Terminology
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R4B
(v5.0.0-draft-final:
Final
QA
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STU
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| Biomedical Research and Regulation Work Group | Maturity Level : N/A | Standards Status : Informative |
Raw JSON ( canonical form + also see JSON Format Specification )
Definition for Code SystemRegulatedAuthorizationBasis
{
"resourceType" : "CodeSystem",
"id" : "regulated-authorization-basis",
"meta" : {
"lastUpdated" : "2022-05-28T13:47:40.239+11:00",
"lastUpdated" : "2023-03-01T23:03:57.298+11:00",
"profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"]
},
"text" : {
"status" : "generated",
"div" : "<div>!-- Snipped for Brevity --></div>"
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This 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>"
},
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 1
}],
"url" : "http://hl7.org/fhir/regulated-authorization-basis",
"identifier" : [{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.1.1643"
"value" : "urn:oid:2.16.840.1.113883.4.642.4.1907"
}],
"version" : "4.3.0",
"version" : "5.0.0-draft-final",
"name" : "RegulatedAuthorizationBasis",
"title" : "RegulatedAuthorizationBasis",
"status" : "draft",
"title" : "Regulated Authorization Basis",
"status" : "active",
"experimental" : false,
"date" : "2021-01-05T10:01:24+11:00",
"publisher" : "HL7 (FHIR Project)",
"contact" : [{
"telecom" : [{
"system" : "url",
"value" : "http://hl7.org/fhir"
},
{
"system" : "email",
"value" : "fhir@lists.hl7.org"
}]
}],
"description" : "RegulatedAuthorizationBasis",
"jurisdiction" : [{
"coding" : [{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}]
}],
"caseSensitive" : true,
"valueSet" : "http://hl7.org/fhir/ValueSet/regulated-authorization-basis",
"content" : "complete",
"concept" : [{
"code" : "Full",
"display" : "Full application"
},
{
"code" : "NewSubstance",
"display" : "New active substance"
},
{
"code" : "KnownSubstance",
"display" : "Known active substance"
},
{
"code" : "SimilarBiological",
"display" : "Similar biological application"
},
{
"code" : "Well-establishedUse",
"display" : "Well-established use application"
},
{
"code" : "TraditionalUse",
"display" : "Traditional use registration for herbal medicinal product application"
},
{
"code" : "Bibliographical",
"display" : "Bibliographical application (stand-alone)"
},
{
"code" : "KnownHumanBlood",
"display" : "Known human blood/plasma derived ancillary medicinal substance"
},
{
"code" : "TemporaryUse",
"display" : "Authorisations for temporary use"
"display" : "Authorizations for temporary use"
},
{
"code" : "ParallelTrade",
"display" : "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.
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FHIR
Release
4B
(v4.3.0)
hl7.fhir.r4b.core#4.3.0
R5
hl7.fhir.core#5.0.0-draft-final
generated
on
Sat,
May
28,
2022
12:50+1000.
Wed,
Mar
1,
2023
23:05+1100.
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