MedicinalProduct.legalStatusOfSupply
FHIR attribute (r4)
In the MedicinalProduct resource for FHIR r4 , the legalStatusOfSupply attribute identifies the The legal status of supply of the medicinal product as classified by the regulator
legalStatusOfSupply (MedicinalProduct) description
Resource Type: MedicinalProduct
Attribute Name: legalStatusOfSupply
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
"legalStatusOfSupply": 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
