R6 Ballot (2nd Draft)

Publish-box (todo)

Example MedicinalProductDefinition/drug-and-device-complete (XML)

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

Raw XML (canonical form + also see XML Format Specification)

A powder and solution for injection that comes with a syringe in the pack (complete example) (id = "drug-and-device-complete")

<?xml version="1.0" encoding="UTF-8"?>

<MedicinalProductDefinition xmlns="http://hl7.org/fhir">
  <id value="drug-and-device-complete"/> 
  <contained> 
    <PackagedProductDefinition> 
      <id value="package"/> 
      <packageFor> 
        <reference value="#"/> 
      </packageFor> 
      <packaging> 
        <packaging> 
          <type> 
            <coding> 
              <code value="cardboard box (outer)"/> 
            </coding> 
          </type> 
          <packaging> 
            <type> 
              <coding> 
                <code value="cardboard box (inner)"/> 
              </coding> 
            </type> 
            <packaging> 
              <type> 
                <coding> 
                  <code value="sachet"/> 
                </coding> 
              </type> 
              <containedItem> 
                <item> 
                  <reference> 
                    <reference value="#powderItem"/> 
                  </reference> 
                </item> 
                <amount> 
                  <value value="5"/> 
                  <unit value="g"/> 
                  <system value="http://unitsofmeasure.org"/> 
                  <code value="g"/> 
                </amount> 
              </containedItem> 
            </packaging> 
            <packaging> 
              <type> 
                <coding> 
                  <code value="bottle"/> 
                </coding> 
              </type> 
              <containedItem> 
                <item> 
                  <reference> 
                    <reference value="#solventItem"/> 
                  </reference> 
                </item> 
                <amount> 
                  <value value="20"/> 
                  <unit value="ml"/> 
                  <system value="http://unitsofmeasure.org"/> 
                  <code value="mL"/> 
                </amount> 
              </containedItem> 
            </packaging> 
          </packaging> 
          <packaging> 
            <type> 
              <coding> 
                <code value="foil bag"/> 
              </coding> 
            </type> 
            <containedItem> 
              <item> 
                <reference> 
                  <reference value="#syringeDevice"/> 
                </reference> 
              </item> 
              <amount> 
                <value value="1"/> 
              </amount> 
            </containedItem> 
          </packaging> 
        </packaging> 
      </packaging> 
    </PackagedProductDefinition> 
  </contained> 
  <contained> 
    <ManufacturedItemDefinition> 
      <id value="solventItem"/> 
      <status value="active"/> 
      <manufacturedDoseForm> 
        <coding> 
          <system value="http://example.org.uk/fhir/doseform"/> 
          <code value="solvent for powder for injection"/> 
        </coding> 
      </manufacturedDoseForm> 
    </ManufacturedItemDefinition> 
  </contained> 
  <contained> 
    <ManufacturedItemDefinition> 
      <id value="powderItem"/> 
      <status value="active"/> 
      <manufacturedDoseForm> 
        <coding> 
          <system value="http://example.org.uk/fhir/doseform"/> 
          <code value="powder for solution for injection"/> 
        </coding> 
      </manufacturedDoseForm> 
    </ManufacturedItemDefinition> 
  </contained> 
  <!--   Schema appears to be broken, deviceName is not present in XSD   -->
  <!--  deviceName>
        <name value="WonderSyringe"/>
        <type value="manufacturer-name"/>
      </deviceName  -->
  <contained> 
    <DeviceDefinition> 
      <id value="syringeDevice"/> 
      <classification> 
        <type> 
          <text value="syringe"/> 
        </type> 
      </classification> 
    </DeviceDefinition> 
  </contained> 
  <contained> 
    <AdministrableProductDefinition> 
      <id value="administrable-form"/> 
      <status value="active"/> 
      <formOf> 
        <reference value="#"/> 
      </formOf> 
      <administrableDoseForm> 
        <coding> 
          <code value="solution for injection"/> 
        </coding> 
      </administrableDoseForm> 
      <producedFrom> 
        <reference value="#powderItem"/> 
      </producedFrom> 
      <producedFrom> 
        <reference value="#solventItem"/> 
      </producedFrom> 
      <routeOfAdministration> 
        <code> 
          <coding> 
            <system value="http://example.org.uk/fhir/route"/> 
            <code value="intramuscular"/> 
          </coding> 
        </code> 
      </routeOfAdministration> 
    </AdministrableProductDefinition> 
  </contained> 
  <identifier> 
    <system value="http://example.org.uk/fhir/product"/> 
    <value value="Wonderdrug+"/> 
  </identifier> 
  <combinedPharmaceuticalDoseForm> 
    <coding> 
      <system value="http://example.org.uk/fhir/doseform"/> 
      <code value="Powder and solution for injection with itegral syringe"/> 
    </coding> 
  </combinedPharmaceuticalDoseForm> 
  <name> 
    <productName value="Wonderdrug liquid 20ml (integral syringe)"/> 
  </name> 
</MedicinalProductDefinition> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.