<?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>