Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 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-fda/ and changes regularly. See the Directory of published versions
Draft as of 2024-11-13 |
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<id value="pqcmc-specification-status-terminology"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet pqcmc-specification-status-terminology</b></p><a name="pqcmc-specification-status-terminology"> </a><a name="hcpqcmc-specification-status-terminology"> </a><a name="pqcmc-specification-status-terminology-en-US"> </a><ul><li>Include these codes as defined in <a href="CodeSystem-cmc-ncit-dummy.html"><code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-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-ncit-dummy.html#cmc-ncit-dummy-C25425">C25425</a></td><td>Approved</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C48660">C48660</a></td><td>Not Applicable</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C134011">C134011</a></td><td>Not Approved</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C134012">C134012</a></td><td>Reported in a CBE or AR</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C134010">C134010</a></td><td>Tentatively Approved</td></tr></table></li></ul></div>
</text>
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<url
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.23"/>
</identifier>
<version value="1.0.0"/>
<name value="PqcmcSpecificationStatusTerminology"/>
<title value="Specification Status Terminology"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2024-11-13T04:45:16+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
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<value value="http://www.hl7.org/Special/committees/rcrim"/>
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<telecom>
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<value value="brr@lists.HL7.org"/>
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<description
value="Terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
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<include>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<concept>
<code value="C25425"/>
<display value="Approved"/>
</concept>
<concept>
<code value="C48660"/>
<display value="Not Applicable"/>
</concept>
<concept>
<code value="C134011"/>
<display value="Not Approved"/>
</concept>
<concept>
<code value="C134012"/>
<display value="Reported in a CBE or AR"/>
</concept>
<concept>
<code value="C134010"/>
<display value="Tentatively Approved"/>
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