Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc/ and changes regularly. See the Directory of published versions

: EVMPD Substance Classification - XML Representation

Draft as of 2024-03-04

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="evmpd-substance-classification"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><ul><li>Include these codes as defined in <a href="CodeSystem-cmc-ema-dummy.html"><code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ema-dummy</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-1">1</a></td><td>Chemical</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-17">17</a></td><td>Mixture</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-2">2</a></td><td>Nucleic Acid</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-3">3</a></td><td>Polymer</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-4">4</a></td><td>Protein - Other</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-5">5</a></td><td>Protein - Vaccine</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-7">7</a></td><td>Structurally Diverse Substance - Immunoglobulin</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-6">6</a></td><td>Structurally Diverse Substance - Vaccine</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-10">10</a></td><td>Structurally Diverse Substance - Allergen</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-11">11</a></td><td>Structurally Diverse Substance - Cell therapy</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-9">9</a></td><td>Structurally Diverse Substance - Herbal</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-12">12</a></td><td>Structurally Diverse Substance - Other</td></tr><tr><td><a href="CodeSystem-cmc-ema-dummy.html#cmc-ema-dummy-8">8</a></td><td>Structurally Diverse Substance - Blood derived</td></tr></table></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <url
       value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/evmpd-substance-classification"/>
  <version value="0.1.20"/>
  <name value="EVMPDSubstanceClassification"/>
  <title value="EVMPD Substance Classification"/>
  <status value="draft"/>
  <experimental value="true"/>
  <date value="2024-03-04T02:24:01+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="brr@lists.HL7.org"/>
    </telecom>
  </contact>
  <description
               value="EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substance classes"/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="US"/>
      <display value="United States of America"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ema-dummy"/>
      <concept>
        <code value="1"/>
        <display value="Chemical"/>
      </concept>
      <concept>
        <code value="17"/>
        <display value="Mixture"/>
      </concept>
      <concept>
        <code value="2"/>
        <display value="Nucleic Acid"/>
      </concept>
      <concept>
        <code value="3"/>
        <display value="Polymer"/>
      </concept>
      <concept>
        <code value="4"/>
        <display value="Protein - Other"/>
      </concept>
      <concept>
        <code value="5"/>
        <display value="Protein - Vaccine"/>
      </concept>
      <concept>
        <code value="7"/>
        <display value="Structurally Diverse Substance - Immunoglobulin"/>
      </concept>
      <concept>
        <code value="6"/>
        <display value="Structurally Diverse Substance - Vaccine"/>
      </concept>
      <concept>
        <code value="10"/>
        <display value="Structurally Diverse Substance - Allergen"/>
      </concept>
      <concept>
        <code value="11"/>
        <display value="Structurally Diverse Substance - Cell therapy"/>
      </concept>
      <concept>
        <code value="9"/>
        <display value="Structurally Diverse Substance - Herbal"/>
      </concept>
      <concept>
        <code value="12"/>
        <display value="Structurally Diverse Substance - Other"/>
      </concept>
      <concept>
        <code value="8"/>
        <display value="Structurally Diverse Substance - Blood derived"/>
      </concept>
    </include>
  </compose>
</ValueSet>