Extensions for Using Data Elements from FHIR R5 in FHIR R4 - Downloaded Version null See the Directory of published versions

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Resource Profile: Profile_R5_MedicinalProductDefinition_R4_MedicinalProduct

This cross-version profile allows R5 MedicinalProductDefinition content to be represented via FHIR R4 MedicinalProduct resources.

Usages:

• Refer to this Profile: R5: References a product from which one or more of the constituent parts of that product can be prepared and used as described by this administrable product (new), R5: Information about use of the product in relation to other therapies described as part of the contraindication (new), R5: Specifics for when this is a contraindication (new), R5: Specifics for when this is an interaction (new)... Show 5 more, R5: The product which this ingredient is a constituent part of (new), R5: Reference to another product, e.g. for linking authorised to investigational product (new), R5: Definitional resources that provide more information about this medication (new), R5: The product that this is a pack for (new) and R5: focus additional types

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
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Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProduct		0..*	MedicinalProduct(4.0.1)	Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:version		0..1	string	R5: A business identifier relating to a specific version of the product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.version Constraints: ext-1
extension:statusDate		0..1	dateTime	R5: The date at which the given status became applicable (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.statusDate Constraints: ext-1
extension:description		0..1	markdown	R5: General description of this product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.description Constraints: ext-1
extension:route		0..*	CodeableConcept	R5: The path by which the product is taken into or makes contact with the body (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.route Constraints: ext-1
extension:indication		0..1	markdown	R5: Description of indication(s) for this product, used when structured indications are not required (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.indication Constraints: ext-1
extension:pediatricUseIndicator		0..1	CodeableConcept	R5: If authorised for use in children (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator Binding: R5MedicinalProductPediatricUseForR4 (0.1.0) (example): Suitability for age groups, in particular children. Constraints: ext-1
extension:classification		0..*	CodeableConcept	R5: Allows the product to be classified by various systems (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.classification Constraints: ext-1
extension:comprisedOf		0..*	Reference(Cross-version Profile for R5.ManufacturedItemDefinition for use in FHIR R4(0.1.0) | Basic | Cross-version Profile for R5.DeviceDefinition for use in FHIR R4(0.1.0) | DeviceDefinition)	R5: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.comprisedOf Constraints: ext-1
extension:ingredient		0..*	CodeableConcept	R5: The ingredients of this medicinal product - when not detailed in other resources (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.ingredient Constraints: ext-1
extension:impurity		0..*	(Complex)	R5: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.impurity Constraints: ext-1
extension:code		0..*	Coding	R5: A code that this product is known by, within some formal terminology (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.code Constraints: ext-1
extension:operation		0..*	(Complex)	R5: A manufacturing or administrative process for the medicinal product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.operation Constraints: ext-1
extension:characteristic		0..*	(Complex)	R5: Key product features such as "sugar free", "modified release" (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.characteristic Constraints: ext-1
Slices for modifierExtension	?!	0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
modifierExtension:status	?!	0..1	CodeableConcept	R5: The status within the lifecycle of this product record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. Constraints: ext-1
name	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:type		0..1	CodeableConcept	R5: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.type Binding: R5MedicinalProductNameTypeForR4 (0.1.0) (example): Type of a name for a Medicinal Product. Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
productName	Σ	1..1	string	The full product name
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	MedicinalProduct	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	MedicinalProduct	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProduct	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProduct	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	MedicinalProduct	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	MedicinalProduct.implicitRules, MedicinalProduct.extension, MedicinalProduct.extension:version, MedicinalProduct.extension:statusDate, MedicinalProduct.extension:description, MedicinalProduct.extension:route, MedicinalProduct.extension:indication, MedicinalProduct.extension:pediatricUseIndicator, MedicinalProduct.extension:classification, MedicinalProduct.extension:comprisedOf, MedicinalProduct.extension:ingredient, MedicinalProduct.extension:impurity, MedicinalProduct.extension:code, MedicinalProduct.extension:operation, MedicinalProduct.extension:characteristic, MedicinalProduct.modifierExtension, MedicinalProduct.modifierExtension:status, MedicinalProduct.name, MedicinalProduct.name.extension, MedicinalProduct.name.extension:type, MedicinalProduct.name.modifierExtension, MedicinalProduct.name.productName	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	MedicinalProduct.extension, MedicinalProduct.extension:version, MedicinalProduct.extension:statusDate, MedicinalProduct.extension:description, MedicinalProduct.extension:route, MedicinalProduct.extension:indication, MedicinalProduct.extension:pediatricUseIndicator, MedicinalProduct.extension:classification, MedicinalProduct.extension:comprisedOf, MedicinalProduct.extension:ingredient, MedicinalProduct.extension:impurity, MedicinalProduct.extension:code, MedicinalProduct.extension:operation, MedicinalProduct.extension:characteristic, MedicinalProduct.modifierExtension, MedicinalProduct.modifierExtension:status, MedicinalProduct.name.extension, MedicinalProduct.name.extension:type, MedicinalProduct.name.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from MedicinalProduct

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProduct		0..*	MedicinalProduct(4.0.1)	Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:version		0..1	string	R5: A business identifier relating to a specific version of the product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.version
extension:statusDate		0..1	dateTime	R5: The date at which the given status became applicable (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.statusDate
extension:description		0..1	markdown	R5: General description of this product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.description
extension:route		0..*	CodeableConcept	R5: The path by which the product is taken into or makes contact with the body (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.route
extension:indication		0..1	markdown	R5: Description of indication(s) for this product, used when structured indications are not required (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.indication
extension:pediatricUseIndicator		0..1	CodeableConcept	R5: If authorised for use in children (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator Binding: R5MedicinalProductPediatricUseForR4 (0.1.0) (example): Suitability for age groups, in particular children.
extension:classification		0..*	CodeableConcept	R5: Allows the product to be classified by various systems (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.classification
extension:comprisedOf		0..*	Reference(Cross-version Profile for R5.ManufacturedItemDefinition for use in FHIR R4(0.1.0) | Basic | Cross-version Profile for R5.DeviceDefinition for use in FHIR R4(0.1.0) | DeviceDefinition)	R5: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.comprisedOf
extension:ingredient		0..*	CodeableConcept	R5: The ingredients of this medicinal product - when not detailed in other resources (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.ingredient
extension:impurity		0..*	(Complex)	R5: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.impurity
extension:code		0..*	Coding	R5: A code that this product is known by, within some formal terminology (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.code
extension:operation		0..*	(Complex)	R5: A manufacturing or administrative process for the medicinal product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.operation
extension:characteristic		0..*	(Complex)	R5: Key product features such as "sugar free", "modified release" (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.characteristic
Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:status		0..1	CodeableConcept	R5: The status within the lifecycle of this product record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
domain
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:domain		0..1	CodeableConcept	R5: domain additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.domain Binding: R5MedicinalProductDomainForR4 (0.1.0) (example): Applicable domain for this product (e.g. human, veterinary).
specialMeasures
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:specialMeasures		0..*	CodeableConcept	R5: specialMeasures additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.specialMeasures Binding: R5MedicinalProductSpecialMeasuresForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
packagedMedicinalProduct
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:packagedMedicinalProduct		0..*	CodeableConcept	R5: Package type for the product additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.packagedMedicinalProduct Binding: R5MedicinalProductPackageTypeForR4 (0.1.0) (example): Types of medicinal product packs
attachedDocument
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:attachedDocument		0..*	Reference(Resource)	R5: Additional documentation about the medicinal product additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
masterFile
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:masterFile		0..*	Reference(Resource)	R5: A master file for the medicinal product (e.g. Pharmacovigilance System Master File) additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
contact
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:type		0..1	CodeableConcept	R5: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.type Binding: R5MedicinalProductContactTypeForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
extension:contact		1..1	Reference(Cross-version Profile for R5.Organization for use in FHIR R4(0.1.0) | Organization | Cross-version Profile for R5.PractitionerRole for use in FHIR R4(0.1.0) | PractitionerRole)	R5: A product specific contact, person (in a role), or an organization (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.contact
name
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:type		0..1	CodeableConcept	R5: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.type Binding: R5MedicinalProductNameTypeForR4 (0.1.0) (example): Type of a name for a Medicinal Product.
namePart
type
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:type		0..1	CodeableConcept	R5: Identifying type for this part of the name (e.g. strength part) additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.part.type Binding: R5MedicinalProductNamePartTypeForR4 (0.1.0) (example): Type of part of a name for a Medicinal Product.
countryLanguage
language
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:language		0..1	CodeableConcept	R5: language URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.usage.language
crossReference
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:product		1..1	(Complex)	R5: Reference to another product, e.g. for linking authorised to investigational product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.product
extension:type		0..1	CodeableConcept	R5: The type of relationship, for instance branded to generic or virtual to actual product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.type Binding: R5MedicinalProductCrossReferenceTypeForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProduct		0..*	MedicinalProduct(4.0.1)	Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:version		0..1	string	R5: A business identifier relating to a specific version of the product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.version Constraints: ext-1
extension:statusDate		0..1	dateTime	R5: The date at which the given status became applicable (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.statusDate Constraints: ext-1
extension:description		0..1	markdown	R5: General description of this product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.description Constraints: ext-1
extension:route		0..*	CodeableConcept	R5: The path by which the product is taken into or makes contact with the body (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.route Constraints: ext-1
extension:indication		0..1	markdown	R5: Description of indication(s) for this product, used when structured indications are not required (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.indication Constraints: ext-1
extension:pediatricUseIndicator		0..1	CodeableConcept	R5: If authorised for use in children (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator Binding: R5MedicinalProductPediatricUseForR4 (0.1.0) (example): Suitability for age groups, in particular children. Constraints: ext-1
extension:classification		0..*	CodeableConcept	R5: Allows the product to be classified by various systems (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.classification Constraints: ext-1
extension:comprisedOf		0..*	Reference(Cross-version Profile for R5.ManufacturedItemDefinition for use in FHIR R4(0.1.0) | Basic | Cross-version Profile for R5.DeviceDefinition for use in FHIR R4(0.1.0) | DeviceDefinition)	R5: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.comprisedOf Constraints: ext-1
extension:ingredient		0..*	CodeableConcept	R5: The ingredients of this medicinal product - when not detailed in other resources (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.ingredient Constraints: ext-1
extension:impurity		0..*	(Complex)	R5: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.impurity Constraints: ext-1
extension:code		0..*	Coding	R5: A code that this product is known by, within some formal terminology (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.code Constraints: ext-1
extension:operation		0..*	(Complex)	R5: A manufacturing or administrative process for the medicinal product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.operation Constraints: ext-1
extension:characteristic		0..*	(Complex)	R5: Key product features such as "sugar free", "modified release" (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.characteristic Constraints: ext-1
Slices for modifierExtension	?!	0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
modifierExtension:status	?!	0..1	CodeableConcept	R5: The status within the lifecycle of this product record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. Constraints: ext-1
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
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:domain		0..1	CodeableConcept	R5: domain additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.domain Binding: R5MedicinalProductDomainForR4 (0.1.0) (example): Applicable domain for this product (e.g. human, veterinary). Constraints: ext-1
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
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
id		0..1	string	xml:id (or equivalent in JSON)
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:specialMeasures		0..*	CodeableConcept	R5: specialMeasures additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.specialMeasures Binding: R5MedicinalProductSpecialMeasuresForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. Constraints: ext-1
value		0..1	string	Primitive value for string Max Length:1048576
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(MedicinalProductPharmaceutical)	Pharmaceutical aspects of product
packagedMedicinalProduct	Σ	0..*	Reference(MedicinalProductPackaged)	Package representation for the product
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:packagedMedicinalProduct		0..*	CodeableConcept	R5: Package type for the product additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.packagedMedicinalProduct Binding: R5MedicinalProductPackageTypeForR4 (0.1.0) (example): Types of medicinal product packs Constraints: ext-1
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
attachedDocument	Σ	0..*	Reference(DocumentReference)	Supporting documentation, typically for regulatory submission
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:attachedDocument		0..1	Reference(Resource)	R5: Additional documentation about the medicinal product additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference Constraints: ext-1
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:masterFile		0..1	Reference(Resource)	R5: A master file for the medicinal product (e.g. Pharmacovigilance System Master File) additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference Constraints: ext-1
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
contact	Σ	0..*	Reference(Organization | PractitionerRole)	A product specific contact, person (in a role), or an organization
id		0..1	string	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:type		0..1	CodeableConcept	R5: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.type Binding: R5MedicinalProductContactTypeForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. Constraints: ext-1
extension:contact		1..1	Reference(Cross-version Profile for R5.Organization for use in FHIR R4(0.1.0) | Organization | Cross-version Profile for R5.PractitionerRole for use in FHIR R4(0.1.0) | PractitionerRole)	R5: A product specific contact, person (in a role), or an organization (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.contact Constraints: ext-1
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	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
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:type		0..1	CodeableConcept	R5: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.type Binding: R5MedicinalProductNameTypeForR4 (0.1.0) (example): Type of a name for a Medicinal Product. Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
productName	Σ	1..1	string	The full product name
namePart	Σ	0..*	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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)
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:type		1..1	CodeableConcept	R5: Identifying type for this part of the name (e.g. strength part) additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.part.type Binding: R5MedicinalProductNamePartTypeForR4 (0.1.0) (example): Type of part of a name for a Medicinal Product. Constraints: ext-1
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
countryLanguage	Σ	0..*	BackboneElement	Country where the name applies
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:language		1..1	CodeableConcept	R5: language URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.usage.language Constraints: ext-1
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
crossReference	Σ	0..*	Identifier	Reference to another product, e.g. for linking authorised to investigational product
id		0..1	string	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:product		1..1	(Complex)	R5: Reference to another product, e.g. for linking authorised to investigational product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.product Constraints: ext-1
extension:type		0..1	CodeableConcept	R5: The type of relationship, for instance branded to generic or virtual to actual product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.type Binding: R5MedicinalProductCrossReferenceTypeForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. Constraints: ext-1
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
manufacturingBusinessOperation	Σ	0..*	BackboneElement	An operation applied to the product, for manufacturing or adminsitrative purpose
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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(Organization)	The manufacturer or establishment associated with the process
regulator	Σ	0..1	Reference(Organization)	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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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			CodeableConcept
indicationReference			Reference(MedicinalProductIndication)
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
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
MedicinalProduct.language	Base	preferred	Common Languages	📍4.0.1	tx.fhir.org
MedicinalProduct.packagedMedicinalProduct.​type	Base	extensible	ResourceType	📍4.0.1	tx.fhir.org
MedicinalProduct.attachedDocument.​type	Base	extensible	ResourceType	📍4.0.1	tx.fhir.org
MedicinalProduct.masterFile.​type	Base	extensible	ResourceType	📍4.0.1	tx.fhir.org
MedicinalProduct.contact.​type	Base	extensible	ResourceType	📍4.0.1	tx.fhir.org
MedicinalProduct.crossReference.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
MedicinalProduct.crossReference.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	MedicinalProduct	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	MedicinalProduct	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProduct	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProduct	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	MedicinalProduct	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	MedicinalProduct.meta, MedicinalProduct.implicitRules, MedicinalProduct.language, MedicinalProduct.text, MedicinalProduct.extension, MedicinalProduct.extension:version, MedicinalProduct.extension:statusDate, MedicinalProduct.extension:description, MedicinalProduct.extension:route, MedicinalProduct.extension:indication, MedicinalProduct.extension:pediatricUseIndicator, MedicinalProduct.extension:classification, MedicinalProduct.extension:comprisedOf, MedicinalProduct.extension:ingredient, MedicinalProduct.extension:impurity, MedicinalProduct.extension:code, MedicinalProduct.extension:operation, MedicinalProduct.extension:characteristic, MedicinalProduct.modifierExtension, MedicinalProduct.modifierExtension:status, MedicinalProduct.identifier, MedicinalProduct.type, MedicinalProduct.domain, MedicinalProduct.domain.extension, MedicinalProduct.domain.extension:domain, MedicinalProduct.domain.system, MedicinalProduct.domain.version, MedicinalProduct.domain.code, MedicinalProduct.domain.display, MedicinalProduct.domain.userSelected, MedicinalProduct.combinedPharmaceuticalDoseForm, MedicinalProduct.legalStatusOfSupply, MedicinalProduct.additionalMonitoringIndicator, MedicinalProduct.specialMeasures, MedicinalProduct.specialMeasures.extension, MedicinalProduct.specialMeasures.extension:specialMeasures, MedicinalProduct.paediatricUseIndicator, MedicinalProduct.productClassification, MedicinalProduct.marketingStatus, MedicinalProduct.pharmaceuticalProduct, MedicinalProduct.packagedMedicinalProduct, MedicinalProduct.packagedMedicinalProduct.extension, MedicinalProduct.packagedMedicinalProduct.extension:packagedMedicinalProduct, MedicinalProduct.packagedMedicinalProduct.reference, MedicinalProduct.packagedMedicinalProduct.type, MedicinalProduct.packagedMedicinalProduct.identifier, MedicinalProduct.packagedMedicinalProduct.display, MedicinalProduct.attachedDocument, MedicinalProduct.attachedDocument.extension, MedicinalProduct.attachedDocument.extension:attachedDocument, MedicinalProduct.attachedDocument.reference, MedicinalProduct.attachedDocument.type, MedicinalProduct.attachedDocument.identifier, MedicinalProduct.attachedDocument.display, MedicinalProduct.masterFile, MedicinalProduct.masterFile.extension, MedicinalProduct.masterFile.extension:masterFile, MedicinalProduct.masterFile.reference, MedicinalProduct.masterFile.type, MedicinalProduct.masterFile.identifier, MedicinalProduct.masterFile.display, MedicinalProduct.contact, MedicinalProduct.contact.extension, MedicinalProduct.contact.extension:type, MedicinalProduct.contact.extension:contact, MedicinalProduct.contact.reference, MedicinalProduct.contact.type, MedicinalProduct.contact.identifier, MedicinalProduct.contact.display, MedicinalProduct.clinicalTrial, MedicinalProduct.name, MedicinalProduct.name.extension, MedicinalProduct.name.extension:type, MedicinalProduct.name.modifierExtension, MedicinalProduct.name.productName, MedicinalProduct.name.namePart, MedicinalProduct.name.namePart.extension, MedicinalProduct.name.namePart.modifierExtension, MedicinalProduct.name.namePart.part, MedicinalProduct.name.namePart.type, MedicinalProduct.name.namePart.type.extension, MedicinalProduct.name.namePart.type.extension:type, MedicinalProduct.name.namePart.type.system, MedicinalProduct.name.namePart.type.version, MedicinalProduct.name.namePart.type.code, MedicinalProduct.name.namePart.type.display, MedicinalProduct.name.namePart.type.userSelected, MedicinalProduct.name.countryLanguage, MedicinalProduct.name.countryLanguage.extension, MedicinalProduct.name.countryLanguage.modifierExtension, MedicinalProduct.name.countryLanguage.country, MedicinalProduct.name.countryLanguage.jurisdiction, MedicinalProduct.name.countryLanguage.language, MedicinalProduct.name.countryLanguage.language.extension, MedicinalProduct.name.countryLanguage.language.extension:language, MedicinalProduct.name.countryLanguage.language.coding, MedicinalProduct.name.countryLanguage.language.text, MedicinalProduct.crossReference, MedicinalProduct.crossReference.extension, MedicinalProduct.crossReference.extension:product, MedicinalProduct.crossReference.extension:type, MedicinalProduct.crossReference.use, MedicinalProduct.crossReference.type, MedicinalProduct.crossReference.system, MedicinalProduct.crossReference.value, MedicinalProduct.crossReference.period, MedicinalProduct.crossReference.assigner, MedicinalProduct.manufacturingBusinessOperation, MedicinalProduct.manufacturingBusinessOperation.extension, MedicinalProduct.manufacturingBusinessOperation.modifierExtension, MedicinalProduct.manufacturingBusinessOperation.operationType, MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber, MedicinalProduct.manufacturingBusinessOperation.effectiveDate, MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator, MedicinalProduct.manufacturingBusinessOperation.manufacturer, MedicinalProduct.manufacturingBusinessOperation.regulator, MedicinalProduct.specialDesignation, MedicinalProduct.specialDesignation.extension, MedicinalProduct.specialDesignation.modifierExtension, MedicinalProduct.specialDesignation.identifier, MedicinalProduct.specialDesignation.type, MedicinalProduct.specialDesignation.intendedUse, MedicinalProduct.specialDesignation.indication[x], MedicinalProduct.specialDesignation.status, MedicinalProduct.specialDesignation.date, MedicinalProduct.specialDesignation.species	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	MedicinalProduct.extension, MedicinalProduct.extension:version, MedicinalProduct.extension:statusDate, MedicinalProduct.extension:description, MedicinalProduct.extension:route, MedicinalProduct.extension:indication, MedicinalProduct.extension:pediatricUseIndicator, MedicinalProduct.extension:classification, MedicinalProduct.extension:comprisedOf, MedicinalProduct.extension:ingredient, MedicinalProduct.extension:impurity, MedicinalProduct.extension:code, MedicinalProduct.extension:operation, MedicinalProduct.extension:characteristic, MedicinalProduct.modifierExtension, MedicinalProduct.modifierExtension:status, MedicinalProduct.domain.extension, MedicinalProduct.domain.extension:domain, MedicinalProduct.specialMeasures.extension, MedicinalProduct.specialMeasures.extension:specialMeasures, MedicinalProduct.packagedMedicinalProduct.extension, MedicinalProduct.packagedMedicinalProduct.extension:packagedMedicinalProduct, MedicinalProduct.attachedDocument.extension, MedicinalProduct.attachedDocument.extension:attachedDocument, MedicinalProduct.masterFile.extension, MedicinalProduct.masterFile.extension:masterFile, MedicinalProduct.contact.extension, MedicinalProduct.contact.extension:type, MedicinalProduct.contact.extension:contact, MedicinalProduct.name.extension, MedicinalProduct.name.extension:type, MedicinalProduct.name.modifierExtension, MedicinalProduct.name.namePart.extension, MedicinalProduct.name.namePart.modifierExtension, MedicinalProduct.name.namePart.type.extension, MedicinalProduct.name.namePart.type.extension:type, MedicinalProduct.name.countryLanguage.extension, MedicinalProduct.name.countryLanguage.modifierExtension, MedicinalProduct.name.countryLanguage.language.extension, MedicinalProduct.name.countryLanguage.language.extension:language, MedicinalProduct.crossReference.extension, MedicinalProduct.crossReference.extension:product, MedicinalProduct.crossReference.extension:type, MedicinalProduct.manufacturingBusinessOperation.extension, MedicinalProduct.manufacturingBusinessOperation.modifierExtension, MedicinalProduct.specialDesignation.extension, MedicinalProduct.specialDesignation.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from MedicinalProduct

Summary

Mandatory: 0 element(4 nested mandatory elements)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.version|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.statusDate|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.description|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.route|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.indication|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.classification|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.comprisedOf|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.ingredient|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.impurity|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.code|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.operation|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.characteristic|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.status|0.1.0 (Modifier)
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.domain|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.specialMeasures|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.packagedMedicinalProduct|0.1.0
• http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.type|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.contact|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.type|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.part.type|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.usage.language|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.product|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.type|0.1.0

Maturity: 0

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProduct		0..*	MedicinalProduct(4.0.1)	Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:version		0..1	string	R5: A business identifier relating to a specific version of the product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.version Constraints: ext-1
extension:statusDate		0..1	dateTime	R5: The date at which the given status became applicable (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.statusDate Constraints: ext-1
extension:description		0..1	markdown	R5: General description of this product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.description Constraints: ext-1
extension:route		0..*	CodeableConcept	R5: The path by which the product is taken into or makes contact with the body (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.route Constraints: ext-1
extension:indication		0..1	markdown	R5: Description of indication(s) for this product, used when structured indications are not required (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.indication Constraints: ext-1
extension:pediatricUseIndicator		0..1	CodeableConcept	R5: If authorised for use in children (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator Binding: R5MedicinalProductPediatricUseForR4 (0.1.0) (example): Suitability for age groups, in particular children. Constraints: ext-1
extension:classification		0..*	CodeableConcept	R5: Allows the product to be classified by various systems (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.classification Constraints: ext-1
extension:comprisedOf		0..*	Reference(Cross-version Profile for R5.ManufacturedItemDefinition for use in FHIR R4(0.1.0) | Basic | Cross-version Profile for R5.DeviceDefinition for use in FHIR R4(0.1.0) | DeviceDefinition)	R5: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.comprisedOf Constraints: ext-1
extension:ingredient		0..*	CodeableConcept	R5: The ingredients of this medicinal product - when not detailed in other resources (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.ingredient Constraints: ext-1
extension:impurity		0..*	(Complex)	R5: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.impurity Constraints: ext-1
extension:code		0..*	Coding	R5: A code that this product is known by, within some formal terminology (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.code Constraints: ext-1
extension:operation		0..*	(Complex)	R5: A manufacturing or administrative process for the medicinal product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.operation Constraints: ext-1
extension:characteristic		0..*	(Complex)	R5: Key product features such as "sugar free", "modified release" (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.characteristic Constraints: ext-1
Slices for modifierExtension	?!	0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
modifierExtension:status	?!	0..1	CodeableConcept	R5: The status within the lifecycle of this product record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. Constraints: ext-1
name	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:type		0..1	CodeableConcept	R5: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.type Binding: R5MedicinalProductNameTypeForR4 (0.1.0) (example): Type of a name for a Medicinal Product. Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
productName	Σ	1..1	string	The full product name
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	MedicinalProduct	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	MedicinalProduct	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProduct	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProduct	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	MedicinalProduct	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	MedicinalProduct.implicitRules, MedicinalProduct.extension, MedicinalProduct.extension:version, MedicinalProduct.extension:statusDate, MedicinalProduct.extension:description, MedicinalProduct.extension:route, MedicinalProduct.extension:indication, MedicinalProduct.extension:pediatricUseIndicator, MedicinalProduct.extension:classification, MedicinalProduct.extension:comprisedOf, MedicinalProduct.extension:ingredient, MedicinalProduct.extension:impurity, MedicinalProduct.extension:code, MedicinalProduct.extension:operation, MedicinalProduct.extension:characteristic, MedicinalProduct.modifierExtension, MedicinalProduct.modifierExtension:status, MedicinalProduct.name, MedicinalProduct.name.extension, MedicinalProduct.name.extension:type, MedicinalProduct.name.modifierExtension, MedicinalProduct.name.productName	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	MedicinalProduct.extension, MedicinalProduct.extension:version, MedicinalProduct.extension:statusDate, MedicinalProduct.extension:description, MedicinalProduct.extension:route, MedicinalProduct.extension:indication, MedicinalProduct.extension:pediatricUseIndicator, MedicinalProduct.extension:classification, MedicinalProduct.extension:comprisedOf, MedicinalProduct.extension:ingredient, MedicinalProduct.extension:impurity, MedicinalProduct.extension:code, MedicinalProduct.extension:operation, MedicinalProduct.extension:characteristic, MedicinalProduct.modifierExtension, MedicinalProduct.modifierExtension:status, MedicinalProduct.name.extension, MedicinalProduct.name.extension:type, MedicinalProduct.name.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Differential View

This structure is derived from MedicinalProduct

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProduct		0..*	MedicinalProduct(4.0.1)	Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:version		0..1	string	R5: A business identifier relating to a specific version of the product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.version
extension:statusDate		0..1	dateTime	R5: The date at which the given status became applicable (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.statusDate
extension:description		0..1	markdown	R5: General description of this product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.description
extension:route		0..*	CodeableConcept	R5: The path by which the product is taken into or makes contact with the body (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.route
extension:indication		0..1	markdown	R5: Description of indication(s) for this product, used when structured indications are not required (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.indication
extension:pediatricUseIndicator		0..1	CodeableConcept	R5: If authorised for use in children (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator Binding: R5MedicinalProductPediatricUseForR4 (0.1.0) (example): Suitability for age groups, in particular children.
extension:classification		0..*	CodeableConcept	R5: Allows the product to be classified by various systems (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.classification
extension:comprisedOf		0..*	Reference(Cross-version Profile for R5.ManufacturedItemDefinition for use in FHIR R4(0.1.0) | Basic | Cross-version Profile for R5.DeviceDefinition for use in FHIR R4(0.1.0) | DeviceDefinition)	R5: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.comprisedOf
extension:ingredient		0..*	CodeableConcept	R5: The ingredients of this medicinal product - when not detailed in other resources (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.ingredient
extension:impurity		0..*	(Complex)	R5: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.impurity
extension:code		0..*	Coding	R5: A code that this product is known by, within some formal terminology (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.code
extension:operation		0..*	(Complex)	R5: A manufacturing or administrative process for the medicinal product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.operation
extension:characteristic		0..*	(Complex)	R5: Key product features such as "sugar free", "modified release" (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.characteristic
Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension:status		0..1	CodeableConcept	R5: The status within the lifecycle of this product record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.status Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
domain
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:domain		0..1	CodeableConcept	R5: domain additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.domain Binding: R5MedicinalProductDomainForR4 (0.1.0) (example): Applicable domain for this product (e.g. human, veterinary).
specialMeasures
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:specialMeasures		0..*	CodeableConcept	R5: specialMeasures additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.specialMeasures Binding: R5MedicinalProductSpecialMeasuresForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
packagedMedicinalProduct
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:packagedMedicinalProduct		0..*	CodeableConcept	R5: Package type for the product additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.packagedMedicinalProduct Binding: R5MedicinalProductPackageTypeForR4 (0.1.0) (example): Types of medicinal product packs
attachedDocument
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:attachedDocument		0..*	Reference(Resource)	R5: Additional documentation about the medicinal product additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
masterFile
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:masterFile		0..*	Reference(Resource)	R5: A master file for the medicinal product (e.g. Pharmacovigilance System Master File) additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference
contact
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:type		0..1	CodeableConcept	R5: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.type Binding: R5MedicinalProductContactTypeForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
extension:contact		1..1	Reference(Cross-version Profile for R5.Organization for use in FHIR R4(0.1.0) | Organization | Cross-version Profile for R5.PractitionerRole for use in FHIR R4(0.1.0) | PractitionerRole)	R5: A product specific contact, person (in a role), or an organization (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.contact
name
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:type		0..1	CodeableConcept	R5: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.type Binding: R5MedicinalProductNameTypeForR4 (0.1.0) (example): Type of a name for a Medicinal Product.
namePart
type
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:type		0..1	CodeableConcept	R5: Identifying type for this part of the name (e.g. strength part) additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.part.type Binding: R5MedicinalProductNamePartTypeForR4 (0.1.0) (example): Type of part of a name for a Medicinal Product.
countryLanguage
language
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:language		0..1	CodeableConcept	R5: language URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.usage.language
crossReference
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:product		1..1	(Complex)	R5: Reference to another product, e.g. for linking authorised to investigational product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.product
extension:type		0..1	CodeableConcept	R5: The type of relationship, for instance branded to generic or virtual to actual product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.type Binding: R5MedicinalProductCrossReferenceTypeForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProduct		0..*	MedicinalProduct(4.0.1)	Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:version		0..1	string	R5: A business identifier relating to a specific version of the product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.version Constraints: ext-1
extension:statusDate		0..1	dateTime	R5: The date at which the given status became applicable (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.statusDate Constraints: ext-1
extension:description		0..1	markdown	R5: General description of this product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.description Constraints: ext-1
extension:route		0..*	CodeableConcept	R5: The path by which the product is taken into or makes contact with the body (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.route Constraints: ext-1
extension:indication		0..1	markdown	R5: Description of indication(s) for this product, used when structured indications are not required (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.indication Constraints: ext-1
extension:pediatricUseIndicator		0..1	CodeableConcept	R5: If authorised for use in children (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator Binding: R5MedicinalProductPediatricUseForR4 (0.1.0) (example): Suitability for age groups, in particular children. Constraints: ext-1
extension:classification		0..*	CodeableConcept	R5: Allows the product to be classified by various systems (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.classification Constraints: ext-1
extension:comprisedOf		0..*	Reference(Cross-version Profile for R5.ManufacturedItemDefinition for use in FHIR R4(0.1.0) | Basic | Cross-version Profile for R5.DeviceDefinition for use in FHIR R4(0.1.0) | DeviceDefinition)	R5: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.comprisedOf Constraints: ext-1
extension:ingredient		0..*	CodeableConcept	R5: The ingredients of this medicinal product - when not detailed in other resources (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.ingredient Constraints: ext-1
extension:impurity		0..*	(Complex)	R5: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.impurity Constraints: ext-1
extension:code		0..*	Coding	R5: A code that this product is known by, within some formal terminology (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.code Constraints: ext-1
extension:operation		0..*	(Complex)	R5: A manufacturing or administrative process for the medicinal product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.operation Constraints: ext-1
extension:characteristic		0..*	(Complex)	R5: Key product features such as "sugar free", "modified release" (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.characteristic Constraints: ext-1
Slices for modifierExtension	?!	0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
modifierExtension:status	?!	0..1	CodeableConcept	R5: The status within the lifecycle of this product record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. Constraints: ext-1
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
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:domain		0..1	CodeableConcept	R5: domain additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.domain Binding: R5MedicinalProductDomainForR4 (0.1.0) (example): Applicable domain for this product (e.g. human, veterinary). Constraints: ext-1
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
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
id		0..1	string	xml:id (or equivalent in JSON)
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:specialMeasures		0..*	CodeableConcept	R5: specialMeasures additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.specialMeasures Binding: R5MedicinalProductSpecialMeasuresForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies. Constraints: ext-1
value		0..1	string	Primitive value for string Max Length:1048576
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(MedicinalProductPharmaceutical)	Pharmaceutical aspects of product
packagedMedicinalProduct	Σ	0..*	Reference(MedicinalProductPackaged)	Package representation for the product
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:packagedMedicinalProduct		0..*	CodeableConcept	R5: Package type for the product additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.packagedMedicinalProduct Binding: R5MedicinalProductPackageTypeForR4 (0.1.0) (example): Types of medicinal product packs Constraints: ext-1
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
attachedDocument	Σ	0..*	Reference(DocumentReference)	Supporting documentation, typically for regulatory submission
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:attachedDocument		0..1	Reference(Resource)	R5: Additional documentation about the medicinal product additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference Constraints: ext-1
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:masterFile		0..1	Reference(Resource)	R5: A master file for the medicinal product (e.g. Pharmacovigilance System Master File) additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference Constraints: ext-1
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
contact	Σ	0..*	Reference(Organization | PractitionerRole)	A product specific contact, person (in a role), or an organization
id		0..1	string	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:type		0..1	CodeableConcept	R5: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.type Binding: R5MedicinalProductContactTypeForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. Constraints: ext-1
extension:contact		1..1	Reference(Cross-version Profile for R5.Organization for use in FHIR R4(0.1.0) | Organization | Cross-version Profile for R5.PractitionerRole for use in FHIR R4(0.1.0) | PractitionerRole)	R5: A product specific contact, person (in a role), or an organization (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.contact Constraints: ext-1
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	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
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:type		0..1	CodeableConcept	R5: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.type Binding: R5MedicinalProductNameTypeForR4 (0.1.0) (example): Type of a name for a Medicinal Product. Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
productName	Σ	1..1	string	The full product name
namePart	Σ	0..*	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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)
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:type		1..1	CodeableConcept	R5: Identifying type for this part of the name (e.g. strength part) additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.part.type Binding: R5MedicinalProductNamePartTypeForR4 (0.1.0) (example): Type of part of a name for a Medicinal Product. Constraints: ext-1
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	0..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
countryLanguage	Σ	0..*	BackboneElement	Country where the name applies
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:language		1..1	CodeableConcept	R5: language URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.usage.language Constraints: ext-1
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
crossReference	Σ	0..*	Identifier	Reference to another product, e.g. for linking authorised to investigational product
id		0..1	string	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:product		1..1	(Complex)	R5: Reference to another product, e.g. for linking authorised to investigational product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.product Constraints: ext-1
extension:type		0..1	CodeableConcept	R5: The type of relationship, for instance branded to generic or virtual to actual product (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.type Binding: R5MedicinalProductCrossReferenceTypeForR4 (0.1.0) (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements. Constraints: ext-1
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
manufacturingBusinessOperation	Σ	0..*	BackboneElement	An operation applied to the product, for manufacturing or adminsitrative purpose
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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(Organization)	The manufacturer or establishment associated with the process
regulator	Σ	0..1	Reference(Organization)	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
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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			CodeableConcept
indicationReference			Reference(MedicinalProductIndication)
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
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
MedicinalProduct.language	Base	preferred	Common Languages	📍4.0.1	tx.fhir.org
MedicinalProduct.packagedMedicinalProduct.​type	Base	extensible	ResourceType	📍4.0.1	tx.fhir.org
MedicinalProduct.attachedDocument.​type	Base	extensible	ResourceType	📍4.0.1	tx.fhir.org
MedicinalProduct.masterFile.​type	Base	extensible	ResourceType	📍4.0.1	tx.fhir.org
MedicinalProduct.contact.​type	Base	extensible	ResourceType	📍4.0.1	tx.fhir.org
MedicinalProduct.crossReference.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
MedicinalProduct.crossReference.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	MedicinalProduct	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	MedicinalProduct	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProduct	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProduct	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	MedicinalProduct	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	MedicinalProduct.meta, MedicinalProduct.implicitRules, MedicinalProduct.language, MedicinalProduct.text, MedicinalProduct.extension, MedicinalProduct.extension:version, MedicinalProduct.extension:statusDate, MedicinalProduct.extension:description, MedicinalProduct.extension:route, MedicinalProduct.extension:indication, MedicinalProduct.extension:pediatricUseIndicator, MedicinalProduct.extension:classification, MedicinalProduct.extension:comprisedOf, MedicinalProduct.extension:ingredient, MedicinalProduct.extension:impurity, MedicinalProduct.extension:code, MedicinalProduct.extension:operation, MedicinalProduct.extension:characteristic, MedicinalProduct.modifierExtension, MedicinalProduct.modifierExtension:status, MedicinalProduct.identifier, MedicinalProduct.type, MedicinalProduct.domain, MedicinalProduct.domain.extension, MedicinalProduct.domain.extension:domain, MedicinalProduct.domain.system, MedicinalProduct.domain.version, MedicinalProduct.domain.code, MedicinalProduct.domain.display, MedicinalProduct.domain.userSelected, MedicinalProduct.combinedPharmaceuticalDoseForm, MedicinalProduct.legalStatusOfSupply, MedicinalProduct.additionalMonitoringIndicator, MedicinalProduct.specialMeasures, MedicinalProduct.specialMeasures.extension, MedicinalProduct.specialMeasures.extension:specialMeasures, MedicinalProduct.paediatricUseIndicator, MedicinalProduct.productClassification, MedicinalProduct.marketingStatus, MedicinalProduct.pharmaceuticalProduct, MedicinalProduct.packagedMedicinalProduct, MedicinalProduct.packagedMedicinalProduct.extension, MedicinalProduct.packagedMedicinalProduct.extension:packagedMedicinalProduct, MedicinalProduct.packagedMedicinalProduct.reference, MedicinalProduct.packagedMedicinalProduct.type, MedicinalProduct.packagedMedicinalProduct.identifier, MedicinalProduct.packagedMedicinalProduct.display, MedicinalProduct.attachedDocument, MedicinalProduct.attachedDocument.extension, MedicinalProduct.attachedDocument.extension:attachedDocument, MedicinalProduct.attachedDocument.reference, MedicinalProduct.attachedDocument.type, MedicinalProduct.attachedDocument.identifier, MedicinalProduct.attachedDocument.display, MedicinalProduct.masterFile, MedicinalProduct.masterFile.extension, MedicinalProduct.masterFile.extension:masterFile, MedicinalProduct.masterFile.reference, MedicinalProduct.masterFile.type, MedicinalProduct.masterFile.identifier, MedicinalProduct.masterFile.display, MedicinalProduct.contact, MedicinalProduct.contact.extension, MedicinalProduct.contact.extension:type, MedicinalProduct.contact.extension:contact, MedicinalProduct.contact.reference, MedicinalProduct.contact.type, MedicinalProduct.contact.identifier, MedicinalProduct.contact.display, MedicinalProduct.clinicalTrial, MedicinalProduct.name, MedicinalProduct.name.extension, MedicinalProduct.name.extension:type, MedicinalProduct.name.modifierExtension, MedicinalProduct.name.productName, MedicinalProduct.name.namePart, MedicinalProduct.name.namePart.extension, MedicinalProduct.name.namePart.modifierExtension, MedicinalProduct.name.namePart.part, MedicinalProduct.name.namePart.type, MedicinalProduct.name.namePart.type.extension, MedicinalProduct.name.namePart.type.extension:type, MedicinalProduct.name.namePart.type.system, MedicinalProduct.name.namePart.type.version, MedicinalProduct.name.namePart.type.code, MedicinalProduct.name.namePart.type.display, MedicinalProduct.name.namePart.type.userSelected, MedicinalProduct.name.countryLanguage, MedicinalProduct.name.countryLanguage.extension, MedicinalProduct.name.countryLanguage.modifierExtension, MedicinalProduct.name.countryLanguage.country, MedicinalProduct.name.countryLanguage.jurisdiction, MedicinalProduct.name.countryLanguage.language, MedicinalProduct.name.countryLanguage.language.extension, MedicinalProduct.name.countryLanguage.language.extension:language, MedicinalProduct.name.countryLanguage.language.coding, MedicinalProduct.name.countryLanguage.language.text, MedicinalProduct.crossReference, MedicinalProduct.crossReference.extension, MedicinalProduct.crossReference.extension:product, MedicinalProduct.crossReference.extension:type, MedicinalProduct.crossReference.use, MedicinalProduct.crossReference.type, MedicinalProduct.crossReference.system, MedicinalProduct.crossReference.value, MedicinalProduct.crossReference.period, MedicinalProduct.crossReference.assigner, MedicinalProduct.manufacturingBusinessOperation, MedicinalProduct.manufacturingBusinessOperation.extension, MedicinalProduct.manufacturingBusinessOperation.modifierExtension, MedicinalProduct.manufacturingBusinessOperation.operationType, MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber, MedicinalProduct.manufacturingBusinessOperation.effectiveDate, MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator, MedicinalProduct.manufacturingBusinessOperation.manufacturer, MedicinalProduct.manufacturingBusinessOperation.regulator, MedicinalProduct.specialDesignation, MedicinalProduct.specialDesignation.extension, MedicinalProduct.specialDesignation.modifierExtension, MedicinalProduct.specialDesignation.identifier, MedicinalProduct.specialDesignation.type, MedicinalProduct.specialDesignation.intendedUse, MedicinalProduct.specialDesignation.indication[x], MedicinalProduct.specialDesignation.status, MedicinalProduct.specialDesignation.date, MedicinalProduct.specialDesignation.species	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	MedicinalProduct.extension, MedicinalProduct.extension:version, MedicinalProduct.extension:statusDate, MedicinalProduct.extension:description, MedicinalProduct.extension:route, MedicinalProduct.extension:indication, MedicinalProduct.extension:pediatricUseIndicator, MedicinalProduct.extension:classification, MedicinalProduct.extension:comprisedOf, MedicinalProduct.extension:ingredient, MedicinalProduct.extension:impurity, MedicinalProduct.extension:code, MedicinalProduct.extension:operation, MedicinalProduct.extension:characteristic, MedicinalProduct.modifierExtension, MedicinalProduct.modifierExtension:status, MedicinalProduct.domain.extension, MedicinalProduct.domain.extension:domain, MedicinalProduct.specialMeasures.extension, MedicinalProduct.specialMeasures.extension:specialMeasures, MedicinalProduct.packagedMedicinalProduct.extension, MedicinalProduct.packagedMedicinalProduct.extension:packagedMedicinalProduct, MedicinalProduct.attachedDocument.extension, MedicinalProduct.attachedDocument.extension:attachedDocument, MedicinalProduct.masterFile.extension, MedicinalProduct.masterFile.extension:masterFile, MedicinalProduct.contact.extension, MedicinalProduct.contact.extension:type, MedicinalProduct.contact.extension:contact, MedicinalProduct.name.extension, MedicinalProduct.name.extension:type, MedicinalProduct.name.modifierExtension, MedicinalProduct.name.namePart.extension, MedicinalProduct.name.namePart.modifierExtension, MedicinalProduct.name.namePart.type.extension, MedicinalProduct.name.namePart.type.extension:type, MedicinalProduct.name.countryLanguage.extension, MedicinalProduct.name.countryLanguage.modifierExtension, MedicinalProduct.name.countryLanguage.language.extension, MedicinalProduct.name.countryLanguage.language.extension:language, MedicinalProduct.crossReference.extension, MedicinalProduct.crossReference.extension:product, MedicinalProduct.crossReference.extension:type, MedicinalProduct.manufacturingBusinessOperation.extension, MedicinalProduct.manufacturingBusinessOperation.modifierExtension, MedicinalProduct.specialDesignation.extension, MedicinalProduct.specialDesignation.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from MedicinalProduct

Summary

Mandatory: 0 element(4 nested mandatory elements)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.version|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.statusDate|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.description|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.route|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.indication|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.pediatricUseIndicator|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.classification|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.comprisedOf|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.ingredient|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.impurity|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.code|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.operation|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.characteristic|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.status|0.1.0 (Modifier)
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.domain|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.specialMeasures|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.packagedMedicinalProduct|0.1.0
• http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.type|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.contact.contact|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.type|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.part.type|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.name.usage.language|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.product|0.1.0
• http://hl7.org/fhir/5.0/StructureDefinition/extension-MedicinalProductDefinition.crossReference.type|0.1.0

Maturity: 0