R6 Ballot (2nd Draft)

Publish-box (todo)

Example MedicinalProductDefinition/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" : "MedicinalProductDefinition",
  "id" : "example",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n\t\t\t<p><b>Generated Narrative</b></p>\n\t\t\t<p><b>Id</b>: example</p>\n\t\t\t<p><b>Identifier</b>: {mpid}</p>\n\t\t\t<p><b>Classification</b>: <span title=\"Codes: {http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem B01AF02}\">ATC: B01AF02</span></p>\n\t\t\t<p><b>Attached Document</b>: (SmPC)</p>\n\t\t\t<p><b>Master File</b>: (Pharmacovigilence Master File)</p>\n\t\t\t<p><b>Product Name</b>: Equilidem 2.5 mg film-coated tablets</p>\n\t\t\t<blockquote>\n\t\t\t\t<p><b>Name Part</b></p><p><b>part</b>:Equilidem</p>\n\t\t\t\t<p><b>type</b>: <span title=\"Codes: \">Invented</span></p>\n\t\t\t</blockquote>\n\t\t\t<blockquote>\n\t\t\t\t<p><b>Name Part</b></p><p><b>part</b>:2.5 mg</p>\n\t\t\t\t<p><b>type</b>: <span title=\"Codes: \">Strength</span></p>\n\t\t\t</blockquote>\n\t\t\t<blockquote>\n\t\t\t\t<p><b>Name Part</b></p>\n\t\t\t\t<p><b>part</b>:film-coated tablets</p>\n\t\t\t\t<p><b>type</b>: <span title=\"Codes: \">Form</span></p>\n\t\t\t\t<p><b>Country &amp; Languages</b></p>\n\t\t\t\t<table class=\"grid\">\n\t\t\t\t\t<tr>\n\t\t\t\t\t\t<td>-</td>\n\t\t\t\t\t\t<td><b>Country</b></td>\n\t\t\t\t\t\t<td><b>Jurisdiction</b></td>\n\t\t\t\t\t\t<td><b>Language</b></td>\n\t\t\t\t\t</tr>\n\t\t\t\t\t<tr>\n\t\t\t\t\t\t<td>*</td>\n\t\t\t\t\t\t<td><span title=\"Codes: {http://ema.europa.eu/example/countryCode EU}\">EU</span></td>\n\t\t\t\t\t\t<td><span title=\"Codes: {http://ema.europa.eu/example/jurisdictionCode EU}\">EU</span></td>\n\t\t\t\t\t\t<td><span title=\"Codes: {urn:ietf:bcp:47}\">EN</span></td>\n\t\t\t\t\t</tr>\n\t\t\t\t</table>\n\t\t\t</blockquote>\n\t\t\t<p><b>Manufacturing &amp; Business Operations</b></p>\n\t\t\t<table class=\"grid\">\n\t\t\t\t<tr>\n\t\t\t\t\t<td>-</td>\n\t\t\t\t\t<td><b>Type</b></td>\n\t\t\t\t\t<td><b>EffectiveDate</b></td>\n\t\t\t\t\t<td><b>Authorization</b></td>\n\t\t\t\t</tr>\n\t\t\t\t<tr>\n\t\t\t\t\t<td>*</td>\n\t\t\t\t\t<td>Batch Release</td>\n\t\t\t\t\t<td>2013-03-15 --&gt; (ongoing)</td>\n\t\t\t\t\t<td><span>1324TZ</span></td>\n\t\t\t\t</tr>\n\t\t\t</table>\n\t\t</div>"
  },
  "identifier" : [{
    "system" : "http://ema.europa.eu/example/MPID",
    "value" : "{mpid}"
  }],
  "classification" : [{
    "coding" : [{
      "system" : "http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem",
      "code" : "B01AF02"
    }]
  }],
  "attachedDocument" : [{
    "reference" : "DocumentReference/example"
  }],
  "masterFile" : [{
    "reference" : "DocumentReference/example"
  }],
  "name" : [{
    "productName" : "Equilidem 2.5 mg film-coated tablets",
    "part" : [{
      "part" : "Equilidem",
      "type" : {
        "coding" : [{
          "code" : "INV"
        }]
      }
    },
    {
      "part" : "2.5 mg",
      "type" : {
        "coding" : [{
          "code" : "STR"
        }]
      }
    },
    {
      "part" : "film-coated tablets",
      "type" : {
        "coding" : [{
          "code" : "FRM"
        }]
      }
    }],
    "usage" : [{
      "country" : {
        "coding" : [{
          "system" : "http://ema.europa.eu/example/countryCode",
          "code" : "EU"
        }]
      },
      "jurisdiction" : {
        "coding" : [{
          "system" : "http://ema.europa.eu/example/jurisdictionCode",
          "code" : "EU"
        }]
      },
      "language" : {
        "coding" : [{
          "system" : "urn:ietf:bcp:47",
          "code" : "en"
        }]
      }
    }]
  }],
  "operation" : [{
    "type" : {
      "concept" : {
        "coding" : [{
          "system" : "http://ema.europa.eu/example/manufacturingOperationType",
          "code" : "Batchrelease"
        }]
      }
    },
    "effectiveDate" : {
      "start" : "2013-03-15"
    }
  }]
}

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.