Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Resource Profile: MedicinalProductDefinition (ePI)

Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi Version: 1.1.0
Standards status: Trial-use Active as of 2026-04-03 Computable Name: MedicinalProductDefinitionUvEpi

MedicinalProductDefinition (ePI) - ported from MedicinalProductDefinitionUvEpi

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized.
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses.
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... version Σ 0..1 string A business identifier relating to a specific version of the product.
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... statusDate Σ 0..1 dateTime Date of status change
... description Σ 0..1 markdown General description of the medicinal product referred by the ePI
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product.
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body.
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... indication Σ 0..1 markdown Narrative text of the authorized indication(s) for this product.
... legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator.
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... status Σ 1..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
..... coding Σ 1..1 Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
.... dateRange Σ 0..1 Period The date when the status became effective.
... packagedMedicinalProduct Σ 0..* CodeableConcept Package representation for the product.
Binding: MedicinalProductPackageType (example): Types of medicinal product packs
... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of manufactured items that are part of this product.
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources.
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... contact Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization.
... name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... Slices for part Σ 0..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by pattern:type
..... part:All Slices Content/Rules for all slices
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
....... coding Σ 1..1 Coding Code defined by a terminology system
........ system Σ 1..1 uri Identity of the terminology system
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
..... part:ScientificNamePart Σ 0..* BackboneElement Non-proprietary name
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... text 0..1 string Plain text representation of the concept
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ version 0..1 string Version of the system - if relevant
........ userSelected 0..1 boolean If this coding was chosen directly by the user
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: ScientificNamePart
........ display ΣC 1..1 string Representation defined by the system
..... part:InventedNamePart Σ 0..* BackboneElement Proprietary name
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... text 0..1 string Plain text representation of the concept
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ version 0..1 string Version of the system - if relevant
........ userSelected 0..1 boolean If this coding was chosen directly by the user
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: InventedNamePart
........ display ΣC 1..1 string Representation defined by the system
..... part:StrengthPart Σ 0..* BackboneElement Strength
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... text 0..1 string Plain text representation of the concept
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ version 0..1 string Version of the system - if relevant
........ userSelected 0..1 boolean If this coding was chosen directly by the user
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: StrengthPart
........ display ΣC 1..1 string Representation defined by the system
..... part:PharmaceuticalDosePart Σ 0..* BackboneElement Dose Form
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... text 0..1 string Plain text representation of the concept
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ version 0..1 string Version of the system - if relevant
........ userSelected 0..1 boolean If this coding was chosen directly by the user
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: DoseFormPart
........ display ΣC 1..1 string Representation defined by the system
..... part:TrademarkOrOtherSuffixPart Σ 0..* BackboneElement Suffix
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... text 0..1 string Plain text representation of the concept
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ version 0..1 string Version of the system - if relevant
........ userSelected 0..1 boolean If this coding was chosen directly by the user
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: TrademarkOrCompanyPart
........ display ΣC 1..1 string Representation defined by the system
.... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system
..... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​type Base example Medicinal Product Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​domain Base example Medicinal Product Domain 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base example Combined Dose Form 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​route Base example SNOMED CT Route Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​legalStatusOfSupply Base example Legal Status Of Supply 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​packagedMedicinalProduct Base example Medicinal Product Package Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part.type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:ScientificNamePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:InventedNamePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:StrengthPart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:PharmaceuticalDosePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:TrademarkOrOtherSuffixPart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.language Base required All Languages 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error MedicinalProductDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error MedicinalProductDefinition 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error MedicinalProductDefinition 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 MedicinalProductDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice MedicinalProductDefinition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... identifier 1..* Identifier Business identifier for this product. Could be an MPID
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... type 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... domain 0..1 CodeableConcept If this medicine applies to human or veterinary uses.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... status 0..1 CodeableConcept The status within the lifecycle of this product record.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... statusDate 0..1 dateTime Date of status change
... description 0..1 markdown General description of the medicinal product referred by the ePI
... combinedPharmaceuticalDoseForm 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... route 0..* CodeableConcept The path by which the product is taken into or makes contact with the body.
... indication 0..1 markdown Narrative text of the authorized indication(s) for this product.
... legalStatusOfSupply 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... additionalMonitoringIndicator
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... specialMeasures
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... pediatricUseIndicator
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... classification
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... marketingStatus 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization.
.... country
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... status
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... dateRange 0..1 Period The date when the status became effective.
... packagedMedicinalProduct 0..* CodeableConcept Package representation for the product.
... comprisedOf 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of manufactured items that are part of this product.
... ingredient 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources.
... contact 0..* BackboneElement A product specific contact, person (in a role), or an organization.
.... type
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... contact 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization.
... name
.... productName 1..1 string The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... type
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... Slices for part 0..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by pattern:type
..... part:All Slices Content/Rules for all slices
...... type
....... coding 1..1 Coding Code defined by a terminology system
........ system 1..1 uri Identity of the terminology system
........ code 1..1 code Symbol in syntax defined by the system
........ display 1..1 string Representation defined by the system
..... part:ScientificNamePart 0..* BackboneElement Non-proprietary name
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: ScientificNamePart
..... part:InventedNamePart 0..* BackboneElement Proprietary name
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: InventedNamePart
..... part:StrengthPart 0..* BackboneElement Strength
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: StrengthPart
..... part:PharmaceuticalDosePart 0..* BackboneElement Dose Form
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: DoseFormPart
..... part:TrademarkOrOtherSuffixPart 0..* BackboneElement Suffix
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: TrademarkOrCompanyPart
.... usage 0..* BackboneElement Country and jurisdiction where the name applies.
..... country
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
..... jurisdiction
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
..... language
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... 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: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 1..* Identifier Business identifier for this product. Could be an MPID
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... 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: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..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)
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized.
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses.
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... version Σ 0..1 string A business identifier relating to a specific version of the product.
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... statusDate Σ 0..1 dateTime Date of status change
... description Σ 0..1 markdown General description of the medicinal product referred by the ePI
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product.
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body.
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... indication Σ 0..1 markdown Narrative text of the authorized indication(s) for this product.
... legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator.
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... classification Σ 0..* CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... country Σ 0..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... jurisdiction Σ 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
.... status Σ 1..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... dateRange Σ 0..1 Period The date when the status became effective.
.... restoreDate Σ 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
... packagedMedicinalProduct Σ 0..* CodeableConcept Package representation for the product.
Binding: MedicinalProductPackageType (example): Types of medicinal product packs
... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of manufactured items that are part of this product.
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources.
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... impurity Σ 0..* CodeableReference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... attachedDocument Σ 0..* Reference(DocumentReference) Additional documentation about the medicinal product
... masterFile Σ 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... contact Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization.
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
... 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
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... Slices for part Σ 0..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by pattern:type
..... part:All Slices Content/Rules for all slices
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
..... part:ScientificNamePart Σ 0..* BackboneElement Non-proprietary name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: ScientificNamePart
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
..... part:InventedNamePart Σ 0..* BackboneElement Proprietary name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: InventedNamePart
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
..... part:StrengthPart Σ 0..* BackboneElement Strength
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: StrengthPart
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
..... part:PharmaceuticalDosePart Σ 0..* BackboneElement Dose Form
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: DoseFormPart
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
..... part:TrademarkOrOtherSuffixPart Σ 0..* BackboneElement Suffix
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: TrademarkOrCompanyPart
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
.... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​identifier.type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​type Base example Medicinal Product Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​domain Base example Medicinal Product Domain 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base example Combined Dose Form 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​route Base example SNOMED CT Route Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​legalStatusOfSupply Base example Legal Status Of Supply 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​additionalMonitoringIndicator Base example Additional Monitoring 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​specialMeasures Base example Special Measures 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​pediatricUseIndicator Base example Pediatric Use 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​packagedMedicinalProduct Base example Medicinal Product Package Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​impurity Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​contact.type Base example Product Contact Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​code Base example SNOMED CT Medication Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part.type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:ScientificNamePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:InventedNamePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:StrengthPart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:PharmaceuticalDosePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:TrademarkOrOtherSuffixPart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​crossReference.type Base example Product Cross Reference Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​operation.confidentialityIndicator Base example Product Confidentiality 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​characteristic.type Base example Product Characteristic 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error MedicinalProductDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error MedicinalProductDefinition 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error MedicinalProductDefinition 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 MedicinalProductDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice MedicinalProductDefinition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 3 elements(68 nested mandatory elements)

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of MedicinalProductDefinition.name.part

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized.
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses.
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... version Σ 0..1 string A business identifier relating to a specific version of the product.
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... statusDate Σ 0..1 dateTime Date of status change
... description Σ 0..1 markdown General description of the medicinal product referred by the ePI
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product.
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body.
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... indication Σ 0..1 markdown Narrative text of the authorized indication(s) for this product.
... legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator.
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... status Σ 1..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
..... coding Σ 1..1 Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
.... dateRange Σ 0..1 Period The date when the status became effective.
... packagedMedicinalProduct Σ 0..* CodeableConcept Package representation for the product.
Binding: MedicinalProductPackageType (example): Types of medicinal product packs
... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of manufactured items that are part of this product.
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources.
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... contact Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization.
... name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... Slices for part Σ 0..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by pattern:type
..... part:All Slices Content/Rules for all slices
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
....... coding Σ 1..1 Coding Code defined by a terminology system
........ system Σ 1..1 uri Identity of the terminology system
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
..... part:ScientificNamePart Σ 0..* BackboneElement Non-proprietary name
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... text 0..1 string Plain text representation of the concept
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ version 0..1 string Version of the system - if relevant
........ userSelected 0..1 boolean If this coding was chosen directly by the user
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: ScientificNamePart
........ display ΣC 1..1 string Representation defined by the system
..... part:InventedNamePart Σ 0..* BackboneElement Proprietary name
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... text 0..1 string Plain text representation of the concept
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ version 0..1 string Version of the system - if relevant
........ userSelected 0..1 boolean If this coding was chosen directly by the user
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: InventedNamePart
........ display ΣC 1..1 string Representation defined by the system
..... part:StrengthPart Σ 0..* BackboneElement Strength
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... text 0..1 string Plain text representation of the concept
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ version 0..1 string Version of the system - if relevant
........ userSelected 0..1 boolean If this coding was chosen directly by the user
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: StrengthPart
........ display ΣC 1..1 string Representation defined by the system
..... part:PharmaceuticalDosePart Σ 0..* BackboneElement Dose Form
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... text 0..1 string Plain text representation of the concept
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ version 0..1 string Version of the system - if relevant
........ userSelected 0..1 boolean If this coding was chosen directly by the user
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: DoseFormPart
........ display ΣC 1..1 string Representation defined by the system
..... part:TrademarkOrOtherSuffixPart Σ 0..* BackboneElement Suffix
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... text 0..1 string Plain text representation of the concept
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ version 0..1 string Version of the system - if relevant
........ userSelected 0..1 boolean If this coding was chosen directly by the user
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: TrademarkOrCompanyPart
........ display ΣC 1..1 string Representation defined by the system
.... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system
..... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​type Base example Medicinal Product Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​domain Base example Medicinal Product Domain 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base example Combined Dose Form 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​route Base example SNOMED CT Route Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​legalStatusOfSupply Base example Legal Status Of Supply 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​packagedMedicinalProduct Base example Medicinal Product Package Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part.type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:ScientificNamePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:InventedNamePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:StrengthPart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:PharmaceuticalDosePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:TrademarkOrOtherSuffixPart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.language Base required All Languages 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error MedicinalProductDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error MedicinalProductDefinition 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error MedicinalProductDefinition 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 MedicinalProductDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice MedicinalProductDefinition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... identifier 1..* Identifier Business identifier for this product. Could be an MPID
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... type 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... domain 0..1 CodeableConcept If this medicine applies to human or veterinary uses.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... status 0..1 CodeableConcept The status within the lifecycle of this product record.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... statusDate 0..1 dateTime Date of status change
... description 0..1 markdown General description of the medicinal product referred by the ePI
... combinedPharmaceuticalDoseForm 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... route 0..* CodeableConcept The path by which the product is taken into or makes contact with the body.
... indication 0..1 markdown Narrative text of the authorized indication(s) for this product.
... legalStatusOfSupply 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... additionalMonitoringIndicator
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... specialMeasures
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... pediatricUseIndicator
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... classification
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... marketingStatus 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization.
.... country
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... status
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... dateRange 0..1 Period The date when the status became effective.
... packagedMedicinalProduct 0..* CodeableConcept Package representation for the product.
... comprisedOf 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of manufactured items that are part of this product.
... ingredient 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources.
... contact 0..* BackboneElement A product specific contact, person (in a role), or an organization.
.... type
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... contact 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization.
... name
.... productName 1..1 string The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... type
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... Slices for part 0..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by pattern:type
..... part:All Slices Content/Rules for all slices
...... type
....... coding 1..1 Coding Code defined by a terminology system
........ system 1..1 uri Identity of the terminology system
........ code 1..1 code Symbol in syntax defined by the system
........ display 1..1 string Representation defined by the system
..... part:ScientificNamePart 0..* BackboneElement Non-proprietary name
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: ScientificNamePart
..... part:InventedNamePart 0..* BackboneElement Proprietary name
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: InventedNamePart
..... part:StrengthPart 0..* BackboneElement Strength
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: StrengthPart
..... part:PharmaceuticalDosePart 0..* BackboneElement Dose Form
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: DoseFormPart
..... part:TrademarkOrOtherSuffixPart 0..* BackboneElement Suffix
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: TrademarkOrCompanyPart
.... usage 0..* BackboneElement Country and jurisdiction where the name applies.
..... country
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
..... jurisdiction
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
..... language
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system

doco Documentation for this format

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... 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: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 1..* Identifier Business identifier for this product. Could be an MPID
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... 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: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..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)
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized.
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses.
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... version Σ 0..1 string A business identifier relating to a specific version of the product.
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... statusDate Σ 0..1 dateTime Date of status change
... description Σ 0..1 markdown General description of the medicinal product referred by the ePI
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product.
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body.
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... indication Σ 0..1 markdown Narrative text of the authorized indication(s) for this product.
... legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator.
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... classification Σ 0..* CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... country Σ 0..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... jurisdiction Σ 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
.... status Σ 1..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... dateRange Σ 0..1 Period The date when the status became effective.
.... restoreDate Σ 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
... packagedMedicinalProduct Σ 0..* CodeableConcept Package representation for the product.
Binding: MedicinalProductPackageType (example): Types of medicinal product packs
... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of manufactured items that are part of this product.
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources.
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... impurity Σ 0..* CodeableReference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... attachedDocument Σ 0..* Reference(DocumentReference) Additional documentation about the medicinal product
... masterFile Σ 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... contact Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization.
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
... 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
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... Slices for part Σ 0..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by pattern:type
..... part:All Slices Content/Rules for all slices
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
..... part:ScientificNamePart Σ 0..* BackboneElement Non-proprietary name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: ScientificNamePart
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
..... part:InventedNamePart Σ 0..* BackboneElement Proprietary name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: InventedNamePart
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
..... part:StrengthPart Σ 0..* BackboneElement Strength
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: StrengthPart
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
..... part:PharmaceuticalDosePart Σ 0..* BackboneElement Dose Form
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: DoseFormPart
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
..... part:TrademarkOrOtherSuffixPart Σ 0..* BackboneElement Suffix
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
Required Pattern: At least the following
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/medicinal-product-name-part-type
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Fixed Value: TrademarkOrCompanyPart
........ display ΣC 1..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
.... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies.
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​identifier.type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​type Base example Medicinal Product Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​domain Base example Medicinal Product Domain 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base example Combined Dose Form 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​route Base example SNOMED CT Route Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​legalStatusOfSupply Base example Legal Status Of Supply 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​additionalMonitoringIndicator Base example Additional Monitoring 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​specialMeasures Base example Special Measures 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​pediatricUseIndicator Base example Pediatric Use 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​packagedMedicinalProduct Base example Medicinal Product Package Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​impurity Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​contact.type Base example Product Contact Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​code Base example SNOMED CT Medication Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part.type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:ScientificNamePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:InventedNamePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:StrengthPart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:PharmaceuticalDosePart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part:TrademarkOrOtherSuffixPart.​type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​crossReference.type Base example Product Cross Reference Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​operation.confidentialityIndicator Base example Product Confidentiality 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​characteristic.type Base example Product Characteristic 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error MedicinalProductDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error MedicinalProductDefinition 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error MedicinalProductDefinition 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 MedicinalProductDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice MedicinalProductDefinition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 3 elements(68 nested mandatory elements)

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of MedicinalProductDefinition.name.part

 

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