Release 4B

This page is part of the FHIR Specification (v4.3.0: R4B - STU). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

Codesystem-regulated-authorization-basis.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: Informative

Raw XML (canonical form + also see XML Format Specification)

Definition for Code SystemRegulatedAuthorizationBasis

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

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="regulated-authorization-basis"/> 
  <meta> 
    <lastUpdated value="2022-05-28T13:47:40.239+11:00"/> 
    <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p> This code system http://hl7.org/fhir/regulated-authorization-basis 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> Authorisations 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="trial-use"/> 
  </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:2.16.840.1.113883.4.642.1.1643"/> 
  </identifier> 
  <version value="4.3.0"/> 
  <name value="RegulatedAuthorizationBasis"/> 
  <title value="RegulatedAuthorizationBasis"/> 
  <status value="draft"/> 
  <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> 
  <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="Authorisations for temporary use"/> 
  </concept> 
  <concept> 
    <code value="ParallelTrade"/> 
    <display value="Parallel traded products"/> 
  </concept> 
</CodeSystem> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.