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Medicinalproductauthorization-example.json

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

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

Example of medicinalproductauthorization

{
  "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>: 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>: Jan 14, 2015</p><p><b>validityPeriod</b>: Aug 16, 2015 --&gt; May 20, 2020</p><p><b>dataExclusivityPeriod</b>: Aug 15, 2010 --&gt; Aug 15, 2020</p><p><b>dateOfFirstAuthorization</b>: Aug 15, 2010</p><p><b>internationalBirthDate</b>: Aug 15, 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>: Aug 2, 2015 --&gt; Aug 21, 2015</p><h3>Applications</h3><table><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"
    }
  ],
  "country": [
    {
      "coding": [
        {
          "system": "http://ema.europa.eu/example/country",
          "code": "EU"
        }
      ]
    }
  ],
  "legalStatusOfSupply": {
    "coding": [
      {
        "system": "http://ema.europa.eu/example/legalstatusofsupply",
        "code": "Subjecttomedicalprescription"
      }
    ]
  },
  "status": {
    "coding": [
      {
        "system": "http://ema.europa.eu/example/authorisationstatus",
        "code": "active"
      }
    ]
  },
  "statusDate": "2015-01-14",
  "validityPeriod": {
    "start": "2015-08-16",
    "end": "2020-05-20"
  },
  "dataExclusivityPeriod": {
    "start": "2010-08-15",
    "end": "2020-08-15"
  },
  "dateOfFirstAuthorization": "2010-08-15",
  "internationalBirthDate": "2010-08-15",
  "jurisdictionalAuthorization": [
    {
      "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.