R4 Ballot #1 #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: (v3.5.0: R4 Ballot 2). #2). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions

11.7.4 11.8.5 Resource MedicinalProductAuthorization - Detailed Descriptions

Biomedical Research and Regulation Work Group Maturity Level : 0   Draft Trial Use Compartments : Not linked to any defined compartments

Detailed Descriptions for the elements in the MedicinalProductAuthorization resource.

MedicinalProductAuthorization
Element Id MedicinalProductAuthorization
Definition

The regulatory authorization of a medicinal product.

Control 1..1
Type DomainResource
Summary true
MedicinalProductAuthorization.identifier
Element Id MedicinalProductAuthorization.identifier
Definition

Business identifier for the marketing authorization, as assigned by a regulator.

Note This is a business identifer, not a resource identifier (see discussion )
Control 0..1 0..*
Type Identifier
Summary true
MedicinalProductAuthorization.subject
Element Id MedicinalProductAuthorization.subject
Definition

The medicinal product that is being authorized.

Control 0..1
Type Reference ( MedicinalProduct | MedicinalProductPackaged )
Summary true
MedicinalProductAuthorization.country
Element Id MedicinalProductAuthorization.country
Definition

The country in which the marketing authorization has been granted.

Control 1..* 0..*
Type CodeableConcept
Summary true
MedicinalProductAuthorization.jurisdiction
Element Id MedicinalProductAuthorization.jurisdiction
Definition

Jurisdiction within a country.

Control 0..*
Type CodeableConcept
Summary true
MedicinalProductAuthorization.legalStatusOfSupply
Element Id MedicinalProductAuthorization.legalStatusOfSupply
Definition

The legal status of supply of the medicinal product as classified by the regulator.

Control 1..1 0..1
Type CodeableConcept
Summary true
MedicinalProductAuthorization.status
Element Id MedicinalProductAuthorization.status
Definition

The status of the marketing authorization.

Control 1..1 0..1
Type CodeableConcept
Summary true
MedicinalProductAuthorization.statusDate
Element Id MedicinalProductAuthorization.statusDate
Definition

The date at which the given status has become applicable.

Control 1..1 0..1
Type dateTime
Summary true
MedicinalProductAuthorization.restoreDate
Element Id MedicinalProductAuthorization.restoreDate
Definition

The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored.

Control 0..1
Type dateTime
Summary true
MedicinalProductAuthorization.validityPeriod
Element Id MedicinalProductAuthorization.validityPeriod
Definition

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.

Control 1..1 0..1
Type Period
Summary true
MedicinalProductAuthorization.dataExclusivityPeriod
Element Id MedicinalProductAuthorization.dataExclusivityPeriod
Definition

A period of time after authorization before generic product applicatiosn can be submitted.

Control 0..1
Type Period
Summary true
MedicinalProductAuthorization.dateOfFirstAuthorization
Element Id MedicinalProductAuthorization.dateOfFirstAuthorization
Definition

The date when the first authorization was granted by a Medicines Regulatory Agency.

Control 0..1
Type dateTime
Summary true
MedicinalProductAuthorization.internationalBirthDate
Element Id MedicinalProductAuthorization.internationalBirthDate
Definition

Date of first marketing authorization for a company's new medicinal product in any country in the World.

Control 1..1 0..1
Type dateTime
Summary true
MedicinalProductAuthorization.jurisdictionalAuthorization Element Id MedicinalProductAuthorization.jurisdictionalAuthorization Definition Authorization in areas within a country. Control 0..* Summary true MedicinalProductAuthorization.jurisdictionalAuthorization.country MedicinalProductAuthorization.legalBasis
Element Id MedicinalProductAuthorization.jurisdictionalAuthorization.country MedicinalProductAuthorization.legalBasis
Definition

Country of authorization. The legal framework against which this authorization is granted.

Control 1..1 0..1
Type CodeableConcept
Summary true
MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction MedicinalProductAuthorization.jurisdictionalAuthorization
Element Id MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction MedicinalProductAuthorization.jurisdictionalAuthorization
Definition

Jurisdiction Authorization in areas within a country.

Control 0..1 Type CodeableConcept 0..*
Summary true
MedicinalProductAuthorization.jurisdictionalAuthorization.number MedicinalProductAuthorization.jurisdictionalAuthorization.identifier
Element Id MedicinalProductAuthorization.jurisdictionalAuthorization.number MedicinalProductAuthorization.jurisdictionalAuthorization.identifier
Definition

The assigned number for the marketing authorization.

Note This is a business identifer, not a resource identifier (see discussion )
Control 0..1 0..*
Type Identifier
Summary true
MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply MedicinalProductAuthorization.jurisdictionalAuthorization.country
Element Id MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply MedicinalProductAuthorization.jurisdictionalAuthorization.country
Definition

The legal status Country of supply in a jurisdiction or region. authorization.

Control 0..1
Type CodeableConcept
Summary true
MedicinalProductAuthorization.holder MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction
Element Id MedicinalProductAuthorization.holder MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction
Definition

Marketing Authorization Holder. Jurisdiction within a country.

Control 1..1 0..*
Type Reference ( Organization CodeableConcept )
Summary true
MedicinalProductAuthorization.regulator MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply
Element Id MedicinalProductAuthorization.regulator MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply
Definition

Medicines Regulatory Agency. The legal status of supply in a jurisdiction or region.

Control 1..1 0..1
Type Reference ( Organization CodeableConcept )
Summary true
MedicinalProductAuthorization.procedure MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod
Element Id MedicinalProductAuthorization.procedure MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod
Definition

The regulatory procedure for granting or amending a marketing start and expected end date of the authorization.

Control 1..1 Summary true MedicinalProductAuthorization.procedure.number Element Id MedicinalProductAuthorization.procedure.number Definition Identifier for this procedure. Control 0..1
Type Identifier Period
Summary true
MedicinalProductAuthorization.procedure.type MedicinalProductAuthorization.holder
Element Id MedicinalProductAuthorization.procedure.type MedicinalProductAuthorization.holder
Definition

Type of procedure. Marketing Authorization Holder.

Control 1..1 0..1
Type CodeableConcept Reference ( Organization )
Summary true
MedicinalProductAuthorization.procedure.date MedicinalProductAuthorization.regulator
Element Id MedicinalProductAuthorization.procedure.date MedicinalProductAuthorization.regulator
Definition

Date of procedure. Medicines Regulatory Agency.

Control 0..1
Type Period Reference ( Organization )
Summary true
MedicinalProductAuthorization.procedure.application MedicinalProductAuthorization.procedure
Element Id MedicinalProductAuthorization.procedure.application MedicinalProductAuthorization.procedure
Definition

Applcations submitted to obtain The regulatory procedure for granting or amending a marketing authorization.

Control 0..* 0..1
Summary true
MedicinalProductAuthorization.procedure.application.number MedicinalProductAuthorization.procedure.identifier
Element Id MedicinalProductAuthorization.procedure.application.number MedicinalProductAuthorization.procedure.identifier
Definition

A unique identifier Identifier for the specific instance of an application shall be provided in text. The application identifier/number this procedure.

Note This is usually assigned by a Medicines Regulatory Agency. business identifer, not a resource identifier (see discussion )
Control 1..1 0..1
Type Identifier
Summary true
MedicinalProductAuthorization.procedure.application.type MedicinalProductAuthorization.procedure.type
Element Id MedicinalProductAuthorization.procedure.application.type MedicinalProductAuthorization.procedure.type
Definition

The type Type of the application. procedure.

Control 1..1
Type CodeableConcept
Summary true
MedicinalProductAuthorization.procedure.application.date MedicinalProductAuthorization.procedure.date[x]
Element Id MedicinalProductAuthorization.procedure.application.date MedicinalProductAuthorization.procedure.date[x]
Definition

Date that the application was made. of procedure.

Control 1..1 0..1
Type Period | dateTime
[x] Note See Choice of Data Types for further information about how to use [x]
Summary true
MedicinalProductAuthorization.marketingStatus MedicinalProductAuthorization.procedure.application
Element Id MedicinalProductAuthorization.marketingStatus MedicinalProductAuthorization.procedure.application
Definition

Marketing status of the medicinal product, in contrast Applcations submitted to obtain a marketing authorizaton. authorization.

Control 0..*
Type MarketingStatus See MedicinalProductAuthorization.procedure
Summary true