EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build

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: Regulatory Entitlement - XML Representation

Active as of 2025-04-04

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="220000000060"/>
  <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 220000000060</b></p><a name="220000000060"> </a><a name="hc220000000060"> </a><a name="220000000060-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/220000000060</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">220000000061<a name="220000000060-220000000061"> </a></td><td>Marketing Authorisation</td></tr><tr><td style="white-space:nowrap">220000000062<a name="220000000060-220000000062"> </a></td><td>Orphan Designation</td></tr><tr><td style="white-space:nowrap">220000000063<a name="220000000060-220000000063"> </a></td><td>Parallel Trade Authorisation</td></tr><tr><td style="white-space:nowrap">220000000065<a name="220000000060-220000000065"> </a></td><td>Paediatric Use</td></tr><tr><td style="white-space:nowrap">220000000077<a name="220000000060-220000000077"> </a></td><td>Market Protection</td></tr><tr><td style="white-space:nowrap">220000000096<a name="220000000060-220000000096"> </a></td><td>GMP Inside EEA</td></tr><tr><td style="white-space:nowrap">220000000097<a name="220000000060-220000000097"> </a></td><td>GMP Outside EEA</td></tr><tr><td style="white-space:nowrap">220000000098<a name="220000000060-220000000098"> </a></td><td>SME</td></tr><tr><td style="white-space:nowrap">220000000099<a name="220000000060-220000000099"> </a></td><td>Manufacturing Authorisation</td></tr></table></div>
  </text>
  <url value="http://spor.ema.europa.eu/v1/lists/220000000060"/>
  <version value="1.0.0"/>
  <name value="RegulatoryEntitlementTypeCs"/>
  <title value="Regulatory Entitlement"/>
  <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"/>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="9"/>
  <concept>
    <code value="220000000061"/>
    <display value="Marketing Authorisation"/>
  </concept>
  <concept>
    <code value="220000000062"/>
    <display value="Orphan Designation"/>
  </concept>
  <concept>
    <code value="220000000063"/>
    <display value="Parallel Trade Authorisation"/>
  </concept>
  <concept>
    <code value="220000000065"/>
    <display value="Paediatric Use"/>
  </concept>
  <concept>
    <code value="220000000077"/>
    <display value="Market Protection"/>
  </concept>
  <concept>
    <code value="220000000096"/>
    <display value="GMP Inside EEA"/>
  </concept>
  <concept>
    <code value="220000000097"/>
    <display value="GMP Outside EEA"/>
  </concept>
  <concept>
    <code value="220000000098"/>
    <display value="SME"/>
  </concept>
  <concept>
    <code value="220000000099"/>
    <display value="Manufacturing Authorisation"/>
  </concept>
</CodeSystem>