EMA Write PMS API Implementation Guide - Enrichments
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: Regulatory Authorization Registration Procedure - XML Representation

Active as of 2025-04-04

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="100000154442"/>
  <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 100000154442</b></p><a name="100000154442"> </a><a name="hc100000154442"> </a><a name="100000154442-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/100000154442</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">100000155059<a name="100000154442-100000155059"> </a></td><td>Centralised Procedure</td></tr><tr><td style="white-space:nowrap">100000155060<a name="100000154442-100000155060"> </a></td><td>Decentralised Procedure</td></tr><tr><td style="white-space:nowrap">100000155061<a name="100000154442-100000155061"> </a></td><td>Mutual Recognition Procedure</td></tr><tr><td style="white-space:nowrap">100000155062<a name="100000154442-100000155062"> </a></td><td>National Procedure</td></tr><tr><td style="white-space:nowrap">200000015759<a name="100000154442-200000015759"> </a></td><td>Non-EU Authorisation Procedure</td></tr><tr><td style="white-space:nowrap">200000016181<a name="100000154442-200000016181"> </a></td><td>Subsequent Recognition Procedure</td></tr><tr><td style="white-space:nowrap">200000023345<a name="100000154442-200000023345"> </a></td><td>EU Other Approval/Authorisation Procedure</td></tr><tr><td style="white-space:nowrap">200000026020<a name="100000154442-200000026020"> </a></td><td>Parallel Trade Procedure</td></tr><tr><td style="white-space:nowrap">200000027034<a name="100000154442-200000027034"> </a></td><td>Exemption to marketing authorisation for veterinary medicinal products intended for animals exclusively kept as pets</td></tr><tr><td style="white-space:nowrap">200000027035<a name="100000154442-200000027035"> </a></td><td>Registration procedure for veterinary homeopathic medicinal products</td></tr><tr><td style="white-space:nowrap">220000005052<a name="100000154442-220000005052"> </a></td><td>EU Registration Procedures - Traditional use registration for herbal medicinal products</td></tr><tr><td style="white-space:nowrap">220000005053<a name="100000154442-220000005053"> </a></td><td>EU Registration Procedures - Simplified registration procedure for homeopathic medicinal products</td></tr></table></div>
  </text>
  <url value="http://spor.ema.europa.eu/v1/lists/100000154442"/>
  <version value="1.0.0"/>
  <name value="RegulatoryAuthorizationRegistrationProcedureCs"/>
  <title value="Regulatory Authorization Registration Procedure"/>
  <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 Authorization Registration Procedure"/>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <count value="12"/>
  <concept>
    <code value="100000155059"/>
    <display value="Centralised Procedure"/>
  </concept>
  <concept>
    <code value="100000155060"/>
    <display value="Decentralised Procedure"/>
  </concept>
  <concept>
    <code value="100000155061"/>
    <display value="Mutual Recognition Procedure"/>
  </concept>
  <concept>
    <code value="100000155062"/>
    <display value="National Procedure"/>
  </concept>
  <concept>
    <code value="200000015759"/>
    <display value="Non-EU Authorisation Procedure"/>
  </concept>
  <concept>
    <code value="200000016181"/>
    <display value="Subsequent Recognition Procedure"/>
  </concept>
  <concept>
    <code value="200000023345"/>
    <display value="EU Other Approval/Authorisation Procedure"/>
  </concept>
  <concept>
    <code value="200000026020"/>
    <display value="Parallel Trade Procedure"/>
  </concept>
  <concept>
    <code value="200000027034"/>
    <display
             value="Exemption to marketing authorisation for veterinary medicinal products intended for animals exclusively kept as pets"/>
  </concept>
  <concept>
    <code value="200000027035"/>
    <display
             value="Registration procedure for veterinary homeopathic medicinal products"/>
  </concept>
  <concept>
    <code value="220000005052"/>
    <display
             value="EU Registration Procedures - Traditional use registration for herbal medicinal products"/>
  </concept>
  <concept>
    <code value="220000005053"/>
    <display
             value="EU Registration Procedures - Simplified registration procedure for homeopathic medicinal products"/>
  </concept>
</CodeSystem>