Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12)
1.0.0 - STU1
Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12), published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/unicom-project-eu/d4.12/ and changes regularly. See the Directory of published versions
Official URL: http://unicom-project.eu/fhir/d4-12/StructureDefinition/PackagedProductD412 | Version: 1.0.0 | |||
Draft as of 2024-08-20 | Computable Name: PackagedProductD412 |
Packaged Product data
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 | PackagedProductDefinition | |||
Slices for identifier | 0..* | Identifier | Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system | |
identifier:pcid | 0..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 | 0..* | Reference(Medicinal Product) | The product that this is a pack for | |
containedItemQuantity | 0..* | Quantity | Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required) | |
description | 0..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: EMA SPOR Legal Status for the Supply (required) | |
jurisdiction | 0..1 | CodeableConcept | The place where the legal status of supply applies 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 | 0..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 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 | ||||
type | 0..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 | 0..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 | |
shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |
containedItem | 0..* | BackboneElement | An item (inner package or manufactured item) within the packaging | |
item | 1..1 | CodeableReference(Packaged Product | Manufactured Item) | 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 | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
PackagedProductDefinition.containedItemQuantity | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.jurisdiction | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG | |
PackagedProductDefinition.marketingStatus.country | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
Slices for identifier | Σ | 0..* | Identifier | Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system |
identifier:pcid | Σ | 0..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 | 0..* | Reference(Medicinal Product) | 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 | 0..* | Quantity | Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required) |
description | Σ | 0..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) |
jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: EMA SPOR Country (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 | 0..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 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 |
Documentation for this format |
Path | Conformance | ValueSet | URI |
PackagedProductDefinition.identifier:pcid.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
PackagedProductDefinition.containedItemQuantity | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.jurisdiction | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG | |
PackagedProductDefinition.marketingStatus.country | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
Slices for identifier | Σ | 0..* | Identifier | Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system | ||||
identifier:pcid | Σ | 0..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 | 0..* | Reference(Medicinal Product) | The product that this is a pack for | ||||
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable | ||||
containedItemQuantity | Σ | 0..* | Quantity | Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required) | ||||
description | Σ | 0..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: EMA SPOR Country (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 | ||||
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 | 0..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 Binding: EMA SPOR Country (required) | ||||
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 | 0..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
identifier | Σ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | ||||
type | Σ | 0..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 | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
material | Σ | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
alternateMaterial | Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
shelfLifeStorage | Σ | 0..* | ProductShelfLife | Shelf Life and storage information | ||||
manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
property | Σ | 0..* | BackboneElement | General characteristics of this item | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
value[x] | Σ | 0..1 | A value for the characteristic | |||||
valueCodeableConcept | CodeableConcept | |||||||
valueQuantity | Quantity | |||||||
valueDate | date | |||||||
valueBoolean | boolean | |||||||
valueAttachment | Attachment | |||||||
containedItem | Σ | 0..* | BackboneElement | 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(Packaged Product | Manufactured Item) | 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 | ||||
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" | ||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
PackagedProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
PackagedProductDefinition.identifier:pcid.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
PackagedProductDefinition.identifier:pcid.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
PackagedProductDefinition.type | example | PackageTypehttp://hl7.org/fhir/ValueSet/package-type from the FHIR Standard | |
PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
PackagedProductDefinition.containedItemQuantity | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.jurisdiction | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG | |
PackagedProductDefinition.marketingStatus.country | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG | |
PackagedProductDefinition.packaging.type | example | PackagingTypehttp://hl7.org/fhir/ValueSet/packaging-type from the FHIR Standard | |
PackagedProductDefinition.packaging.material | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-material from the FHIR Standard | |
PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-material from the FHIR Standard | |
PackagedProductDefinition.packaging.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 0 element(1 nested mandatory 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 | PackagedProductDefinition | |||
Slices for identifier | 0..* | Identifier | Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system | |
identifier:pcid | 0..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 | 0..* | Reference(Medicinal Product) | The product that this is a pack for | |
containedItemQuantity | 0..* | Quantity | Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required) | |
description | 0..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: EMA SPOR Legal Status for the Supply (required) | |
jurisdiction | 0..1 | CodeableConcept | The place where the legal status of supply applies 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 | 0..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 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 | ||||
type | 0..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 | 0..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 | |
shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |
containedItem | 0..* | BackboneElement | An item (inner package or manufactured item) within the packaging | |
item | 1..1 | CodeableReference(Packaged Product | Manufactured Item) | 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 | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
PackagedProductDefinition.containedItemQuantity | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.jurisdiction | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG | |
PackagedProductDefinition.marketingStatus.country | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
Slices for identifier | Σ | 0..* | Identifier | Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system |
identifier:pcid | Σ | 0..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 | 0..* | Reference(Medicinal Product) | 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 | 0..* | Quantity | Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required) |
description | Σ | 0..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) |
jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: EMA SPOR Country (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 | 0..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 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 |
Documentation for this format |
Path | Conformance | ValueSet | URI |
PackagedProductDefinition.identifier:pcid.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
PackagedProductDefinition.containedItemQuantity | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.jurisdiction | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG | |
PackagedProductDefinition.marketingStatus.country | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
PackagedProductDefinition | 0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
Slices for identifier | Σ | 0..* | Identifier | Identifier for the packaged product: PCID, national ID, or other Slice: Unordered, Open by pattern:system | ||||
identifier:pcid | Σ | 0..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 | 0..* | Reference(Medicinal Product) | The product that this is a pack for | ||||
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable | ||||
containedItemQuantity | Σ | 0..* | Quantity | Pack size. Repeated for combination packages. Binding: EMA SPOR Unit of Presentation (required) | ||||
description | Σ | 0..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: EMA SPOR Country (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 | ||||
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 | 0..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 Binding: EMA SPOR Country (required) | ||||
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 | 0..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
identifier | Σ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | ||||
type | Σ | 0..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 | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
material | Σ | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
alternateMaterial | Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
shelfLifeStorage | Σ | 0..* | ProductShelfLife | Shelf Life and storage information | ||||
manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
property | Σ | 0..* | BackboneElement | General characteristics of this item | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
value[x] | Σ | 0..1 | A value for the characteristic | |||||
valueCodeableConcept | CodeableConcept | |||||||
valueQuantity | Quantity | |||||||
valueDate | date | |||||||
valueBoolean | boolean | |||||||
valueAttachment | Attachment | |||||||
containedItem | Σ | 0..* | BackboneElement | 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(Packaged Product | Manufactured Item) | 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 | ||||
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" | ||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
PackagedProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
PackagedProductDefinition.identifier:pcid.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
PackagedProductDefinition.identifier:pcid.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
PackagedProductDefinition.type | example | PackageTypehttp://hl7.org/fhir/ValueSet/package-type from the FHIR Standard | |
PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
PackagedProductDefinition.containedItemQuantity | required | UnitOfPresentation (a valid code from Unit of Presentation EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/unit-of-presentation-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.code | required | LegalStatusForTheSupply (a valid code from Legal Status for the Supply EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs from this IG | |
PackagedProductDefinition.legalStatusOfSupply.jurisdiction | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG | |
PackagedProductDefinition.marketingStatus.country | required | CountryEMA (a valid code from Country EMA)http://unicom-project.eu/fhir/d4-12/ValueSet/country-ema-vs from this IG | |
PackagedProductDefinition.packaging.type | example | PackagingTypehttp://hl7.org/fhir/ValueSet/packaging-type from the FHIR Standard | |
PackagedProductDefinition.packaging.material | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-material from the FHIR Standard | |
PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-material from the FHIR Standard | |
PackagedProductDefinition.packaging.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 0 element(1 nested mandatory element)
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron