http://hl7.org/fhir/StructureDefinition/MedicinalProduct|4.0.1

Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).

Structure JSON Dependencies FHIRSchema Other Versions Dependant (0)Elements Summary

Name	Flags	Card	Type	Description & Constraints
MedicinalProduct		0..*		Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
identifier	Σ	0..*	Identifier	Business identifier for this product. Could be an MPID
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized
domain	Σ	0..1	Coding	If this medicine applies to human or veterinary uses
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
specialMeasures	Σ	0..*	string	Whether the Medicinal Product is subject to special measures for regulatory reasons
paediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children
productClassification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorizaton
pharmaceuticalProduct	Σ	0..*	Reference	Pharmaceutical aspects of product
packagedMedicinalProduct	Σ	0..*	Reference	Package representation for the product
attachedDocument	Σ	0..*	Reference	Supporting documentation, typically for regulatory submission
masterFile	Σ	0..*	Reference	A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
contact	Σ	0..*	Reference	A product specific contact, person (in a role), or an organization
clinicalTrial	Σ	0..*	Reference	Clinical trials or studies that this product is involved in
name *	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
productName *	Σ	1..1	string	The full product name
namePart	Σ	0..*	BackboneElement	Coding words or phrases of the name
part *	Σ	1..1	string	A fragment of a product name
type *	Σ	1..1	Coding	Idenifying type for this part of the name (e.g. strength part)
countryLanguage	Σ	0..*	BackboneElement	Country where the name applies
country *	Σ	1..1	CodeableConcept	Country code for where this name applies
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies
language *	Σ	1..1	CodeableConcept	Language code for this name
crossReference	Σ	0..*	Identifier	Reference to another product, e.g. for linking authorised to investigational product
manufacturingBusinessOperation	Σ	0..*	BackboneElement	An operation applied to the product, for manufacturing or adminsitrative purpose
operationType	Σ	0..1	CodeableConcept	The type of manufacturing operation
authorisationReferenceNumber	Σ	0..1	Identifier	Regulatory authorization reference number
effectiveDate	Σ	0..1	dateTime	Regulatory authorization date
confidentialityIndicator	Σ	0..1	CodeableConcept	To indicate if this proces is commercially confidential
manufacturer	Σ	0..*	Reference	The manufacturer or establishment associated with the process
regulator	Σ	0..1	Reference	A regulator which oversees the operation
specialDesignation	Σ	0..*	BackboneElement	Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
identifier	Σ	0..*	Identifier	Identifier for the designation, or procedure number
type	Σ	0..1	CodeableConcept	The type of special designation, e.g. orphan drug, minor use
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment
indication[x]	Σ	0..1		Condition for which the medicinal use applies
indicationCodeableConcept	Σ	0..1	CodeableConcept
indicationReference	Σ	0..1	Reference
status	Σ	0..1	CodeableConcept	For example granted, pending, expired or withdrawn
date	Σ	0..1	dateTime	Date when the designation was granted
species	Σ	0..1	CodeableConcept	Animal species for which this applies