<?xml version="1.0" encoding="UTF-8"?><CodeSystem xmlns="http://hl7.org/fhir"><id value="regulated-authorization-case-type"/><meta><lastUpdated value="2026-04-01T05:55:04.283+11:00"/></meta><text><status value="generated"/><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><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></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></text><extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"><valueCode value="brr"/></extension><extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"><valueCode value="informative"/></extension><extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"><valueInteger value="1"/></extension><url value="http://hl7.org/fhir/regulated-authorization-case-type"/><identifier><system value="urn:ietf:rfc:3986"/><value value="urn:oid:2.16.840.1.113883.4.642.4.1910"/></identifier><version value="6.0.0-ballot4"/><name value="RegulatedAuthorizationCaseType"/><title value="Regulated Authorization Case Type"/><status value="active"/><experimental value="false"/><date value="2021-01-05T10:01:24+11:00"/><publisher value="HL7 (FHIR Project)"/><contact><telecom><system value="url"/><value value="http://hl7.org/fhir"/></telecom><telecom><system value="email"/><value value="fhir@lists.hl7.org"/></telecom></contact><description value="RegulatedAuthorizationCaseType"/><jurisdiction><coding><system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/><code value="001"/><display value="World"/></coding></jurisdiction><caseSensitive value="true"/><valueSet value="http://hl7.org/fhir/ValueSet/regulated-authorization-case-type"/><content value="complete"/><concept><code value="InitialMAA"/><display value="Initial Marketing Authorization Application"/></concept><concept><code value="Variation"/><display value="Variation"/></concept><concept><code value="LineExtension"/><display value="Line Extension"/></concept><concept><code value="PSUR"/><display value="Periodic Safety Update Report"/></concept><concept><code value="Renewal"/><display value="Renewal"/></concept><concept><code value="Follow-up"/><display value="Follow-up Measure"/></concept><concept><code value="100000155699"/><display value="Specific Obligation"/></concept><concept><code value="AnnualReassessment"/><display value="Annual Reassessment"/></concept><concept><code value="UrgentSafetyRestriction"/><display value="Urgent Safety Restriction"/></concept><concept><code value="PaediatricSubmission"/><display value="Paediatric Submission"/></concept><concept><code value="TransferMA"/><display value="Transfer of a marketing authorization"/></concept><concept><code value="LiftingSuspension"/><display value="Lifting of a Suspension"/></concept><concept><code value="Withdrawal"/><display value="Withdrawal"/></concept><concept><code value="Reformatting"/><display value="Reformatting"/></concept><concept><code value="RMP"/><display value="Risk Management Plan"/></concept><concept><code value="ReviewSuspension"/><display value="Review of a Suspension of MA"/></concept><concept><code value="SupplementalInformation"/><display value="Supplemental Information"/></concept><concept><code value="RepeatUse"/><display value="Repeat Use Procedure"/></concept><concept><code value="SignalDetection"/><display value="Signal detection"/></concept><concept><code value="FLU"/><display value="FLU STRAIN UPDATE"/></concept><concept><code value="PANDEMIC"/><display value="PANDEMIC UPDATE"/></concept><concept><code value="Orphan"/><display value="Orphan Designation Application"/></concept></CodeSystem>