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RegulatedAuthorization "example" Version "1"

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Generated Narrative

identifier: id: EU/1/11/999/001

region: EU

status: active

statusDate: 2015-01-14

validityPeriod: 2014-09-03 --> 2020-05-20

jurisdictionalAuthorization: RegulatedAuthorization/Jurusdictional1

holder: Organization/example

regulator: Organization/example

case

identifier: id: EMEA/H/C/009999/IA/0099/G

type: VariationTypeIA

date: 2014-09-02 --> 2015-08-21

Applications

-
*
*

{
  "resourceType" : "RegulatedAuthorization",
  "id" : "example",
  "meta" : {
    "versionId" : "1",
    "lastUpdated" : "2021-05-24T10:51:08.676Z",
    "tag" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
        "code" : "HTEST",
        "display" : "test health data"
      }
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>identifier</b>: id: EU/1/11/999/001</p><p><b>region</b>: <span>EU</span></p><p><b>status</b>: <span>active</span></p><p><b>statusDate</b>: 2015-01-14</p><p><b>validityPeriod</b>: 2014-09-03 --&gt; 2020-05-20</p><p><b>jurisdictionalAuthorization</b>: <a>RegulatedAuthorization/Jurusdictional1</a></p><p><b>holder</b>: <a>Organization/example</a></p><p><b>regulator</b>: <a>Organization/example</a></p><blockquote><p><b>case</b></p><p><b>identifier</b>: id: EMEA/H/C/009999/IA/0099/G</p><p><b>type</b>: <span>VariationTypeIA</span></p><p><b>date</b>: 2014-09-02 --&gt; 2015-08-21</p><h3>Applications</h3><table><tr><td>-</td></tr><tr><td>*</td></tr><tr><td>*</td></tr></table></blockquote></div>"
  },
  "identifier" : [
    {
      "system" : "http://ema.europa.eu/example/marketingAuthorisationNumber",
      "value" : "EU/1/11/999/001"
    }
  ],
  "region" : [
    {
      "coding" : [
        {
          "system" : "http://ema.europa.eu/example/country",
          "code" : "EU"
        }
      ]
    }
  ],
  "status" : {
    "coding" : [
      {
        "system" : "http://ema.europa.eu/example/authorisationstatus",
        "code" : "active"
      }
    ]
  },
  "statusDate" : "2015-01-14",
  "validityPeriod" : {
    "start" : "2014-09-03",
    "end" : "2020-05-20"
  },
  "jurisdictionalAuthorization" : [
    {
      "id" : "1",
      "reference" : "RegulatedAuthorization/Jurusdictional1"
    }
  ],
  "holder" : {
    "reference" : "Organization/example"
  },
  "regulator" : {
    "reference" : "Organization/example"
  },
  "case" : {
    "identifier" : {
      "system" : "http://ema.europa.eu/example/procedureidentifier-number",
      "value" : "EMEA/H/C/009999/IA/0099/G"
    },
    "type" : {
      "coding" : [
        {
          "system" : "http://ema.europa.eu/example/marketingAuthorisationProcedureType",
          "code" : "VariationTypeIA"
        }
      ]
    },
    "datePeriod" : {
      "start" : "2014-09-02",
      "end" : "2015-08-21"
    },
    "application" : [
      {
        "identifier" : {
          "system" : "http://ema.europa.eu/example/applicationidentifier-number",
          "value" : "IA38G"
        },
        "type" : {
          "coding" : [
            {
              "system" : "http://ema.europa.eu/example/marketingAuthorisationApplicationType",
              "code" : "GroupTypeIAVariationNotification"
            }
          ]
        },
        "dateDateTime" : "2015-08-01"
      },
      {
        "identifier" : {
          "system" : "http://ema.europa.eu/example/applicationidentifier-number",
          "value" : "IA38F"
        },
        "type" : {
          "coding" : [
            {
              "system" : "http://ema.europa.eu/example/marketingAuthorisationApplicationType",
              "code" : "GroupTypeIAVariationNotification"
            }
          ]
        },
        "dateDateTime" : "2014-09-01"
      }
    ]
  }
}

RegulatedAuthorization "basic-drug-auth" Version "1"

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Generated Narrative

subject: MedicinalProductDefinition/equilidem

type: Regulatory Drug Marketing Approval

status: active

statusDate: 2016-01-01

holder: EquiliDrugCo Holdings Inc.

regulator: FDA


{
  "resourceType" : "RegulatedAuthorization",
  "id" : "basic-drug-auth",
  "meta" : {
    "versionId" : "1",
    "lastUpdated" : "2021-05-24T10:51:08.610Z",
    "tag" : [
      {
        "system" : "http://terminology.hl7.org/CodeSystem/v3-ActReason",
        "code" : "HTEST",
        "display" : "test health data"
      }
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>subject</b>: <a>MedicinalProductDefinition/equilidem</a></p><p><b>type</b>: <span>Regulatory Drug Marketing Approval</span></p><p><b>status</b>: <span>active</span></p><p><b>statusDate</b>: 2016-01-01</p><p><b>holder</b>: <a>EquiliDrugCo Holdings Inc.</a></p><p><b>regulator</b>: <a>FDA</a></p></div>"
  },
  "subject" : {
    "reference" : "MedicinalProductDefinition/equilidem"
  },
  "type" : {
    "text" : "Regulatory Drug Marketing Approval"
  },
  "status" : {
    "coding" : [
      {
        "code" : "active"
      }
    ]
  },
  "statusDate" : "2016-01-01",
  "holder" : {
    "reference" : "Organization/EqlidrugCo",
    "display" : "EquiliDrugCo Holdings Inc."
  },
  "regulator" : {
    "reference" : "Organization/FDA",
    "display" : "FDA"
  }
}