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11.7 Resource MedicinalProductAuthorization - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Draft

Compartments: Not linked to any defined compartments

The regulatory authorization of a medicinal product.

11.7.1 Scope and Usage

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

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductAuthorization	Σ D		DomainResource	The regulatory authorization of a medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..1	Identifier	Business identifier for the marketing authorization, as assigned by a regulator
country	Σ	1..*	CodeableConcept	The country in which the marketing authorization has been granted
legalStatusOfSupply	Σ	1..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator
status	Σ	1..1	CodeableConcept	The status of the marketing authorization
statusDate	Σ	1..1	dateTime	The date at which the given status has become applicable
restoreDate	Σ	0..1	dateTime	The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
validityPeriod	Σ	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
dataExclusivityPeriod	Σ	0..1	Period	A period of time after authorization before generic product applicatiosn can be submitted
dateOfFirstAuthorization	Σ	0..1	dateTime	The date when the first authorization was granted by a Medicines Regulatory Agency
internationalBirthDate	Σ	1..1	dateTime	Date of first marketing authorization for a company's new medicinal product in any country in the World
jurisdictionalAuthorization	Σ	0..*	BackboneElement	Authorization in areas within a country
country	Σ	1..1	CodeableConcept	Country of authorization
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction within a country
number	Σ	0..1	Identifier	The assigned number for the marketing authorization
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply in a jurisdiction or region
holder	Σ	1..1	Reference(Organization)	Marketing Authorization Holder
regulator	Σ	1..1	Reference(Organization)	Medicines Regulatory Agency
procedure	Σ	1..1	BackboneElement	The regulatory procedure for granting or amending a marketing authorization
number	Σ	0..1	Identifier	Identifier for this procedure
type	Σ	1..1	CodeableConcept	Type of procedure
date	Σ	0..1	Period	Date of procedure
application	Σ	0..*	BackboneElement	Applcations submitted to obtain a marketing authorization
number	Σ	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
type	Σ	1..1	CodeableConcept	The type of the application
date	Σ	1..1	dateTime	Date that that application was made
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorizaton
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductAuthorization xmlns="http://hl7.org/fhir"> 
 <!-- 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 that application was made -->
  </application>
 </procedure>
 <marketingStatus><!-- 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorizaton --></marketingStatus>
</MedicinalProductAuthorization>

JSON Template

{
  "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 that application was made
    }]
  },
  "marketingStatus" : [{ MarketingStatus }] // Marketing status of the medicinal product, in contrast to marketing authorizaton
}

Turtle Template

@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: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 that 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.