Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12)
1.0.0 - STU1 International flag

Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12), published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/unicom-project-eu/d4.12/ and changes regularly. See the Directory of published versions

: Regulatory Entitlement Status EMA SPOR - XML Representation

Draft as of 2024-08-20

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="regulatoryStatus-ema-cs"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem regulatoryStatus-ema-cs</b></p><a name="regulatoryStatus-ema-cs"> </a><a name="hcregulatoryStatus-ema-cs"> </a><a name="regulatoryStatus-ema-cs-en-US"> </a><p>This case-insensitive code system <code>https://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">100000072121<a name="regulatoryStatus-ema-cs-100000072121"> </a></td><td>Revoked</td></tr><tr><td style="white-space:nowrap">200000029967<a name="regulatoryStatus-ema-cs-200000029967"> </a></td><td>Harmonised</td></tr><tr><td style="white-space:nowrap">200000017708<a name="regulatoryStatus-ema-cs-200000017708"> </a></td><td>Valid - Renewed/Varied</td></tr><tr><td style="white-space:nowrap">200000017707<a name="regulatoryStatus-ema-cs-200000017707"> </a></td><td>Valid - Transferred marketing authorisation</td></tr><tr><td style="white-space:nowrap">100000072099<a name="regulatoryStatus-ema-cs-100000072099"> </a></td><td>Valid</td></tr><tr><td style="white-space:nowrap">100000072100<a name="regulatoryStatus-ema-cs-100000072100"> </a></td><td>Expired</td></tr><tr><td style="white-space:nowrap">100000072112<a name="regulatoryStatus-ema-cs-100000072112"> </a></td><td>Not renewed</td></tr><tr><td style="white-space:nowrap">100000072113<a name="regulatoryStatus-ema-cs-100000072113"> </a></td><td>Withdrawn</td></tr><tr><td style="white-space:nowrap">100000072114<a name="regulatoryStatus-ema-cs-100000072114"> </a></td><td>Withdrawn, unspecified</td></tr><tr><td style="white-space:nowrap">200000026056<a name="regulatoryStatus-ema-cs-200000026056"> </a></td><td>Presubmission</td></tr><tr><td style="white-space:nowrap">100000072122<a name="regulatoryStatus-ema-cs-100000072122"> </a></td><td>Suspended</td></tr><tr><td style="white-space:nowrap">100000072123<a name="regulatoryStatus-ema-cs-100000072123"> </a></td><td>Expired due to Sunset Clause</td></tr><tr><td style="white-space:nowrap">200000010409<a name="regulatoryStatus-ema-cs-200000010409"> </a></td><td>Surrendered</td></tr><tr><td style="white-space:nowrap">220000000066<a name="regulatoryStatus-ema-cs-220000000066"> </a></td><td>Pending</td></tr><tr><td style="white-space:nowrap">220000000067<a name="regulatoryStatus-ema-cs-220000000067"> </a></td><td>Rejected</td></tr></table></div>
  </text>
  <url value="https://spor.ema.europa.eu/v1/lists/100000072049"/>
  <version value="1.0.0"/>
  <name value="RegulatoryStatus_EMA_CS"/>
  <title value="Regulatory Entitlement Status EMA SPOR"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2024-08-20T21:53:59+00:00"/>
  <publisher value="UNICOM"/>
  <contact>
    <name value="UNICOM"/>
    <telecom>
      <system value="url"/>
      <value value="https://unicom-project.eu/"/>
    </telecom>
  </contact>
  <contact>
    <name value="Rutt Lindström"/>
    <telecom>
      <system value="email"/>
      <value value="rutt.lindstrom@tehik.ee"/>
      <use value="work"/>
    </telecom>
  </contact>
  <description value="Regulatory Entitlement Status EMA SPOR"/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <caseSensitive value="false"/>
  <compositional value="false"/>
  <content value="complete"/>
  <count value="15"/>
  <concept>
    <code value="100000072121"/>
    <display value="Revoked"/>
  </concept>
  <concept>
    <code value="200000029967"/>
    <display value="Harmonised"/>
  </concept>
  <concept>
    <code value="200000017708"/>
    <display value="Valid - Renewed/Varied"/>
  </concept>
  <concept>
    <code value="200000017707"/>
    <display value="Valid - Transferred marketing authorisation"/>
  </concept>
  <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="200000026056"/>
    <display value="Presubmission"/>
  </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="220000000066"/>
    <display value="Pending"/>
  </concept>
  <concept>
    <code value="220000000067"/>
    <display value="Rejected"/>
  </concept>
</CodeSystem>