<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="regulated-authorization-basis"/>
  <meta>
    <lastUpdated value="2026-04-01T05:55:04.283+11:00"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p class="res-header-id">
        <b>Generated Narrative: CodeSystem regulated-authorization-basis</b>
      </p>
      <a name="regulated-authorization-basis"> </a>
      <a name="hcregulated-authorization-basis"> </a>
      <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%">
        <p style="margin-bottom: 0px">Last updated: 2021-01-05T10:01:24.148+11:00</p>
      </div>
      <p>This case-sensitive code system 
        <code>http://hl7.org/fhir/regulated-authorization-basis</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">Full
            <a name="regulated-authorization-basis-Full"> </a>
          </td>
          <td>Full application</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">NewSubstance
            <a name="regulated-authorization-basis-NewSubstance"> </a>
          </td>
          <td>New active substance</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">KnownSubstance
            <a name="regulated-authorization-basis-KnownSubstance"> </a>
          </td>
          <td>Known active substance</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">SimilarBiological
            <a name="regulated-authorization-basis-SimilarBiological"> </a>
          </td>
          <td>Similar biological application</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">Well-establishedUse
            <a name="regulated-authorization-basis-Well-establishedUse"> </a>
          </td>
          <td>Well-established use application</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">TraditionalUse
            <a name="regulated-authorization-basis-TraditionalUse"> </a>
          </td>
          <td>Traditional use registration for herbal medicinal product application</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">Bibliographical
            <a name="regulated-authorization-basis-Bibliographical"> </a>
          </td>
          <td>Bibliographical application (stand-alone)</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">KnownHumanBlood
            <a name="regulated-authorization-basis-KnownHumanBlood"> </a>
          </td>
          <td>Known human blood/plasma derived ancillary medicinal substance</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">TemporaryUse
            <a name="regulated-authorization-basis-TemporaryUse"> </a>
          </td>
          <td>Authorizations for temporary use</td>
        </tr>
        <tr>
          <td style="white-space:nowrap">ParallelTrade
            <a name="regulated-authorization-basis-ParallelTrade"> </a>
          </td>
          <td>Parallel traded products</td>
        </tr>
      </table>
    </div>
  </text>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="informative"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <url value="http://hl7.org/fhir/regulated-authorization-basis"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.4.1907"/>
  </identifier>
  <version value="6.0.0-ballot4"/>
  <name value="RegulatedAuthorizationBasis"/>
  <title value="Regulated Authorization Basis"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2021-01-05T10:01:24+11:00"/>
  <publisher value="HL7 (FHIR Project)"/>
  <contact>
    <telecom>
      <system value="url"/>
      <value value="http://hl7.org/fhir"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="fhir@lists.hl7.org"/>
    </telecom>
  </contact>
  <description value="RegulatedAuthorizationBasis"/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <caseSensitive value="true"/>
  <valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-basis"/>
  <content value="complete"/>
  <concept>
    <code value="Full"/>
    <display value="Full application"/>
  </concept>
  <concept>
    <code value="NewSubstance"/>
    <display value="New active substance"/>
  </concept>
  <concept>
    <code value="KnownSubstance"/>
    <display value="Known active substance"/>
  </concept>
  <concept>
    <code value="SimilarBiological"/>
    <display value="Similar biological application"/>
  </concept>
  <concept>
    <code value="Well-establishedUse"/>
    <display value="Well-established use application"/>
  </concept>
  <concept>
    <code value="TraditionalUse"/>
    <display value="Traditional use registration for herbal medicinal product application"/>
  </concept>
  <concept>
    <code value="Bibliographical"/>
    <display value="Bibliographical application (stand-alone)"/>
  </concept>
  <concept>
    <code value="KnownHumanBlood"/>
    <display value="Known human blood/plasma derived ancillary medicinal substance"/>
  </concept>
  <concept>
    <code value="TemporaryUse"/>
    <display value="Authorizations for temporary use"/>
  </concept>
  <concept>
    <code value="ParallelTrade"/>
    <display value="Parallel traded products"/>
  </concept>
</CodeSystem>