Besa Fhir Help File

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Class TRegulatedAuthorization

Description
Hierarchy
Fields
Methods
Properties

Unit

bsFhir_r4b

Declaration

type TRegulatedAuthorization = class(TDomainResource)

Description

Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to 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 : TReferenceArray read GetsubjectArray;
Public property type_ : TCodeableConcept read Gettype_ write Settype_;
Public property description : string read Getdescription write Setdescription;
Public property descriptionElement : Tmarkdown read GetdescriptionElement write SetdescriptionElement;
Public property region : TCodeableConceptArray read GetregionArray;
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 validityPeriod : TPeriod read GetvalidityPeriod write SetvalidityPeriod;
Public property indication : TCodeableReference read Getindication write Setindication;
Public property intendedUse : TCodeableConcept read GetintendedUse write SetintendedUse;
Public property basis : TCodeableConceptArray read GetbasisArray;
Public property holder : TReference read Getholder write Setholder;
Public property regulator : TReference read Getregulator write Setregulator;
Public property case_ : TRegulatedAuthorizationCase read Getcase_ write Setcase_;

Description

Methods

Public constructor Create; override;
 

Properties

Public property identifier : TIdentifierArray read GetidentifierArray;

Business identifier for the authorization, typically assigned by the authorizing body.

Public property subject : TReferenceArray read GetsubjectArray;

The product type, treatment, facility or activity that is being authorized.

Public property type_ : TCodeableConcept read Gettype_ write Settype_;

Overall type of this authorization, for example drug marketing approval, orphan drug designation.

Public property description : string read Getdescription write Setdescription;

General textual supporting information.

Public property descriptionElement : Tmarkdown read GetdescriptionElement write SetdescriptionElement;
 
Public property region : TCodeableConceptArray read GetregionArray;

The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.

Public property status : TCodeableConcept read Getstatus write Setstatus;

The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.

Public property statusDate : string read GetstatusDate write SetstatusDate;

The date at which the current status was assigned.

Public property statusDateElement : TdateTime_ read GetstatusDateElement write SetstatusDateElement;
 
Public property validityPeriod : TPeriod read GetvalidityPeriod write SetvalidityPeriod;

The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.

Public property indication : TCodeableReference read Getindication write Setindication;

Condition for which the use of the regulated product applies.

Public property intendedUse : TCodeableConcept read GetintendedUse write SetintendedUse;

The intended use of the product, e.g. prevention, treatment, diagnosis.

Public property basis : TCodeableConceptArray read GetbasisArray;

The legal or regulatory framework against which this authorization is granted, or other reasons for it.

Public property holder : TReference read Getholder write Setholder;

The organization that has been granted this authorization, by some authoritative body (the 'regulator').

Public property regulator : TReference read Getregulator write Setregulator;

The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.

Public property case_ : TRegulatedAuthorizationCase read Getcase_ write Setcase_;

The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).

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