Release 4B
This page is part of the FHIR Specification (v4.3.0: R4B - STU). 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
Codesystem-regulated-authorization-case-type.xml

Biomedical Research and Regulation Work Group
Maturity Level: N/A
Standards Status: Informative
Raw XML (canonical form + also see XML Format Specification)
Definition for Code SystemRegulatedAuthorizationCaseType
<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="regulated-authorization-case-type"/> 
  <meta> 
    <lastUpdated value="2022-05-28T13:47:40.239+11:00"/> 
    <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p> This code system http://hl7.org/fhir/regulated-authorization-case-type 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> 
  </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="trial-use"/> 
  </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:2.16.840.1.113883.4.642.1.1645"/> 
  </identifier> 
  <version value="4.3.0"/> 
  <name value="RegulatedAuthorizationCaseType"/> 
  <title value="RegulatedAuthorizationCaseType"/> 
  <status value="draft"/> 
  <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> 
  <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 Authorisation 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 authorisation"/> 
  </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>
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.