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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemRegulatedAuthorizationBasis
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- <http://hl7.org/fhir/CodeSystem/regulated-authorization-basis> a fhir:CodeSystem ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "regulated-authorization-basis"] ; # fhir:meta [ fhir:lastUpdated [ fhir:v "2025-03-19T00:49:06.036+11:00"^^xsd:dateTime ] ; fhir:profile ( [ fhir:v "http://hl7.org/fhir/StructureDefinition/shareablecodesystem"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/StructureDefinition/shareablecodesystem> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<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>"^^rdf:XMLLiteral ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "brr" ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "trial-use" ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 1 ] ] ) ; # fhir:url [ fhir:v "http://hl7.org/fhir/regulated-authorization-basis"^^xsd:anyURI] ; # fhir:identifier ( [ fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ; fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.4.1907" ] ] ) ; # fhir:version [ fhir:v "6.0.0-ballot2"] ; # fhir:name [ fhir:v "RegulatedAuthorizationBasis"] ; # fhir:title [ fhir:v "Regulated Authorization Basis"] ; # fhir:status [ fhir:v "active"] ; # fhir:experimental [ fhir:v false] ; # fhir:date [ fhir:v "2021-01-05T10:01:24+11:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "HL7 (FHIR Project)"] ; # fhir:contact ( [ fhir:telecom ( [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://hl7.org/fhir" ] ] [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "fhir@lists.hl7.org" ] ] ) ] ) ; # fhir:description [ fhir:v "RegulatedAuthorizationBasis"] ; # fhir:jurisdiction ( [ fhir:coding ( [ fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ; fhir:code [ fhir:v "001" ] ; fhir:display [ fhir:v "World" ] ] ) ] ) ; # fhir:caseSensitive [ fhir:v true] ; # fhir:valueSet [ fhir:v "http://hl7.org/fhir/ValueSet/regulated-authorization-basis"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/regulated-authorization-basis> ] ; # fhir:hierarchyMeaning [] ; # fhir:content [ fhir:v "complete"] ; # fhir:concept ( [ fhir:code [ fhir:v "Full" ] ; fhir:display [ fhir:v "Full application" ] ] [ fhir:code [ fhir:v "NewSubstance" ] ; fhir:display [ fhir:v "New active substance" ] ] [ fhir:code [ fhir:v "KnownSubstance" ] ; fhir:display [ fhir:v "Known active substance" ] ] [ fhir:code [ fhir:v "SimilarBiological" ] ; fhir:display [ fhir:v "Similar biological application" ] ] [ fhir:code [ fhir:v "Well-establishedUse" ] ; fhir:display [ fhir:v "Well-established use application" ] ] [ fhir:code [ fhir:v "TraditionalUse" ] ; fhir:display [ fhir:v "Traditional use registration for herbal medicinal product application" ] ] [ fhir:code [ fhir:v "Bibliographical" ] ; fhir:display [ fhir:v "Bibliographical application (stand-alone)" ] ] [ fhir:code [ fhir:v "KnownHumanBlood" ] ; fhir:display [ fhir:v "Known human blood/plasma derived ancillary medicinal substance" ] ] [ fhir:code [ fhir:v "TemporaryUse" ] ; fhir:display [ fhir:v "Authorizations for temporary use" ] ] [ fhir:code [ fhir:v "ParallelTrade" ] ; fhir:display [ fhir:v "Parallel traded products" ] ] ) . # # -------------------------------------------------------------------------------------
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 Tue, Mar 18, 2025 13:55+0000.
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