R6 Ballot (2nd Draft)

Publish-box (todo)

Example RegulatedAuthorization/example (JSON)

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

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

General example

{
  "resourceType" : "RegulatedAuthorization",
  "id" : "example",
  "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"
  },
  "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/marketingAuthorizationProcedureType",
        "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/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.