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

Подробное описание элементов ресурса MedicinalProductAuthorization.

MedicinalProductAuthorization
Element IdMedicinalProductAuthorization
Definition

The regulatory authorization of a medicinal product.

Control0..*
TypeDomainResource
Summarytrue
MedicinalProductAuthorization.identifier
Element IdMedicinalProductAuthorization.identifier
Definition

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

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Summarytrue
MedicinalProductAuthorization.subject
Element IdMedicinalProductAuthorization.subject
Definition

The medicinal product that is being authorized.

Control0..1
TypeReference(MedicinalProduct | MedicinalProductPackaged)
Summarytrue
MedicinalProductAuthorization.country
Element IdMedicinalProductAuthorization.country
Definition

The country in which the marketing authorization has been granted.

Control0..*
TypeCodeableConcept
Summarytrue
MedicinalProductAuthorization.jurisdiction
Element IdMedicinalProductAuthorization.jurisdiction
Definition

Jurisdiction within a country.

Control0..*
TypeCodeableConcept
Summarytrue
MedicinalProductAuthorization.status
Element IdMedicinalProductAuthorization.status
Definition

The status of the marketing authorization.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductAuthorization.statusDate
Element IdMedicinalProductAuthorization.statusDate
Definition

The date at which the given status has become applicable.

Control0..1
TypedateTime
Summarytrue
MedicinalProductAuthorization.restoreDate
Element IdMedicinalProductAuthorization.restoreDate
Definition

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

Control0..1
TypedateTime
Summarytrue
MedicinalProductAuthorization.validityPeriod
Element IdMedicinalProductAuthorization.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.

Control0..1
TypePeriod
Summarytrue
MedicinalProductAuthorization.dataExclusivityPeriod
Element IdMedicinalProductAuthorization.dataExclusivityPeriod
Definition

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

Control0..1
TypePeriod
Summarytrue
MedicinalProductAuthorization.dateOfFirstAuthorization
Element IdMedicinalProductAuthorization.dateOfFirstAuthorization
Definition

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

Control0..1
TypedateTime
Summarytrue
MedicinalProductAuthorization.internationalBirthDate
Element IdMedicinalProductAuthorization.internationalBirthDate
Definition

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

Control0..1
TypedateTime
Summarytrue
MedicinalProductAuthorization.legalBasis
Element IdMedicinalProductAuthorization.legalBasis
Definition

The legal framework against which this authorization is granted.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductAuthorization.jurisdictionalAuthorization
Element IdMedicinalProductAuthorization.jurisdictionalAuthorization
Definition

Authorization in areas within a country.

Control0..*
Summarytrue
MedicinalProductAuthorization.jurisdictionalAuthorization.identifier
Element IdMedicinalProductAuthorization.jurisdictionalAuthorization.identifier
Definition

The assigned number for the marketing authorization.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Summarytrue
MedicinalProductAuthorization.jurisdictionalAuthorization.country
Element IdMedicinalProductAuthorization.jurisdictionalAuthorization.country
Definition

Country of authorization.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction
Element IdMedicinalProductAuthorization.jurisdictionalAuthorization.jurisdiction
Definition

Jurisdiction within a country.

Control0..*
TypeCodeableConcept
Summarytrue
MedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply
Element IdMedicinalProductAuthorization.jurisdictionalAuthorization.legalStatusOfSupply
Definition

The legal status of supply in a jurisdiction or region.

Control0..1
TypeCodeableConcept
Summarytrue
MedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod
Element IdMedicinalProductAuthorization.jurisdictionalAuthorization.validityPeriod
Definition

The start and expected end date of the authorization.

Control0..1
TypePeriod
Summarytrue
MedicinalProductAuthorization.holder
Element IdMedicinalProductAuthorization.holder
Definition

Marketing Authorization Holder.

Control0..1
TypeReference(Organization)
Summarytrue
MedicinalProductAuthorization.regulator
Element IdMedicinalProductAuthorization.regulator
Definition

Medicines Regulatory Agency.

Control0..1
TypeReference(Organization)
Summarytrue
MedicinalProductAuthorization.procedure
Element IdMedicinalProductAuthorization.procedure
Definition

The regulatory procedure for granting or amending a marketing authorization.

Control0..1
Summarytrue
MedicinalProductAuthorization.procedure.identifier
Element IdMedicinalProductAuthorization.procedure.identifier
Definition

Identifier for this procedure.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Summarytrue
MedicinalProductAuthorization.procedure.type
Element IdMedicinalProductAuthorization.procedure.type
Definition

Type of procedure.

Control1..1
TypeCodeableConcept
Summarytrue
MedicinalProductAuthorization.procedure.date[x]
Element IdMedicinalProductAuthorization.procedure.date[x]
Definition

Date of procedure.

Control0..1
TypePeriod|dateTime
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
MedicinalProductAuthorization.procedure.application
Element IdMedicinalProductAuthorization.procedure.application
Definition

Applcations submitted to obtain a marketing authorization.

Control0..*
TypeSee MedicinalProductAuthorization.procedure
Summarytrue