Class TMedicinalProductAuthorization

Unit

Declaration

type TMedicinalProductAuthorization = class(TDomainResource)

Description

The regulatory authorization of a medicinal product. If the element is present, it must have either a @value, an @id, or extensions

Hierarchy

Overview

Methods

Public constructor Create; override;

Properties

Public property identifier : TIdentifierArray read GetidentifierArray;
Public property subject : TReference read Getsubject write Setsubject;
Public property country : TCodeableConceptArray read GetcountryArray;
Public property jurisdiction : TCodeableConceptArray read GetjurisdictionArray;
Public property status : TCodeableConcept read Getstatus write Setstatus;
Public property statusDate : string read GetstatusDate write SetstatusDate;
Public property statusDateElement : TdateTime_ read GetstatusDateElement write SetstatusDateElement;
Public property restoreDate : string read GetrestoreDate write SetrestoreDate;
Public property restoreDateElement : TdateTime_ read GetrestoreDateElement write SetrestoreDateElement;
Public property validityPeriod : TPeriod read GetvalidityPeriod write SetvalidityPeriod;
Public property dataExclusivityPeriod : TPeriod read GetdataExclusivityPeriod write SetdataExclusivityPeriod;
Public property dateOfFirstAuthorization : string read GetdateOfFirstAuthorization write SetdateOfFirstAuthorization;
Public property dateOfFirstAuthorizationElement : TdateTime_ read GetdateOfFirstAuthorizationElement write SetdateOfFirstAuthorizationElement;
Public property internationalBirthDate : string read GetinternationalBirthDate write SetinternationalBirthDate;
Public property internationalBirthDateElement : TdateTime_ read GetinternationalBirthDateElement write SetinternationalBirthDateElement;
Public property legalBasis : TCodeableConcept read GetlegalBasis write SetlegalBasis;
Public property jurisdictionalAuthorization : TMedicinalProductAuthorizationJurisdictionalAuthorizationArray read GetjurisdictionalAuthorizationArray;
Public property holder : TReference read Getholder write Setholder;
Public property regulator : TReference read Getregulator write Setregulator;
Public property procedure_ : TMedicinalProductAuthorizationProcedure read Getprocedure_ write Setprocedure_;

Description

Methods

Public constructor Create; override;
 

Properties

Public property identifier : TIdentifierArray read GetidentifierArray;

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

Public property subject : TReference read Getsubject write Setsubject;

The medicinal product that is being authorized.

Public property country : TCodeableConceptArray read GetcountryArray;

The country in which the marketing authorization has been granted.

Public property jurisdiction : TCodeableConceptArray read GetjurisdictionArray;

Jurisdiction within a country.

Public property status : TCodeableConcept read Getstatus write Setstatus;

The status of the marketing authorization.

Public property statusDate : string read GetstatusDate write SetstatusDate;

The date at which the given status has become applicable.

Public property statusDateElement : TdateTime_ read GetstatusDateElement write SetstatusDateElement;
 
Public property restoreDate : string read GetrestoreDate write SetrestoreDate;

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

Public property restoreDateElement : TdateTime_ read GetrestoreDateElement write SetrestoreDateElement;
 
Public property validityPeriod : TPeriod read GetvalidityPeriod write SetvalidityPeriod;

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.

Public property dataExclusivityPeriod : TPeriod read GetdataExclusivityPeriod write SetdataExclusivityPeriod;

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

Public property dateOfFirstAuthorization : string read GetdateOfFirstAuthorization write SetdateOfFirstAuthorization;

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

Public property dateOfFirstAuthorizationElement : TdateTime_ read GetdateOfFirstAuthorizationElement write SetdateOfFirstAuthorizationElement;
 
Public property internationalBirthDate : string read GetinternationalBirthDate write SetinternationalBirthDate;

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

Public property internationalBirthDateElement : TdateTime_ read GetinternationalBirthDateElement write SetinternationalBirthDateElement;
 
Public property legalBasis : TCodeableConcept read GetlegalBasis write SetlegalBasis;

The legal framework against which this authorization is granted.

Public property jurisdictionalAuthorization : TMedicinalProductAuthorizationJurisdictionalAuthorizationArray read GetjurisdictionalAuthorizationArray;

Authorization in areas within a country.

Public property holder : TReference read Getholder write Setholder;

Marketing Authorization Holder.

Public property regulator : TReference read Getregulator write Setregulator;

Medicines Regulatory Agency.

Public property procedure_ : TMedicinalProductAuthorizationProcedure read Getprocedure_ write Setprocedure_;

The regulatory procedure for granting or amending a marketing authorization.


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