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11.8 Resource MedicinalProductAuthorization - Content

Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial UseSecurity Category: Anonymous 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 MedicinalProductPackaged

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductAuthorization ΣTUDomainResourceThe regulatory authorization of a medicinal product
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the marketing authorization, as assigned by a regulator
... subject Σ0..1Reference(MedicinalProduct | MedicinalProductPackaged)The medicinal product that is being authorized
... country Σ0..*CodeableConceptThe country in which the marketing authorization has been granted
... jurisdiction Σ0..*CodeableConceptJurisdiction within a country
... status Σ0..1CodeableConceptThe status of the marketing authorization
... statusDate Σ0..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 Σ0..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 Σ0..1dateTimeDate of first marketing authorization for a company's new medicinal product in any country in the World
... legalBasis Σ0..1CodeableConceptThe legal framework against which this authorization is granted
... jurisdictionalAuthorization Σ0..*BackboneElementAuthorization in areas within a country
.... identifier Σ0..*IdentifierThe assigned number for the marketing authorization
.... country Σ0..1CodeableConceptCountry of authorization
.... jurisdiction Σ0..*CodeableConceptJurisdiction within a country
.... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply in a jurisdiction or region
.... validityPeriod Σ0..1PeriodThe start and expected end date of the authorization
... holder Σ0..1Reference(Organization)Marketing Authorization Holder
... regulator Σ0..1Reference(Organization)Medicines Regulatory Agency
... procedure Σ0..1BackboneElementThe regulatory procedure for granting or amending a marketing authorization
.... identifier Σ0..1IdentifierIdentifier for this procedure
.... type Σ1..1CodeableConceptType of procedure
.... date[x] Σ0..1Date of procedure
..... datePeriodPeriod
..... dateDateTimedateTime
.... application Σ0..*see procedureApplcations submitted to obtain a marketing authorization

doco Documentation for this format

UML Diagram (Legend)

MedicinalProductAuthorization (DomainResource)Business identifier for the marketing authorization, as assigned by a regulatoridentifier : Identifier [0..*]The medicinal product that is being authorizedsubject : Reference [0..1] « MedicinalProduct| MedicinalProductPackaged »The country in which the marketing authorization has been grantedcountry : CodeableConcept [0..*]Jurisdiction within a countryjurisdiction : CodeableConcept [0..*]The status of the marketing authorizationstatus : CodeableConcept [0..1]The date at which the given status has become applicablestatusDate : dateTime [0..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 [0..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 [0..1]The legal framework against which this authorization is grantedlegalBasis : CodeableConcept [0..1]Marketing Authorization Holderholder : Reference [0..1] « Organization »Medicines Regulatory Agencyregulator : Reference [0..1] « Organization »JurisdictionalAuthorizationThe assigned number for the marketing authorizationidentifier : Identifier [0..*]Country of authorizationcountry : CodeableConcept [0..1]Jurisdiction within a countryjurisdiction : CodeableConcept [0..*]The legal status of supply in a jurisdiction or regionlegalStatusOfSupply : CodeableConcept [0..1]The start and expected end date of the authorizationvalidityPeriod : Period [0..1]ProcedureIdentifier for this procedureidentifier : Identifier [0..1]Type of proceduretype : CodeableConcept [1..1]Date of proceduredate[x] : Type [0..1] « Period|dateTime »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[0..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..* Identifier Business identifier for the marketing authorization, as assigned by a regulator --></identifier>
 <subject><!-- 0..1 Reference(MedicinalProduct|MedicinalProductPackaged) The medicinal product that is being authorized --></subject>
 <country><!-- 0..* CodeableConcept The country in which the marketing authorization has been granted --></country>
 <jurisdiction><!-- 0..* CodeableConcept Jurisdiction within a country --></jurisdiction>
 <status><!-- 0..1 CodeableConcept The status of the marketing authorization --></status>
 <statusDate value="[dateTime]"/><!-- 0..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><!-- 0..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]"/><!-- 0..1 Date of first marketing authorization for a company's new medicinal product in any country in the World -->
 <legalBasis><!-- 0..1 CodeableConcept The legal framework against which this authorization is granted --></legalBasis>
 <jurisdictionalAuthorization>  <!-- 0..* Authorization in areas within a country -->
  <identifier><!-- 0..* Identifier The assigned number for the marketing authorization --></identifier>
  <country><!-- 0..1 CodeableConcept Country of authorization --></country>
  <jurisdiction><!-- 0..* CodeableConcept Jurisdiction within a country --></jurisdiction>
  <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply in a jurisdiction or region --></legalStatusOfSupply>
  <validityPeriod><!-- 0..1 Period The start and expected end date of the authorization --></validityPeriod>
 </jurisdictionalAuthorization>
 <holder><!-- 0..1 Reference(Organization) Marketing Authorization Holder --></holder>
 <regulator><!-- 0..1 Reference(Organization) Medicines Regulatory Agency --></regulator>
 <procedure>  <!-- 0..1 The regulatory procedure for granting or amending a marketing authorization -->
  <identifier><!-- 0..1 Identifier Identifier for this procedure --></identifier>
  <type><!-- 1..1 CodeableConcept Type of procedure --></type>
  <date[x]><!-- 0..1 Period|dateTime Date of procedure --></date[x]>
  <application><!-- 0..* Content as for MedicinalProductAuthorization.procedure Applcations submitted to obtain a marketing authorization --></application>
 </procedure>
</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
  "subject" : { Reference(MedicinalProduct|MedicinalProductPackaged) }, // The medicinal product that is being authorized
  "country" : [{ CodeableConcept }], // The country in which the marketing authorization has been granted
  "jurisdiction" : [{ CodeableConcept }], // Jurisdiction within a country
  "status" : { CodeableConcept }, // The status of the marketing authorization
  "statusDate" : "<dateTime>", // 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 }, // 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>", // Date of first marketing authorization for a company's new medicinal product in any country in the World
  "legalBasis" : { CodeableConcept }, // The legal framework against which this authorization is granted
  "jurisdictionalAuthorization" : [{ // Authorization in areas within a country
    "identifier" : [{ Identifier }], // The assigned number for the marketing authorization
    "country" : { CodeableConcept }, // Country of authorization
    "jurisdiction" : [{ CodeableConcept }], // Jurisdiction within a country
    "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply in a jurisdiction or region
    "validityPeriod" : { Period } // The start and expected end date of the authorization
  }],
  "holder" : { Reference(Organization) }, // Marketing Authorization Holder
  "regulator" : { Reference(Organization) }, // Medicines Regulatory Agency
  "procedure" : { // The regulatory procedure for granting or amending a marketing authorization
    "identifier" : { Identifier }, // Identifier for this procedure
    "type" : { CodeableConcept }, // R!  Type of procedure
    // date[x]: Date of procedure. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "application" : [{ Content as for MedicinalProductAuthorization.procedure }] // Applcations submitted to obtain a marketing authorization
  }
}

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..* Business identifier for the marketing authorization, as assigned by a regulator
  fhir:MedicinalProductAuthorization.subject [ Reference(MedicinalProduct|MedicinalProductPackaged) ]; # 0..1 The medicinal product that is being authorized
  fhir:MedicinalProductAuthorization.country [ CodeableConcept ], ... ; # 0..* The country in which the marketing authorization has been granted
  fhir:MedicinalProductAuthorization.jurisdiction [ CodeableConcept ], ... ; # 0..* Jurisdiction within a country
  fhir:MedicinalProductAuthorization.status [ CodeableConcept ]; # 0..1 The status of the marketing authorization
  fhir:MedicinalProductAuthorization.statusDate [ dateTime ]; # 0..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 ]; # 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 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 ]; # 0..1 Date of first marketing authorization for a company's new medicinal product in any country in the World
  fhir:MedicinalProductAuthorization.legalBasis [ CodeableConcept ]; # 0..1 The legal framework against which this authorization is granted
  fhir:MedicinalProductAuthorization.jurisdictionalAuthorization [ # 0..* Authorization in areas within a country
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.identifier [ Identifier ], ... ; # 0..* The assigned number for the marketing authorization
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.country [ CodeableConcept ]; # 0..1 Country of authorization
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction [ CodeableConcept ], ... ; # 0..* Jurisdiction within a country
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply in a jurisdiction or region
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod [ Period ]; # 0..1 The start and expected end date of the authorization
  ], ...;
  fhir:MedicinalProductAuthorization.holder [ Reference(Organization) ]; # 0..1 Marketing Authorization Holder
  fhir:MedicinalProductAuthorization.regulator [ Reference(Organization) ]; # 0..1 Medicines Regulatory Agency
  fhir:MedicinalProductAuthorization.procedure [ # 0..1 The regulatory procedure for granting or amending a marketing authorization
    fhir:MedicinalProductAuthorization.procedure.identifier [ Identifier ]; # 0..1 Identifier for this procedure
    fhir:MedicinalProductAuthorization.procedure.type [ CodeableConcept ]; # 1..1 Type of procedure
    # MedicinalProductAuthorization.procedure.date[x] : 0..1 Date of procedure. One of these 2
      fhir:MedicinalProductAuthorization.procedure.datePeriod [ Period ]
      fhir:MedicinalProductAuthorization.procedure.dateDateTime [ dateTime ]
    fhir:MedicinalProductAuthorization.procedure.application [ See MedicinalProductAuthorization.procedure ], ... ; # 0..* Applcations submitted to obtain a marketing authorization
  ];
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = Not Mapped)

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductAuthorization ΣTUDomainResourceThe regulatory authorization of a medicinal product
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the marketing authorization, as assigned by a regulator
... subject Σ0..1Reference(MedicinalProduct | MedicinalProductPackaged)The medicinal product that is being authorized
... country Σ0..*CodeableConceptThe country in which the marketing authorization has been granted
... jurisdiction Σ0..*CodeableConceptJurisdiction within a country
... status Σ0..1CodeableConceptThe status of the marketing authorization
... statusDate Σ0..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 Σ0..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 Σ0..1dateTimeDate of first marketing authorization for a company's new medicinal product in any country in the World
... legalBasis Σ0..1CodeableConceptThe legal framework against which this authorization is granted
... jurisdictionalAuthorization Σ0..*BackboneElementAuthorization in areas within a country
.... identifier Σ0..*IdentifierThe assigned number for the marketing authorization
.... country Σ0..1CodeableConceptCountry of authorization
.... jurisdiction Σ0..*CodeableConceptJurisdiction within a country
.... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply in a jurisdiction or region
.... validityPeriod Σ0..1PeriodThe start and expected end date of the authorization
... holder Σ0..1Reference(Organization)Marketing Authorization Holder
... regulator Σ0..1Reference(Organization)Medicines Regulatory Agency
... procedure Σ0..1BackboneElementThe regulatory procedure for granting or amending a marketing authorization
.... identifier Σ0..1IdentifierIdentifier for this procedure
.... type Σ1..1CodeableConceptType of procedure
.... date[x] Σ0..1Date of procedure
..... datePeriodPeriod
..... dateDateTimedateTime
.... application Σ0..*see procedureApplcations submitted to obtain a marketing authorization

doco Documentation for this format

UML Diagram (Legend)

MedicinalProductAuthorization (DomainResource)Business identifier for the marketing authorization, as assigned by a regulatoridentifier : Identifier [0..*]The medicinal product that is being authorizedsubject : Reference [0..1] « MedicinalProduct| MedicinalProductPackaged »The country in which the marketing authorization has been grantedcountry : CodeableConcept [0..*]Jurisdiction within a countryjurisdiction : CodeableConcept [0..*]The status of the marketing authorizationstatus : CodeableConcept [0..1]The date at which the given status has become applicablestatusDate : dateTime [0..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 [0..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 [0..1]The legal framework against which this authorization is grantedlegalBasis : CodeableConcept [0..1]Marketing Authorization Holderholder : Reference [0..1] « Organization »Medicines Regulatory Agencyregulator : Reference [0..1] « Organization »JurisdictionalAuthorizationThe assigned number for the marketing authorizationidentifier : Identifier [0..*]Country of authorizationcountry : CodeableConcept [0..1]Jurisdiction within a countryjurisdiction : CodeableConcept [0..*]The legal status of supply in a jurisdiction or regionlegalStatusOfSupply : CodeableConcept [0..1]The start and expected end date of the authorizationvalidityPeriod : Period [0..1]ProcedureIdentifier for this procedureidentifier : Identifier [0..1]Type of proceduretype : CodeableConcept [1..1]Date of proceduredate[x] : Type [0..1] « Period|dateTime »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[0..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..* Identifier Business identifier for the marketing authorization, as assigned by a regulator --></identifier>
 <subject><!-- 0..1 Reference(MedicinalProduct|MedicinalProductPackaged) The medicinal product that is being authorized --></subject>
 <country><!-- 0..* CodeableConcept The country in which the marketing authorization has been granted --></country>
 <jurisdiction><!-- 0..* CodeableConcept Jurisdiction within a country --></jurisdiction>
 <status><!-- 0..1 CodeableConcept The status of the marketing authorization --></status>
 <statusDate value="[dateTime]"/><!-- 0..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><!-- 0..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]"/><!-- 0..1 Date of first marketing authorization for a company's new medicinal product in any country in the World -->
 <legalBasis><!-- 0..1 CodeableConcept The legal framework against which this authorization is granted --></legalBasis>
 <jurisdictionalAuthorization>  <!-- 0..* Authorization in areas within a country -->
  <identifier><!-- 0..* Identifier The assigned number for the marketing authorization --></identifier>
  <country><!-- 0..1 CodeableConcept Country of authorization --></country>
  <jurisdiction><!-- 0..* CodeableConcept Jurisdiction within a country --></jurisdiction>
  <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply in a jurisdiction or region --></legalStatusOfSupply>
  <validityPeriod><!-- 0..1 Period The start and expected end date of the authorization --></validityPeriod>
 </jurisdictionalAuthorization>
 <holder><!-- 0..1 Reference(Organization) Marketing Authorization Holder --></holder>
 <regulator><!-- 0..1 Reference(Organization) Medicines Regulatory Agency --></regulator>
 <procedure>  <!-- 0..1 The regulatory procedure for granting or amending a marketing authorization -->
  <identifier><!-- 0..1 Identifier Identifier for this procedure --></identifier>
  <type><!-- 1..1 CodeableConcept Type of procedure --></type>
  <date[x]><!-- 0..1 Period|dateTime Date of procedure --></date[x]>
  <application><!-- 0..* Content as for MedicinalProductAuthorization.procedure Applcations submitted to obtain a marketing authorization --></application>
 </procedure>
</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
  "subject" : { Reference(MedicinalProduct|MedicinalProductPackaged) }, // The medicinal product that is being authorized
  "country" : [{ CodeableConcept }], // The country in which the marketing authorization has been granted
  "jurisdiction" : [{ CodeableConcept }], // Jurisdiction within a country
  "status" : { CodeableConcept }, // The status of the marketing authorization
  "statusDate" : "<dateTime>", // 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 }, // 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>", // Date of first marketing authorization for a company's new medicinal product in any country in the World
  "legalBasis" : { CodeableConcept }, // The legal framework against which this authorization is granted
  "jurisdictionalAuthorization" : [{ // Authorization in areas within a country
    "identifier" : [{ Identifier }], // The assigned number for the marketing authorization
    "country" : { CodeableConcept }, // Country of authorization
    "jurisdiction" : [{ CodeableConcept }], // Jurisdiction within a country
    "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply in a jurisdiction or region
    "validityPeriod" : { Period } // The start and expected end date of the authorization
  }],
  "holder" : { Reference(Organization) }, // Marketing Authorization Holder
  "regulator" : { Reference(Organization) }, // Medicines Regulatory Agency
  "procedure" : { // The regulatory procedure for granting or amending a marketing authorization
    "identifier" : { Identifier }, // Identifier for this procedure
    "type" : { CodeableConcept }, // R!  Type of procedure
    // date[x]: Date of procedure. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "application" : [{ Content as for MedicinalProductAuthorization.procedure }] // Applcations submitted to obtain a marketing authorization
  }
}

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..* Business identifier for the marketing authorization, as assigned by a regulator
  fhir:MedicinalProductAuthorization.subject [ Reference(MedicinalProduct|MedicinalProductPackaged) ]; # 0..1 The medicinal product that is being authorized
  fhir:MedicinalProductAuthorization.country [ CodeableConcept ], ... ; # 0..* The country in which the marketing authorization has been granted
  fhir:MedicinalProductAuthorization.jurisdiction [ CodeableConcept ], ... ; # 0..* Jurisdiction within a country
  fhir:MedicinalProductAuthorization.status [ CodeableConcept ]; # 0..1 The status of the marketing authorization
  fhir:MedicinalProductAuthorization.statusDate [ dateTime ]; # 0..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 ]; # 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 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 ]; # 0..1 Date of first marketing authorization for a company's new medicinal product in any country in the World
  fhir:MedicinalProductAuthorization.legalBasis [ CodeableConcept ]; # 0..1 The legal framework against which this authorization is granted
  fhir:MedicinalProductAuthorization.jurisdictionalAuthorization [ # 0..* Authorization in areas within a country
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.identifier [ Identifier ], ... ; # 0..* The assigned number for the marketing authorization
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.country [ CodeableConcept ]; # 0..1 Country of authorization
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction [ CodeableConcept ], ... ; # 0..* Jurisdiction within a country
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply in a jurisdiction or region
    fhir:MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod [ Period ]; # 0..1 The start and expected end date of the authorization
  ], ...;
  fhir:MedicinalProductAuthorization.holder [ Reference(Organization) ]; # 0..1 Marketing Authorization Holder
  fhir:MedicinalProductAuthorization.regulator [ Reference(Organization) ]; # 0..1 Medicines Regulatory Agency
  fhir:MedicinalProductAuthorization.procedure [ # 0..1 The regulatory procedure for granting or amending a marketing authorization
    fhir:MedicinalProductAuthorization.procedure.identifier [ Identifier ]; # 0..1 Identifier for this procedure
    fhir:MedicinalProductAuthorization.procedure.type [ CodeableConcept ]; # 1..1 Type of procedure
    # MedicinalProductAuthorization.procedure.date[x] : 0..1 Date of procedure. One of these 2
      fhir:MedicinalProductAuthorization.procedure.datePeriod [ Period ]
      fhir:MedicinalProductAuthorization.procedure.dateDateTime [ dateTime ]
    fhir:MedicinalProductAuthorization.procedure.application [ See MedicinalProductAuthorization.procedure ], ... ; # 0..* Applcations submitted to obtain a marketing authorization
  ];
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = Not Mapped)

 

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
countrytokenThe country in which the marketing authorization has been grantedMedicinalProductAuthorization.country
holderreferenceMarketing Authorization HolderMedicinalProductAuthorization.holder
(Organization)
identifiertokenBusiness identifier for the marketing authorization, as assigned by a regulatorMedicinalProductAuthorization.identifier
statustokenThe status of the marketing authorizationMedicinalProductAuthorization.status
subjectreferenceThe medicinal product that is being authorizedMedicinalProductAuthorization.subject
(MedicinalProductPackaged, MedicinalProduct)