holder><!-- 1..1 Reference(Organization) Marketing Authorization Holder --></holder>
 <regulator><!-- 1..1 Reference(Organization) Medicines Regulatory Agency --></regulator>
 <procedure>  <!-- 1..1 The regulatory procedure for granting or amending a marketing authorization -->
  <number><!-- 0..1 Identifier Identifier for this procedure --></number>
  <type><!-- 1..1 CodeableConcept Type of procedure --></type>
  <date><!-- 0..1 Period Date of procedure --></date>
  <application>  <!-- 0..* Applcations submitted to obtain a marketing authorization -->
   <number><!-- 1..1 Identifier A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency --></number>
   <type><!-- 1..1 CodeableConcept The type of the application --></type>
   <date value="[dateTime]"/><!-- 1..1 Date that the application was made -->
  </application>
 </procedure>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorizaton --></marketingStatus>
</MedicinalProductAuthorization>

JSON Template

{doco
  "resourceType" : "MedicinalProductAuthorization",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // Business identifier for the marketing authorization, as assigned by a regulator
  "country" : [{ CodeableConcept }], // R!  The country in which the marketing authorization has been granted
  "legalStatusOfSupply" : { CodeableConcept }, // R!  The legal status of supply of the medicinal product as classified by the regulator
  "status" : { CodeableConcept }, // R!  The status of the marketing authorization
  "statusDate" : "<dateTime>", // R!  The date at which the given status has become applicable
  "restoreDate" : "<dateTime>", // The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
  "validityPeriod" : { Period }, // R!  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
  "dataExclusivityPeriod" : { Period }, // A period of time after authorization before generic product applicatiosn can be submitted
  "dateOfFirstAuthorization" : "<dateTime>", // The date when the first authorization was granted by a Medicines Regulatory Agency
  "internationalBirthDate" : "<dateTime>", // R!  Date of first marketing authorization for a company's new medicinal product in any country in the World
  "jurisdictionalAuthorization" : [{ // Authorization in areas within a country
    "country" : { CodeableConcept }, // R!  Country of authorization
    "jurisdiction" : { CodeableConcept }, // Jurisdiction within a country
    "number" : { Identifier }, // The assigned number for the marketing authorization
    "legalStatusOfSupply" : { CodeableConcept } // The legal status of supply in a jurisdiction or region
  }],
  "holder" : { Reference(Organization) }, // R!  Marketing Authorization Holder
  "regulator" : { Reference(Organization) }, // R!  Medicines Regulatory Agency
  "procedure" : { // R!  The regulatory procedure for granting or amending a marketing authorization
    "number" : { Identifier }, // Identifier for this procedure
    "type" : { CodeableConcept }, // R!  Type of procedure
    "date" : { Period }, // Date of procedure
    "application" : [{ // Applcations submitted to obtain a marketing authorization
      "number" : { Identifier }, // R!  A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency
      "type" : { CodeableConcept }, // R!  The type of the application
      "date" : "<dateTime>" // R!  Date that the application was made
    }]
  },
  "marketingStatus" : [{ MarketingStatus }] // Marketing status of the medicinal product, in contrast to marketing authorizaton
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:MedicinalProductAuthorization;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:MedicinalProductAuthorization.identifier [ Identifier ]; # 0..1 Business identifier for the marketing authorization, as assigned by a regulator
  fhir:MedicinalProductAuthorization.country [ CodeableConcept ], ... ; # 1..* The country in which the marketing authorization has been granted
  fhir:MedicinalProductAuthorization.legalStatusOfSupply [ CodeableConcept ]; # 1..1 The legal status of supply of the medicinal product as classified by the regulator
  fhir:MedicinalProductAuthorization.status [ CodeableConcept ]; # 1..1 The status of the marketing authorization
  fhir:MedicinalProductAuthorization.statusDate [ dateTime ]; # 1..1 The date at which the given status has become applicable
  fhir:MedicinalProductAuthorization.restoreDate [ dateTime ]; # 0..1 The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
  fhir:MedicinalProductAuthorization.validityPeriod [ Period ]; # 1..1 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:MedicinalProductAuthorization.dataExclusivityPeriod [ Period ]; # 0..1 A period of time after authorization before generic product applicatiosn can be submitted
  fhir:MedicinalProductAuthorization.dateOfFirstAuthorization [ dateTime ]; # 0..1 The date when the first authorization was granted by a Medicines Regulatory Agency
  fhir:MedicinalProductAuthorization.internationalBirthDate [ dateTime ]; # 1..1 Date of first marketing authorization for a company's new medicinal product in any country in the World
  fhir:MedicinalProductAuthorization.jurisdictionalAuthorization [ # 0..* Authorization in areas within a country
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.country [ CodeableConcept ]; # 1..1 Country of authorization
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction [ CodeableConcept ]; # 0..1 Jurisdiction within a country
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.number [ Identifier ]; # 0..1 The assigned number for the marketing authorization
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply in a jurisdiction or region
  ], ...;
  fhir:MedicinalProductAuthorization.holder [ Reference(Organization) ]; # 1..1 Marketing Authorization Holder
  fhir:MedicinalProductAuthorization.regulator [ Reference(Organization) ]; # 1..1 Medicines Regulatory Agency
  fhir:MedicinalProductAuthorization.procedure [ # 1..1 The regulatory procedure for granting or amending a marketing authorization
    fhir:MedicinalProductAuthorization.procedure.number [ Identifier ]; # 0..1 Identifier for this procedure
    fhir:MedicinalProductAuthorization.procedure.type [ CodeableConcept ]; # 1..1 Type of procedure
    fhir:MedicinalProductAuthorization.procedure.date [ Period ]; # 0..1 Date of procedure
    fhir:MedicinalProductAuthorization.procedure.application [ # 0..* Applcations submitted to obtain a marketing authorization
      fhir:MedicinalProductAuthorization.procedure.application.number [ Identifier ]; # 1..1 A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency
      fhir:MedicinalProductAuthorization.procedure.application.type [ CodeableConcept ]; # 1..1 The type of the application
      fhir:MedicinalProductAuthorization.procedure.application.date [ dateTime ]; # 1..1 Date that the application was made
    ], ...;
  ];
  fhir:MedicinalProductAuthorization.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing status of the medicinal product, in contrast to marketing authorizaton
]

Changes since DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.

 

Alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis