<?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>