MedicinalProduct - FHIR Resource (r4)
This MedicinalProduct Resource uses the FHIR API standard for access and structure.
Validate an MedicinalProduct FHIR Resource (r4)
MedicinalProduct Attributes
AttributeField is listTypeDescription
Description: Business identifier for this product. Could be an MPID
FHIR Version: r4
Attribute Type : Identifier
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"identifier": [
{
"system": "http://ema.europa.eu/example/MPID",
"value": "{mpid}"
}
]Learn more about the (MedicinalProduct) identifier FHIR attribute
Description: Regulatory type, e.g. Investigational or Authorized
FHIR Version: r4
Attribute Type : CodeableConcept
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"type": Learn more about the (MedicinalProduct) type FHIR attribute
Description: If this medicine applies to human or veterinary uses
FHIR Version: r4
Attribute Type : Coding
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"domain": Learn more about the (MedicinalProduct) domain FHIR attribute
Description: The dose form for a single part product, or combined form of a multiple part product
FHIR Version: r4
Attribute Type : CodeableConcept
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"combinedPharmaceuticalDoseForm": Learn more about the (MedicinalProduct) combinedPharmaceuticalDoseForm FHIR attribute
Description: The legal status of supply of the medicinal product as classified by the regulator
FHIR Version: r4
Attribute Type : CodeableConcept
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"legalStatusOfSupply": Learn more about the (MedicinalProduct) legalStatusOfSupply FHIR attribute
Description: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
FHIR Version: r4
Attribute Type : CodeableConcept
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"additionalMonitoringIndicator": Learn more about the (MedicinalProduct) additionalMonitoringIndicator FHIR attribute
Description: Whether the Medicinal Product is subject to special measures for regulatory reasons
FHIR Version: r4
Attribute Type : string
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"specialMeasures": Learn more about the (MedicinalProduct) specialMeasures FHIR attribute
Description: If authorised for use in children
FHIR Version: r4
Attribute Type : CodeableConcept
Required: N/A
Countability: Singleton
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"paediatricUseIndicator": Learn more about the (MedicinalProduct) paediatricUseIndicator FHIR attribute
Description: Allows the product to be classified by various systems
FHIR Version: r4
Attribute Type : CodeableConcept
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"productClassification": [
{
"coding": [
{
"system": "http://ema.europa.eu/example/WHOAnatomicalTherapeuticChemicalATCClassificationSystem",
"code": "WHOAnatomicalTherapeuticChemicalATCClassificationSystem|B01AF02"
}
]
}
]Learn more about the (MedicinalProduct) productClassification FHIR attribute
Description: Marketing status of the medicinal product, in contrast to marketing authorizaton
FHIR Version: r4
Attribute Type : MarketingStatus
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"marketingStatus": Learn more about the (MedicinalProduct) marketingStatus FHIR attribute
Description: Pharmaceutical aspects of product
FHIR Version: r4
Attribute Type : Reference
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"pharmaceuticalProduct": Learn more about the (MedicinalProduct) pharmaceuticalProduct FHIR attribute
Description: Package representation for the product
FHIR Version: r4
Attribute Type : Reference
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"packagedMedicinalProduct": Learn more about the (MedicinalProduct) packagedMedicinalProduct FHIR attribute
Description: Supporting documentation, typically for regulatory submission
FHIR Version: r4
Attribute Type : Reference
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"attachedDocument": [
{
"reference": "DocumentReference/example"
}
]Learn more about the (MedicinalProduct) attachedDocument FHIR attribute
Description: A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
FHIR Version: r4
Attribute Type : Reference
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"masterFile": [
{
"reference": "DocumentReference/example"
}
]Learn more about the (MedicinalProduct) masterFile FHIR attribute
Description: A product specific contact, person (in a role), or an organization
FHIR Version: r4
Attribute Type : Reference
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"contact": Learn more about the (MedicinalProduct) contact FHIR attribute
Description: Clinical trials or studies that this product is involved in
FHIR Version: r4
Attribute Type : Reference
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"clinicalTrial": Learn more about the (MedicinalProduct) clinicalTrial FHIR attribute
Description: The product's name, including full name and possibly coded parts
FHIR Version: r4
Attribute Type : Data Type
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
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"
}
]
}
}
]
}
]Learn more about the (MedicinalProduct) name FHIR attribute
Description: Reference to another product, e.g. for linking authorised to investigational product
FHIR Version: r4
Attribute Type : Identifier
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"crossReference": Learn more about the (MedicinalProduct) crossReference FHIR attribute
Description: An operation applied to the product, for manufacturing or adminsitrative purpose
FHIR Version: r4
Attribute Type : Data Type
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"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"
}
}
]Learn more about the (MedicinalProduct) manufacturingBusinessOperation FHIR attribute
Description: Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
FHIR Version: r4
Attribute Type : Data Type
Required: N/A
Countability: Array
Flags: N/A
Terminology bindings: N/A
Requirements: N/A
Comments: N/A
Example:
"specialDesignation": Learn more about the (MedicinalProduct) specialDesignation FHIR attribute
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 Parameter | Field Type | Resource Fields Searched |
|---|---|---|
identifier | text | identifier |
name | text | name.productName |
name-language | text | name.countryLanguage.language |
