MedicinalProductDefinition

draftResource78 elementsv5.0.0

Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use, drug catalogs, to support prescribing, adverse events management etc.).

Metadata

hl7.org/fhir

Canonical URL: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
ID: MedicinalProductDefinition
Type
Base Definition
Derivation: specialization
Publisher: Health Level Seven International (Biomedical Research and Regulation)
Version: 5.0.0

Path	Card.	Type	Description
`MedicinalProductDefinition`	`0..*`		Detailed definition of a medicinal product
`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 contentrequired: all-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 Authorizedexample: medicinal-product-type
`domain`	`0..1`	CodeableConcept	If this medicine applies to human or veterinary usesexample: medicinal-product-domain
`version`	`0..1`	string	A business identifier relating to a specific version of the product
`status`	`0..1`	CodeableConcept	The status within the lifecycle of this product recordpreferred: publication-status
`statusDate`	`0..1`	dateTime	The date at which the given status became applicable
`description`	`0..1`	markdown	General description of this product
`combinedPharmaceuticalDoseForm`	`0..1`	CodeableConcept	The dose form for a single part product, or combined form of a multiple part productexample: combined-dose-form
`route`	`0..*`	CodeableConcept	The path by which the product is taken into or makes contact with the bodyexample: route-codes
`indication`	`0..1`	markdown	Description of indication(s) for this product, used when structured indications are not required
`legalStatusOfSupply`	`0..1`	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulatorexample: legal-status-of-supply
`additionalMonitoringIndicator`	`0..1`	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasonsexample: medicinal-product-additional-monitoring
`specialMeasures`	`0..*`	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasonsexample: medicinal-product-special-measures
`pediatricUseIndicator`	`0..1`	CodeableConcept	If authorised for use in childrenexample: medicinal-product-pediatric-use
`classification`	`0..*`	CodeableConcept	Allows the product to be classified by various systemsexample: medicinal-product-classification
`marketingStatus`	`0..*`	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
`packagedMedicinalProduct`	`0..*`	CodeableConcept	Package type for the productexample: medicinal-product-package-type
`comprisedOf`	`0..*`	Reference	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
`ingredient`	`0..*`	CodeableConcept	The ingredients of this medicinal product - when not detailed in other resourcesexample: substance-codes
`impurity`	`0..*`	CodeableReference	Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug productexample: substance-codes
`attachedDocument`	`0..*`	Reference	Additional documentation about the medicinal product
`masterFile`	`0..*`	Reference	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
`contact`	`0..*`	BackboneElement	A product specific contact, person (in a role), or an organization
`clinicalTrial`	`0..*`	Reference	Clinical trials or studies that this product is involved in
`code`	`0..*`	Coding	A code that this product is known by, within some formal terminologyexample: medication-codes
`name`	`1..*`	BackboneElement	The product's name, including full name and possibly coded parts
`crossReference`	`0..*`	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
`operation`	`0..*`	BackboneElement	A manufacturing or administrative process for the medicinal product
`characteristic`	`0..*`	BackboneElement	Key product features such as "sugar free", "modified release"