UnicomIG
0.1.0 - ci-build

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

Resource Profile: PPL Packaged Product profile

Official URL: http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition Version: 0.1.0
Draft as of 2024-10-11 Computable Name: PPLPackagedProductDefinition

Packaged Product

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
... Slices for identifier 1..* Identifier Identifier for the packaged product: PCID, national ID, or other
Slice: Unordered, Open by pattern:system
.... identifier:pcid 1..1 Identifier PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/example/pcid
... packageFor 1..* Reference(PPL Medicinal Product profile) The product that this is a pack for
... containedItemQuantity 1..* Quantity Pack size. Repeated for combination packages.
.... code 0..1 code Coded form of the unit
Binding: EMA SPOR Unit of Presentation (required)
... legalStatusOfSupply 0..1 BackboneElement Legal status of supply on the packaged product level.
.... code 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use
Binding: EMA SPOR Legal Status for the Supply (required)
.... jurisdiction
..... coding 0..* Coding Code defined by a terminology system
Binding: EMA SPOR Country (required)
... marketingStatus 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
.... country 1..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
..... coding 0..* Coding Code defined by a terminology system
Binding: EMA SPOR Country (required)
.... status
..... coding
...... system 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052
... packaging 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
.... type 1..1 CodeableConcept Container type
..... coding
...... system 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073346
.... quantity 1..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... material 0..* CodeableConcept Material type of the package item
Binding: EMA SPOR Material (required)
.... shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information
..... type 1..1 CodeableConcept This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
...... coding
....... system 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073343
..... period[x] 1..1 Duration, string The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
.... containedItem 0..* BackboneElement An item (inner package or manufactured item) within the packaging
..... item 1..1 CodeableReference(PPL Packaged Product profile | PPL Manufactured Item profile) 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 0..1 Quantity Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition
...... code 0..1 code Coded form of the unit
Binding: EMA SPOR All Units Combined (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
PackagedProductDefinition.containedItemQuantity.coderequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs
from this IG
PackagedProductDefinition.legalStatusOfSupply.coderequiredLegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)
http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs
from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdiction.codingrequiredCountryEMA (a valid code from Country EMA)
http://unicom-project.eu/fhir/ValueSet/country-ema-vs
from this IG
PackagedProductDefinition.marketingStatus.country.codingrequiredCountryEMA (a valid code from Country EMA)
http://unicom-project.eu/fhir/ValueSet/country-ema-vs
from this IG
PackagedProductDefinition.packaging.materialrequiredMaterial (a valid code from Material EMA)
http://unicom-project.eu/fhir/ValueSet/material-vs
from this IG
PackagedProductDefinition.packaging.containedItem.amount.coderequiredAllUnits
http://unicom-project.eu/fhir/ValueSet/all-units-vs
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
.... identifier:pcid Σ 1..1 Identifier PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/example/pcid
... packageFor Σ 1..* Reference(PPL Medicinal Product profile) 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.

... containedItemQuantity Σ 1..* Quantity Pack size. Repeated for combination packages.
.... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

.... code ΣC 0..1 code Coded form of the unit
Binding: EMA SPOR Unit of Presentation (required)
... description Σ 1..1 markdown Textual description. Note that this is not the name of the package or product
... legalStatusOfSupply Σ 0..1 BackboneElement Legal status of supply on the packaged product level.
.... 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: EMA SPOR Legal Status for the Supply (required)
... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... country Σ 1..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: EMA SPOR Country (required)
.... status Σ 1..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
... packaging Σ 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 Σ 1..1 CodeableConcept Container type
Binding: PackagingType (example): A high level categorisation of a package.

.... quantity Σ 1..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: EMA SPOR Material (required)
.... shelfLifeStorage Σ 0..* ProductShelfLife Shelf Life and storage information
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 1..1 CodeableConcept This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
..... period[x] Σ 1..1 The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
...... periodDuration Duration
...... periodString string
.... containedItem Σ 0..* BackboneElement An item (inner package or manufactured item) within the packaging
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... item Σ 1..1 CodeableReference(PPL Packaged Product profile | PPL Manufactured Item profile) 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 Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... code ΣC 0..1 code Coded form of the unit
Binding: EMA SPOR All Units Combined (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.identifier:pcid.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
PackagedProductDefinition.containedItemQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.containedItemQuantity.coderequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs
from this IG
PackagedProductDefinition.legalStatusOfSupply.coderequiredLegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)
http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs
from this IG
PackagedProductDefinition.marketingStatus.country.codingrequiredCountryEMA (a valid code from Country EMA)
http://unicom-project.eu/fhir/ValueSet/country-ema-vs
from this IG
PackagedProductDefinition.packaging.typeexamplePackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.materialrequiredMaterial (a valid code from Material EMA)
http://unicom-project.eu/fhir/ValueSet/material-vs
from this IG
PackagedProductDefinition.packaging.containedItem.amount.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.packaging.containedItem.amount.coderequiredAllUnits
http://unicom-project.eu/fhir/ValueSet/all-units-vs
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
... Slices for identifier Σ 1..* Identifier Identifier for the packaged product: PCID, national ID, or other
Slice: Unordered, Open by pattern:system
.... identifier:pcid Σ 1..1 Identifier PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/example/pcid
..... value ΣC 0..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... 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 Σ 1..* Reference(PPL Medicinal Product profile) 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 1..* Quantity Pack size. Repeated for combination packages.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... value Σ 0..1 decimal Numerical value (with implicit precision)
.... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

.... unit Σ 0..1 string Unit representation
.... system ΣC 0..1 uri System that defines coded unit form
.... code ΣC 0..1 code Coded form of the unit
Binding: EMA SPOR Unit of Presentation (required)
... description Σ 1..1 markdown Textual description. Note that this is not the name of the package or product
... legalStatusOfSupply Σ 0..1 BackboneElement Legal status of supply on the packaged product level.
.... 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: EMA SPOR Legal Status for the Supply (required)
.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: EMA SPOR Country (required)
..... text Σ 0..1 string Plain text representation of the concept
... 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
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... country Σ 1..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: EMA SPOR Country (required)
..... text Σ 0..1 string Plain text representation of the concept
.... jurisdiction Σ 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
.... status Σ 1..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... dateRange Σ 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
.... restoreDate Σ 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
... 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 Σ 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 Σ 1..1 CodeableConcept Container type
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
..... coding Σ 0..* Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073346
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... 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 Σ 1..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: EMA SPOR Material (required)
.... 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
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 1..1 CodeableConcept This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073343
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..1 code Symbol in syntax defined by the system
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... period[x] Σ 1..1 The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
...... periodDuration Duration
...... periodString string
..... specialPrecautionsForStorage Σ 0..* CodeableConcept Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
.... 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 An item (inner package or manufactured item) 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(PPL Packaged Product profile | PPL Manufactured Item profile) 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 Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value Σ 0..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit Σ 0..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
...... code ΣC 0..1 code Coded form of the unit
Binding: EMA SPOR All Units Combined (required)
.... packaging Σ 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.identifier:pcid.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:pcid.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
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.containedItemQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.containedItemQuantity.coderequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs
from this IG
PackagedProductDefinition.legalStatusOfSupply.coderequiredLegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)
http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs
from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdiction.codingrequiredCountryEMA (a valid code from Country EMA)
http://unicom-project.eu/fhir/ValueSet/country-ema-vs
from this IG
PackagedProductDefinition.marketingStatus.country.codingrequiredCountryEMA (a valid code from Country EMA)
http://unicom-project.eu/fhir/ValueSet/country-ema-vs
from this IG
PackagedProductDefinition.packaging.typeexamplePackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.materialrequiredMaterial (a valid code from Material EMA)
http://unicom-project.eu/fhir/ValueSet/material-vs
from this IG
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
PackagedProductDefinition.packaging.containedItem.amount.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.packaging.containedItem.amount.coderequiredAllUnits
http://unicom-project.eu/fhir/ValueSet/all-units-vs
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()

This structure is derived from PackagedProductDefinition

Summary

Mandatory: 9 elements(3 nested mandatory 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.identifier

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
... Slices for identifier 1..* Identifier Identifier for the packaged product: PCID, national ID, or other
Slice: Unordered, Open by pattern:system
.... identifier:pcid 1..1 Identifier PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/example/pcid
... packageFor 1..* Reference(PPL Medicinal Product profile) The product that this is a pack for
... containedItemQuantity 1..* Quantity Pack size. Repeated for combination packages.
.... code 0..1 code Coded form of the unit
Binding: EMA SPOR Unit of Presentation (required)
... legalStatusOfSupply 0..1 BackboneElement Legal status of supply on the packaged product level.
.... code 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use
Binding: EMA SPOR Legal Status for the Supply (required)
.... jurisdiction
..... coding 0..* Coding Code defined by a terminology system
Binding: EMA SPOR Country (required)
... marketingStatus 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
.... country 1..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
..... coding 0..* Coding Code defined by a terminology system
Binding: EMA SPOR Country (required)
.... status
..... coding
...... system 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052
... packaging 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
.... type 1..1 CodeableConcept Container type
..... coding
...... system 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073346
.... quantity 1..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... material 0..* CodeableConcept Material type of the package item
Binding: EMA SPOR Material (required)
.... shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information
..... type 1..1 CodeableConcept This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
...... coding
....... system 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073343
..... period[x] 1..1 Duration, string The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
.... containedItem 0..* BackboneElement An item (inner package or manufactured item) within the packaging
..... item 1..1 CodeableReference(PPL Packaged Product profile | PPL Manufactured Item profile) 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 0..1 Quantity Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition
...... code 0..1 code Coded form of the unit
Binding: EMA SPOR All Units Combined (required)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
PackagedProductDefinition.containedItemQuantity.coderequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs
from this IG
PackagedProductDefinition.legalStatusOfSupply.coderequiredLegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)
http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs
from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdiction.codingrequiredCountryEMA (a valid code from Country EMA)
http://unicom-project.eu/fhir/ValueSet/country-ema-vs
from this IG
PackagedProductDefinition.marketingStatus.country.codingrequiredCountryEMA (a valid code from Country EMA)
http://unicom-project.eu/fhir/ValueSet/country-ema-vs
from this IG
PackagedProductDefinition.packaging.materialrequiredMaterial (a valid code from Material EMA)
http://unicom-project.eu/fhir/ValueSet/material-vs
from this IG
PackagedProductDefinition.packaging.containedItem.amount.coderequiredAllUnits
http://unicom-project.eu/fhir/ValueSet/all-units-vs
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
.... identifier:pcid Σ 1..1 Identifier PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/example/pcid
... packageFor Σ 1..* Reference(PPL Medicinal Product profile) 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.

... containedItemQuantity Σ 1..* Quantity Pack size. Repeated for combination packages.
.... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

.... code ΣC 0..1 code Coded form of the unit
Binding: EMA SPOR Unit of Presentation (required)
... description Σ 1..1 markdown Textual description. Note that this is not the name of the package or product
... legalStatusOfSupply Σ 0..1 BackboneElement Legal status of supply on the packaged product level.
.... 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: EMA SPOR Legal Status for the Supply (required)
... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... country Σ 1..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: EMA SPOR Country (required)
.... status Σ 1..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
... packaging Σ 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 Σ 1..1 CodeableConcept Container type
Binding: PackagingType (example): A high level categorisation of a package.

.... quantity Σ 1..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: EMA SPOR Material (required)
.... shelfLifeStorage Σ 0..* ProductShelfLife Shelf Life and storage information
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 1..1 CodeableConcept This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
..... period[x] Σ 1..1 The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
...... periodDuration Duration
...... periodString string
.... containedItem Σ 0..* BackboneElement An item (inner package or manufactured item) within the packaging
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... item Σ 1..1 CodeableReference(PPL Packaged Product profile | PPL Manufactured Item profile) 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 Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... code ΣC 0..1 code Coded form of the unit
Binding: EMA SPOR All Units Combined (required)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.identifier:pcid.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
PackagedProductDefinition.containedItemQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.containedItemQuantity.coderequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs
from this IG
PackagedProductDefinition.legalStatusOfSupply.coderequiredLegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)
http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs
from this IG
PackagedProductDefinition.marketingStatus.country.codingrequiredCountryEMA (a valid code from Country EMA)
http://unicom-project.eu/fhir/ValueSet/country-ema-vs
from this IG
PackagedProductDefinition.packaging.typeexamplePackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.materialrequiredMaterial (a valid code from Material EMA)
http://unicom-project.eu/fhir/ValueSet/material-vs
from this IG
PackagedProductDefinition.packaging.containedItem.amount.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.packaging.containedItem.amount.coderequiredAllUnits
http://unicom-project.eu/fhir/ValueSet/all-units-vs
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
... Slices for identifier Σ 1..* Identifier Identifier for the packaged product: PCID, national ID, or other
Slice: Unordered, Open by pattern:system
.... identifier:pcid Σ 1..1 Identifier PCID for the product. Consists of MPID + unique package code. For the same product PCID is different if the package material is different.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/example/pcid
..... value ΣC 0..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... 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 Σ 1..* Reference(PPL Medicinal Product profile) 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 1..* Quantity Pack size. Repeated for combination packages.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... value Σ 0..1 decimal Numerical value (with implicit precision)
.... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

.... unit Σ 0..1 string Unit representation
.... system ΣC 0..1 uri System that defines coded unit form
.... code ΣC 0..1 code Coded form of the unit
Binding: EMA SPOR Unit of Presentation (required)
... description Σ 1..1 markdown Textual description. Note that this is not the name of the package or product
... legalStatusOfSupply Σ 0..1 BackboneElement Legal status of supply on the packaged product level.
.... 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: EMA SPOR Legal Status for the Supply (required)
.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: EMA SPOR Country (required)
..... text Σ 0..1 string Plain text representation of the concept
... 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
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... country Σ 1..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: EMA SPOR Country (required)
..... text Σ 0..1 string Plain text representation of the concept
.... jurisdiction Σ 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
.... status Σ 1..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... dateRange Σ 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
.... restoreDate Σ 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
... 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 Σ 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 Σ 1..1 CodeableConcept Container type
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
..... coding Σ 0..* Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073346
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... 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 Σ 1..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: EMA SPOR Material (required)
.... 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
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 1..1 CodeableConcept This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 0..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000073343
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..1 code Symbol in syntax defined by the system
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... period[x] Σ 1..1 The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
...... periodDuration Duration
...... periodString string
..... specialPrecautionsForStorage Σ 0..* CodeableConcept Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
.... 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 An item (inner package or manufactured item) 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(PPL Packaged Product profile | PPL Manufactured Item profile) 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 Number of the manufactured items (e.g. tablets) in this package layer or the amount of manufactured item (e.g. 20 g) in the unit of presentation defined in manufactured item definition
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... value Σ 0..1 decimal Numerical value (with implicit precision)
...... comparator ?!Σ 0..1 code < | <= | >= | > | ad - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

...... unit Σ 0..1 string Unit representation
...... system ΣC 0..1 uri System that defines coded unit form
...... code ΣC 0..1 code Coded form of the unit
Binding: EMA SPOR All Units Combined (required)
.... packaging Σ 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.identifier:pcid.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
PackagedProductDefinition.identifier:pcid.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
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.containedItemQuantity.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.containedItemQuantity.coderequiredUnitOfPresentation (a valid code from Unit of Presentation EMA)
http://unicom-project.eu/fhir/ValueSet/unit-of-presentation-vs
from this IG
PackagedProductDefinition.legalStatusOfSupply.coderequiredLegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)
http://unicom-project.eu/fhir/ValueSet/legal-status-for-the-supply-vs
from this IG
PackagedProductDefinition.legalStatusOfSupply.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdiction.codingrequiredCountryEMA (a valid code from Country EMA)
http://unicom-project.eu/fhir/ValueSet/country-ema-vs
from this IG
PackagedProductDefinition.marketingStatus.country.codingrequiredCountryEMA (a valid code from Country EMA)
http://unicom-project.eu/fhir/ValueSet/country-ema-vs
from this IG
PackagedProductDefinition.packaging.typeexamplePackagingType
http://hl7.org/fhir/ValueSet/packaging-type
from the FHIR Standard
PackagedProductDefinition.packaging.materialrequiredMaterial (a valid code from Material EMA)
http://unicom-project.eu/fhir/ValueSet/material-vs
from this IG
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
PackagedProductDefinition.packaging.containedItem.amount.comparatorrequiredQuantityComparator
http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
from the FHIR Standard
PackagedProductDefinition.packaging.containedItem.amount.coderequiredAllUnits
http://unicom-project.eu/fhir/ValueSet/all-units-vs
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()

This structure is derived from PackagedProductDefinition

Summary

Mandatory: 9 elements(3 nested mandatory 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.identifier

 

Other representations of profile: CSV, Excel, Schematron