Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Resource Profile: ContainerClosure

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ContainerClosure Version: 1.1.6
Active as of 2024-09-22 Computable Name: ContainerClosure
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.52

Container Closure for drug product referred to in Drug Product Description.

Usage:

Formal Views of Profile Content

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

This structure is derived from PackagedProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... packageFor S 1..1 Reference(Drug Product Description) The product that this is a pack for
... description S 1..1 markdown Container Closure System Description
... attachedDocument S 0..* Reference(Graphic Reference) Container Closure System Depiction
.... type S 1..1 CodeableConcept The physical type of the container of the items
..... Slices for coding S 2..2 Coding Code defined by a terminology system
Slice: Unordered, Closed by value:$this
...... coding:ContainerType S 1..1 Coding Container Type
Binding: Container Type Terminology (required)
...... coding:ClosureType S 1..1 Coding Closure Type
Binding: Closure Type Terminology (required)
.... quantity S 0..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... packaging S 0..* Allows containers (and parts of containers) within containers, still as a part of single packaged product

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
PackagedProductDefinition.packaging.type.coding:ContainerTyperequiredPqcmcContainerTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology
from this IG
PackagedProductDefinition.packaging.type.coding:ClosureTyperequiredPqcmcClosureTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... 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 0..1 CodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... description SΣ 1..1 markdown Container Closure System Description
... attachedDocument SΣ 0..* Reference(Graphic Reference) Container Closure System Depiction
... packaging SΣ 1..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (example): A high level categorisation of a package.

..... Slices for coding SΣ 2..2 Coding Code defined by a terminology system
Slice: Unordered, Closed by value:$this
...... coding:ContainerType SΣ 1..1 Coding Container Type
Binding: Container Type Terminology (required)
...... coding:ClosureType SΣ 1..1 Coding Closure Type
Binding: Closure Type Terminology (required)
.... quantity SΣ 0..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... packaging SΣ 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
PackagedProductDefinition.packaging.typeexamplePackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.type.coding:ContainerTyperequiredPqcmcContainerTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology
from this IG
PackagedProductDefinition.packaging.type.coding:ClosureTyperequiredPqcmcClosureTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA 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
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... 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
... 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 A unique identifier for this package as whole - not for the content of the package
... name Σ 0..1 string A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
... type Σ 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example): A high level categorisation of a package.

... packageFor SΣ 1..1 Reference(Drug Product Description) The product that this is a pack for
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... containedItemQuantity Σ 0..* Quantity A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
... description SΣ 1..1 markdown Container Closure System Description
... legalStatusOfSupply Σ 0..* BackboneElement The legal status of supply of the packaged item as classified by the regulator
.... 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
.... code Σ 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

... 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
... copackagedIndicator Σ 0..1 boolean Identifies if the drug product is supplied with another item such as a diluent or adjuvant
... manufacturer Σ 0..* Reference(Organization) Manufacturer of this package type (multiple means these are all possible manufacturers)
... attachedDocument SΣ 0..* Reference(Graphic Reference) Container Closure System Depiction
... packaging SΣ 1..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
.... 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
.... identifier Σ 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
.... type SΣ 1..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (example): A high level categorisation of a package.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... Slices for coding SΣ 2..2 Coding Code defined by a terminology system
Slice: Unordered, Closed by value:$this
...... coding:ContainerType SΣ 1..1 Coding Container Type
Binding: Container Type Terminology (required)
...... coding:ClosureType SΣ 1..1 Coding Closure Type
Binding: Closure Type Terminology (required)
..... text Σ 0..1 string Plain text representation of the concept
.... componentPart Σ 0..1 boolean Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
.... quantity SΣ 0..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... material Σ 0..* CodeableConcept Material type of the package item
Binding: PackageMaterial (example): A material used in the construction of packages and their components.


.... alternateMaterial Σ 0..* CodeableConcept A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
Binding: PackageMaterial (example): A material used in the construction of packages and their components.


.... shelfLifeStorage Σ 0..* ProductShelfLife Shelf Life and storage information
.... manufacturer Σ 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... 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
...... valueAttachment Attachment
.... containedItem Σ 0..* BackboneElement The item(s) within the packaging
..... 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
..... item Σ 1..1 CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
..... amount Σ 0..1 Quantity The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
.... packaging SΣ 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product
... characteristic Σ 0..* See property (PackagedProductDefinition) Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
PackagedProductDefinition.typeexamplePackageType
http://hl7.org/fhir/ValueSet/package-type
from the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.codeexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
PackagedProductDefinition.packaging.typeexamplePackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.type.coding:ContainerTyperequiredPqcmcContainerTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology
from this IG
PackagedProductDefinition.packaging.type.coding:ClosureTyperequiredPqcmcClosureTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology
from this IG
PackagedProductDefinition.packaging.materialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA 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()

This structure is derived from PackagedProductDefinition

Summary

Mandatory: 6 elements
Must-Support: 10 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of PackagedProductDefinition.packaging.type.coding (Closed)

Differential View

This structure is derived from PackagedProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... packageFor S 1..1 Reference(Drug Product Description) The product that this is a pack for
... description S 1..1 markdown Container Closure System Description
... attachedDocument S 0..* Reference(Graphic Reference) Container Closure System Depiction
.... type S 1..1 CodeableConcept The physical type of the container of the items
..... Slices for coding S 2..2 Coding Code defined by a terminology system
Slice: Unordered, Closed by value:$this
...... coding:ContainerType S 1..1 Coding Container Type
Binding: Container Type Terminology (required)
...... coding:ClosureType S 1..1 Coding Closure Type
Binding: Closure Type Terminology (required)
.... quantity S 0..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... packaging S 0..* Allows containers (and parts of containers) within containers, still as a part of single packaged product

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
PackagedProductDefinition.packaging.type.coding:ContainerTyperequiredPqcmcContainerTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology
from this IG
PackagedProductDefinition.packaging.type.coding:ClosureTyperequiredPqcmcClosureTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... 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 0..1 CodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... description SΣ 1..1 markdown Container Closure System Description
... attachedDocument SΣ 0..* Reference(Graphic Reference) Container Closure System Depiction
... packaging SΣ 1..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (example): A high level categorisation of a package.

..... Slices for coding SΣ 2..2 Coding Code defined by a terminology system
Slice: Unordered, Closed by value:$this
...... coding:ContainerType SΣ 1..1 Coding Container Type
Binding: Container Type Terminology (required)
...... coding:ClosureType SΣ 1..1 Coding Closure Type
Binding: Closure Type Terminology (required)
.... quantity SΣ 0..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... packaging SΣ 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
PackagedProductDefinition.packaging.typeexamplePackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.type.coding:ContainerTyperequiredPqcmcContainerTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology
from this IG
PackagedProductDefinition.packaging.type.coding:ClosureTyperequiredPqcmcClosureTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA 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
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... 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
... 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 A unique identifier for this package as whole - not for the content of the package
... name Σ 0..1 string A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
... type Σ 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example): A high level categorisation of a package.

... packageFor SΣ 1..1 Reference(Drug Product Description) The product that this is a pack for
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... containedItemQuantity Σ 0..* Quantity A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
... description SΣ 1..1 markdown Container Closure System Description
... legalStatusOfSupply Σ 0..* BackboneElement The legal status of supply of the packaged item as classified by the regulator
.... 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
.... code Σ 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

... 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
... copackagedIndicator Σ 0..1 boolean Identifies if the drug product is supplied with another item such as a diluent or adjuvant
... manufacturer Σ 0..* Reference(Organization) Manufacturer of this package type (multiple means these are all possible manufacturers)
... attachedDocument SΣ 0..* Reference(Graphic Reference) Container Closure System Depiction
... packaging SΣ 1..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
.... 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
.... identifier Σ 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
.... type SΣ 1..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (example): A high level categorisation of a package.

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... Slices for coding SΣ 2..2 Coding Code defined by a terminology system
Slice: Unordered, Closed by value:$this
...... coding:ContainerType SΣ 1..1 Coding Container Type
Binding: Container Type Terminology (required)
...... coding:ClosureType SΣ 1..1 Coding Closure Type
Binding: Closure Type Terminology (required)
..... text Σ 0..1 string Plain text representation of the concept
.... componentPart Σ 0..1 boolean Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
.... quantity SΣ 0..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... material Σ 0..* CodeableConcept Material type of the package item
Binding: PackageMaterial (example): A material used in the construction of packages and their components.


.... alternateMaterial Σ 0..* CodeableConcept A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
Binding: PackageMaterial (example): A material used in the construction of packages and their components.


.... shelfLifeStorage Σ 0..* ProductShelfLife Shelf Life and storage information
.... manufacturer Σ 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... 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
...... valueAttachment Attachment
.... containedItem Σ 0..* BackboneElement The item(s) within the packaging
..... 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
..... item Σ 1..1 CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
..... amount Σ 0..1 Quantity The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
.... packaging SΣ 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product
... characteristic Σ 0..* See property (PackagedProductDefinition) Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
PackagedProductDefinition.typeexamplePackageType
http://hl7.org/fhir/ValueSet/package-type
from the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.codeexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
PackagedProductDefinition.packaging.typeexamplePackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.type.coding:ContainerTyperequiredPqcmcContainerTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology
from this IG
PackagedProductDefinition.packaging.type.coding:ClosureTyperequiredPqcmcClosureTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology
from this IG
PackagedProductDefinition.packaging.materialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
from the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA 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()

This structure is derived from PackagedProductDefinition

Summary

Mandatory: 6 elements
Must-Support: 10 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of PackagedProductDefinition.packaging.type.coding (Closed)

 

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