Release 4B 5

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0: R5 - STU ). The This is the current published version which supercedes in it's permanent home (it will always be available at this version is 5.0.0 . URL). For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R5 R4B

Regulatedauthorization-example.json

Example RegulatedAuthorization/example (JSON)

Biomedical Research and Regulation Work Group Maturity Level : N/A Standards Status : Informative Compartments : Not linked to any No defined compartments

Raw JSON ( canonical form + also see JSON Format Specification )

General example 

{
  "resourceType": "RegulatedAuthorization",
  "id": "example",
  "text": {
    "status": "generated",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><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\">Resource &quot;example&quot; </p></div><p><b>identifier</b>: id: EU/1/11/999/001</p><p><b>region</b>: EU <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (country#EU)</span></p><p><b>status</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (authorisationstatus#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>holder</b>: <a href=\"todo.html\">Organization/example</a></p><p><b>regulator</b>: <a href=\"todo.html\">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>: VariationTypeIA <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (marketingAuthorisationProcedureType#VariationTypeIA)</span></p><p><b>date</b>: 2014-09-02 --&gt; 2015-08-21</p><h3>Applications</h3><table class=\"grid\"><tr><td>-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Date[x]</b></td></tr><tr><td>*</td><td>id: IA38G</td><td>GroupTypeIAVariationNotification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (marketingAuthorisationApplicationType#GroupTypeIAVariationNotification)</span></td><td>2015-08-01</td></tr><tr><td>*</td><td>id: IA38F</td><td>GroupTypeIAVariationNotification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (marketingAuthorisationApplicationType#GroupTypeIAVariationNotification)</span></td><td>2014-09-01</td></tr></table></blockquote></div>"

  "resourceType" : "RegulatedAuthorization",
  "id" : "example",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: RegulatedAuthorization</b><a name=\"example\"> </a></p><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\">Resource RegulatedAuthorization &quot;example&quot; </p></div><p><b>identifier</b>: id:\u00a0EU/1/11/999/001</p><p><b>region</b>: EU <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (country#EU)</span></p><p><b>status</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (authorizationstatus#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>holder</b>: <span title=\" dataExclusivityPeriod&gt;\n    &lt;start value=&quot;2010-08-15&quot;/&gt;\n    &lt;end value=&quot;2020-08-15&quot;/&gt;\n  &lt;/dataExclusivityPeriod&gt;\n  &lt;dateOfFirstAuthorization value=&quot;2010-08-15&quot;/&gt;\n  &lt;internationalBirthDate value=&quot;2010-08-15&quot;/ &amp;#10; jurisdictionalAuthorization id=&quot;1&quot;&gt;\n    &lt;reference value=&quot;RegulatedAuthorization/Jurusdictional1&quot;/&gt;\n  &lt;/jurisdictionalAuthorization \"><a href=\"broken-link.html\">Organization/example</a></span></p><p><b>regulator</b>: <a href=\"broken-link.html\">Organization/example</a></p><blockquote><p><b>case</b></p><p><b>identifier</b>: id:\u00a0EMEA/H/C/009999/IA/0099/G</p><p><b>type</b>: VariationTypeIA <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (marketingAuthorizationProcedureType#VariationTypeIA)</span></p><p><b>date</b>: 2014-09-02 --&gt; 2015-08-21</p><h3>Applications</h3><table class=\"grid\"><tr><td>-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Date[x]</b></td></tr><tr><td>*</td><td>id:\u00a0IA38G</td><td>GroupTypeIAVariationNotification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (marketingAuthorizationApplicationType#GroupTypeIAVariationNotification)</span></td><td>2015-08-01</td></tr><tr><td>*</td><td>id:\u00a0IA38F</td><td>GroupTypeIAVariationNotification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (marketingAuthorizationApplicationType#GroupTypeIAVariationNotification)</span></td><td>2014-09-01</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"
      }
    ]

  "identifier" : [{
    "system" : "http://ema.europa.eu/example/marketingAuthorizationNumber",
    "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/authorizationstatus",
      "code" : "active"
    }]

  },
  "statusDate": "2015-01-14",
  "validityPeriod": {
    "start": "2014-09-03",
    "end": "2020-05-20"

  "statusDate" : "2015-01-14",
  "validityPeriod" : {
    "start" : "2014-09-03",
    "end" : "2020-05-20"

  },
  "holder": {
    "reference": "Organization/example"

  "holder" : {
    "reference" : "Organization/example"

  },
  "regulator": {
    "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"

  "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"
        }
      ]

    "type" : {
      "coding" : [{
        "system" : "http://ema.europa.eu/example/marketingAuthorizationProcedureType",
        "code" : "VariationTypeIA"
      }]

    },
    "datePeriod": {
      "start": "2014-09-02",
      "end": "2015-08-21"

    "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"

    "application" : [{
      "identifier" : {
        "system" : "http://ema.europa.eu/example/applicationidentifier-number",
        "value" : "IA38G"

      },
      {
        "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"
      }
    ]

      "type" : {
        "coding" : [{
          "system" : "http://ema.europa.eu/example/marketingAuthorizationApplicationType",
          "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/marketingAuthorizationApplicationType",
          "code" : "GroupTypeIAVariationNotification"
        }]
      },
      "dateDateTime" : "2014-09-01"
    }]

  }
}

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.