EMA Write PMS API Implementation Guide - Enrichments
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: Regulatory Entitlement Status - XML Representation

Active as of 2025-04-04

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="100000072049"/>
  <meta>
    <versionId value="5.0.0"/>
    <lastUpdated value="2023-08-03T11:35:00.198Z"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem 100000072049</b></p><a name="100000072049"> </a><a name="hc100000072049"> </a><a name="100000072049-en-US"> </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">version: 5.0.0; Last updated: 2023-08-03 11:35:00+0000</p></div><p>This case-sensitive code system <code>http://spor.ema.europa.eu/v1/lists/100000072049</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">100000072099<a name="100000072049-100000072099"> </a></td><td>Valid</td></tr><tr><td style="white-space:nowrap">100000072100<a name="100000072049-100000072100"> </a></td><td>Expired</td></tr><tr><td style="white-space:nowrap">100000072112<a name="100000072049-100000072112"> </a></td><td>Not renewed</td></tr><tr><td style="white-space:nowrap">100000072113<a name="100000072049-100000072113"> </a></td><td>Withdrawn</td></tr><tr><td style="white-space:nowrap">100000072114<a name="100000072049-100000072114"> </a></td><td>Withdrawn, unspecified</td></tr><tr><td style="white-space:nowrap">100000072121<a name="100000072049-100000072121"> </a></td><td>Revoked</td></tr><tr><td style="white-space:nowrap">100000072122<a name="100000072049-100000072122"> </a></td><td>Suspended</td></tr><tr><td style="white-space:nowrap">100000072123<a name="100000072049-100000072123"> </a></td><td>Expired due to Sunset Clause</td></tr><tr><td style="white-space:nowrap">200000010409<a name="100000072049-200000010409"> </a></td><td>Surrendered</td></tr><tr><td style="white-space:nowrap">200000017707<a name="100000072049-200000017707"> </a></td><td>Valid - Transferred marketing authorisation</td></tr><tr><td style="white-space:nowrap">200000017708<a name="100000072049-200000017708"> </a></td><td>Valid - Renewed/Varied</td></tr><tr><td style="white-space:nowrap">200000026056<a name="100000072049-200000026056"> </a></td><td>Presubmission</td></tr><tr><td style="white-space:nowrap">220000000066<a name="100000072049-220000000066"> </a></td><td>Pending</td></tr><tr><td style="white-space:nowrap">220000000067<a name="100000072049-220000000067"> </a></td><td>Rejected</td></tr><tr><td style="white-space:nowrap">200000032263<a name="100000072049-200000032263"> </a></td><td>Not valid - Superseded by marketing authorisation transfer</td></tr></table></div>
  </text>
  <url value="http://spor.ema.europa.eu/v1/lists/100000072049"/>
  <version value="1.0.0"/>
  <name value="RegulatoryEntitlementStatusCs"/>
  <title value="Regulatory Entitlement Status"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2025-04-04T16:15:09+01:00"/>
  <publisher value="EMA"/>
  <contact>
    <name value="EMA"/>
    <telecom>
      <system value="url"/>
      <value value="https://support.ema.europa.eu/esc"/>
    </telecom>
  </contact>
  <description value="Regulatory Entitlement Status"/>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="15"/>
  <concept>
    <code value="100000072099"/>
    <display value="Valid"/>
  </concept>
  <concept>
    <code value="100000072100"/>
    <display value="Expired"/>
  </concept>
  <concept>
    <code value="100000072112"/>
    <display value="Not renewed"/>
  </concept>
  <concept>
    <code value="100000072113"/>
    <display value="Withdrawn"/>
  </concept>
  <concept>
    <code value="100000072114"/>
    <display value="Withdrawn, unspecified"/>
  </concept>
  <concept>
    <code value="100000072121"/>
    <display value="Revoked"/>
  </concept>
  <concept>
    <code value="100000072122"/>
    <display value="Suspended"/>
  </concept>
  <concept>
    <code value="100000072123"/>
    <display value="Expired due to Sunset Clause"/>
  </concept>
  <concept>
    <code value="200000010409"/>
    <display value="Surrendered"/>
  </concept>
  <concept>
    <code value="200000017707"/>
    <display value="Valid - Transferred marketing authorisation"/>
  </concept>
  <concept>
    <code value="200000017708"/>
    <display value="Valid - Renewed/Varied"/>
  </concept>
  <concept>
    <code value="200000026056"/>
    <display value="Presubmission"/>
  </concept>
  <concept>
    <code value="220000000066"/>
    <display value="Pending"/>
  </concept>
  <concept>
    <code value="220000000067"/>
    <display value="Rejected"/>
  </concept>
  <concept>
    <code value="200000032263"/>
    <display
             value="Not valid - Superseded by marketing authorisation transfer"/>
  </concept>
</CodeSystem>