This page is part of the FHIR Specification (v5.0.0-ballot: R5 Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B
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" : "2022-09-10T05:52:37.223+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 Authorisation 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 authorisation</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-ballot", "name" : "RegulatedAuthorizationCaseType", "title" : "RegulatedAuthorizationCaseType", "status" : "draft", "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" }] }], "caseSensitive" : true, "valueSet" : "http://hl7.org/fhir/ValueSet/regulated-authorization-case-type", "content" : "complete", "concept" : [{ "code" : "InitialMAA", "display" : "Initial Marketing Authorisation 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 authorisation" }, { "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 Ballot hl7.fhir.core#5.0.0-ballot generated on Sat, Sep 10, 2022 04:55+1000.
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