MedicinalProduct

draftResource65 elementsv4.0.1

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

Metadata

Canonical URL: http://hl7.org/fhir/StructureDefinition/MedicinalProduct
ID: MedicinalProduct
Type
Base Definition
Derivation: specialization
Publisher: Health Level Seven International (Biomedical Research and Regulation)
Version: 4.0.1

Path	Card.	Type	Description
`MedicinalProduct`	`0..*`		Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
`id`	`0..1`	string	Logical id of this artifact
`meta`	`0..1`	Meta	Metadata about the resource
`implicitRules`	`0..1`	uri	A set of rules under which this content was created
`language`	`0..1`	code	Language of the resource contentpreferred: languages
`text`	`0..1`	Narrative	Text summary of the resource, for human interpretation
`contained`	`0..*`	Resource	Contained, inline Resources
`extension`	`0..*`	Extension	Additional content defined by implementations
`modifierExtension`	`0..*`	Extension	Extensions that cannot be ignored
`identifier`	`0..*`	Identifier	Business identifier for this product. Could be an MPID
`type`	`0..1`	CodeableConcept	Regulatory type, e.g. Investigational or Authorized
`domain`	`0..1`	Coding	If this medicine applies to human or veterinary uses
`combinedPharmaceuticalDoseForm`	`0..1`	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product
`legalStatusOfSupply`	`0..1`	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator
`additionalMonitoringIndicator`	`0..1`	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
`specialMeasures`	`0..*`	string	Whether the Medicinal Product is subject to special measures for regulatory reasons
`paediatricUseIndicator`	`0..1`	CodeableConcept	If authorised for use in children
`productClassification`	`0..*`	CodeableConcept	Allows the product to be classified by various systems
`marketingStatus`	`0..*`	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorizaton
`pharmaceuticalProduct`	`0..*`	Reference	Pharmaceutical aspects of product
`packagedMedicinalProduct`	`0..*`	Reference	Package representation for the product
`attachedDocument`	`0..*`	Reference	Supporting documentation, typically for regulatory submission
`masterFile`	`0..*`	Reference	A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
`contact`	`0..*`	Reference	A product specific contact, person (in a role), or an organization
`clinicalTrial`	`0..*`	Reference	Clinical trials or studies that this product is involved in
`name`	`1..*`	BackboneElement	The product's name, including full name and possibly coded parts
`crossReference`	`0..*`	Identifier	Reference to another product, e.g. for linking authorised to investigational product
`manufacturingBusinessOperation`	`0..*`	BackboneElement	An operation applied to the product, for manufacturing or adminsitrative purpose
`specialDesignation`	`0..*`	BackboneElement	Indicates if the medicinal product has an orphan designation for the treatment of a rare disease