R6 Ballot (2nd Draft)

Publish-box (todo)

Example RegulatedAuthorization/basic-drug-auth (JSON)

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

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

Basic Example of a drug authorization for Equilidem

{
  "resourceType" : "RegulatedAuthorization",
  "id" : "basic-drug-auth",
  "subject" : [{
    "reference" : "MedicinalProductDefinition/equilidem"
  }],
  "type" : {
    "text" : "Regulatory Drug Marketing Approval"
  },
  "status" : {
    "coding" : [{
      "code" : "active"
    }]
  },
  "statusDate" : "2016-01-01",
  "holder" : {
    "reference" : "Organization/EqlidrugCo",
    "display" : "EquiliDrugCo Holdings Inc."
  },
  "regulator" : {
    "reference" : "Organization/FDA",
    "display" : "FDA"
  }
}

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.