UnicomIG
0.1.0 - ci-build

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

Resource Profile: PPL Manufactured Item profile

Official URL: http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition Version: 0.1.0
Active as of 2023-02-03 Computable Name: PPLManufacturedItemDefinition

Manufactured item is the countable element inside the package

Usage:

Formal Views of Profile Content

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

This structure is derived from ManufacturedItemDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition 0..*ManufacturedItemDefinitionThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
... manufacturedDoseForm 1..1CodeableConceptDose form of the manufactured item (before preparing for administration)
Binding: Pharmaceutical Dose Form (required)
... unitOfPresentation 1..1CodeableConceptUnit of presentation of the manufactured item (before preparing for administration)
Binding: Unit of Presentation EMA (required)
... ingredient 0..0

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
ManufacturedItemDefinition.manufacturedDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
ManufacturedItemDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)
NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition 0..*ManufacturedItemDefinitionThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!Σ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... unitOfPresentation Σ1..1CodeableConceptUnit of presentation of the manufactured item (before preparing for administration)
Binding: Unit of Presentation EMA (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ManufacturedItemDefinition.statusrequiredPublicationStatus
ManufacturedItemDefinition.manufacturedDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
ManufacturedItemDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorManufacturedItemDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorManufacturedItemDefinitionIf 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-4errorManufacturedItemDefinitionIf 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-5errorManufacturedItemDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceManufacturedItemDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition 0..*ManufacturedItemDefinitionThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierUnique identifier
... status ?!Σ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... manufacturedDoseForm Σ1..1CodeableConceptDose form of the manufactured item (before preparing for administration)
Binding: Pharmaceutical Dose Form (required)
... unitOfPresentation Σ1..1CodeableConceptUnit of presentation of the manufactured item (before preparing for administration)
Binding: Unit of Presentation EMA (required)
... manufacturer Σ0..*Reference(Organization)Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ManufacturedItemDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
ManufacturedItemDefinition.statusrequiredPublicationStatus
ManufacturedItemDefinition.manufacturedDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
ManufacturedItemDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)

Constraints

IdGradePath(s)DetailsRequirements
dom-r4bwarningManufacturedItemDefinition.containedContaining 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-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 1 element
Prohibited: 2 elements

Differential View

This structure is derived from ManufacturedItemDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition 0..*ManufacturedItemDefinitionThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
... manufacturedDoseForm 1..1CodeableConceptDose form of the manufactured item (before preparing for administration)
Binding: Pharmaceutical Dose Form (required)
... unitOfPresentation 1..1CodeableConceptUnit of presentation of the manufactured item (before preparing for administration)
Binding: Unit of Presentation EMA (required)
... ingredient 0..0

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
ManufacturedItemDefinition.manufacturedDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
ManufacturedItemDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition 0..*ManufacturedItemDefinitionThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!Σ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... unitOfPresentation Σ1..1CodeableConceptUnit of presentation of the manufactured item (before preparing for administration)
Binding: Unit of Presentation EMA (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ManufacturedItemDefinition.statusrequiredPublicationStatus
ManufacturedItemDefinition.manufacturedDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
ManufacturedItemDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorManufacturedItemDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorManufacturedItemDefinitionIf 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-4errorManufacturedItemDefinitionIf 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-5errorManufacturedItemDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceManufacturedItemDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ManufacturedItemDefinition 0..*ManufacturedItemDefinitionThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierUnique identifier
... status ?!Σ1..1codedraft | active | retired | unknown
Binding: PublicationStatus (required): The lifecycle status of an artifact.

... manufacturedDoseForm Σ1..1CodeableConceptDose form of the manufactured item (before preparing for administration)
Binding: Pharmaceutical Dose Form (required)
... unitOfPresentation Σ1..1CodeableConceptUnit of presentation of the manufactured item (before preparing for administration)
Binding: Unit of Presentation EMA (required)
... manufacturer Σ0..*Reference(Organization)Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
ManufacturedItemDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
ManufacturedItemDefinition.statusrequiredPublicationStatus
ManufacturedItemDefinition.manufacturedDoseFormrequiredPharmaceuticalDoseForm (a valid code from Pharmaceutical Dose Form EMA)
ManufacturedItemDefinition.unitOfPresentationrequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
ManufacturedItemDefinition.property.typeexampleNoBinding (a valid code from Domain EMA)

Constraints

IdGradePath(s)DetailsRequirements
dom-r4bwarningManufacturedItemDefinition.containedContaining 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-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 1 element
Prohibited: 2 elements

 

Other representations of profile: CSV, Excel, Schematron