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Medicinalproductdefinition-example.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: Not linked to any defined compartments

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

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General example (id = "example")

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

<MedicinalProductDefinition xmlns="http://hl7.org/fhir">
  <id value="example"/> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p> <b> Generated Narrative</b> </p> 
      <p> <b> Id</b> : example</p> 
      <p> <b> Identifier</b> : {mpid}</p> 
      <p> <b> Classification</b> : <span title="Codes: {http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem
         B01AF02}">ATC: B01AF02</span> </p> 
      <p> <b> Attached Document</b> : (SmPC)</p> 
      <p> <b> Master File</b> : (Pharmacovigilence Master File)</p> 
      <p> <b> Product Name</b> : Equilidem 2.5 mg film-coated tablets</p> 
      <blockquote> 
        <p> <b> Name Part</b> </p> <p> <b> part</b> :Equilidem</p> 
        <p> <b> type</b> : <span title="Codes: ">Invented</span> </p> 
      </blockquote> 
      <blockquote> 
        <p> <b> Name Part</b> </p> <p> <b> part</b> :2.5 mg</p> 
        <p> <b> type</b> : <span title="Codes: ">Strength</span> </p> 
      </blockquote> 
      <blockquote> 
        <p> <b> Name Part</b> </p> 
        <p> <b> part</b> :film-coated tablets</p> 
        <p> <b> type</b> : <span title="Codes: ">Form</span> </p> 
        <p> <b> Country &amp; Languages</b> </p> 
        <table class="grid">
          <tr> 
            <td> -</td> 
            <td> <b> Country</b> </td> 
            <td> <b> Jurisdiction</b> </td> 
            <td> <b> Language</b> </td> 
          </tr> 
          <tr> 
            <td> *</td> 
            <td> <span title="Codes: {http://ema.europa.eu/example/countryCode EU}">EU</span> </td> 
            <td> <span title="Codes: {http://ema.europa.eu/example/jurisdictionCode EU}">EU</span> </td> 
            <td> <span title="Codes: {http://ema.europa.eu/example/languageCode EN}">EN</span> </td> 
          </tr> 
        </table> 
      </blockquote> 
      <p> <b> Manufacturing &amp; Business Operations</b> </p> 
      <table class="grid">
        <tr> 
          <td> -</td> 
          <td> <b> Type</b> </td> 
          <td> <b> EffectiveDate</b> </td> 
          <td> <b> Authorization</b> </td> 
        </tr> 
        <tr> 
          <td> *</td> 
          <td> Batch Release</td> 
          <td> 2013-03-15 --&gt; (ongoing)</td> 
          <td> <span> 1324TZ</span> </td> 
        </tr> 
      </table> 
    </div> 
  </text> 
  <identifier> 
    <system value="http://ema.europa.eu/example/MPID"/> 
    <value value="{mpid}"/> 
  </identifier> 
  <classification> 
    <coding> 
      <system value="http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem"/> 
      <code value="B01AF02"/> 
    </coding> 
  </classification> 
  <attachedDocument> 
    <reference value="DocumentReference/example"/> 
  </attachedDocument> 
  <masterFile> 
    <reference value="DocumentReference/example"/> 
  </masterFile> 
  <name> 
    <productName value="Equilidem 2.5 mg film-coated tablets"/> 
    <namePart> 
      <part value="Equilidem"/> 
      <type> 
        <coding> 
          <code value="INV"/> 
        </coding> 
      </type> 
    </namePart> 
    <namePart> 
      <part value="2.5 mg"/> 
      <type> 
        <coding> 
          <code value="STR"/> 
        </coding> 
      </type> 
    </namePart> 
    <namePart> 
      <part value="film-coated tablets"/> 
      <type> 
        <coding> 
          <code value="FRM"/> 
        </coding> 
      </type> 
    </namePart> 
    <countryLanguage> 
      <country> 
        <coding> 
          <system value="http://ema.europa.eu/example/countryCode"/> 
          <code value="EU"/> 
        </coding> 
      </country> 
      <jurisdiction> 
        <coding> 
          <system value="http://ema.europa.eu/example/jurisdictionCode"/> 
          <code value="EU"/> 
        </coding> 
      </jurisdiction> 
      <language> 
        <coding> 
          <system value="http://ema.europa.eu/example/languageCode"/> 
          <code value="EN"/> 
        </coding> 
      </language> 
    </countryLanguage> 
  </name> 
  <operation> 
    <type> 
      <concept> 
        <coding> 
          <system value="http://ema.europa.eu/example/manufacturingOperationType"/> 
          <code value="Batchrelease"/> 
        </coding> 
      </concept> 
    </type> 
    <effectiveDate> 
      <start value="2013-03-15"/> 
    </effectiveDate> 
    <authorization> 
      <identifier> 
        <system value="http://ema.europa.eu/example/manufacturingAuthorisationReferenceNumber"/> 
        <value value="1324TZ"/> 
      </identifier> 
    </authorization> 
  </operation> 
</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.