Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

: Release Profile Terminology - XML Representation

Active as of 2024-04-08

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="pqcmc-release-profile"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><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-C42730">C42730</a></td><td>Delayed-Release Profile</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42713">C42713</a></td><td>Extended-Release Profile</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C42669">C42669</a></td><td>Immediate Release Profile</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C48660">C48660</a></td><td>Not Applicable</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/pqcmc-release-profile"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.21"/>
  </identifier>
  <version value="1.0.0-ballot"/>
  <name value="PqcmcReleaseProfile"/>
  <title value="Release Profile Terminology"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2024-04-08T17:51:06+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="A category of terminology used to qualify the information pertaining to release profile 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"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <concept>
        <code value="C42730"/>
        <display value="Delayed-Release Profile"/>
      </concept>
      <concept>
        <code value="C42713"/>
        <display value="Extended-Release Profile"/>
      </concept>
      <concept>
        <code value="C42669"/>
        <display value="Immediate Release Profile"/>
      </concept>
      <concept>
        <code value="C48660"/>
        <display value="Not Applicable"/>
      </concept>
    </include>
  </compose>
</ValueSet>