Release 5 Preview #2

Regulatedauthorization-example.json

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: Not linked to any defined compartments

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

Example of regulatedauthorization

{
  "resourceType": "RegulatedAuthorization",
  "id": "example",
  "text": {
    "status": "generated",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>id</b>: example</p><p><b>identifier</b>: 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>: 2015-08-16 --&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>: EMEA/H/C/009999/IA/0099/G</p><p><b>type</b>: <span>VariationTypeIA</span></p><p><b>date</b>: 2015-08-02 --&gt; 2015-08-21</p><h3>Applications</h3><table><tr><td>-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Date[x]</b></td></tr><tr><td>*</td><td>IA38G</td><td><span>GroupTypeIAVariationNotification</span></td><td>2015-08-01</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"
      }
    ]
  },
  "statusDate": "2015-01-14",
  "validityPeriod": {
    "start": "2015-08-16",
    "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": "2015-08-02",
      "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"
      }
    ]
  }
}

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.