<?xml version="1.0" encoding="UTF-8"?>
<!-- 
 * #%L
 * org.hl7.fhir.r5
 * %%
 * Copyright (C) 2014 - 2019 Health Level 7
 * %%
 * Licensed under the Apache License, Version 2.0 (the "License");
 * you may not use this file except in compliance with the License.
 * You may obtain a copy of the License at
 * 
 *      http://www.apache.org/licenses/LICENSE-2.0
 * 
 * Unless required by applicable law or agreed to in writing, software
 * distributed under the License is distributed on an "AS IS" BASIS,
 * WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied.
 * See the License for the specific language governing permissions and
 * limitations under the License.
 * #L%
 */

/*
  Copyright (c) 2011+, HL7, Inc.
  All rights reserved.
  
  Redistribution and use in source and binary forms, with or without modification, 
  are permitted provided that the following conditions are met:
  
   * Redistributions of source code must retain the above copyright notice, this 
     list of conditions and the following disclaimer.
   * Redistributions in binary form must reproduce the above copyright notice, 
     this list of conditions and the following disclaimer in the documentation 
     and/or other materials provided with the distribution.
   * Neither the name of HL7 nor the names of its contributors may be used to 
     endorse or promote products derived from this software without specific 
     prior written permission.
  
  THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS "AS IS" AND 
  ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED 
  WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. 
  IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, 
  INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT 
  NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR 
  PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, 
  WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) 
  ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE 
  POSSIBILITY OF SUCH DAMAGE.
  

  Generated on Sun, Jun 14, 2026 12:41+0000 for FHIR v6.0.0-ballot4 

  Note: the schemas &amp; schematrons do not contain all of the rules about what makes resources
  valid. Implementers will still need to be familiar with the content of the specification and with
  any profiles that apply to the resources in order to make a conformant implementation.

-->
<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns="http://hl7.org/fhir" xmlns:xhtml="http://www.w3.org/1999/xhtml" targetNamespace="http://hl7.org/fhir" elementFormDefault="qualified" version="1.0">
  <xs:include schemaLocation="fhir-base.xsd"/>
  <xs:element name="RegulatedAuthorization" type="RegulatedAuthorization">
    <xs:annotation>
      <xs:documentation xml:lang="en">Regulatory approval, clearance or licensing 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.</xs:documentation>
    </xs:annotation>
  </xs:element>
  <xs:complexType name="RegulatedAuthorization">
    <xs:annotation>
      <xs:documentation xml:lang="en">Regulatory approval, clearance or licensing 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.</xs:documentation>
      <xs:documentation xml:lang="en">If the element is present, it must have either a @value, an @id, or extensions</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="DomainResource">
        <xs:sequence>
          <xs:element name="identifier" minOccurs="0" maxOccurs="unbounded" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">Business identifier for the authorization, typically assigned by the authorizing body.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="subject" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The product type, treatment, facility or activity that is being authorized.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Overall type of this authorization, for example drug marketing approval, orphan drug designation.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="description" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">General textual supporting information.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="region" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="status" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="statusDate" minOccurs="0" maxOccurs="1" type="dateTime">
            <xs:annotation>
              <xs:documentation xml:lang="en">The date at which the current status was assigned.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="validityPeriod" minOccurs="0" maxOccurs="1" type="Period">
            <xs:annotation>
              <xs:documentation xml:lang="en">The time period in which the regulatory approval, clearance or licensing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="indication" minOccurs="0" maxOccurs="unbounded" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Condition for which the use of the regulated product applies.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="intendedUse" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The intended use of the product, e.g. prevention, treatment, diagnosis.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="basis" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The legal or regulatory framework against which this authorization is granted, or other reasons for it.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="holder" minOccurs="0" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The organization that has been granted this authorization, by some authoritative body (the 'regulator').</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="regulator" minOccurs="0" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="attachedDocument" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Additional information or supporting documentation about the authorization.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="case" type="RegulatedAuthorization.Case" minOccurs="0" maxOccurs="1">
            <xs:annotation>
              <xs:documentation xml:lang="en">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).</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="RegulatedAuthorization.Case">
    <xs:annotation>
      <xs:documentation xml:lang="en">Regulatory approval, clearance or licensing 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.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="identifier" minOccurs="0" maxOccurs="unbounded" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">Identifier by which this case can be referenced.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The defining type of case.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="status" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The status associated with the case.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:choice minOccurs="0" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">Relevant date for this case.</xs:documentation>
            </xs:annotation>
            <xs:element name="datePeriod" type="Period"/>
            <xs:element name="dateDateTime" type="dateTime"/>
          </xs:choice>
          <xs:element name="application" type="RegulatedAuthorization.Case" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
</xs:schema>
