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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
{
"resourceType" : "CodeSystem",
"id" : "regulated-authorization-case-type",
"meta" : {
"lastUpdated" : "2023-03-26T15:21:02.749+11:00",
"profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This 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>"
},
"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-case-type",
"identifier" : [{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.4.1910"
}],
"version" : "5.0.0",
"name" : "RegulatedAuthorizationCaseType",
"title" : "Regulated Authorization Case Type",
"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" : "RegulatedAuthorizationCaseType",
"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-case-type",
"content" : "complete",
"concept" : [{
"code" : "InitialMAA",
"display" : "Initial Marketing Authorization Application"
},
{
"code" : "Variation",
"display" : "Variation"
},
{
"code" : "LineExtension",
"display" : "Line Extension"
},
{
"code" : "PSUR",
"display" : "Periodic Safety Update Report"
},
{
"code" : "Renewal",
"display" : "Renewal"
},
{
"code" : "Follow-up",
"display" : "Follow-up Measure"
},
{
"code" : "100000155699",
"display" : "Specific Obligation"
},
{
"code" : "AnnualReassessment",
"display" : "Annual Reassessment"
},
{
"code" : "UrgentSafetyRestriction",
"display" : "Urgent Safety Restriction"
},
{
"code" : "PaediatricSubmission",
"display" : "Paediatric Submission"
},
{
"code" : "TransferMA",
"display" : "Transfer of a marketing authorization"
},
{
"code" : "LiftingSuspension",
"display" : "Lifting of a Suspension"
},
{
"code" : "Withdrawal",
"display" : "Withdrawal"
},
{
"code" : "Reformatting",
"display" : "Reformatting"
},
{
"code" : "RMP",
"display" : "Risk Management Plan"
},
{
"code" : "ReviewSuspension",
"display" : "Review of a Suspension of MA"
},
{
"code" : "SupplementalInformation",
"display" : "Supplemental Information"
},
{
"code" : "RepeatUse",
"display" : "Repeat Use Procedure"
},
{
"code" : "SignalDetection",
"display" : "Signal detection"
},
{
"code" : "FLU",
"display" : "FLU STRAIN UPDATE"
},
{
"code" : "PANDEMIC",
"display" : "PANDEMIC UPDATE"
},
{
"code" : "Orphan",
"display" : "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 R5 hl7.fhir.core#5.0.0 generated on Sun, Mar 26, 2023 15:22+1100.
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