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
Active as of 2024-04-08 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="cmc-product-name-types"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>This case-sensitive code system <code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style="white-space:nowrap">PROP<a name="cmc-product-name-types-PROP"> </a></td><td>Proprietary</td></tr><tr><td style="white-space:nowrap">NON<a name="cmc-product-name-types-NON"> </a></td><td>Non-Proprietary</td></tr></table></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/CodeSystem/cmc-product-name-types"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.16.2"/>
</identifier>
<version value="1.0.0-ballot"/>
<name value="CmcProductNameTypes"/>
<title value="Product Name Types Code Types"/>
<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="Indicates patent or trademark status. Codes temporarily defined as part of the PQ-CMC-FDA implementation guide. These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems"/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<caseSensitive value="true"/>
<content value="complete"/>
<count value="2"/>
<concept>
<code value="PROP"/>
<display value="Proprietary"/>
</concept>
<concept>
<code value="NON"/>
<display value="Non-Proprietary"/>
</concept>
</CodeSystem>