UnicomIG
0.1.0 - ci-build

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

Logical Model: DRAFT: Medicinal Product in crossborder eP/eD

Official URL: http://unicom-project.eu/fhir/StructureDefinition/CrossBorderProduct Version: 0.1.0
Draft as of 2025-06-02 Computable Name: CrossBorderProduct

DRAFT. Crossborder eP/eD/PS medicinal product as a implementation-agnostic logical model

Usages:

  • This Logical Model is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. CrossBorderProduct 0..* Base DRAFT: Medicinal Product in crossborder eP/eD
... medicinalProductIdentifier 0..* II MPID or national identifier
... packagedProductIdentifier 0..* II PCID or national
... pharmaceuticalProductIdentifier 0..* II PhPID
... packSize 1..* PQ Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)
... fullName 0..* ST Name of the product
... doseForm 1..1 CD Authorised dose form for eD; authorised or pharmaceutical for eP
... constitution 1..* Class Content of the product - defines ingredients, manufactured items, or device
ele-1: All FHIR elements must have a @value or children
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... ingredient 0..* Class Ingredients, by default only active ingredients
ele-1: All FHIR elements must have a @value or children
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... role 1..1 CD (might not be needed if only active ingredients are expected)
..... substance 1..1 CD Substance
..... strengthInfo 1..* Class Concentration or presentation strength
ele-1: All FHIR elements must have a @value or children
...... @id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... strength 1..1 RTO Concentration or presentation strength of the precise active ingredient
...... referenceStrength 0..* Class Reference strength; according to the substance+strength type above
ele-1: All FHIR elements must have a @value or children
....... @id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
....... referenceSubstance 1..1 CD Substance for reference strength
....... strength 1..1 RTO Reference strength
.... manufacturedItem 0..* Class Manufactured item if the prescription contains more than one type of items
ele-1: All FHIR elements must have a @value or children
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... doseForm 1..1 CD Manufactured item dose form
..... unitOfPresentation 0..* CD Unit of presentation for the manufactured item
..... containedQuantity 0..1 PQ Manufactured item quantity for liquids (3ml/vial)
..... manufacturedItemQuantity 1..1 PQ Number of such manufactured items in this product (5 vials)
.... device 0..* Class Administrative device included in the product
ele-1: All FHIR elements must have a @value or children
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... deviceQuantity 1..1 PQ Number of such devices
..... device 1..1 CD Device coded
... marketingAuthorisationHolder 0..1 ST MAH name - do we need more?
... routeOfAdministration 1..* CD Route of Administration - if we need it on product level

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. CrossBorderProduct 0..* Base DRAFT: Medicinal Product in crossborder eP/eD
... medicinalProductIdentifier 0..* II MPID or national identifier
... packagedProductIdentifier 0..* II PCID or national
... pharmaceuticalProductIdentifier 0..* II PhPID
... packSize 1..* PQ Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)
... fullName 0..* ST Name of the product
... doseForm 1..1 CD Authorised dose form for eD; authorised or pharmaceutical for eP
... constitution 1..* Class Content of the product - defines ingredients, manufactured items, or device
.... ingredient 0..* Class Ingredients, by default only active ingredients
..... role 1..1 CD (might not be needed if only active ingredients are expected)
..... substance 1..1 CD Substance
..... strengthInfo 1..* Class Concentration or presentation strength
...... strength 1..1 RTO Concentration or presentation strength of the precise active ingredient
...... referenceStrength 0..* Class Reference strength; according to the substance+strength type above
....... referenceSubstance 1..1 CD Substance for reference strength
....... strength 1..1 RTO Reference strength
.... manufacturedItem 0..* Class Manufactured item if the prescription contains more than one type of items
..... doseForm 1..1 CD Manufactured item dose form
..... unitOfPresentation 0..* CD Unit of presentation for the manufactured item
..... containedQuantity 0..1 PQ Manufactured item quantity for liquids (3ml/vial)
..... manufacturedItemQuantity 1..1 PQ Number of such manufactured items in this product (5 vials)
.... device 0..* Class Administrative device included in the product
..... deviceQuantity 1..1 PQ Number of such devices
..... device 1..1 CD Device coded
... marketingAuthorisationHolder 0..1 ST MAH name - do we need more?
... routeOfAdministration 1..* CD Route of Administration - if we need it on product level

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. CrossBorderProduct 0..* Base DRAFT: Medicinal Product in crossborder eP/eD
... medicinalProductIdentifier 0..* II MPID or national identifier
... packagedProductIdentifier 0..* II PCID or national
... pharmaceuticalProductIdentifier 0..* II PhPID
... packSize 1..* PQ Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)
... fullName 0..* ST Name of the product
... doseForm 1..1 CD Authorised dose form for eD; authorised or pharmaceutical for eP
... constitution 1..* Class Content of the product - defines ingredients, manufactured items, or device
.... @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
.... ingredient 0..* Class Ingredients, by default only active ingredients
..... @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
..... role 1..1 CD (might not be needed if only active ingredients are expected)
..... substance 1..1 CD Substance
..... strengthInfo 1..* Class Concentration or presentation strength
...... @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
...... strength 1..1 RTO Concentration or presentation strength of the precise active ingredient
...... referenceStrength 0..* Class Reference strength; according to the substance+strength type above
....... @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
....... referenceSubstance 1..1 CD Substance for reference strength
....... strength 1..1 RTO Reference strength
.... manufacturedItem 0..* Class Manufactured item if the prescription contains more than one type of items
..... @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
..... doseForm 1..1 CD Manufactured item dose form
..... unitOfPresentation 0..* CD Unit of presentation for the manufactured item
..... containedQuantity 0..1 PQ Manufactured item quantity for liquids (3ml/vial)
..... manufacturedItemQuantity 1..1 PQ Number of such manufactured items in this product (5 vials)
.... device 0..* Class Administrative device included in the product
..... @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
..... deviceQuantity 1..1 PQ Number of such devices
..... device 1..1 CD Device coded
... marketingAuthorisationHolder 0..1 ST MAH name - do we need more?
... routeOfAdministration 1..* CD Route of Administration - if we need it on product level

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. CrossBorderProduct 0..* Base DRAFT: Medicinal Product in crossborder eP/eD
... medicinalProductIdentifier 0..* II MPID or national identifier
... packagedProductIdentifier 0..* II PCID or national
... pharmaceuticalProductIdentifier 0..* II PhPID
... packSize 1..* PQ Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)
... fullName 0..* ST Name of the product
... doseForm 1..1 CD Authorised dose form for eD; authorised or pharmaceutical for eP
... constitution 1..* Class Content of the product - defines ingredients, manufactured items, or device
ele-1: All FHIR elements must have a @value or children
.... @id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... ingredient 0..* Class Ingredients, by default only active ingredients
ele-1: All FHIR elements must have a @value or children
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... role 1..1 CD (might not be needed if only active ingredients are expected)
..... substance 1..1 CD Substance
..... strengthInfo 1..* Class Concentration or presentation strength
ele-1: All FHIR elements must have a @value or children
...... @id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... strength 1..1 RTO Concentration or presentation strength of the precise active ingredient
...... referenceStrength 0..* Class Reference strength; according to the substance+strength type above
ele-1: All FHIR elements must have a @value or children
....... @id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
....... referenceSubstance 1..1 CD Substance for reference strength
....... strength 1..1 RTO Reference strength
.... manufacturedItem 0..* Class Manufactured item if the prescription contains more than one type of items
ele-1: All FHIR elements must have a @value or children
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... doseForm 1..1 CD Manufactured item dose form
..... unitOfPresentation 0..* CD Unit of presentation for the manufactured item
..... containedQuantity 0..1 PQ Manufactured item quantity for liquids (3ml/vial)
..... manufacturedItemQuantity 1..1 PQ Number of such manufactured items in this product (5 vials)
.... device 0..* Class Administrative device included in the product
ele-1: All FHIR elements must have a @value or children
..... @id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... deviceQuantity 1..1 PQ Number of such devices
..... device 1..1 CD Device coded
... marketingAuthorisationHolder 0..1 ST MAH name - do we need more?
... routeOfAdministration 1..* CD Route of Administration - if we need it on product level

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from Base

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. CrossBorderProduct 0..* Base DRAFT: Medicinal Product in crossborder eP/eD
... medicinalProductIdentifier 0..* II MPID or national identifier
... packagedProductIdentifier 0..* II PCID or national
... pharmaceuticalProductIdentifier 0..* II PhPID
... packSize 1..* PQ Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)
... fullName 0..* ST Name of the product
... doseForm 1..1 CD Authorised dose form for eD; authorised or pharmaceutical for eP
... constitution 1..* Class Content of the product - defines ingredients, manufactured items, or device
.... ingredient 0..* Class Ingredients, by default only active ingredients
..... role 1..1 CD (might not be needed if only active ingredients are expected)
..... substance 1..1 CD Substance
..... strengthInfo 1..* Class Concentration or presentation strength
...... strength 1..1 RTO Concentration or presentation strength of the precise active ingredient
...... referenceStrength 0..* Class Reference strength; according to the substance+strength type above
....... referenceSubstance 1..1 CD Substance for reference strength
....... strength 1..1 RTO Reference strength
.... manufacturedItem 0..* Class Manufactured item if the prescription contains more than one type of items
..... doseForm 1..1 CD Manufactured item dose form
..... unitOfPresentation 0..* CD Unit of presentation for the manufactured item
..... containedQuantity 0..1 PQ Manufactured item quantity for liquids (3ml/vial)
..... manufacturedItemQuantity 1..1 PQ Number of such manufactured items in this product (5 vials)
.... device 0..* Class Administrative device included in the product
..... deviceQuantity 1..1 PQ Number of such devices
..... device 1..1 CD Device coded
... marketingAuthorisationHolder 0..1 ST MAH name - do we need more?
... routeOfAdministration 1..* CD Route of Administration - if we need it on product level

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. CrossBorderProduct 0..* Base DRAFT: Medicinal Product in crossborder eP/eD
... medicinalProductIdentifier 0..* II MPID or national identifier
... packagedProductIdentifier 0..* II PCID or national
... pharmaceuticalProductIdentifier 0..* II PhPID
... packSize 1..* PQ Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)
... fullName 0..* ST Name of the product
... doseForm 1..1 CD Authorised dose form for eD; authorised or pharmaceutical for eP
... constitution 1..* Class Content of the product - defines ingredients, manufactured items, or device
.... @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
.... ingredient 0..* Class Ingredients, by default only active ingredients
..... @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
..... role 1..1 CD (might not be needed if only active ingredients are expected)
..... substance 1..1 CD Substance
..... strengthInfo 1..* Class Concentration or presentation strength
...... @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
...... strength 1..1 RTO Concentration or presentation strength of the precise active ingredient
...... referenceStrength 0..* Class Reference strength; according to the substance+strength type above
....... @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
....... referenceSubstance 1..1 CD Substance for reference strength
....... strength 1..1 RTO Reference strength
.... manufacturedItem 0..* Class Manufactured item if the prescription contains more than one type of items
..... @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
..... doseForm 1..1 CD Manufactured item dose form
..... unitOfPresentation 0..* CD Unit of presentation for the manufactured item
..... containedQuantity 0..1 PQ Manufactured item quantity for liquids (3ml/vial)
..... manufacturedItemQuantity 1..1 PQ Number of such manufactured items in this product (5 vials)
.... device 0..* Class Administrative device included in the product
..... @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
..... deviceQuantity 1..1 PQ Number of such devices
..... device 1..1 CD Device coded
... marketingAuthorisationHolder 0..1 ST MAH name - do we need more?
... routeOfAdministration 1..* CD Route of Administration - if we need it on product level

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

 

Other representations of profile: CSV, Excel