Release 4B 5

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0: R5 - STU ). The This is the current published version which supercedes in it's permanent home (it will always be available at this version is 5.0.0 . URL). For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R5 R4B

Medicinalproductdefinition-example.json

Example MedicinalProductDefinition/example (JSON)

Biomedical Research and Regulation Work Group Maturity Level : N/A Standards Status : Informative Compartments : Not linked to any 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: {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>"

  "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": [

  "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"
        }]
      }
    },

    {
      "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": [

      "part" : "2.5 mg",
      "type" : {
        "coding" : [{
          "code" : "STR"
        }]
      }
    },

    {
      "type": {
        "concept": {
          "coding": [
            {
              "system": "http://ema.europa.eu/example/manufacturingOperationType",
              "code": "Batchrelease"
            }
          ]
        }

      "part" : "film-coated tablets",
      "type" : {
        "coding" : [{
          "code" : "FRM"
        }]
      }
    }],
    "usage" : [{
      "country" : {
        "coding" : [{
          "system" : "http://ema.europa.eu/example/countryCode",
          "code" : "EU"
        }]

      },
      "effectiveDate": {
        "start": "2013-03-15"

      "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.