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/ and changes regularly. See the Directory of published versions

Logical Model: CrossBorderProduct - Detailed Descriptions

Draft as of 2024-06-21

Definitions for the CrossBorderProduct logical model.

Guidance on how to interpret the contents of this table can be found here

0. CrossBorderProduct
Definition

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

ShortDRAFT: Medicinal Product in crossborder eP/eD
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. CrossBorderProduct.medicinalProductIdentifier
Definition

MPID or national identifier

ShortMPID or national identifier
Control0..*
TypeElement(II)
4. CrossBorderProduct.packagedProductIdentifier
Definition

PCID or national

ShortPCID or national
Control0..*
TypeElement(II)
6. CrossBorderProduct.pharmaceuticalProductIdentifier
Definition

PhPID

ShortPhPID
Control0..*
TypeElement(II)
8. CrossBorderProduct.atc
Definition

ATC code

ShortATC code
Control1..1
TypeElement(CD)
10. CrossBorderProduct.packSize
Definition

Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)

ShortOverall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)
Control1..*
TypeElement(PQ)
12. CrossBorderProduct.fullName
Definition

Name of the product

ShortName of the product
Control0..*
TypeElement(ST)
14. CrossBorderProduct.doseForm
Definition

Authorised dose form for eD; authorised or pharmaceutical for eP

ShortAuthorised dose form for eD; authorised or pharmaceutical for eP
Control1..1
TypeElement(CD)
16. CrossBorderProduct.constitution
Definition

Content of the product - defines ingredients, manufactured items, or device

ShortContent of the product - defines ingredients, manufactured items, or device
Control1..*
TypeBackboneElement(Class)
18. CrossBorderProduct.constitution.ingredient
Definition

Ingredients, by default only active ingredients

ShortIngredients, by default only active ingredients
Control0..*
TypeBackboneElement(Class)
20. CrossBorderProduct.constitution.ingredient.role
Definition

(might not be needed if only active ingredients are expected)

Short(might not be needed if only active ingredients are expected)
Control1..1
TypeElement(CD)
22. CrossBorderProduct.constitution.ingredient.substance
Definition

Substance

ShortSubstance
Control1..1
TypeElement(CD)
24. CrossBorderProduct.constitution.ingredient.strengthInfo
Definition

Concentration or presentation strength

ShortConcentration or presentation strength
Control1..*
TypeBackboneElement(Class)
26. CrossBorderProduct.constitution.ingredient.strengthInfo.strength
Definition

Concentration or presentation strength of the precise active ingredient

ShortConcentration or presentation strength of the precise active ingredient
Control1..1
TypeElement(RTO)
28. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength
Definition

Reference strength; according to the substance+strength type above

ShortReference strength; according to the substance+strength type above
Control0..*
TypeBackboneElement(Class)
30. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.referenceSubstance
Definition

Substance for reference strength

ShortSubstance for reference strength
Control1..1
TypeElement(CD)
32. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.strength
Definition

Reference strength

ShortReference strength
Control1..1
TypeElement(RTO)
34. CrossBorderProduct.constitution.manufacturedItem
Definition

Manufactured item if the prescription contains more than one type of items

ShortManufactured item if the prescription contains more than one type of items
Control0..*
TypeBackboneElement(Class)
36. CrossBorderProduct.constitution.manufacturedItem.doseForm
Definition

Manufactured item dose form

ShortManufactured item dose form
Control1..1
TypeElement(CD)
38. CrossBorderProduct.constitution.manufacturedItem.unitOfPresentation
Definition

Unit of presentation for the manufactured item

ShortUnit of presentation for the manufactured item
Control0..*
TypeElement(CD)
40. CrossBorderProduct.constitution.manufacturedItem.containedQuantity
Definition

Manufactured item quantity for liquids (3ml/vial)

ShortManufactured item quantity for liquids (3ml/vial)
Control0..1
TypeElement(PQ)
42. CrossBorderProduct.constitution.manufacturedItem.manufacturedItemQuantity
Definition

Number of such manufactured items in this product (5 vials)

ShortNumber of such manufactured items in this product (5 vials)
Control1..1
TypeElement(PQ)
44. CrossBorderProduct.constitution.device
Definition

Administrative device included in the product

ShortAdministrative device included in the product
Control0..*
TypeBackboneElement(Class)
46. CrossBorderProduct.constitution.device.deviceQuantity
Definition

Number of such devices

ShortNumber of such devices
Control1..1
TypeElement(PQ)
48. CrossBorderProduct.constitution.device.device
Definition

Device coded

ShortDevice coded
Control1..1
TypeElement(CD)
50. CrossBorderProduct.marketingAuthorisationHolder
Definition

MAH name - do we need more?

ShortMAH name - do we need more?
Control0..1
TypeElement(ST)
52. CrossBorderProduct.routeOfAdministration
Definition

Route of Administration - if we need it on product level

ShortRoute of Administration - if we need it on product level
Control1..*
TypeElement(CD)

Guidance on how to interpret the contents of this table can be found here

0. CrossBorderProduct
Definition

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


Base definition for all types defined in FHIR type system.

ShortDRAFT: Medicinal Product in crossborder eP/eDBase for all types and resources
Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. CrossBorderProduct.medicinalProductIdentifier
Definition

MPID or national identifier

ShortMPID or national identifier
Control0..*
TypeElement(II)
4. CrossBorderProduct.packagedProductIdentifier
Definition

PCID or national

ShortPCID or national
Control0..*
TypeElement(II)
6. CrossBorderProduct.pharmaceuticalProductIdentifier
Definition

PhPID

ShortPhPID
Control0..*
TypeElement(II)
8. CrossBorderProduct.atc
Definition

ATC code

ShortATC code
Control1..1
TypeElement(CD)
10. CrossBorderProduct.packSize
Definition

Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)

ShortOverall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)
Control1..*
TypeElement(PQ)
12. CrossBorderProduct.fullName
Definition

Name of the product

ShortName of the product
Control0..*
TypeElement(ST)
14. CrossBorderProduct.doseForm
Definition

Authorised dose form for eD; authorised or pharmaceutical for eP

ShortAuthorised dose form for eD; authorised or pharmaceutical for eP
Control1..1
TypeElement(CD)
16. CrossBorderProduct.constitution
Definition

Content of the product - defines ingredients, manufactured items, or device

ShortContent of the product - defines ingredients, manufactured items, or device
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. CrossBorderProduct.constitution.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
20. CrossBorderProduct.constitution.ingredient
Definition

Ingredients, by default only active ingredients

ShortIngredients, by default only active ingredients
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. CrossBorderProduct.constitution.ingredient.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
24. CrossBorderProduct.constitution.ingredient.role
Definition

(might not be needed if only active ingredients are expected)

Short(might not be needed if only active ingredients are expected)
Control1..1
TypeElement(CD)
26. CrossBorderProduct.constitution.ingredient.substance
Definition

Substance

ShortSubstance
Control1..1
TypeElement(CD)
28. CrossBorderProduct.constitution.ingredient.strengthInfo
Definition

Concentration or presentation strength

ShortConcentration or presentation strength
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. CrossBorderProduct.constitution.ingredient.strengthInfo.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
32. CrossBorderProduct.constitution.ingredient.strengthInfo.strength
Definition

Concentration or presentation strength of the precise active ingredient

ShortConcentration or presentation strength of the precise active ingredient
Control1..1
TypeElement(RTO)
34. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength
Definition

Reference strength; according to the substance+strength type above

ShortReference strength; according to the substance+strength type above
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
38. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.referenceSubstance
Definition

Substance for reference strength

ShortSubstance for reference strength
Control1..1
TypeElement(CD)
40. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.strength
Definition

Reference strength

ShortReference strength
Control1..1
TypeElement(RTO)
42. CrossBorderProduct.constitution.manufacturedItem
Definition

Manufactured item if the prescription contains more than one type of items

ShortManufactured item if the prescription contains more than one type of items
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. CrossBorderProduct.constitution.manufacturedItem.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
46. CrossBorderProduct.constitution.manufacturedItem.doseForm
Definition

Manufactured item dose form

ShortManufactured item dose form
Control1..1
TypeElement(CD)
48. CrossBorderProduct.constitution.manufacturedItem.unitOfPresentation
Definition

Unit of presentation for the manufactured item

ShortUnit of presentation for the manufactured item
Control0..*
TypeElement(CD)
50. CrossBorderProduct.constitution.manufacturedItem.containedQuantity
Definition

Manufactured item quantity for liquids (3ml/vial)

ShortManufactured item quantity for liquids (3ml/vial)
Control0..1
TypeElement(PQ)
52. CrossBorderProduct.constitution.manufacturedItem.manufacturedItemQuantity
Definition

Number of such manufactured items in this product (5 vials)

ShortNumber of such manufactured items in this product (5 vials)
Control1..1
TypeElement(PQ)
54. CrossBorderProduct.constitution.device
Definition

Administrative device included in the product

ShortAdministrative device included in the product
Control0..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. CrossBorderProduct.constitution.device.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
58. CrossBorderProduct.constitution.device.deviceQuantity
Definition

Number of such devices

ShortNumber of such devices
Control1..1
TypeElement(PQ)
60. CrossBorderProduct.constitution.device.device
Definition

Device coded

ShortDevice coded
Control1..1
TypeElement(CD)
62. CrossBorderProduct.marketingAuthorisationHolder
Definition

MAH name - do we need more?

ShortMAH name - do we need more?
Control0..1
TypeElement(ST)
64. CrossBorderProduct.routeOfAdministration
Definition

Route of Administration - if we need it on product level

ShortRoute of Administration - if we need it on product level
Control1..*
TypeElement(CD)

Guidance on how to interpret the contents of this table can be found here

0. CrossBorderProduct
Definition

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

ShortDRAFT: Medicinal Product in crossborder eP/eD
Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. CrossBorderProduct.medicinalProductIdentifier
Definition

MPID or national identifier

ShortMPID or national identifier
Control0..*
TypeElement(II)
4. CrossBorderProduct.packagedProductIdentifier
Definition

PCID or national

ShortPCID or national
Control0..*
TypeElement(II)
6. CrossBorderProduct.pharmaceuticalProductIdentifier
Definition

PhPID

ShortPhPID
Control0..*
TypeElement(II)
8. CrossBorderProduct.atc
Definition

ATC code

ShortATC code
Control1..1
TypeElement(CD)
10. CrossBorderProduct.packSize
Definition

Overall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)

ShortOverall amount of product (100ml; 20 tablets; 1 creme & 6 pessaries)
Control1..*
TypeElement(PQ)
12. CrossBorderProduct.fullName
Definition

Name of the product

ShortName of the product
Control0..*
TypeElement(ST)
14. CrossBorderProduct.doseForm
Definition

Authorised dose form for eD; authorised or pharmaceutical for eP

ShortAuthorised dose form for eD; authorised or pharmaceutical for eP
Control1..1
TypeElement(CD)
16. CrossBorderProduct.constitution
Definition

Content of the product - defines ingredients, manufactured items, or device

ShortContent of the product - defines ingredients, manufactured items, or device
Control1..*
TypeBackboneElement(Class)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. CrossBorderProduct.constitution.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
20. CrossBorderProduct.constitution.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on CrossBorderProduct.constitution.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 22. CrossBorderProduct.constitution.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    24. CrossBorderProduct.constitution.ingredient
    Definition

    Ingredients, by default only active ingredients

    ShortIngredients, by default only active ingredients
    Control0..*
    TypeBackboneElement(Class)
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. CrossBorderProduct.constitution.ingredient.id
    Definition

    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

    ShortUnique id for inter-element referencing
    Control0..1
    This element is affected by the following invariants: ele-1
    Typeid
    Is Modifierfalse
    XML FormatIn the XML format, this property is represented as an attribute.
    Summaryfalse
    28. CrossBorderProduct.constitution.ingredient.extension
    Definition

    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on CrossBorderProduct.constitution.ingredient.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 30. CrossBorderProduct.constitution.ingredient.modifierExtension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      32. CrossBorderProduct.constitution.ingredient.role
      Definition

      (might not be needed if only active ingredients are expected)

      Short(might not be needed if only active ingredients are expected)
      Control1..1
      TypeElement(CD)
      34. CrossBorderProduct.constitution.ingredient.substance
      Definition

      Substance

      ShortSubstance
      Control1..1
      TypeElement(CD)
      36. CrossBorderProduct.constitution.ingredient.strengthInfo
      Definition

      Concentration or presentation strength

      ShortConcentration or presentation strength
      Control1..*
      TypeBackboneElement(Class)
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. CrossBorderProduct.constitution.ingredient.strengthInfo.id
      Definition

      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

      ShortUnique id for inter-element referencing
      Control0..1
      This element is affected by the following invariants: ele-1
      Typeid
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      40. CrossBorderProduct.constitution.ingredient.strengthInfo.extension
      Definition

      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on CrossBorderProduct.constitution.ingredient.strengthInfo.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 42. CrossBorderProduct.constitution.ingredient.strengthInfo.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content, modifiers
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        44. CrossBorderProduct.constitution.ingredient.strengthInfo.strength
        Definition

        Concentration or presentation strength of the precise active ingredient

        ShortConcentration or presentation strength of the precise active ingredient
        Control1..1
        TypeElement(RTO)
        46. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength
        Definition

        Reference strength; according to the substance+strength type above

        ShortReference strength; according to the substance+strength type above
        Control0..*
        TypeBackboneElement(Class)
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        48. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typeid
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        50. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.extension
        Definition

        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 52. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          54. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.referenceSubstance
          Definition

          Substance for reference strength

          ShortSubstance for reference strength
          Control1..1
          TypeElement(CD)
          56. CrossBorderProduct.constitution.ingredient.strengthInfo.referenceStrength.strength
          Definition

          Reference strength

          ShortReference strength
          Control1..1
          TypeElement(RTO)
          58. CrossBorderProduct.constitution.manufacturedItem
          Definition

          Manufactured item if the prescription contains more than one type of items

          ShortManufactured item if the prescription contains more than one type of items
          Control0..*
          TypeBackboneElement(Class)
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          60. CrossBorderProduct.constitution.manufacturedItem.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typeid
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          62. CrossBorderProduct.constitution.manufacturedItem.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on CrossBorderProduct.constitution.manufacturedItem.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 64. CrossBorderProduct.constitution.manufacturedItem.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            66. CrossBorderProduct.constitution.manufacturedItem.doseForm
            Definition

            Manufactured item dose form

            ShortManufactured item dose form
            Control1..1
            TypeElement(CD)
            68. CrossBorderProduct.constitution.manufacturedItem.unitOfPresentation
            Definition

            Unit of presentation for the manufactured item

            ShortUnit of presentation for the manufactured item
            Control0..*
            TypeElement(CD)
            70. CrossBorderProduct.constitution.manufacturedItem.containedQuantity
            Definition

            Manufactured item quantity for liquids (3ml/vial)

            ShortManufactured item quantity for liquids (3ml/vial)
            Control0..1
            TypeElement(PQ)
            72. CrossBorderProduct.constitution.manufacturedItem.manufacturedItemQuantity
            Definition

            Number of such manufactured items in this product (5 vials)

            ShortNumber of such manufactured items in this product (5 vials)
            Control1..1
            TypeElement(PQ)
            74. CrossBorderProduct.constitution.device
            Definition

            Administrative device included in the product

            ShortAdministrative device included in the product
            Control0..*
            TypeBackboneElement(Class)
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            76. CrossBorderProduct.constitution.device.id
            Definition

            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

            ShortUnique id for inter-element referencing
            Control0..1
            This element is affected by the following invariants: ele-1
            Typeid
            Is Modifierfalse
            XML FormatIn the XML format, this property is represented as an attribute.
            Summaryfalse
            78. CrossBorderProduct.constitution.device.extension
            Definition

            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

            ShortAdditional content defined by implementations
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifierfalse
            Summaryfalse
            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on CrossBorderProduct.constitution.device.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 80. CrossBorderProduct.constitution.device.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              82. CrossBorderProduct.constitution.device.deviceQuantity
              Definition

              Number of such devices

              ShortNumber of such devices
              Control1..1
              TypeElement(PQ)
              84. CrossBorderProduct.constitution.device.device
              Definition

              Device coded

              ShortDevice coded
              Control1..1
              TypeElement(CD)
              86. CrossBorderProduct.marketingAuthorisationHolder
              Definition

              MAH name - do we need more?

              ShortMAH name - do we need more?
              Control0..1
              TypeElement(ST)
              88. CrossBorderProduct.routeOfAdministration
              Definition

              Route of Administration - if we need it on product level

              ShortRoute of Administration - if we need it on product level
              Control1..*
              TypeElement(CD)