Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 2.0.0-ballot 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

: PQCMC Name Part Terminology - XML Representation

Active as of 2024-12-04

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="pqcmc-name-part-terminology"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet pqcmc-name-part-terminology</b></p><a name="pqcmc-name-part-terminology"> </a><a name="hcpqcmc-name-part-terminology"> </a><a name="pqcmc-name-part-terminology-en-US"> </a><ul><li>Include these codes as defined in <a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html"><code>http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-CON">CON</a></td><td>container name</td><td>**Description:** This refers to the container if present in the medicinal product name.<br/><br/>EXAMPLES:<br/><br/> *  For Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season): pre-filled syringe</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-DEV">DEV</a></td><td>device name</td><td>**Description:** This refers to the qualifiers in the name for devices and is at the moment mainly applicable to insulins and inhalation products.<br/><br/>EXAMPLES:<br/><br/> *  For the medicinal product Actrapid FlexPen 100 IU/ml Solution for injection Subcutaneous use: FlexPen.</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-FLAV">FLAV</a></td><td>FlavorName</td><td>**Description:** This refers to a flavor of the medicinal product if present in the medicinal product name.<br/><br/>**Examples:**<br/><br/> *  For 'CoughCure Linctus Orange Flavor', the flavor part is &quot;Orange&quot;<br/> *  For 'Wonderdrug Syrup Cherry Flavor', the flavor part is &quot;Cherry&quot;</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-FORMUL">FORMUL</a></td><td>FormulationPartName</td><td>**Description:** This refers to the formulation of the medicinal product if present in the medicinal product name.<br/><br/>**Examples:**<br/><br/> *  For 'SpecialMed Sugar Free Cough Syrup', the formulation name part is &quot;Sugar Free&quot;<br/> *  For 'QuickCure Gluten-free Bulk Fibre', the formulation name part is &quot;gluten-free&quot;</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-FRM">FRM</a></td><td>form name</td><td>**Description:** This refers to the pharmaceutical form/ if present in the medicinal product name.<br/><br/>EXAMPLES:<br/><br/> *  For Agenerase 50 mg soft capsules: Soft Capsules<br/> *  For Ludiomil 25mg-Filmtabletten: Filmtabletten<br/> *  For Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season): suspension for injection</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-INV">INV</a></td><td>invented name</td><td>**Description:** This refers to the product name without the trademark or the name of the marketing authorization holder or any other descriptor reflected in the product name and, if appropriate, whether it is intended e.g. for babies, children or adults.<br/><br/>EXAMPLES:<br/><br/> *  Agenerase<br/> *  Optaflu<br/> *  Ludiomil</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-POPUL">POPUL</a></td><td>TargetPopulationName</td><td>**Description:** This refers to the target population for the medicinal product if present in the medicinal product name<br/><br/>**Examples:**<br/><br/> *  For 'Broncho-Drug 3.5 mg-capsules for children', the target population part is &quot;children&quot;<br/> *  For 'Adult Chesty Cough Syrup', the target population part is &quot;adult&quot;</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-SCI">SCI</a></td><td>scientific name</td><td>**Description:** This refers to the product common or scientific name without the trademark or the name of the marketing authorization holder or any other descriptor reflected in the product name.<br/><br/>EXAMPLES:<br/><br/> *  For Agenerase: N/A<br/> *  For Optaflu: Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season)<br/> *  For Ludiomil: N/A</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-STR">STR</a></td><td>strength name</td><td>**Description:** This refers to the strength if present in the medicinal product name. The use of decimal points should be accommodated if required.<br/><br/>EXAMPLES:<br/><br/> *  For Agenerase 50 mg soft capsules: 50mg<br/> *  For Ludiomil 25mg-Filmtabletten: 25 mg<br/> *  For Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell culture) (2007/2008 season): N/A</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-TIME">TIME</a></td><td>TimeOrPeriodName</td><td>**Description:** This refers to a time or time period that may be specified in the text of the medicinal product name<br/><br/>**Example:**<br/><br/> *  For an influenza vaccine 'Drug-FLU season 2008/2009', the time/period part is &quot;2008/2009 season&quot;</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-TMK">TMK</a></td><td>trademark name</td><td>**Description:** This refers to trademark/company element if present in the medicinal product name.<br/><br/>EXAMPLES:<br/><br/> *  for Insulin Human Winthrop Comb 15: Winthrop</td></tr><tr><td><a href="http://terminology.hl7.org/6.1.0/CodeSystem-v3-EntityNamePartQualifierR2.html#v3-EntityNamePartQualifierR2-USE">USE</a></td><td>intended use name</td><td>**Description:** This refers to the intended use if present in the medicinal product name without the trademark or the name of the marketing authorization holder or any other descriptor reflected in the product name.<br/><br/>**Examples:**<br/><br/> *  For 'Drug-BI Caplets - Heartburn Relief', the intended use part is: &quot;Heartburn Relief&quot;<br/> *  For 'Medicine Honey Syrup for Soothing Coughs' the intended use part is &quot;Soothing Coughs&quot;</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-name-part-terminology"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.14"/>
  </identifier>
  <version value="2.0.0-ballot"/>
  <name value="PqcmcNamePartTerminology"/>
  <title value="PQCMC Name Part Terminology"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2024-12-04T20:50:29+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="Terminology used to qualify the information pertaining to Name Part data 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
      <concept>
        <code value="CON"/>
        <display value="container name"/>
      </concept>
      <concept>
        <code value="DEV"/>
        <display value="device name"/>
      </concept>
      <concept>
        <code value="FLAV"/>
        <display value="FlavorName"/>
      </concept>
      <concept>
        <code value="FORMUL"/>
        <display value="FormulationPartName"/>
      </concept>
      <concept>
        <code value="FRM"/>
        <display value="form name"/>
      </concept>
      <concept>
        <code value="INV"/>
        <display value="invented name"/>
      </concept>
      <concept>
        <code value="POPUL"/>
        <display value="TargetPopulationName"/>
      </concept>
      <concept>
        <code value="SCI"/>
        <display value="scientific name"/>
      </concept>
      <concept>
        <code value="STR"/>
        <display value="strength name"/>
      </concept>
      <concept>
        <code value="TIME"/>
        <display value="TimeOrPeriodName"/>
      </concept>
      <concept>
        <code value="TMK"/>
        <display value="trademark name"/>
      </concept>
      <concept>
        <code value="USE"/>
        <display value="intended use name"/>
      </concept>
    </include>
  </compose>
</ValueSet>