<?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 Thu, Apr 9, 2026 17:12+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="Ingredient" type="Ingredient">
    <xs:annotation>
      <xs:documentation xml:lang="en">An ingredient of a manufactured item or pharmaceutical product.</xs:documentation>
    </xs:annotation>
  </xs:element>
  <xs:complexType name="Ingredient">
    <xs:annotation>
      <xs:documentation xml:lang="en">An ingredient of a manufactured item or pharmaceutical 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="1" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">The identifier(s) of this Ingredient that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itself is not appropriate.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="status" minOccurs="1" maxOccurs="1" type="PublicationStatus">
            <xs:annotation>
              <xs:documentation xml:lang="en">The status of this ingredient. Enables tracking the life-cycle of the content.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="for" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The product which this ingredient is a constituent part of.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="role" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A classification of the ingredient identifying its purpose within the product, e.g. active, inactive.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="function" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A classification of the ingredient identifying its precise purpose(s) in the drug product. This extends the Ingredient.role to add more detail. Example: antioxidant, alkalizing agent.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="group" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A classification of the ingredient according to where in the physical item it tends to be used, such the outer shell of a tablet, inner body or ink.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="allergenicIndicator" minOccurs="0" maxOccurs="1" type="boolean">
            <xs:annotation>
              <xs:documentation xml:lang="en">If the ingredient is a known or suspected allergen. Note that this is a property of the substance, so if a reference to a SubstanceDefinition is used to describe that (rather than just a code), the allergen information should go there, not here.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="comment" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">A place for providing any notes that are relevant to the component, e.g. removed during process, adjusted for loss on drying.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="manufacturer" type="Ingredient.Manufacturer" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">The organization(s) that manufacture this ingredient. Can be used to indicate:         1) Organizations we are aware of that manufacture this ingredient         2) Specific Manufacturer(s) currently being used         3) Set of organisations allowed to manufacture this ingredient for this product         Users must be clear on the application of context relevant to their use case.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="substance" type="Ingredient.Substance" minOccurs="1" maxOccurs="1">
            <xs:annotation>
              <xs:documentation xml:lang="en">The substance that comprises this ingredient.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="Ingredient.Manufacturer">
    <xs:annotation>
      <xs:documentation xml:lang="en">An ingredient of a manufactured item or pharmaceutical product.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="role" minOccurs="0" maxOccurs="1" type="IngredientManufacturerRole">
            <xs:annotation>
              <xs:documentation xml:lang="en">The way in which this manufacturer is associated with the ingredient. For example whether it is a possible one (others allowed), or an exclusive authorized one for this ingredient. Note that this is not the manufacturing process role.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="manufacturer" minOccurs="1" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">An organization that manufactures this ingredient.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="Ingredient.Substance">
    <xs:annotation>
      <xs:documentation xml:lang="en">An ingredient of a manufactured item or pharmaceutical product.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="code" minOccurs="1" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">A code or full resource that represents the ingredient's substance.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="strength" type="Ingredient.Strength" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. The allowed repetitions do not represent different strengths, but are different representations - mathematically equivalent - of a single strength.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="Ingredient.Strength">
    <xs:annotation>
      <xs:documentation xml:lang="en">An ingredient of a manufactured item or pharmaceutical product.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:choice minOccurs="0" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">The quantity of substance in the unit of presentation, or in the volume (or mass) of the single pharmaceutical product or manufactured item. Unit of presentation refers to the quantity that the item occurs in e.g. a strength per tablet size, perhaps 'per 20mg' (the size of the tablet). It is not generally normalized as a unitary unit, which would be 'per mg').</xs:documentation>
            </xs:annotation>
            <xs:element name="presentationRatio" type="Ratio"/>
            <xs:element name="presentationRatioRange" type="RatioRange"/>
            <xs:element name="presentationCodeableConcept" type="CodeableConcept"/>
            <xs:element name="presentationQuantity" type="Quantity"/>
          </xs:choice>
          <xs:element name="textPresentation" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">A textual representation of either the whole of the presentation strength or a part of it - with the rest being in Strength.presentation as a ratio.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:choice minOccurs="0" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">The strength per unitary volume (or mass).</xs:documentation>
            </xs:annotation>
            <xs:element name="concentrationRatio" type="Ratio"/>
            <xs:element name="concentrationRatioRange" type="RatioRange"/>
            <xs:element name="concentrationCodeableConcept" type="CodeableConcept"/>
            <xs:element name="concentrationQuantity" type="Quantity"/>
          </xs:choice>
          <xs:element name="textConcentration" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">A textual representation of either the whole of the concentration strength or a part of it - with the rest being in Strength.concentration as a ratio.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="basis" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A code that indicates if the strength is, for example, based on the ingredient substance as stated or on the substance base (when the ingredient is a salt).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="measurementPoint" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">For when strength is measured at a particular point or distance. There are products where strength is measured at a particular point. For example, the strength of the ingredient in some inhalers is measured at a particular position relative to the point of aerosolization.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="country" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The country or countries for which the strength range applies.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="referenceStrength" type="Ingredient.ReferenceStrength" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Strength expressed in terms of a reference substance. For when the ingredient strength is additionally expressed as equivalent to the strength of some other closely related substance (e.g. salt vs. base). Reference strength represents the strength (quantitative composition) of the active moiety of the active substance. There are situations when the active substance and active moiety are different, therefore both a strength and a reference strength are needed.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="Ingredient.ReferenceStrength">
    <xs:annotation>
      <xs:documentation xml:lang="en">An ingredient of a manufactured item or pharmaceutical product.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="substance" minOccurs="1" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Relevant reference substance.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:choice minOccurs="1" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">Strength expressed in terms of a reference substance.</xs:documentation>
            </xs:annotation>
            <xs:element name="strengthRatio" type="Ratio"/>
            <xs:element name="strengthRatioRange" type="RatioRange"/>
            <xs:element name="strengthQuantity" type="Quantity"/>
          </xs:choice>
          <xs:element name="measurementPoint" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">For when strength is measured at a particular point or distance.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="country" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The country or countries for which the strength range applies.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
</xs:schema>
