MedicinalProductAuthorization - FHIR Resource (r4)


This MedicinalProductAuthorization Resource uses the FHIR API standard for access and structure.

Validate an MedicinalProductAuthorization FHIR Resource (r4)



Resource Attributes

AttributeField is listTypeDescription
countrytrueCodeableConcept# The country in which the marketing authorization has been granted
dataExclusivityPeriodfalsePeriod# A period of time after authorization before generic product applicatiosn can be submitted
dateOfFirstAuthorizationfalsedateTime# The date when the first authorization was granted by a Medicines Regulatory Agency
holderfalseReference# Marketing Authorization Holder
identifiertrueIdentifier# Business identifier for the marketing authorization, as assigned by a regulator
internationalBirthDatefalsedateTime# Date of first marketing authorization for a company's new medicinal product in any country in the World
jurisdictiontrueCodeableConcept# Jurisdiction within a country
jurisdictionalAuthorizationtrueData Type# Authorization in areas within a country
legalBasisfalseCodeableConcept# The legal framework against which this authorization is granted
procedurefalseData Type# The regulatory procedure for granting or amending a marketing authorization
regulatorfalseReference# Medicines Regulatory Agency
restoreDatefalsedateTime# The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
statusfalseCodeableConcept# The status of the marketing authorization
statusDatefalsedateTime# The date at which the given status has become applicable
subjectfalseReference# The medicinal product that is being authorized
validityPeriodfalsePeriod# The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format

MedicinalProductAuthorization Example

{
  "resourceType": "MedicinalProductAuthorization",
  "id": "example",
  "text": {
    "status": "generated",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative with Details</b></p><p><b>id</b>: example</p><p><b>identifier</b>: EU/1/11/999/001</p><p><b>country</b>: EU <span>(Details : {http://ema.europa.eu/example/country code 'EU' = 'EU)</span></p><p><b>status</b>: active <span>(Details : {http://ema.europa.eu/example/authorisationstatus code 'active' = 'active)</span></p><p><b>statusDate</b>: 14/01/2015</p><p><b>validityPeriod</b>: 16/08/2015 --&gt; 20/05/2020</p><p><b>dataExclusivityPeriod</b>: 15/08/2010 --&gt; 15/08/2020</p><p><b>dateOfFirstAuthorization</b>: 15/08/2010</p><p><b>internationalBirthDate</b>: 15/08/2010</p><blockquote><p><b>jurisdictionalAuthorization</b></p><p><b>identifier</b>: 123-456-789</p><p><b>country</b>: NO <span>(Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span></p></blockquote><blockquote><p><b>jurisdictionalAuthorization</b></p><p><b>identifier</b>: 123-456-123</p><p><b>country</b>: NO <span>(Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span></p></blockquote><p><b>holder</b>: <a>Organization/example</a></p><p><b>regulator</b>: <a>Organization/example</a></p><blockquote><p><b>procedure</b></p><p><b>identifier</b>: EMEA/H/C/009999/IA/0099/G</p><p><b>type</b>: VariationTypeIA <span>(Details : {http://ema.europa.eu/example/marketingAuthorisationProcedureType code 'VariationTypeIA' = 'VariationTypeIA)</span></p><p><b>date</b>: 02/08/2015 --&gt; 21/08/2015</p><h3>Applications</h3><table><tr><td>-</td></tr><tr><td>*</td></tr></table></blockquote></div>"
  },
  "identifier": [
    {
      "system": "http://ema.europa.eu/example/marketingAuthorisationNumber",
      "value": "EU/1/11/999/001"
    }
  ],
  "country": [
    {
      "coding": [
        {
          "system": "http://ema.europa.eu/example/country",
          "code": "EU"
        }
      ]
    }
  ],
  "status": {
    "coding": [
      {
        "system": "http://ema.europa.eu/example/authorisationstatus",
        "code": "active"
      }
    ]
  },
  "statusDate": "2015-01-14",
  "validityPeriod": {
    "start": "2015-08-16",
    "end": "2020-05-20"
  },
  "dataExclusivityPeriod": {
    "start": "2010-08-15",
    "end": "2020-08-15"
  },
  "dateOfFirstAuthorization": "2010-08-15",
  "internationalBirthDate": "2010-08-15",
  "jurisdictionalAuthorization": [
    {
      "id": "1",
      "identifier": [
        {
          "system": "http://ema.europa.eu/example/marketingauthorisationnumber",
          "value": "123-456-789"
        }
      ],
      "country": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/countryCode",
            "code": "NO"
          }
        ]
      }
    },
    {
      "id": "2",
      "identifier": [
        {
          "system": "http://ema.europa.eu/example/marketingauthorisationnumber",
          "value": "123-456-123"
        }
      ],
      "country": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/countryCode",
            "code": "NO"
          }
        ]
      }
    }
  ],
  "holder": {
    "reference": "Organization/example"
  },
  "regulator": {
    "reference": "Organization/example"
  },
  "procedure": {
    "identifier": {
      "system": "http://ema.europa.eu/example/procedureidentifier-number",
      "value": "EMEA/H/C/009999/IA/0099/G"
    },
    "type": {
      "coding": [
        {
          "system": "http://ema.europa.eu/example/marketingAuthorisationProcedureType",
          "code": "VariationTypeIA"
        }
      ]
    },
    "datePeriod": {
      "start": "2015-08-02",
      "end": "2015-08-21"
    },
    "application": [
      {
        "identifier": {
          "system": "http://ema.europa.eu/example/applicationidentifier-number",
          "value": "IA38G"
        },
        "type": {
          "coding": [
            {
              "system": "http://ema.europa.eu/example/marketingAuthorisationApplicationType",
              "code": "GroupTypeIAVariationNotification"
            }
          ]
        },
        "dateDateTime": "2015-08-01"
      }
    ]
  }
}

MedicinalProductAuthorization Structure

{
  "resourceType" : "MedicinalProductAuthorization",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for the marketing authorization, as assigned by a regulator
  "subject" : { Reference(MedicinalProduct|MedicinalProductPackaged) }, // The medicinal product that is being authorized
  "country" : [{ CodeableConcept }], // The country in which the marketing authorization has been granted
  "jurisdiction" : [{ CodeableConcept }], // Jurisdiction within a country
  "status" : { CodeableConcept }, // The status of the marketing authorization
  "statusDate" : "<dateTime>", // The date at which the given status has become applicable
  "restoreDate" : "<dateTime>", // The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored
  "validityPeriod" : { Period }, // The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format
  "dataExclusivityPeriod" : { Period }, // A period of time after authorization before generic product applicatiosn can be submitted
  "dateOfFirstAuthorization" : "<dateTime>", // The date when the first authorization was granted by a Medicines Regulatory Agency
  "internationalBirthDate" : "<dateTime>", // Date of first marketing authorization for a company's new medicinal product in any country in the World
  "legalBasis" : { CodeableConcept }, // The legal framework against which this authorization is granted
  "jurisdictionalAuthorization" : [{ // Authorization in areas within a country
    "identifier" : [{ Identifier }], // The assigned number for the marketing authorization
    "country" : { CodeableConcept }, // Country of authorization
    "jurisdiction" : [{ CodeableConcept }], // Jurisdiction within a country
    "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply in a jurisdiction or region
    "validityPeriod" : { Period } // The start and expected end date of the authorization
  }],
  "holder" : { Reference(Organization) }, // Marketing Authorization Holder
  "regulator" : { Reference(Organization) }, // Medicines Regulatory Agency
  "procedure" : { // The regulatory procedure for granting or amending a marketing authorization
    "identifier" : { Identifier }, // Identifier for this procedure
    "type" : { CodeableConcept }, // R!  Type of procedure
    // date[x]: Date of procedure. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "application" : [{ Content as for MedicinalProductAuthorization.procedure }] // Applcations submitted to obtain a marketing authorization
  }
}

MedicinalProductAuthorization Search Parameters

The following search parameters can be used to query MedicinalProductAuthorization resources. Just submit them like so:

https://api.1up.health/fhir/r4/MedicinalProductAuthorization?query-param=queryvalue
Search ParameterField TypeResource Fields Searched
countrytextcountry
holderreferenceholder
identifiertextidentifier
statustextstatus
subjectreferencesubject