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: CrossBorderProduct - Detailed Descriptions

Draft as of 2025-06-02

Definitions for the CrossBorderProduct logical model.

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

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.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
Typeidstring
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
    Typeidstring
    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
      Typeidstring
      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
        Typeidstring
        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
          Typeidstring
          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
            Typeidstring
            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)

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

              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 foundhere

              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)