European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
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European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v0.4.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

: ePI Regulated Authorization example 1 - JSON Representation

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{
  "resourceType" : "RegulatedAuthorization",
  "id" : "06a1cd7d-ced4-4181-9d8f-fd2ed7393c57",
  "meta" : {
    "profile" : [
      🔗 "http://ema.europa.eu/fhir/StructureDefinition/EUEpiRegulatedAuthorization"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization 06a1cd7d-ced4-4181-9d8f-fd2ed7393c57</b></p><a name=\"06a1cd7d-ced4-4181-9d8f-fd2ed7393c57\"> </a><a name=\"hc06a1cd7d-ced4-4181-9d8f-fd2ed7393c57\"> </a><a name=\"06a1cd7d-ced4-4181-9d8f-fd2ed7393c57-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/epiId</code>/EPI/23/1024</p><p><b>subject</b>: Reference to EPI/23/1024 (Identifier: <code>http://ema.europa.eu/fhir/epiId</code>/EPI/23/1024)</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/220000000060 220000000061}\">electronic Product Information (ePI) Authorisation</span></p><p><b>description</b>: </p><div><p>This is the authorization for EPI/23/1024</p>\n</div><p><b>region</b>: <span title=\"Codes:{http://ema.europa.eu/fhir/CodeSystem/region EU}\">EU</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>statusDate</b>: 2024-01-31</p><p><b>validityPeriod</b>: 2024-01-31 --&gt; (ongoing)</p><p><b>holder</b>: UAT ORG (ORG-200036100) (Identifier: <code>https://spor.ema.europa.eu/v1/organisations</code>/ORG-200036100)</p><p><b>regulator</b>: European Medicines Agency (Identifier: <code>https://spor.ema.europa.eu/v1/organisations</code>/ORG-100013412)</p><h3>Cases</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Identifier</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><code>http://ema.europa.eu/fhir/procedureIdentifierNumber</code>/001</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000154442 100000155059}\">CAP</span></td></tr></table></div>"
  },
  "identifier" : [
    {
      "system" : "http://ema.europa.eu/fhir/epiId",
      "value" : "EPI/23/1024"
    }
  ],
  "subject" : [
    {
      "identifier" : {
        "system" : "http://ema.europa.eu/fhir/epiId",
        "value" : "EPI/23/1024"
      },
      "display" : "Reference to EPI/23/1024"
    }
  ],
  "type" : {
    "coding" : [
      {
        "system" : "https://spor.ema.europa.eu/v1/lists/220000000060",
        "code" : "220000000061",
        "display" : "electronic Product Information (ePI) Authorisation"
      }
    ]
  },
  "description" : "This is the authorization for EPI/23/1024",
  "region" : [
    {
      "coding" : [
        {
          "system" : "http://ema.europa.eu/fhir/CodeSystem/region",
          "code" : "EU"
        }
      ]
    }
  ],
  "status" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/publication-status",
        "code" : "active",
        "display" : "Active"
      }
    ]
  },
  "statusDate" : "2024-01-31",
  "validityPeriod" : {
    "start" : "2024-01-31"
  },
  "holder" : {
    "identifier" : {
      "system" : "https://spor.ema.europa.eu/v1/organisations",
      "value" : "ORG-200036100"
    },
    "display" : "UAT ORG (ORG-200036100)"
  },
  "regulator" : {
    "identifier" : {
      "system" : "https://spor.ema.europa.eu/v1/organisations",
      "value" : "ORG-100013412"
    },
    "display" : "European Medicines Agency"
  },
  "case" : {
    "identifier" : {
      "system" : "http://ema.europa.eu/fhir/procedureIdentifierNumber",
      "value" : "001"
    },
    "type" : {
      "coding" : [
        {
          "system" : "https://spor.ema.europa.eu/v1/lists/100000154442",
          "code" : "100000155059",
          "display" : "CAP"
        }
      ]
    }
  }
}