UnicomIG, published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/unicom-ig/ and changes regularly. See the Directory of published versions

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Resource Profile: PPL Manufactured Item profile

Manufactured item is the countable element inside the package

Usage:

• Refer to this Resource Profile: PPL Administrable Product profile, PPL Ingredient profile and PPL Packaged Product profile
• Examples for this Resource Profile: ManufacturedItemDefinition/Agen-5mg-Tablet-EE-MID, ManufacturedItemDefinition/CanifugCremolum-100mg-Pessary-EE-MID, ManufacturedItemDefinition/CanifugCremolum-10mg1g-Cream-EE-MID and ManufacturedItemDefinition/Cefuroxime-MIP-1500mg-EE-MID

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from ManufacturedItemDefinition

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition			ManufacturedItemDefinition
manufacturedDoseForm		1..1	CodeableConcept	Dose form of the manufactured item (before preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required)
unitOfPresentation		1..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration) Binding: EMA SPOR Unit of Presentation (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vs from this IG
ManufacturedItemDefinition.unitOfPresentation	required	UnitOfPresentation (a valid code from Unit of Presentation EMA) http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs from this IG

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged 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
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form of the manufactured item (before preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required)
unitOfPresentation	Σ	1..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration) Binding: EMA SPOR Unit of Presentation (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vs from this IG
ManufacturedItemDefinition.unitOfPresentation	required	UnitOfPresentation (a valid code from Unit of Presentation EMA) http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	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	ManufacturedItemDefinition	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	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	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()

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged 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 Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Unique identifier
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	Σ	0..1	string	A descriptive name applied to this item
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form of the manufactured item (before preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required)
unitOfPresentation	Σ	1..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration) Binding: EMA SPOR Unit of Presentation (required)
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item, one of several possible
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient	Σ	0..*	CodeableConcept	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
property	Σ	0..*	BackboneElement	General characteristics of this item
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
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
component	Σ	0..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
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	Defining type of the component e.g. shell, layer, ink
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
amount	Σ	0..*	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
constituent	Σ	0..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
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
amount	Σ	0..*	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
location	Σ	0..*	CodeableConcept	The physical location of the constituent/ingredient within the component
function	Σ	0..*	CodeableConcept	The function of this constituent within the component e.g. binder
hasIngredient	Σ	0..*	CodeableReference(Ingredient)	The ingredient that is the constituent of the given component
property	Σ	0..*	See property (ManufacturedItemDefinition)	General characteristics of this component
component	Σ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ManufacturedItemDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vs from this IG
ManufacturedItemDefinition.unitOfPresentation	required	UnitOfPresentation (a valid code from Unit of Presentation EMA) http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs from this IG
ManufacturedItemDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	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	ManufacturedItemDefinition	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	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	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()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 1 element

Differential View

This structure is derived from ManufacturedItemDefinition

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition			ManufacturedItemDefinition
manufacturedDoseForm		1..1	CodeableConcept	Dose form of the manufactured item (before preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required)
unitOfPresentation		1..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration) Binding: EMA SPOR Unit of Presentation (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vs from this IG
ManufacturedItemDefinition.unitOfPresentation	required	UnitOfPresentation (a valid code from Unit of Presentation EMA) http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged 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
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form of the manufactured item (before preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required)
unitOfPresentation	Σ	1..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration) Binding: EMA SPOR Unit of Presentation (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vs from this IG
ManufacturedItemDefinition.unitOfPresentation	required	UnitOfPresentation (a valid code from Unit of Presentation EMA) http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	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	ManufacturedItemDefinition	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	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition		0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged 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 Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Unique identifier
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	Σ	0..1	string	A descriptive name applied to this item
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form of the manufactured item (before preparing for administration) Binding: EMA SPOR Pharmaceutical Dose Form (required)
unitOfPresentation	Σ	1..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration) Binding: EMA SPOR Unit of Presentation (required)
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item, one of several possible
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient	Σ	0..*	CodeableConcept	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
property	Σ	0..*	BackboneElement	General characteristics of this item
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
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
component	Σ	0..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
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	Defining type of the component e.g. shell, layer, ink
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
amount	Σ	0..*	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
constituent	Σ	0..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
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
amount	Σ	0..*	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
location	Σ	0..*	CodeableConcept	The physical location of the constituent/ingredient within the component
function	Σ	0..*	CodeableConcept	The function of this constituent within the component e.g. binder
hasIngredient	Σ	0..*	CodeableReference(Ingredient)	The ingredient that is the constituent of the given component
property	Σ	0..*	See property (ManufacturedItemDefinition)	General characteristics of this component
component	Σ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ManufacturedItemDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA) http://unicom-project.eu/fhir/ValueSet/pharmaceutical-doseform-vs from this IG
ManufacturedItemDefinition.unitOfPresentation	required	UnitOfPresentation (a valid code from Unit of Presentation EMA) http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs from this IG
ManufacturedItemDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	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	ManufacturedItemDefinition	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	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	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()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 1 element

Other representations of profile: CSV, Excel, Schematron