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

• Narrative Content
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• JSON
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: Regulatory Entitlement Status EMA SPOR - JSON Representation

Draft as of 2024-08-20

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{
  "resourceType" : "CodeSystem",
  "id" : "regulatoryStatus-ema-cs",
  "text" : {
    "status" : "generated",
    "div" : "<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Withdrawn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Withdrawn, unspecified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>"
  },
  "url" : "https://spor.ema.europa.eu/v1/lists/100000072049",
  "version" : "1.0.0",
  "name" : "RegulatoryStatus_EMA_CS",
  "title" : "Regulatory Entitlement Status EMA SPOR",
  "status" : "draft",
  "experimental" : false,
  "date" : "2024-08-20T21:53:59+00:00",
  "publisher" : "UNICOM",
  "contact" : [
    {
      "name" : "UNICOM",
      "telecom" : [
        {
          "system" : "url",
          "value" : "https://unicom-project.eu/"
        }
      ]
    },
    {
      "name" : "Rutt Lindström",
      "telecom" : [
        {
          "system" : "email",
          "value" : "rutt.lindstrom@tehik.ee",
          "use" : "work"
        }
      ]
    }
  ],
  "description" : "Regulatory Entitlement Status EMA SPOR",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001",
          "display" : "World"
        }
      ]
    }
  ],
  "caseSensitive" : false,
  "compositional" : false,
  "content" : "complete",
  "count" : 15,
  "concept" : [
    {
      "code" : "100000072121",
      "display" : "Revoked"
    },
    {
      "code" : "200000029967",
      "display" : "Harmonised"
    },
    {
      "code" : "200000017708",
      "display" : "Valid - Renewed/Varied"
    },
    {
      "code" : "200000017707",
      "display" : "Valid - Transferred marketing authorisation"
    },
    {
      "code" : "100000072099",
      "display" : "Valid"
    },
    {
      "code" : "100000072100",
      "display" : "Expired"
    },
    {
      "code" : "100000072112",
      "display" : "Not renewed"
    },
    {
      "code" : "100000072113",
      "display" : "Withdrawn"
    },
    {
      "code" : "100000072114",
      "display" : "Withdrawn, unspecified"
    },
    {
      "code" : "200000026056",
      "display" : "Presubmission"
    },
    {
      "code" : "100000072122",
      "display" : "Suspended"
    },
    {
      "code" : "100000072123",
      "display" : "Expired due to Sunset Clause"
    },
    {
      "code" : "200000010409",
      "display" : "Surrendered"
    },
    {
      "code" : "220000000066",
      "display" : "Pending"
    },
    {
      "code" : "220000000067",
      "display" : "Rejected"
    }
  ]
}