Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq | Version: 1.0.0-ballot | |||
| Active as of 2023-12-18 | Computable Name: PackagedProductDefinitionDrugPq | |||
This PackagedProductDefinition profile represents information about the packaging for a drug product or drug substance.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from PackagedProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
  packageFor | S | 0..* | Reference(MedicinalProductDefinition) | The product that this is a pack for |
| description | S | 0..1 | markdown | Textual description. Note that this is not the name of the package or product |
 packaging | S | 0..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 |
 type | S | 0..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package. |
| material | S | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (preferred): A material used in the construction of packages and their components. |
| shelfLifeStorage | S | 0..* | ProductShelfLife | Shelf Life and storage information |
| manufacturer | S | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) |
 property | S | 0..* | BackboneElement | General characteristics of this item |
  type | S | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ValueSet - Package Property (example) |
| containedItem | S | 0..* | BackboneElement | The item(s) within the packaging |
| amount | S | 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 | S | 0..* | Allows containers (and parts of containers) within containers, still as a part of single packaged product Binding: Closure Type Terminology (example) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.packaging.type | preferred | PackagingType |
| PackagedProductDefinition.packaging.material | preferred | PackageMaterial |
| PackagedProductDefinition.packaging.property.type | example | VsPackagePropertyPQ (a valid code from CodeSystem - Package Property) |
| PackagedProductDefinition.packaging.packaging | example | PqcmcClosureTypeTerminology |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
 packageFor | SΣ | 0..* | Reference(MedicinalProductDefinition) | 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. |
| description | SΣ | 0..1 | markdown | Textual description. Note that this is not the name of the package or product |
| packaging | SΣ | 0..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 | 0..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package. |
| material | SΣ | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (preferred): A material used in the construction of packages and their components. |
| shelfLifeStorage | SΣ | 0..* | ProductShelfLife | Shelf Life and storage information |
| manufacturer | SΣ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) |
| property | SΣ | 0..* | BackboneElement | General characteristics of this item |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ValueSet - Package Property (example) |
| containedItem | SΣ | 0..* | BackboneElement | The item(s) within the packaging |
| 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 | SΣ | 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 |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.packaging.type | preferred | PackagingType |
| PackagedProductDefinition.packaging.material | preferred | PackageMaterial |
| PackagedProductDefinition.packaging.property.type | example | VsPackagePropertyPQ (a valid code from CodeSystem - Package Property) |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | 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 | PackagedProductDefinition | 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 | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | 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 | ||||
|---|---|---|---|---|---|---|---|---|
| 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 | ||||
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| 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 | 0..* | Reference(MedicinalProductDefinition) | 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 | 0..1 | markdown | Textual description. Note that this is not the name of the package or product | ||||
| 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 | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | ||||
| packaging | SΣ | 0..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 | 0..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package. | ||||
| 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 | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
| material | SΣ | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (preferred): 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 | SΣ | 0..* | ProductShelfLife | Shelf Life and storage information | ||||
| manufacturer | SΣ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
| property | SΣ | 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 | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ValueSet - Package Property (example) | ||||
 value[x] | Σ | 0..1 | A value for the characteristic | |||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueQuantity | Quantity | |||||||
| valueDate | date | |||||||
| valueBoolean | boolean | |||||||
| valueAttachment | Attachment | |||||||
| containedItem | SΣ | 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 | SΣ | 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" | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.language | required | AllLanguages |
| PackagedProductDefinition.type | example | PackageType |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.legalStatusOfSupply.code | example | LegalStatusOfSupply |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | example | JurisdictionValueSet |
| PackagedProductDefinition.packaging.type | preferred | PackagingType |
| PackagedProductDefinition.packaging.material | preferred | PackageMaterial |
| PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterial |
| PackagedProductDefinition.packaging.property.type | example | VsPackagePropertyPQ (a valid code from CodeSystem - Package Property) |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | 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 | PackagedProductDefinition | 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 | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | 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 PackagedProductDefinition
Differential View
This structure is derived from PackagedProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
| packageFor | S | 0..* | Reference(MedicinalProductDefinition) | The product that this is a pack for |
| description | S | 0..1 | markdown | Textual description. Note that this is not the name of the package or product |
| packaging | S | 0..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 |
| type | S | 0..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package. |
| material | S | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (preferred): A material used in the construction of packages and their components. |
| shelfLifeStorage | S | 0..* | ProductShelfLife | Shelf Life and storage information |
| manufacturer | S | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) |
| property | S | 0..* | BackboneElement | General characteristics of this item |
| type | S | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ValueSet - Package Property (example) |
| containedItem | S | 0..* | BackboneElement | The item(s) within the packaging |
| amount | S | 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 | S | 0..* | Allows containers (and parts of containers) within containers, still as a part of single packaged product Binding: Closure Type Terminology (example) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.packaging.type | preferred | PackagingType |
| PackagedProductDefinition.packaging.material | preferred | PackageMaterial |
| PackagedProductDefinition.packaging.property.type | example | VsPackagePropertyPQ (a valid code from CodeSystem - Package Property) |
| PackagedProductDefinition.packaging.packaging | example | PqcmcClosureTypeTerminology |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| packageFor | SΣ | 0..* | Reference(MedicinalProductDefinition) | 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. |
| description | SΣ | 0..1 | markdown | Textual description. Note that this is not the name of the package or product |
| packaging | SΣ | 0..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 | 0..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package. |
| material | SΣ | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (preferred): A material used in the construction of packages and their components. |
| shelfLifeStorage | SΣ | 0..* | ProductShelfLife | Shelf Life and storage information |
| manufacturer | SΣ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) |
| property | SΣ | 0..* | BackboneElement | General characteristics of this item |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ValueSet - Package Property (example) |
| containedItem | SΣ | 0..* | BackboneElement | The item(s) within the packaging |
| 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 | SΣ | 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 |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.packaging.type | preferred | PackagingType |
| PackagedProductDefinition.packaging.material | preferred | PackageMaterial |
| PackagedProductDefinition.packaging.property.type | example | VsPackagePropertyPQ (a valid code from CodeSystem - Package Property) |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | 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 | PackagedProductDefinition | 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 | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | 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 | ||||
|---|---|---|---|---|---|---|---|---|
| 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 | ||||
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| 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 | 0..* | Reference(MedicinalProductDefinition) | 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 | 0..1 | markdown | Textual description. Note that this is not the name of the package or product | ||||
| 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 | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | ||||
| packaging | SΣ | 0..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 | 0..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (preferred): A high level categorisation of a package. | ||||
| 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 | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
| material | SΣ | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (preferred): 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 | SΣ | 0..* | ProductShelfLife | Shelf Life and storage information | ||||
| manufacturer | SΣ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
| property | SΣ | 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 | SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ValueSet - Package Property (example) | ||||
| value[x] | Σ | 0..1 | A value for the characteristic | |||||
| valueCodeableConcept | CodeableConcept | |||||||
| valueQuantity | Quantity | |||||||
| valueDate | date | |||||||
| valueBoolean | boolean | |||||||
| valueAttachment | Attachment | |||||||
| containedItem | SΣ | 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 | SΣ | 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" | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.language | required | AllLanguages |
| PackagedProductDefinition.type | example | PackageType |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.legalStatusOfSupply.code | example | LegalStatusOfSupply |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | example | JurisdictionValueSet |
| PackagedProductDefinition.packaging.type | preferred | PackagingType |
| PackagedProductDefinition.packaging.material | preferred | PackageMaterial |
| PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterial |
| PackagedProductDefinition.packaging.property.type | example | VsPackagePropertyPQ (a valid code from CodeSystem - Package Property) |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | 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 | PackagedProductDefinition | 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 | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | 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 PackagedProductDefinition
Other representations of profile: CSV, Excel, Schematron
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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