<?xml version="1.0" encoding="UTF-8"?>
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/*
  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, 
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  ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE 
  POSSIBILITY OF SUCH DAMAGE.
  

  Generated on Mon, Mar 30, 2026 16:23+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="MedicinalProductDefinition" type="MedicinalProductDefinition">
    <xs:annotation>
      <xs:documentation xml:lang="en">A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).</xs:documentation>
    </xs:annotation>
  </xs:element>
  <xs:complexType name="MedicinalProductDefinition">
    <xs:annotation>
      <xs:documentation xml:lang="en">A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).</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 this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Regulatory type, e.g. Investigational or Authorized.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="domain" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">If this medicine applies to human or veterinary uses.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="version" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.</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 within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status.</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 given status became applicable.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="description" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">General description of this product.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="combinedPharmaceuticalDoseForm" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="route" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licensed or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="indication" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="legalStatusOfSupply" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The legal status of supply of the medicinal product as classified by the regulator.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="additionalMonitoringIndicator" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="specialMeasures" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="pediatricUseIndicator" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">If authorised for use in children, or infants, neonates etc.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="classification" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Allows the product to be classified by various systems, commonly WHO ATC.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="marketingStatus" minOccurs="0" maxOccurs="unbounded" type="MarketingStatus">
            <xs:annotation>
              <xs:documentation xml:lang="en">Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="packagedMedicinalProduct" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Package type for the product. See also the PackagedProductDefinition resource.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="comprisedOf" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="ingredient" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="impurity" minOccurs="0" maxOccurs="unbounded" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.</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 medicinal product.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="masterFile" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="contact" type="MedicinalProductDefinition.Contact" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">A product specific contact, person (in a role), or an organization.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="clinicalTrial" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Clinical trials or studies that this product is involved in.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="code" minOccurs="0" maxOccurs="unbounded" type="Coding">
            <xs:annotation>
              <xs:documentation xml:lang="en">A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="name" type="MedicinalProductDefinition.Name" minOccurs="1" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">The product's name, including full name and possibly coded parts.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="crossReference" type="MedicinalProductDefinition.CrossReference" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="operation" type="MedicinalProductDefinition.Operation" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">A manufacturing or administrative process or step associated with (or performed on) the medicinal product.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="characteristic" type="MedicinalProductDefinition.Characteristic" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Allows the key product features to be recorded, such as &quot;sugar free&quot;, &quot;modified release&quot;, &quot;parallel import&quot;.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="MedicinalProductDefinition.Contact">
    <xs:annotation>
      <xs:documentation xml:lang="en">A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="contact" minOccurs="1" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">A product specific contact, person (in a role), or an organization.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="MedicinalProductDefinition.Name">
    <xs:annotation>
      <xs:documentation xml:lang="en">A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="productName" minOccurs="1" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The full product name.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="part" type="MedicinalProductDefinition.Part" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Coding words or phrases of the name.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="usage" type="MedicinalProductDefinition.Usage" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Country and jurisdiction where the name applies, and associated language.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="MedicinalProductDefinition.Part">
    <xs:annotation>
      <xs:documentation xml:lang="en">A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="part" minOccurs="1" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">A fragment of a product name.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Identifying type for this part of the name (e.g. strength part).</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="MedicinalProductDefinition.Usage">
    <xs:annotation>
      <xs:documentation xml:lang="en">A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="country" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Country code for where this name applies.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="jurisdiction" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="language" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Language code for this name.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="MedicinalProductDefinition.CrossReference">
    <xs:annotation>
      <xs:documentation xml:lang="en">A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="product" minOccurs="1" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Reference to another product, e.g. for linking authorised to investigational product.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="MedicinalProductDefinition.Operation">
    <xs:annotation>
      <xs:documentation xml:lang="en">A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="effectiveDate" minOccurs="0" maxOccurs="1" type="Period">
            <xs:annotation>
              <xs:documentation xml:lang="en">Date range of applicability.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="organization" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="confidentialityIndicator" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Specifies whether this particular business or manufacturing process is considered proprietary or confidential.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="MedicinalProductDefinition.Characteristic">
    <xs:annotation>
      <xs:documentation xml:lang="en">A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="type" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A code expressing the type of characteristic.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:choice minOccurs="0" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">A value for the characteristic.text.</xs:documentation>
            </xs:annotation>
            <xs:element name="valueCodeableConcept" type="CodeableConcept"/>
            <xs:element name="valueMarkdown" type="markdown"/>
            <xs:element name="valueQuantity" type="Quantity"/>
            <xs:element name="valueRange" type="Range"/>
            <xs:element name="valueInteger" type="integer"/>
            <xs:element name="valueDate" type="date"/>
            <xs:element name="valueBoolean" type="boolean"/>
            <xs:element name="valueAttachment" type="Attachment"/>
          </xs:choice>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
</xs:schema>
