MedicinalProduct - FHIR Resource (r4)


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

Validate an MedicinalProduct FHIR Resource (r4)



Resource Attributes

AttributeField is listTypeDescription
additionalMonitoringIndicatorfalseCodeableConcept# Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
attachedDocumenttrueReference# Supporting documentation, typically for regulatory submission
clinicalTrialtrueReference# Clinical trials or studies that this product is involved in
combinedPharmaceuticalDoseFormfalseCodeableConcept# The dose form for a single part product, or combined form of a multiple part product
contacttrueReference# A product specific contact, person (in a role), or an organization
crossReferencetrueIdentifier# Reference to another product, e.g. for linking authorised to investigational product
domainfalseCoding# If this medicine applies to human or veterinary uses
identifiertrueIdentifier# Business identifier for this product. Could be an MPID
legalStatusOfSupplyfalseCodeableConcept# The legal status of supply of the medicinal product as classified by the regulator
manufacturingBusinessOperationtrueData Type# An operation applied to the product, for manufacturing or adminsitrative purpose
marketingStatustrueMarketingStatus# Marketing status of the medicinal product, in contrast to marketing authorizaton
masterFiletrueReference# A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
nametrueData Type# The product's name, including full name and possibly coded parts
packagedMedicinalProducttrueReference# Package representation for the product
paediatricUseIndicatorfalseCodeableConcept# If authorised for use in children
pharmaceuticalProducttrueReference# Pharmaceutical aspects of product
productClassificationtrueCodeableConcept# Allows the product to be classified by various systems
specialDesignationtrueData Type# Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
specialMeasurestruestring# Whether the Medicinal Product is subject to special measures for regulatory reasons
typefalseCodeableConcept# Regulatory type, e.g. Investigational or Authorized

MedicinalProduct Example

{
  "resourceType": "MedicinalProduct",
  "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>: {mpid}</p><p><b>productClassification</b>: WHOAnatomicalTherapeuticChemicalATCClassificationSystem|B01AF02 <span>(Details : {http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem code 'WHOAnatomicalTherapeuticChemicalATCClassificationSystem|B01AF02' = 'WHOAnatomicalTherapeuticChemicalATCClassificationSystem|B01AF02)</span></p><p><b>attachedDocument</b>: <a>DocumentReference/example</a></p><p><b>masterFile</b>: <a>DocumentReference/example</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: Equilidem 2.5 mg film-coated tablets</p><blockquote><p><b>namePart</b></p><p><b>part</b>: Equilidem</p><p><b>type</b>: INV (Details: [not stated] code INV = 'INV', stated as 'null')</p></blockquote><blockquote><p><b>namePart</b></p><p><b>part</b>: 2.5 mg</p><p><b>type</b>: STR (Details: [not stated] code STR = 'STR', stated as 'null')</p></blockquote><blockquote><p><b>namePart</b></p><p><b>part</b>: film-coated tablets</p><p><b>type</b>: FRM (Details: [not stated] code FRM = 'FRM', stated as 'null')</p></blockquote><h3>CountryLanguages</h3><table><tr><td>-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td>*</td><td>EU <span>(Details : {http://ema.europa.eu/example/countryCode code 'EU' = 'EU)</span></td><td>EU <span>(Details : {http://ema.europa.eu/example/jurisdictionCode code 'EU' = 'EU)</span></td><td>EN <span>(Details : {http://ema.europa.eu/example/languageCode code 'EN' = 'EN)</span></td></tr></table></blockquote><h3>ManufacturingBusinessOperations</h3><table><tr><td>-</td><td><b>OperationType</b></td><td><b>AuthorisationReferenceNumber</b></td><td><b>EffectiveDate</b></td><td><b>Manufacturer</b></td><td><b>Regulator</b></td></tr><tr><td>*</td><td>Batchrelease <span>(Details : {http://ema.europa.eu/example/manufacturingOperationType code 'Batchrelease' = 'Batchrelease)</span></td><td>1324TZ</td><td>15/03/2013</td><td><a>Organization/example</a></td><td><a>Organization/example</a></td></tr></table></div>"
  },
  "identifier": [
    {
      "system": "http://ema.europa.eu/example/MPID",
      "value": "{mpid}"
    }
  ],
  "productClassification": [
    {
      "coding": [
        {
          "system": "http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem",
          "code": "WHOAnatomicalTherapeuticChemicalATCClassificationSystem|B01AF02"
        }
      ]
    }
  ],
  "attachedDocument": [
    {
      "reference": "DocumentReference/example"
    }
  ],
  "masterFile": [
    {
      "reference": "DocumentReference/example"
    }
  ],
  "name": [
    {
      "productName": "Equilidem 2.5 mg film-coated tablets",
      "namePart": [
        {
          "part": "Equilidem",
          "type": {
            "code": "INV"
          }
        },
        {
          "part": "2.5 mg",
          "type": {
            "code": "STR"
          }
        },
        {
          "part": "film-coated tablets",
          "type": {
            "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"
              }
            ]
          }
        }
      ]
    }
  ],
  "manufacturingBusinessOperation": [
    {
      "operationType": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/manufacturingOperationType",
            "code": "Batchrelease"
          }
        ]
      },
      "authorisationReferenceNumber": {
        "system": "http://ema.europa.eu/example/manufacturingAuthorisationReferenceNumber",
        "value": "1324TZ"
      },
      "effectiveDate": "2013-03-15",
      "manufacturer": [
        {
          "reference": "Organization/example"
        }
      ],
      "regulator": {
        "reference": "Organization/example"
      }
    }
  ]
}

MedicinalProduct Structure

{
  "resourceType" : "MedicinalProduct",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for this product. Could be an MPID
  "type" : { CodeableConcept }, // Regulatory type, e.g. Investigational or Authorized
  "domain" : { Coding }, // If this medicine applies to human or veterinary uses
  "combinedPharmaceuticalDoseForm" : { CodeableConcept }, // The dose form for a single part product, or combined form of a multiple part product
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "additionalMonitoringIndicator" : { CodeableConcept }, // Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
  "specialMeasures" : ["<string>"], // Whether the Medicinal Product is subject to special measures for regulatory reasons
  "paediatricUseIndicator" : { CodeableConcept }, // If authorised for use in children
  "productClassification" : [{ CodeableConcept }], // Allows the product to be classified by various systems
  "marketingStatus" : [{ MarketingStatus }], // Marketing status of the medicinal product, in contrast to marketing authorizaton
  "pharmaceuticalProduct" : [{ Reference(MedicinalProductPharmaceutical) }], // Pharmaceutical aspects of product
  "packagedMedicinalProduct" : [{ Reference(MedicinalProductPackaged) }], // Package representation for the product
  "attachedDocument" : [{ Reference(DocumentReference) }], // Supporting documentation, typically for regulatory submission
  "masterFile" : [{ Reference(DocumentReference) }], // A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
  "contact" : [{ Reference(Organization|PractitionerRole) }], // A product specific contact, person (in a role), or an organization
  "clinicalTrial" : [{ Reference(ResearchStudy) }], // Clinical trials or studies that this product is involved in
  "name" : [{ // R!  The product's name, including full name and possibly coded parts
    "productName" : "<string>", // R!  The full product name
    "namePart" : [{ // Coding words or phrases of the name
      "part" : "<string>", // R!  A fragment of a product name
      "type" : { Coding } // R!  Idenifying type for this part of the name (e.g. strength part)
    }],
    "countryLanguage" : [{ // Country where the name applies
      "country" : { CodeableConcept }, // R!  Country code for where this name applies
      "jurisdiction" : { CodeableConcept }, // Jurisdiction code for where this name applies
      "language" : { CodeableConcept } // R!  Language code for this name
    }]
  }],
  "crossReference" : [{ Identifier }], // Reference to another product, e.g. for linking authorised to investigational product
  "manufacturingBusinessOperation" : [{ // An operation applied to the product, for manufacturing or adminsitrative purpose
    "operationType" : { CodeableConcept }, // The type of manufacturing operation
    "authorisationReferenceNumber" : { Identifier }, // Regulatory authorization reference number
    "effectiveDate" : "<dateTime>", // Regulatory authorization date
    "confidentialityIndicator" : { CodeableConcept }, // To indicate if this proces is commercially confidential
    "manufacturer" : [{ Reference(Organization) }], // The manufacturer or establishment associated with the process
    "regulator" : { Reference(Organization) } // A regulator which oversees the operation
  }],
  "specialDesignation" : [{ // Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
    "identifier" : [{ Identifier }], // Identifier for the designation, or procedure number
    "type" : { CodeableConcept }, // The type of special designation, e.g. orphan drug, minor use
    "intendedUse" : { CodeableConcept }, // The intended use of the product, e.g. prevention, treatment
    // indication[x]: Condition for which the medicinal use applies. One of these 2:
    "indicationCodeableConcept" : { CodeableConcept },
    "indicationReference" : { Reference(MedicinalProductIndication) },
    "status" : { CodeableConcept }, // For example granted, pending, expired or withdrawn
    "date" : "<dateTime>", // Date when the designation was granted
    "species" : { CodeableConcept } // Animal species for which this applies
  }]
}

MedicinalProduct Search Parameters

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

https://api.1up.health/fhir/r4/MedicinalProduct?query-param=queryvalue
Search ParameterField TypeResource Fields Searched
identifiertextidentifier
nametextname.productName
name-languagetextname.countryLanguage.language