Package org.linuxforhealth.fhir.model.resource

Class RegulatedAuthorization

  • All Implemented Interfaces:
    Visitable
    @Generated("org.linuxforhealth.fhir.tools.CodeGenerator")
public class RegulatedAuthorization
extends DomainResource
    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.

    Maturity level: FMM1 (Trial Use)

    • Method Detail

      • getIdentifier

        public java.util.List<Identifier> getIdentifier()
        Business identifier for the authorization, typically assigned by the authorizing body.
        Returns:
        An unmodifiable list containing immutable objects of type Identifier that may be empty.

      • getSubject

        public java.util.List<Reference> getSubject()
        The product type, treatment, facility or activity that is being authorized.
        Returns:
        An unmodifiable list containing immutable objects of type Reference that may be empty.

      • getType

        public CodeableConcept getType()
        Overall type of this authorization, for example drug marketing approval, orphan drug designation.
        Returns:
        An immutable object of type CodeableConcept that may be null.

      • getDescription

        public Markdown getDescription()
        General textual supporting information.
        Returns:
        An immutable object of type Markdown that may be null.

      • getRegion

        public java.util.List<CodeableConcept> getRegion()
        The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.
        Returns:
        An unmodifiable list containing immutable objects of type CodeableConcept that may be empty.

      • getStatus

        public CodeableConcept getStatus()
        The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.
        Returns:
        An immutable object of type CodeableConcept that may be null.

      • getStatusDate

        public DateTime getStatusDate()
        The date at which the current status was assigned.
        Returns:
        An immutable object of type DateTime that may be null.

      • getValidityPeriod

        public Period getValidityPeriod()
        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.
        Returns:
        An immutable object of type Period that may be null.

      • getIndication

        public CodeableReference getIndication()
        Condition for which the use of the regulated product applies.
        Returns:
        An immutable object of type CodeableReference that may be null.

      • getIntendedUse

        public CodeableConcept getIntendedUse()
        The intended use of the product, e.g. prevention, treatment, diagnosis.
        Returns:
        An immutable object of type CodeableConcept that may be null.

      • getBasis

        public java.util.List<CodeableConcept> getBasis()
        The legal or regulatory framework against which this authorization is granted, or other reasons for it.
        Returns:
        An unmodifiable list containing immutable objects of type CodeableConcept that may be empty.

      • getHolder

        public Reference getHolder()
        The organization that has been granted this authorization, by some authoritative body (the 'regulator').
        Returns:
        An immutable object of type Reference that may be null.

      • getRegulator

        public Reference getRegulator()
        The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.
        Returns:
        An immutable object of type Reference that may be null.

      • getCase

        public RegulatedAuthorization.Case getCase()
        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).
        Returns:
        An immutable object of type RegulatedAuthorization.Case that may be null.

      • accept

        public void accept​(java.lang.String elementName,
                   int elementIndex,
                   Visitor visitor)
        Description copied from interface: Visitable
        Accept a Visitor and invoke the appropriate visit methods. A typical implementation would look like this: 
         if (visitor.preVisit(this)) {
     visitor.visitStart(elementName, elementIndex, this);
     if (visitor.visit(elementName, elementIndex, this)) {
         // visit children
     }
     visitor.visitEnd(elementName, elementIndex, this);
     visitor.postVisit(this);
 }
        Specified by:
        accept in interface Visitable
        Specified by:
        accept in class AbstractVisitable
        Parameters:
        elementName - the name of the element in the context of this visit
        elementIndex - the index of the element in a list or -1 if it is not contained within a List
        visitor - the visitor to use

      • equals

        public boolean equals​(java.lang.Object obj)
        Overrides:
        equals in class java.lang.Object

      • hashCode

        public int hashCode()
        Overrides:
        hashCode in class java.lang.Object