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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards 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="2024-10-03T04:31:51.554+11:00"/> <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> </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> <a name="regulated-authorization-basis-en-US"> </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> <p style="margin-bottom: 0px">Profile: <a href="shareablecodesystem.html">Shareable CodeSystem</a> </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="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:2.16.840.1.113883.4.642.4.1907"/> </identifier> <version value="6.0.0-ballot2"/> <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>
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.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot2 generated on Wed, Oct 2, 2024 17:55+0000.
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