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
Draft as of 2024-03-04 |
<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>
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<valueCode value="brr"/>
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<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"/>
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<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
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<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>