Release 5 Draft Ballot

This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

Regulatedauthorization-example-basic-drug-auth.json

Biomedical Research and Regulation Work Group

Maturity Level: N/A

Standards Status: Informative

Compartments: Not linked to any 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",
  "text": {
    "status": "generated",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>subject</b>: <a>MedicinalProductDefinition/equilidem</a></p><p><b>type</b>: <span>Regulatory Drug Marketing Approval</span></p><p><b>status</b>: <span>active</span></p><p><b>statusDate</b>: 2016-01-01</p><p><b>holder</b>: <a>EquiliDrugCo Holdings Inc.</a></p><p><b>regulator</b>: <a>FDA</a></p></div>"
  },
  "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.