This page is part of the FHIR Specification (v4.0.1: R4 - Mixed Normative and STU) in it's permanent home (it will always be available at this URL). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.12 Resource MedicinalProductAuthorization - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

The regulatory authorization of a medicinal product.

11.12.1 Scope and Usage

This resource is still undergoing development and review by the appropriate Workgroups. At this time, is considered only as a draft resource not suitable for production implementation

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

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductAuthorization	Σ TU		DomainResource	The regulatory authorization of a medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business identifier for the marketing authorization, as assigned by a regulator
subject	Σ	0..1	Reference(MedicinalProduct \| MedicinalProductPackaged)	The medicinal product that is being authorized
country	Σ	0..*	CodeableConcept	The country in which the marketing authorization has been granted
jurisdiction	Σ	0..*	CodeableConcept	Jurisdiction within a country
status	Σ	0..1	CodeableConcept	The status of the marketing authorization
statusDate	Σ	0..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	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
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	0..1	dateTime	Date of first marketing authorization for a company's new medicinal product in any country in the World
legalBasis	Σ	0..1	CodeableConcept	The legal framework against which this authorization is granted
jurisdictionalAuthorization	Σ	0..*	BackboneElement	Authorization in areas within a country
identifier	Σ	0..*	Identifier	The assigned number for the marketing authorization
country	Σ	0..1	CodeableConcept	Country of authorization
jurisdiction	Σ	0..*	CodeableConcept	Jurisdiction within a country
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply in a jurisdiction or region
validityPeriod	Σ	0..1	Period	The start and expected end date of the authorization
holder	Σ	0..1	Reference(Organization)	Marketing Authorization Holder
regulator	Σ	0..1	Reference(Organization)	Medicines Regulatory Agency
procedure	Σ	0..1	BackboneElement	The regulatory procedure for granting or amending a marketing authorization
identifier	Σ	0..1	Identifier	Identifier for this procedure
type	Σ	1..1	CodeableConcept	Type of procedure
date[x]	Σ	0..1		Date of procedure
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	see procedure	Applcations submitted to obtain a marketing authorization
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..* 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

{
  "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/> .


[ 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.

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductAuthorization	Σ TU		DomainResource	The regulatory authorization of a medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business identifier for the marketing authorization, as assigned by a regulator
subject	Σ	0..1	Reference(MedicinalProduct \| MedicinalProductPackaged)	The medicinal product that is being authorized
country	Σ	0..*	CodeableConcept	The country in which the marketing authorization has been granted
jurisdiction	Σ	0..*	CodeableConcept	Jurisdiction within a country
status	Σ	0..1	CodeableConcept	The status of the marketing authorization
statusDate	Σ	0..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	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
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	0..1	dateTime	Date of first marketing authorization for a company's new medicinal product in any country in the World
legalBasis	Σ	0..1	CodeableConcept	The legal framework against which this authorization is granted
jurisdictionalAuthorization	Σ	0..*	BackboneElement	Authorization in areas within a country
identifier	Σ	0..*	Identifier	The assigned number for the marketing authorization
country	Σ	0..1	CodeableConcept	Country of authorization
jurisdiction	Σ	0..*	CodeableConcept	Jurisdiction within a country
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply in a jurisdiction or region
validityPeriod	Σ	0..1	Period	The start and expected end date of the authorization
holder	Σ	0..1	Reference(Organization)	Marketing Authorization Holder
regulator	Σ	0..1	Reference(Organization)	Medicines Regulatory Agency
procedure	Σ	0..1	BackboneElement	The regulatory procedure for granting or amending a marketing authorization
identifier	Σ	0..1	Identifier	Identifier for this procedure
type	Σ	1..1	CodeableConcept	Type of procedure
date[x]	Σ	0..1		Date of procedure
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	see procedure	Applcations submitted to obtain a marketing authorization
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..* 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

{
  "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/> .


[ 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 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

11.12.3 Search Parameters

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

Name	Type	Description	Expression	In Common
country	token	The country in which the marketing authorization has been granted	MedicinalProductAuthorization.country
holder	reference	Marketing Authorization Holder	MedicinalProductAuthorization.holder (Organization)
identifier	token	Business identifier for the marketing authorization, as assigned by a regulator	MedicinalProductAuthorization.identifier
status	token	The status of the marketing authorization	MedicinalProductAuthorization.status
subject	reference	The medicinal product that is being authorized	MedicinalProductAuthorization.subject (MedicinalProductPackaged, MedicinalProduct)