SPL Mapping FHIR R5 Implementation Guide
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SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.5 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

Resource Profile: SubmittedManufacturedItem - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 1

Definitions for the SubmittedManufacturedItem resource profile.

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

0. ManufacturedItemDefinition
Definition

The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product.

ShortThe definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. ManufacturedItemDefinition.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. ManufacturedItemDefinition.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. ManufacturedItemDefinition.extension
Definition

An Extension


May be used to represent additional information that is not part of the basic definition of the resource. 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.

ShortExtensionAdditional 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
Must Supportfalse
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 ManufacturedItemDefinition.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. ManufacturedItemDefinition.extension:marketingStatusDates
    Slice NamemarketingStatusDates
    Definition

    Used to indicate the date range of the marketing status of a manufactured item. This is being added in R5.

    ShortManufactured Item Marketing Status Date Range
    Control0..1
    TypeExtension(Manufactured Item Marketing Status Date Range) (Extension Type: Period)
    Is Modifierfalse
    Must Supporttrue
    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())
    10. ManufacturedItemDefinition.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it 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 is allowed to 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
    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 resource that contains them
    Must Supportfalse
    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
    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())
    12. ManufacturedItemDefinition.status
    Definition

    The status of this item. Enables tracking the life-cycle of the content.

    Shortdraft | active | retired | unknown
    Comments

    Allows filtering of manufactured items that are appropriate for use versus not.

    Control1..1
    BindingThe codes SHALL be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status|5.0.0
    (required to http://hl7.org/fhir/ValueSet/publication-status|5.0.0)

    The lifecycle status of an artifact.

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Pattern Valueactive
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. ManufacturedItemDefinition.manufacturedDoseForm
    Definition

    Dose form as manufactured and before any transformation into the pharmaceutical product.

    ShortDose form as manufactured (before any necessary transformation)
    Control1..1
    BindingThe codes SHALL be taken from For example codes, see SPL Dose Formhttp://hl7.org/fhir/ValueSet/manufactured-dose-form
    (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-splDoseForm)
    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. ManufacturedItemDefinition.property
    Definition

    General characteristics of this item.

    ShortGeneral characteristics of this item
    Control0..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on ManufacturedItemDefinition.property. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ type
    • 18. ManufacturedItemDefinition.property.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. ManufacturedItemDefinition.property.type
      Definition

      A code expressing the type of characteristic.

      ShortA code expressing the type of characteristic
      Control1..1
      BindingThe codes SHALL be taken from For example codes, see SPL Product Characteristic Types ValueSethttp://hl7.org/fhir/ValueSet/product-characteristic-codes
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicCodes)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. ManufacturedItemDefinition.property.value[x]
      Definition

      A value for the characteristic.

      ShortA value for the characteristic
      Control10..1
      TypeChoice of: CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary)
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      24. ManufacturedItemDefinition.property:Color
      Slice NameColor
      Definition

      General characteristics of this item.

      ShortGeneral characteristics of this item
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      26. ManufacturedItemDefinition.property:Color.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())
      28. ManufacturedItemDefinition.property:Color.type
      Definition

      A code expressing the type of characteristic.

      ShortA code expressing the type of characteristic
      Control1..1
      BindingThe codes SHALL be taken from For example codes, see SPL Product Characteristic Types ValueSethttp://hl7.org/fhir/ValueSet/product-characteristic-codes
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicCodes)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLCOLOR"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      30. ManufacturedItemDefinition.property:Color.value[x]
      Definition

      A value for the characteristic.

      ShortA value for the characteristic
      Control10..1
      BindingThe codes SHALL be taken from For codes, see SPL Color
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-splColor)
      TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      32. ManufacturedItemDefinition.property:Imprint
      Slice NameImprint
      Definition

      General characteristics of this item.

      ShortGeneral characteristics of this item
      Control0..1*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      34. ManufacturedItemDefinition.property:Imprint.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())
      36. ManufacturedItemDefinition.property:Imprint.type
      Definition

      A code expressing the type of characteristic.

      ShortA code expressing the type of characteristic
      Control1..1
      BindingThe codes SHALL be taken from For example codes, see SPL Product Characteristic Types ValueSethttp://hl7.org/fhir/ValueSet/product-characteristic-codes
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicCodes)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLIMPRINT"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. ManufacturedItemDefinition.property:Imprint.value[x]
      Definition

      A value for the characteristic.

      ShortText is only allowed as the imprint is a string.A value for the characteristic
      Control10..1
      TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      40. ManufacturedItemDefinition.property:Imprint.value[x].coding
      Definition

      A reference to a code defined by a terminology system.

      ShortCode defined by a terminology system
      Comments

      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

      Control0..0*
      TypeCoding
      Is Modifierfalse
      Summarytrue
      Requirements

      Allows for alternative encodings within a code system, and translations to other code systems.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. ManufacturedItemDefinition.property:Imprint.value[x].text
      Definition

      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

      ShortPlain text representation of the concept
      Comments

      Very often the text is the same as a displayName of one of the codings.

      Control10..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      44. ManufacturedItemDefinition.property:Score
      Slice NameScore
      Definition

      General characteristics of this item.

      ShortGeneral characteristics of this item
      Control0..1*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. ManufacturedItemDefinition.property:Score.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())
      48. ManufacturedItemDefinition.property:Score.type
      Definition

      A code expressing the type of characteristic.

      ShortA code expressing the type of characteristic
      Control1..1
      BindingThe codes SHALL be taken from For example codes, see SPL Product Characteristic Types ValueSethttp://hl7.org/fhir/ValueSet/product-characteristic-codes
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicCodes)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLSCORE"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      50. ManufacturedItemDefinition.property:Score.value[x]
      Definition

      A value for the characteristic.

      ShortA value for the characteristic
      Control10..1
      TypeQuantity, date, boolean, Reference(Binary), markdown, Attachment, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      52. ManufacturedItemDefinition.property:Shape
      Slice NameShape
      Definition

      General characteristics of this item.

      ShortGeneral characteristics of this item
      Control0..1*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      54. ManufacturedItemDefinition.property:Shape.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())
      56. ManufacturedItemDefinition.property:Shape.type
      Definition

      A code expressing the type of characteristic.

      ShortA code expressing the type of characteristic
      Control1..1
      BindingThe codes SHALL be taken from For example codes, see SPL Product Characteristic Types ValueSethttp://hl7.org/fhir/ValueSet/product-characteristic-codes
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicCodes)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLSHAPE"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      58. ManufacturedItemDefinition.property:Shape.value[x]
      Definition

      A value for the characteristic.

      ShortA value for the characteristic
      Control10..1
      BindingThe codes SHALL be taken from For codes, see SPL Shape
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-splShape)
      TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      60. ManufacturedItemDefinition.property:Size
      Slice NameSize
      Definition

      General characteristics of this item.

      ShortGeneral characteristics of this item
      Control0..1*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      62. ManufacturedItemDefinition.property:Size.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())
      64. ManufacturedItemDefinition.property:Size.type
      Definition

      A code expressing the type of characteristic.

      ShortA code expressing the type of characteristic
      Control1..1
      BindingThe codes SHALL be taken from For example codes, see SPL Product Characteristic Types ValueSethttp://hl7.org/fhir/ValueSet/product-characteristic-codes
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicCodes)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLSIZE"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      66. ManufacturedItemDefinition.property:Size.value[x]
      Definition

      A value for the characteristic.

      ShortA value for the characteristic
      Control10..1
      TypeQuantity, date, boolean, Reference(Binary), markdown, Attachment, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      68. ManufacturedItemDefinition.property:Flavor
      Slice NameFlavor
      Definition

      General characteristics of this item.

      ShortGeneral characteristics of this item
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      70. ManufacturedItemDefinition.property:Flavor.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())
      72. ManufacturedItemDefinition.property:Flavor.type
      Definition

      A code expressing the type of characteristic.

      ShortA code expressing the type of characteristic
      Control1..1
      BindingThe codes SHALL be taken from For example codes, see SPL Product Characteristic Types ValueSethttp://hl7.org/fhir/ValueSet/product-characteristic-codes
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicCodes)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLFLAVOR"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      74. ManufacturedItemDefinition.property:Flavor.value[x]
      Definition

      A value for the characteristic.

      ShortA value for the characteristic
      Control10..1
      BindingThe codes SHALL be taken from For codes, see SPL Flavor
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-splFlavor)
      TypeCodeableConcept, date, boolean, Reference(Binary), markdown, Quantity, Attachment
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      76. ManufacturedItemDefinition.property:Image
      Slice NameImage
      Definition

      General characteristics of this item.

      ShortGeneral characteristics of this item
      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      78. ManufacturedItemDefinition.property:Image.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())
      80. ManufacturedItemDefinition.property:Image.type
      Definition

      A code expressing the type of characteristic.

      ShortA code expressing the type of characteristic
      Control1..1
      BindingThe codes SHALL be taken from For example codes, see SPL Product Characteristic Types ValueSethttp://hl7.org/fhir/ValueSet/product-characteristic-codes
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicCodes)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLIMAGE"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      82. ManufacturedItemDefinition.property:Image.value[x]
      Definition

      A value for the characteristic.

      ShortA value for the characteristic
      Control10..1
      TypeAttachment, date, boolean, Reference(Binary), markdown, Quantity, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))