UnicomIG, published by UNICOM. This is not an authorized publication; it is the continuous build for version 0.1.0). 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: Processing Profile - Manufactured Item

Intermediate profile for processing PPL Manufactured Item data

Usage:

• Refer to this Resource Profile:

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
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This structure is derived from ManufacturedItemDefinition

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
manufacturedDoseForm		1..1	CodeableConcept	Dose form of the manufactured item (before preparing for administration) Binding: Pharmaceutical Dose Form (required)
unitOfPresentation		0..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration)
ingredient		0..0
property		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.property.type	required	NoBinding (a valid code from Domain EMA)

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
modifierExtension	?!	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: Pharmaceutical Dose Form (required)
unitOfPresentation	Σ	0..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration) Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ManufacturedItemDefinition.status	required	PublicationStatus
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.unitOfPresentation	example	UnitOfPresentation
ManufacturedItemDefinition.property.type	required	NoBinding (a valid code from Domain EMA)

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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Unique identifier
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: Pharmaceutical Dose Form (required)
unitOfPresentation	Σ	0..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration) Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ManufacturedItemDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
ManufacturedItemDefinition.status	required	PublicationStatus
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.unitOfPresentation	example	UnitOfPresentation
ManufacturedItemDefinition.property.type	required	NoBinding (a valid code from Domain EMA)

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-r4b	warning	ManufacturedItemDefinition.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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

Prohibited: 2 elements

Differential View

This structure is derived from ManufacturedItemDefinition

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
manufacturedDoseForm		1..1	CodeableConcept	Dose form of the manufactured item (before preparing for administration) Binding: Pharmaceutical Dose Form (required)
unitOfPresentation		0..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration)
ingredient		0..0
property		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.property.type	required	NoBinding (a valid code from Domain EMA)

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
modifierExtension	?!	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: Pharmaceutical Dose Form (required)
unitOfPresentation	Σ	0..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration) Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ManufacturedItemDefinition.status	required	PublicationStatus
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.unitOfPresentation	example	UnitOfPresentation
ManufacturedItemDefinition.property.type	required	NoBinding (a valid code from Domain EMA)

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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Unique identifier
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: Pharmaceutical Dose Form (required)
unitOfPresentation	Σ	0..1	CodeableConcept	Unit of presentation of the manufactured item (before preparing for administration) Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ManufacturedItemDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
ManufacturedItemDefinition.status	required	PublicationStatus
ManufacturedItemDefinition.manufacturedDoseForm	required	PharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.unitOfPresentation	example	UnitOfPresentation
ManufacturedItemDefinition.property.type	required	NoBinding (a valid code from Domain EMA)

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-r4b	warning	ManufacturedItemDefinition.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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

Prohibited: 2 elements

Other representations of profile: CSV, Excel, Schematron