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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemRegulatedAuthorizationCaseType
@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-case-type> a fhir:CodeSystem ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "regulated-authorization-case-type"] ; # fhir:meta [ fhir:lastUpdated [ fhir:v "2025-02-22T02:24:17.236+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-case-type</b></p><a name=\"regulated-authorization-case-type\"> </a><a name=\"hcregulated-authorization-case-type\"> </a><a name=\"regulated-authorization-case-type-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-case-type</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\">InitialMAA<a name=\"regulated-authorization-case-type-InitialMAA\"> </a></td><td>Initial Marketing Authorization Application</td></tr><tr><td style=\"white-space:nowrap\">Variation<a name=\"regulated-authorization-case-type-Variation\"> </a></td><td>Variation</td></tr><tr><td style=\"white-space:nowrap\">LineExtension<a name=\"regulated-authorization-case-type-LineExtension\"> </a></td><td>Line Extension</td></tr><tr><td style=\"white-space:nowrap\">PSUR<a name=\"regulated-authorization-case-type-PSUR\"> </a></td><td>Periodic Safety Update Report</td></tr><tr><td style=\"white-space:nowrap\">Renewal<a name=\"regulated-authorization-case-type-Renewal\"> </a></td><td>Renewal</td></tr><tr><td style=\"white-space:nowrap\">Follow-up<a name=\"regulated-authorization-case-type-Follow-up\"> </a></td><td>Follow-up Measure</td></tr><tr><td style=\"white-space:nowrap\">100000155699<a name=\"regulated-authorization-case-type-100000155699\"> </a></td><td>Specific Obligation</td></tr><tr><td style=\"white-space:nowrap\">AnnualReassessment<a name=\"regulated-authorization-case-type-AnnualReassessment\"> </a></td><td>Annual Reassessment</td></tr><tr><td style=\"white-space:nowrap\">UrgentSafetyRestriction<a name=\"regulated-authorization-case-type-UrgentSafetyRestriction\"> </a></td><td>Urgent Safety Restriction</td></tr><tr><td style=\"white-space:nowrap\">PaediatricSubmission<a name=\"regulated-authorization-case-type-PaediatricSubmission\"> </a></td><td>Paediatric Submission</td></tr><tr><td style=\"white-space:nowrap\">TransferMA<a name=\"regulated-authorization-case-type-TransferMA\"> </a></td><td>Transfer of a marketing authorization</td></tr><tr><td style=\"white-space:nowrap\">LiftingSuspension<a name=\"regulated-authorization-case-type-LiftingSuspension\"> </a></td><td>Lifting of a Suspension</td></tr><tr><td style=\"white-space:nowrap\">Withdrawal<a name=\"regulated-authorization-case-type-Withdrawal\"> </a></td><td>Withdrawal</td></tr><tr><td style=\"white-space:nowrap\">Reformatting<a name=\"regulated-authorization-case-type-Reformatting\"> </a></td><td>Reformatting</td></tr><tr><td style=\"white-space:nowrap\">RMP<a name=\"regulated-authorization-case-type-RMP\"> </a></td><td>Risk Management Plan</td></tr><tr><td style=\"white-space:nowrap\">ReviewSuspension<a name=\"regulated-authorization-case-type-ReviewSuspension\"> </a></td><td>Review of a Suspension of MA</td></tr><tr><td style=\"white-space:nowrap\">SupplementalInformation<a name=\"regulated-authorization-case-type-SupplementalInformation\"> </a></td><td>Supplemental Information</td></tr><tr><td style=\"white-space:nowrap\">RepeatUse<a name=\"regulated-authorization-case-type-RepeatUse\"> </a></td><td>Repeat Use Procedure</td></tr><tr><td style=\"white-space:nowrap\">SignalDetection<a name=\"regulated-authorization-case-type-SignalDetection\"> </a></td><td>Signal detection</td></tr><tr><td style=\"white-space:nowrap\">FLU<a name=\"regulated-authorization-case-type-FLU\"> </a></td><td>FLU STRAIN UPDATE</td></tr><tr><td style=\"white-space:nowrap\">PANDEMIC<a name=\"regulated-authorization-case-type-PANDEMIC\"> </a></td><td>PANDEMIC UPDATE</td></tr><tr><td style=\"white-space:nowrap\">Orphan<a name=\"regulated-authorization-case-type-Orphan\"> </a></td><td>Orphan Designation Application</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"^^xsd:integer ] ] ) ; # fhir:url [ fhir:v "http://hl7.org/fhir/regulated-authorization-case-type"^^xsd:anyURI] ; # fhir:identifier ( [ fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ; fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.4.1910" ] ] ) ; # fhir:version [ fhir:v "6.0.0-ballot2"] ; # fhir:name [ fhir:v "RegulatedAuthorizationCaseType"] ; # fhir:title [ fhir:v "Regulated Authorization Case Type"] ; # fhir:status [ fhir:v "active"] ; # fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # 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 "RegulatedAuthorizationCaseType"] ; # 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"^^xsd:boolean] ; # fhir:valueSet [ fhir:v "http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/ValueSet/regulated-authorization-case-type> ] ; # fhir:hierarchyMeaning [] ; # fhir:content [ fhir:v "complete"] ; # fhir:concept ( [ fhir:code [ fhir:v "InitialMAA" ] ; fhir:display [ fhir:v "Initial Marketing Authorization Application" ] ] [ fhir:code [ fhir:v "Variation" ] ; fhir:display [ fhir:v "Variation" ] ] [ fhir:code [ fhir:v "LineExtension" ] ; fhir:display [ fhir:v "Line Extension" ] ] [ fhir:code [ fhir:v "PSUR" ] ; fhir:display [ fhir:v "Periodic Safety Update Report" ] ] [ fhir:code [ fhir:v "Renewal" ] ; fhir:display [ fhir:v "Renewal" ] ] [ fhir:code [ fhir:v "Follow-up" ] ; fhir:display [ fhir:v "Follow-up Measure" ] ] [ fhir:code [ fhir:v "100000155699" ] ; fhir:display [ fhir:v "Specific Obligation" ] ] [ fhir:code [ fhir:v "AnnualReassessment" ] ; fhir:display [ fhir:v "Annual Reassessment" ] ] [ fhir:code [ fhir:v "UrgentSafetyRestriction" ] ; fhir:display [ fhir:v "Urgent Safety Restriction" ] ] [ fhir:code [ fhir:v "PaediatricSubmission" ] ; fhir:display [ fhir:v "Paediatric Submission" ] ] [ fhir:code [ fhir:v "TransferMA" ] ; fhir:display [ fhir:v "Transfer of a marketing authorization" ] ] [ fhir:code [ fhir:v "LiftingSuspension" ] ; fhir:display [ fhir:v "Lifting of a Suspension" ] ] [ fhir:code [ fhir:v "Withdrawal" ] ; fhir:display [ fhir:v "Withdrawal" ] ] [ fhir:code [ fhir:v "Reformatting" ] ; fhir:display [ fhir:v "Reformatting" ] ] [ fhir:code [ fhir:v "RMP" ] ; fhir:display [ fhir:v "Risk Management Plan" ] ] [ fhir:code [ fhir:v "ReviewSuspension" ] ; fhir:display [ fhir:v "Review of a Suspension of MA" ] ] [ fhir:code [ fhir:v "SupplementalInformation" ] ; fhir:display [ fhir:v "Supplemental Information" ] ] [ fhir:code [ fhir:v "RepeatUse" ] ; fhir:display [ fhir:v "Repeat Use Procedure" ] ] [ fhir:code [ fhir:v "SignalDetection" ] ; fhir:display [ fhir:v "Signal detection" ] ] [ fhir:code [ fhir:v "FLU" ] ; fhir:display [ fhir:v "FLU STRAIN UPDATE" ] ] [ fhir:code [ fhir:v "PANDEMIC" ] ; fhir:display [ fhir:v "PANDEMIC UPDATE" ] ] [ fhir:code [ fhir:v "Orphan" ] ; fhir:display [ fhir:v "Orphan Designation Application" ] ] ) . # # -------------------------------------------------------------------------------------
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 Fri, Feb 21, 2025 15:32+0000.
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