This page is part of the FHIR Specification ~~(v3.3.0:~~ (v3.5.0: R4 Ballot ~~2).~~ #2). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions
Medicinalproductauthorization-example.json

Biomedical Research and Regulation Work Group
Maturity Level : N/A
Ballot Status : Informative
Compartments : Not linked to any defined compartments
Raw JSON ( canonical form + also see JSON Format Specification )
Example of medicinalproductauthorization
{
  "resourceType": "AdverseEvent",

  "resourceType": "MedicinalProductAuthorization",

  "id": "example",
  "text": {
    "status": "generated",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative with Details</b></p><p><b>id</b>: example</p><p><b>identifier</b>: 49476534</p><p><b>actuality</b>: actual</p><p><b>event</b>: This was a mild rash on the left forearm <span>(Details : {SNOMED CT code '304386008' = 'O/E - itchy rash', given as 'O/E - itchy rash'})</span></p><p><b>subject</b>: <a>Patient/example</a></p><p><b>date</b>: 29/01/2017 12:34:56 PM</p><p><b>seriousness</b>: Non-serious <span>(Details : {http://hl7.org/fhir/adverse-event-seriousness code 'Non-serious' = 'Non-serious', given as 'Non-serious'})</span></p><p><b>severity</b>: Mild <span>(Details : {http://hl7.org/fhir/adverse-event-severity code 'Mild' = 'Mild', given as 'Mild'})</span></p><p><b>recorder</b>: <a>Practitioner/example</a></p><h3>SuspectEntities</h3><table><tr><td>-</td><td><b>Instance</b></td></tr><tr><td>*</td><td><a>Medication/example</a></td></tr></table></div>"
  },
  "identifier": {
    "system": "http://acme.com/ids/patients/risks",
    "value": "49476534"
  },
  "actuality": "actual",
  "event": {
    "coding": [
      {
        "system": "http://snomed.info/sct",
        "code": "304386008",
        "display": "O/E - itchy rash"
      }
    ],
    "text": "This was a mild rash on the left forearm"
  },
  "subject": {
    "reference": "Patient/example"

    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative with Details</b></p><p><b>id</b>: example</p><p><b>identifier</b>: EU/1/11/999/001</p><p><b>country</b>: EU <span>(Details : {http://ema.europa.eu/example/country code 'EU' = 'EU)</span></p><p><b>legalStatusOfSupply</b>: Subjecttomedicalprescription <span>(Details : {http://ema.europa.eu/example/legalstatusofsupply code 'Subjecttomedicalprescription' = 'Subjecttomedicalprescription)</span></p><p><b>status</b>: active <span>(Details : {http://ema.europa.eu/example/authorisationstatus code 'active' = 'active)</span></p><p><b>statusDate</b>: 14/01/2015</p><p><b>validityPeriod</b>: 16/08/2015 --&gt; 20/05/2020</p><p><b>dataExclusivityPeriod</b>: 15/08/2010 --&gt; 15/08/2020</p><p><b>dateOfFirstAuthorization</b>: 15/08/2010</p><p><b>internationalBirthDate</b>: 15/08/2010</p><blockquote><p><b>jurisdictionalAuthorization</b></p><p><b>identifier</b>: 123-456-789</p><p><b>country</b>: NO <span>(Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span></p></blockquote><blockquote><p><b>jurisdictionalAuthorization</b></p><p><b>identifier</b>: 123-456-123</p><p><b>country</b>: NO <span>(Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span></p></blockquote><p><b>holder</b>: <a>Organization/example</a></p><p><b>regulator</b>: <a>Organization/example</a></p><blockquote><p><b>procedure</b></p><p><b>identifier</b>: EMEA/H/C/009999/IA/0099/G</p><p><b>type</b>: VariationTypeIA <span>(Details : {http://ema.europa.eu/example/marketingAuthorisationProcedureType code 'VariationTypeIA' = 'VariationTypeIA)</span></p><p><b>date</b>: 02/08/2015 --&gt; 21/08/2015</p><h3>Applications</h3><table><tr><td>-</td></tr><tr><td>*</td></tr></table></blockquote></div>"

  },
  "date": "2017-01-29T12:34:56+00:00",
  "seriousness": {

  "identifier": [
    {
      "system": "http://ema.europa.eu/example/marketingAuthorisationNumber",
      "value": "EU/1/11/999/001"
    }
  ],
  "country": [
    {
      "coding": [
        {
          "system": "http://ema.europa.eu/example/country",
          "code": "EU"
        }
      ]
    }
  ],
  "legalStatusOfSupply": {

    "coding": [
      {
        "system": "http://hl7.org/fhir/adverse-event-seriousness",
        "code": "Non-serious",
        "display": "Non-serious"

        "system": "http://ema.europa.eu/example/legalstatusofsupply",
        "code": "Subjecttomedicalprescription"

      }
    ]
  },
  "severity": {

  "status": {

    "coding": [
      {
        "system": "http://hl7.org/fhir/adverse-event-severity",
        "code": "Mild",
        "display": "Mild"

        "system": "http://ema.europa.eu/example/authorisationstatus",
        "code": "active"

      }
    ]
  },
  "recorder": {
    "reference": "Practitioner/example"

  "statusDate": "2015-01-14",
  "validityPeriod": {
    "start": "2015-08-16",
    "end": "2020-05-20"

  },
  "suspectEntity": [

  "dataExclusivityPeriod": {
    "start": "2010-08-15",
    "end": "2020-08-15"
  },
  "dateOfFirstAuthorization": "2010-08-15",
  "internationalBirthDate": "2010-08-15",
  "jurisdictionalAuthorization": [

    {
      "instance": {
        "reference": "Medication/example"

      "id": "1",
      "identifier": [
        {
          "system": "http://ema.europa.eu/example/marketingauthorisationnumber",
          "value": "123-456-789"
        }
      ],
      "country": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/countryCode",
            "code": "NO"
          }
        ]
      }
    },
    {
      "id": "2",
      "identifier": [
        {
          "system": "http://ema.europa.eu/example/marketingauthorisationnumber",
          "value": "123-456-123"
        }
      ],
      "country": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/countryCode",
            "code": "NO"
          }
        ]

      }
    }
  ]

  ],
  "holder": {
    "reference": "Organization/example"
  },
  "regulator": {
    "reference": "Organization/example"
  },
  "procedure": {
    "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.