Release 5 Preview #3

Medicinalproductdefinition-example.json

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: Not linked to any 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: {http://ema.europa.eu/example/languageCode EN}\">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",
      "namePart": [
        {
          "part": "Equilidem",
          "type": {
            "coding": [
              {
                "code": "INV"
              }
            ]
          }
        },
        {
          "part": "2.5 mg",
          "type": {
            "coding": [
              {
                "code": "STR"
              }
            ]
          }
        },
        {
          "part": "film-coated tablets",
          "type": {
            "coding": [
              {
                "code": "FRM"
              }
            ]
          }
        }
      ],
      "countryLanguage": [
        {
          "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": "http://ema.europa.eu/example/languageCode",
                "code": "EN"
              }
            ]
          }
        }
      ]
    }
  ],
  "operation": [
    {
      "type": {
        "concept": {
          "coding": [
            {
              "system": "http://ema.europa.eu/example/manufacturingOperationType",
              "code": "Batchrelease"
            }
          ]
        }
      },
      "effectiveDate": {
        "start": "2013-03-15"
      },
      "authorization": {
        "identifier": {
          "system": "http://ema.europa.eu/example/manufacturingAuthorisationReferenceNumber",
          "value": "1324TZ"
        }
      }
    }
  ]
}

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.