UnicomIG
0.1.0 - ci-build
UnicomIG
0.1.0 - ci-build
UnicomIG, published by UNICOM. This is not an authorized publication; it is the continuous build for version 0.1.0). This version is based on the current content of https://github.com/hl7-eu/unicom-ig and changes regularly. See the Directory of published versions
| Official URL: http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition | Version: 0.1.0 | |||
| Active as of 2023-02-03 | Computable Name: PPLPackagedProductDefinition | |||
Packaged Product
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 | |
  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: Unit of Presentation EMA (required) | |
| description | 1..1 | markdown | Textual description. Note that this is not the name of the package or product | |
| 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: Legal Status for the Supply (required) | |
 jurisdiction | ||||
| coding | 0..* | Coding | Code defined by a terminology system Binding: Country (EMA SPOR RMS) (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 authorisation 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: Country (EMA SPOR RMS) (required) | |
| status | ||||
| coding | ||||
| system | 0..1 | uri | Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052 | |
| package | 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: Material (required) | |
| shelfLifeStorage | 0..* | BackboneElement | 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 | |
| property | 0..0 | |||
| 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: All Units Combined (required) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.containedItemQuantity.code | required | UnitOfPresentation (a valid code from Unit of Presentation EMA) |
| PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction.coding | required | CountryEMA (a valid code from Country EMA) |
| PackagedProductDefinition.marketingStatus.country.coding | required | CountryEMA (a valid code from Country EMA) |
| PackagedProductDefinition.package.material | required | Material (a valid code from Material EMA) |
| PackagedProductDefinition.package.property.type | example | NoBinding (a valid code from Domain EMA) |
| PackagedProductDefinition.package.containedItem.amount.code | required | AllUnits |
| 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 |
 modifierExtension | ?! | 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. |
 use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) |
| 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 | < | <= | >= | > - how to understand the value Binding: QuantityComparator (required) |
| code | Σ | 0..1 | code | Coded form of the unit Binding: Unit of Presentation EMA (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: 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 authorisation 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: Country (EMA SPOR RMS) (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 |
| package | 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: Material (required) |
| shelfLifeStorage | Σ | 0..* | BackboneElement | 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 | < | <= | >= | > - how to understand the value Binding: QuantityComparator (required) |
| code | Σ | 0..1 | code | Coded form of the unit Binding: All Units Combined (required) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.identifier:pcid.use | required | IdentifierUse |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.containedItemQuantity.comparator | required | QuantityComparator |
| PackagedProductDefinition.containedItemQuantity.code | required | UnitOfPresentation (a valid code from Unit of Presentation EMA) |
| PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) |
| PackagedProductDefinition.marketingStatus.country.coding | required | CountryEMA (a valid code from Country EMA) |
| PackagedProductDefinition.package.type | example | PackagingType |
| PackagedProductDefinition.package.material | required | Material (a valid code from Material EMA) |
| PackagedProductDefinition.package.property.type | example | NoBinding (a valid code from Domain EMA) |
| PackagedProductDefinition.package.containedItem.amount.comparator | required | QuantityComparator |
| PackagedProductDefinition.package.containedItem.amount.code | required | AllUnits |
| 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | 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: CommonLanguages (preferred): IETF language tag
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
 extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| 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) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/example/pcid | ||||
| value | Σ | 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 | < | <= | >= | > - how to understand the value Binding: QuantityComparator (required) | ||||
| unit | Σ | 0..1 | string | Unit representation | ||||
| system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code | Σ | 0..1 | code | Coded form of the unit Binding: Unit of Presentation EMA (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: Legal Status for the Supply (required) | ||||
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: Jurisdiction ValueSet (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: Country (EMA SPOR RMS) (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 authorisation 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: Country (EMA SPOR RMS) (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 authorisation 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 | Σ | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | Σ | 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 Authorisation 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 Authorisation 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 | ||||
| characteristic | Σ | 0..* | CodeableConcept | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" Binding: PackageCharacteristic (example): A characteristic of a package. | ||||
| copackagedIndicator | Σ | 0..1 | boolean | 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) | ||||
| package | 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 | Σ | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | Σ | 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 | ||||
| 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: 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..* | BackboneElement | Shelf Life and storage information | ||||
| 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 | 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 | Σ | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | Σ | 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 package Item (multiple means these are all possible manufacturers) | ||||
| 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 | < | <= | >= | > - how to understand the value Binding: QuantityComparator (required) | ||||
| unit | Σ | 0..1 | string | Unit representation | ||||
| system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code | Σ | 0..1 | code | Coded form of the unit Binding: All Units Combined (required) | ||||
| package | Σ | 0..* | See package (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still a single packaged product | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | ||||
| PackagedProductDefinition.language | preferred | CommonLanguages
| ||||
| PackagedProductDefinition.identifier:pcid.use | required | IdentifierUse | ||||
| PackagedProductDefinition.identifier:pcid.type | extensible | Identifier Type Codes | ||||
| PackagedProductDefinition.type | example | PackageType | ||||
| PackagedProductDefinition.status | preferred | PublicationStatus | ||||
| PackagedProductDefinition.containedItemQuantity.comparator | required | QuantityComparator | ||||
| PackagedProductDefinition.containedItemQuantity.code | required | UnitOfPresentation (a valid code from Unit of Presentation EMA) | ||||
| PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) | ||||
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | example | Jurisdiction ValueSet | ||||
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction.coding | required | CountryEMA (a valid code from Country EMA) | ||||
| PackagedProductDefinition.marketingStatus.country.coding | required | CountryEMA (a valid code from Country EMA) | ||||
| PackagedProductDefinition.characteristic | example | PackageCharacteristic | ||||
| PackagedProductDefinition.package.type | example | PackagingType | ||||
| PackagedProductDefinition.package.material | required | Material (a valid code from Material EMA) | ||||
| PackagedProductDefinition.package.alternateMaterial | example | PackageMaterial | ||||
| PackagedProductDefinition.package.property.type | example | NoBinding (a valid code from Domain EMA) | ||||
| PackagedProductDefinition.package.containedItem.amount.comparator | required | QuantityComparator | ||||
| PackagedProductDefinition.package.containedItem.amount.code | required | AllUnits |
| Id | Grade | Path(s) | Details | Requirements |
| dom-r4b | warning | PackagedProductDefinition.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 9 elements (3 nested mandatory elements)
Prohibited: 1 element
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
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 | |
| 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: Unit of Presentation EMA (required) | |
| description | 1..1 | markdown | Textual description. Note that this is not the name of the package or product | |
| 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: Legal Status for the Supply (required) | |
| jurisdiction | ||||
| coding | 0..* | Coding | Code defined by a terminology system Binding: Country (EMA SPOR RMS) (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 authorisation 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: Country (EMA SPOR RMS) (required) | |
| status | ||||
| coding | ||||
| system | 0..1 | uri | Identity of the terminology system Required Pattern: https://spor.ema.europa.eu/v1/lists/100000072052 | |
| package | 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: Material (required) | |
| shelfLifeStorage | 0..* | BackboneElement | 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 | |
| property | 0..0 | |||
| 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: All Units Combined (required) | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.containedItemQuantity.code | required | UnitOfPresentation (a valid code from Unit of Presentation EMA) |
| PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction.coding | required | CountryEMA (a valid code from Country EMA) |
| PackagedProductDefinition.marketingStatus.country.coding | required | CountryEMA (a valid code from Country EMA) |
| PackagedProductDefinition.package.material | required | Material (a valid code from Material EMA) |
| PackagedProductDefinition.package.property.type | example | NoBinding (a valid code from Domain EMA) |
| PackagedProductDefinition.package.containedItem.amount.code | required | AllUnits |
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 |
| modifierExtension | ?! | 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. |
| use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required) |
| 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 | < | <= | >= | > - how to understand the value Binding: QuantityComparator (required) |
| code | Σ | 0..1 | code | Coded form of the unit Binding: Unit of Presentation EMA (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: 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 authorisation 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: Country (EMA SPOR RMS) (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 |
| package | 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: Material (required) |
| shelfLifeStorage | Σ | 0..* | BackboneElement | 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 | < | <= | >= | > - how to understand the value Binding: QuantityComparator (required) |
| code | Σ | 0..1 | code | Coded form of the unit Binding: All Units Combined (required) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| PackagedProductDefinition.identifier:pcid.use | required | IdentifierUse |
| PackagedProductDefinition.status | preferred | PublicationStatus |
| PackagedProductDefinition.containedItemQuantity.comparator | required | QuantityComparator |
| PackagedProductDefinition.containedItemQuantity.code | required | UnitOfPresentation (a valid code from Unit of Presentation EMA) |
| PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) |
| PackagedProductDefinition.marketingStatus.country.coding | required | CountryEMA (a valid code from Country EMA) |
| PackagedProductDefinition.package.type | example | PackagingType |
| PackagedProductDefinition.package.material | required | Material (a valid code from Material EMA) |
| PackagedProductDefinition.package.property.type | example | NoBinding (a valid code from Domain EMA) |
| PackagedProductDefinition.package.containedItem.amount.comparator | required | QuantityComparator |
| PackagedProductDefinition.package.containedItem.amount.code | required | AllUnits |
| 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | 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: CommonLanguages (preferred): IETF language tag
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| 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) | ||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible) | ||||
| system | Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://ema.europa.eu/example/pcid | ||||
| value | Σ | 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 | < | <= | >= | > - how to understand the value Binding: QuantityComparator (required) | ||||
| unit | Σ | 0..1 | string | Unit representation | ||||
| system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code | Σ | 0..1 | code | Coded form of the unit Binding: Unit of Presentation EMA (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: Legal Status for the Supply (required) | ||||
| jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: Jurisdiction ValueSet (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: Country (EMA SPOR RMS) (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 authorisation 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: Country (EMA SPOR RMS) (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 authorisation 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 | Σ | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | Σ | 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 Authorisation 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 Authorisation 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 | ||||
| characteristic | Σ | 0..* | CodeableConcept | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" Binding: PackageCharacteristic (example): A characteristic of a package. | ||||
| copackagedIndicator | Σ | 0..1 | boolean | 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) | ||||
| package | 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 | Σ | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | Σ | 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 | ||||
| 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: 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..* | BackboneElement | Shelf Life and storage information | ||||
| 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 | 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 | Σ | 0..1 | code | Symbol in syntax defined by the system | ||||
| display | Σ | 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 package Item (multiple means these are all possible manufacturers) | ||||
| 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 | < | <= | >= | > - how to understand the value Binding: QuantityComparator (required) | ||||
| unit | Σ | 0..1 | string | Unit representation | ||||
| system | ΣC | 0..1 | uri | System that defines coded unit form | ||||
| code | Σ | 0..1 | code | Coded form of the unit Binding: All Units Combined (required) | ||||
| package | Σ | 0..* | See package (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still a single packaged product | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | ||||
| PackagedProductDefinition.language | preferred | CommonLanguages
| ||||
| PackagedProductDefinition.identifier:pcid.use | required | IdentifierUse | ||||
| PackagedProductDefinition.identifier:pcid.type | extensible | Identifier Type Codes | ||||
| PackagedProductDefinition.type | example | PackageType | ||||
| PackagedProductDefinition.status | preferred | PublicationStatus | ||||
| PackagedProductDefinition.containedItemQuantity.comparator | required | QuantityComparator | ||||
| PackagedProductDefinition.containedItemQuantity.code | required | UnitOfPresentation (a valid code from Unit of Presentation EMA) | ||||
| PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA) | ||||
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | example | Jurisdiction ValueSet | ||||
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction.coding | required | CountryEMA (a valid code from Country EMA) | ||||
| PackagedProductDefinition.marketingStatus.country.coding | required | CountryEMA (a valid code from Country EMA) | ||||
| PackagedProductDefinition.characteristic | example | PackageCharacteristic | ||||
| PackagedProductDefinition.package.type | example | PackagingType | ||||
| PackagedProductDefinition.package.material | required | Material (a valid code from Material EMA) | ||||
| PackagedProductDefinition.package.alternateMaterial | example | PackageMaterial | ||||
| PackagedProductDefinition.package.property.type | example | NoBinding (a valid code from Domain EMA) | ||||
| PackagedProductDefinition.package.containedItem.amount.comparator | required | QuantityComparator | ||||
| PackagedProductDefinition.package.containedItem.amount.code | required | AllUnits |
| Id | Grade | Path(s) | Details | Requirements |
| dom-r4b | warning | PackagedProductDefinition.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 9 elements (3 nested mandatory elements)
Prohibited: 1 element
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ UNICOM. Package hl7.eu.fhir.unicom#0.1.0 based on FHIR 4.3.0. Generated 2023-02-03
Links: Table of Contents |
QA Report
The UNICOM Innovation Action has received funding from the European Union's Horizon 2020
research and innovation programme under grant agreement No. 875299.
