11.7 11.8 Resource MedicinalProductAuthorization - Content

<MedicinalProductAuthorization xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>
 <</country>
 <</legalStatusOfSupply>
 <</status>
 <

 <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>
 <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator --></legalStatusOfSupply>
 <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>

 <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 -->
  <</country>
  <</jurisdiction>
  <</number>

  <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>
 <</regulator>
 <
  <</number>

 <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>
  <
   <</number>
   <</type>
   <
  </application>

  <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>
 <</marketingStatus>

</MedicinalProductAuthorization>

{
  "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
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "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
  }

}

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


[ 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:
  fhir:
  fhir:
  fhir:
  fhir:

  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.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply of the medicinal product as classified by the regulator
  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:

  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:

  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:
    fhir:
    fhir:

    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:
  fhir:
  fhir:
    fhir:

  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
    fhir:
    fhir:
      fhir:
      fhir:
      fhir:
    ], ...;

    # 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

  ];
  fhir:

]

This resource did not exist in Release 2

This analysis is available as XML or JSON .

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

<MedicinalProductAuthorization xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>
 <</country>
 <</legalStatusOfSupply>
 <</status>
 <

 <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>
 <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator --></legalStatusOfSupply>
 <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>

 <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 -->
  <</country>
  <</jurisdiction>
  <</number>

  <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>
 <</regulator>
 <
  <</number>

 <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>
  <
   <</number>
   <</type>
   <
  </application>

  <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>
 <</marketingStatus>

</MedicinalProductAuthorization>

{
  "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
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "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
  }

}

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


[ 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:
  fhir:
  fhir:
  fhir:
  fhir:

  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.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply of the medicinal product as classified by the regulator
  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:

  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:

  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:
    fhir:
    fhir:

    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:
  fhir:
  fhir:
    fhir:

  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
    fhir:
    fhir:
      fhir:
      fhir:
      fhir:
    ], ...;

    # 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

  ];
  fhir:

]

This resource did not exist in Release 2

This analysis is available as XML or JSON .

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