SPL Mapping FHIR Implementation Guide
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SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 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
2. ManufacturedItemDefinition.extension
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
  • 4. ManufacturedItemDefinition.extension:marketingStatusDates
    Slice NamemarketingStatusDates
    Control0..1
    TypeExtension(Manufactured Item Marketing Status Date Range) (Extension Type: Period)
    Must Supporttrue
    6. ManufacturedItemDefinition.status
    Pattern Valueactive
    8. ManufacturedItemDefinition.manufacturedDoseForm
    BindingThe codes SHALL be taken from http://evs.nci.nih.gov/valueset/FDA/C54456
    (required to http://evs.nci.nih.gov/valueset/FDA/C54456)
    Must Supporttrue
    10. ManufacturedItemDefinition.property
    Must Supporttrue
    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
    • 12. ManufacturedItemDefinition.property.type
      BindingThe codes SHALL be taken from SPL Product Characteristic Types ValueSet
      (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes)
      Must Supporttrue
      14. ManufacturedItemDefinition.property.value[x]
      Control1..?
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      Must Supporttrue
      16. ManufacturedItemDefinition.property:Color
      Slice NameColor
      Control0..*
      18. ManufacturedItemDefinition.property:Color.type
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLCOLOR"
        }]
      }
      20. ManufacturedItemDefinition.property:Color.value[x]
      BindingThe codes SHALL be taken from http://evs.nci.nih.gov/valueset/FDA/C54453
      (required to http://evs.nci.nih.gov/valueset/FDA/C54453)
      TypeCodeableConcept
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      22. ManufacturedItemDefinition.property:Imprint
      Slice NameImprint
      Control0..1
      24. ManufacturedItemDefinition.property:Imprint.type
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLIMPRINT"
        }]
      }
      26. ManufacturedItemDefinition.property:Imprint.value[x]
      ShortText is only allowed as the imprint is a string.
      TypeCodeableConcept
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      28. ManufacturedItemDefinition.property:Imprint.value[x].coding
      Control0..0
      30. ManufacturedItemDefinition.property:Imprint.value[x].text
      Control1..?
      32. ManufacturedItemDefinition.property:Score
      Slice NameScore
      Control0..1
      34. ManufacturedItemDefinition.property:Score.type
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLSCORE"
        }]
      }
      36. ManufacturedItemDefinition.property:Score.value[x]
      TypeQuantity
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      38. ManufacturedItemDefinition.property:Shape
      Slice NameShape
      Control0..1
      40. ManufacturedItemDefinition.property:Shape.type
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLSHAPE"
        }]
      }
      42. ManufacturedItemDefinition.property:Shape.value[x]
      BindingThe codes SHALL be taken from http://evs.nci.nih.gov/valueset/FDA/C54454
      (required to http://evs.nci.nih.gov/valueset/FDA/C54454)
      TypeCodeableConcept
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      44. ManufacturedItemDefinition.property:Size
      Slice NameSize
      Control0..1
      46. ManufacturedItemDefinition.property:Size.type
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLSIZE"
        }]
      }
      48. ManufacturedItemDefinition.property:Size.value[x]
      TypeQuantity
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      50. ManufacturedItemDefinition.property:Flavor
      Slice NameFlavor
      Control0..*
      52. ManufacturedItemDefinition.property:Flavor.type
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLFLAVOR"
        }]
      }
      54. ManufacturedItemDefinition.property:Flavor.value[x]
      BindingThe codes SHALL be taken from http://evs.nci.nih.gov/valueset/FDA/C73339
      (required to http://evs.nci.nih.gov/valueset/FDA/C73339)
      TypeCodeableConcept
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      56. ManufacturedItemDefinition.property:Image
      Slice NameImage
      Control0..*
      58. ManufacturedItemDefinition.property:Image.type
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLIMAGE"
        }]
      }
      60. ManufacturedItemDefinition.property:Image.value[x]
      TypeAttachment
      [x] NoteSee Choice of Data Types for further information about how to use [x]

      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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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 it's 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 it's 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.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 manageable, 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
      • 6. 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
        This element is affected by the following invariants: ele-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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ele-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())
        8. 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 manageable, 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
        Summaryfalse
        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())
        10. 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|4.3.0
        (required to http://hl7.org/fhir/ValueSet/publication-status|4.3.0)

        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()))
        12. 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 http://evs.nci.nih.gov/valueset/FDA/C54456http://hl7.org/fhir/ValueSet/manufactured-dose-form
        (required to http://evs.nci.nih.gov/valueset/FDA/C54456)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        14. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
        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
        • 16. 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 manageable, 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())
          18. 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-SubmittedMedicinalProductCharacteristicTypes)
          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          20. ManufacturedItemDefinition.property.value[x]
          Definition

          A value for the characteristic.

          ShortA value for the characteristic
          Control10..1
          TypeChoice of: CodeableConcept, Quantity, date, boolean, Attachment
          [x] NoteSee Choice of Data Types for 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()))
          22. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          24. 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 manageable, 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())
          26. ManufacturedItemDefinition.property:Color.type
          Definition

          A code expressing the type of characteristic.

          ShortA code expressing the type of characteristic
          Control1..1
          BindingFor example codes, see product-characteristic-codeshttp://hl7.org/fhir/ValueSet/product-characteristic-codes
          (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

          This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          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()))
          28. ManufacturedItemDefinition.property:Color.value[x]
          Definition

          A value for the characteristic.

          ShortA value for the characteristic
          Control0..1
          BindingThe codes SHALL be taken from For codes, see http://evs.nci.nih.gov/valueset/FDA/C54453
          (required to http://evs.nci.nih.gov/valueset/FDA/C54453)
          TypeCodeableConcept, date, boolean, Quantity, Attachment
          [x] NoteSee Choice of Data Types for further information about how to use [x]
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          30. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          32. 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 manageable, 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())
          34. ManufacturedItemDefinition.property:Imprint.type
          Definition

          A code expressing the type of characteristic.

          ShortA code expressing the type of characteristic
          Control1..1
          BindingFor example codes, see product-characteristic-codeshttp://hl7.org/fhir/ValueSet/product-characteristic-codes
          (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

          This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          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()))
          36. 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
          Control0..1
          TypeCodeableConcept, date, boolean, Quantity, Attachment
          [x] NoteSee Choice of Data Types for further information about how to use [x]
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. 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()))
          40. 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()))
          42. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          44. 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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

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

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

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

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

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

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

          A code expressing the type of characteristic.

          ShortA code expressing the type of characteristic
          Control1..1
          BindingFor example codes, see product-characteristic-codeshttp://hl7.org/fhir/ValueSet/product-characteristic-codes
          (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

          This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          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()))
          48. ManufacturedItemDefinition.property:Score.value[x]
          Definition

          A value for the characteristic.

          ShortA value for the characteristic
          Control0..1
          TypeQuantity, date, boolean, Attachment, CodeableConcept
          [x] NoteSee Choice of Data Types for further information about how to use [x]
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          50. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          52. 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 manageable, 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. ManufacturedItemDefinition.property:Shape.type
          Definition

          A code expressing the type of characteristic.

          ShortA code expressing the type of characteristic
          Control1..1
          BindingFor example codes, see product-characteristic-codeshttp://hl7.org/fhir/ValueSet/product-characteristic-codes
          (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

          This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          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()))
          56. ManufacturedItemDefinition.property:Shape.value[x]
          Definition

          A value for the characteristic.

          ShortA value for the characteristic
          Control0..1
          BindingThe codes SHALL be taken from For codes, see http://evs.nci.nih.gov/valueset/FDA/C54454
          (required to http://evs.nci.nih.gov/valueset/FDA/C54454)
          TypeCodeableConcept, date, boolean, Quantity, Attachment
          [x] NoteSee Choice of Data Types for further information about how to use [x]
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          58. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          60. 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 manageable, 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())
          62. ManufacturedItemDefinition.property:Size.type
          Definition

          A code expressing the type of characteristic.

          ShortA code expressing the type of characteristic
          Control1..1
          BindingFor example codes, see product-characteristic-codeshttp://hl7.org/fhir/ValueSet/product-characteristic-codes
          (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

          This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          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()))
          64. ManufacturedItemDefinition.property:Size.value[x]
          Definition

          A value for the characteristic.

          ShortA value for the characteristic
          Control0..1
          TypeQuantity, date, boolean, Attachment, CodeableConcept
          [x] NoteSee Choice of Data Types for further information about how to use [x]
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          66. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          68. 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 manageable, 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())
          70. ManufacturedItemDefinition.property:Flavor.type
          Definition

          A code expressing the type of characteristic.

          ShortA code expressing the type of characteristic
          Control1..1
          BindingFor example codes, see product-characteristic-codeshttp://hl7.org/fhir/ValueSet/product-characteristic-codes
          (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

          This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          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()))
          72. ManufacturedItemDefinition.property:Flavor.value[x]
          Definition

          A value for the characteristic.

          ShortA value for the characteristic
          Control0..1
          BindingThe codes SHALL be taken from For codes, see http://evs.nci.nih.gov/valueset/FDA/C73339
          (required to http://evs.nci.nih.gov/valueset/FDA/C73339)
          TypeCodeableConcept, date, boolean, Quantity, Attachment
          [x] NoteSee Choice of Data Types for further information about how to use [x]
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          74. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
          76. 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 manageable, 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())
          78. ManufacturedItemDefinition.property:Image.type
          Definition

          A code expressing the type of characteristic.

          ShortA code expressing the type of characteristic
          Control1..1
          BindingFor example codes, see product-characteristic-codeshttp://hl7.org/fhir/ValueSet/product-characteristic-codes
          (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

          This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          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()))
          80. ManufacturedItemDefinition.property:Image.value[x]
          Definition

          A value for the characteristic.

          ShortA value for the characteristic
          Control0..1
          TypeAttachment, date, boolean, Quantity, CodeableConcept
          [x] NoteSee Choice of Data Types for further information about how to use [x]
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

          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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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.id
          Definition

          The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

          ShortLogical id of this artifact
          Comments

          The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

          Control0..1
          Typeid
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          4. ManufacturedItemDefinition.meta
          Definition

          The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

          ShortMetadata about the resource
          Control0..1
          TypeMeta
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          6. 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 it's 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 it's 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()))
          8. ManufacturedItemDefinition.language
          Definition

          The base language in which the resource is written.

          ShortLanguage of the resource content
          Comments

          Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

          Control0..1
          BindingThe codes SHOULD be taken from CommonLanguages
          (preferred to http://hl7.org/fhir/ValueSet/languages)

          IETF language tag

          Additional BindingsPurpose
          AllLanguagesMax Binding
          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          10. ManufacturedItemDefinition.text
          Definition

          A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

          ShortText summary of the resource, for human interpretation
          Comments

          Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

          Control0..1
          TypeNarrative
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate Namesnarrative, html, xhtml, display
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          12. ManufacturedItemDefinition.contained
          Definition

          These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

          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..*
          TypeResource
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate Namesinline resources, anonymous resources, contained resources
          Invariantsdom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems (($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic))
          14. ManufacturedItemDefinition.extension
          Definition

          An Extension

          ShortExtension
          Control0..*
          TypeExtension
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          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
          • 16. 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
            This element is affected by the following invariants: ele-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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            18. 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 manageable, 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
            Summaryfalse
            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())
            20. ManufacturedItemDefinition.identifier
            Definition

            Unique identifier.

            ShortUnique identifier
            NoteThis is a business identifier, not a resource identifier (see discussion)
            Control0..*
            TypeIdentifier
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            22. 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 PublicationStatus
            (required to http://hl7.org/fhir/ValueSet/publication-status|4.3.0)

            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()))
            24. 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 http://evs.nci.nih.gov/valueset/FDA/C54456
            (required to http://evs.nci.nih.gov/valueset/FDA/C54456)
            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            26. ManufacturedItemDefinition.unitOfPresentation
            Definition

            The “real world” units in which the quantity of the manufactured item is described.

            ShortThe “real world” units in which the quantity of the item is described
            Control0..1
            BindingFor example codes, see UnitOfPresentation
            (example to http://hl7.org/fhir/ValueSet/unit-of-presentation)

            The presentation type in which an administrable medicinal product is given to a patient.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            28. ManufacturedItemDefinition.manufacturer
            Definition

            Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues).

            ShortManufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
            Control0..*
            TypeReference(Organization)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            30. ManufacturedItemDefinition.ingredient
            Definition

            The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource.

            ShortThe ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
            Control0..*
            BindingFor example codes, see substance-codes
            (example to http://hl7.org/fhir/ValueSet/substance-codes)

            This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            32. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
            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
            • 34. ManufacturedItemDefinition.property.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
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              36. ManufacturedItemDefinition.property.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 manageable, 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())
              38. 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 manageable, 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())
              40. 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 SPL Product Characteristic Types ValueSet
              (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypes)
              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              42. ManufacturedItemDefinition.property.value[x]
              Definition

              A value for the characteristic.

              ShortA value for the characteristic
              Control1..1
              TypeChoice of: CodeableConcept, Quantity, date, boolean, Attachment
              [x] NoteSee Choice of Data Types for 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()))
              44. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
              46. ManufacturedItemDefinition.property:Color.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
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              48. ManufacturedItemDefinition.property:Color.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 manageable, 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())
              50. 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 manageable, 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())
              52. ManufacturedItemDefinition.property:Color.type
              Definition

              A code expressing the type of characteristic.

              ShortA code expressing the type of characteristic
              Control1..1
              BindingFor example codes, see product-characteristic-codes
              (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

              This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              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()))
              54. ManufacturedItemDefinition.property:Color.value[x]
              Definition

              A value for the characteristic.

              ShortA value for the characteristic
              Control0..1
              BindingThe codes SHALL be taken from http://evs.nci.nih.gov/valueset/FDA/C54453
              (required to http://evs.nci.nih.gov/valueset/FDA/C54453)
              TypeCodeableConcept
              [x] NoteSee Choice of Data Types for further information about how to use [x]
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              56. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
              58. ManufacturedItemDefinition.property:Imprint.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
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              60. ManufacturedItemDefinition.property:Imprint.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 manageable, 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())
              62. 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 manageable, 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:Imprint.type
              Definition

              A code expressing the type of characteristic.

              ShortA code expressing the type of characteristic
              Control1..1
              BindingFor example codes, see product-characteristic-codes
              (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

              This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              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()))
              66. ManufacturedItemDefinition.property:Imprint.value[x]
              Definition

              A value for the characteristic.

              ShortText is only allowed as the imprint is a string.
              Control0..1
              TypeCodeableConcept
              [x] NoteSee Choice of Data Types for further information about how to use [x]
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              68. ManufacturedItemDefinition.property:Imprint.value[x].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
              Typeid
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              70. ManufacturedItemDefinition.property:Imprint.value[x].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 manageable, 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 ManufacturedItemDefinition.property.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 72. 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()))
                74. 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.

                Control1..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()))
                76. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                78. ManufacturedItemDefinition.property:Score.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
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                80. ManufacturedItemDefinition.property:Score.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 manageable, 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())
                82. 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 manageable, 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())
                84. ManufacturedItemDefinition.property:Score.type
                Definition

                A code expressing the type of characteristic.

                ShortA code expressing the type of characteristic
                Control1..1
                BindingFor example codes, see product-characteristic-codes
                (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

                This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                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()))
                86. ManufacturedItemDefinition.property:Score.value[x]
                Definition

                A value for the characteristic.

                ShortA value for the characteristic
                Control0..1
                TypeQuantity
                [x] NoteSee Choice of Data Types for further information about how to use [x]
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                88. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                90. ManufacturedItemDefinition.property:Shape.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
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                92. ManufacturedItemDefinition.property:Shape.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 manageable, 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())
                94. 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 manageable, 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())
                96. ManufacturedItemDefinition.property:Shape.type
                Definition

                A code expressing the type of characteristic.

                ShortA code expressing the type of characteristic
                Control1..1
                BindingFor example codes, see product-characteristic-codes
                (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

                This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                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()))
                98. ManufacturedItemDefinition.property:Shape.value[x]
                Definition

                A value for the characteristic.

                ShortA value for the characteristic
                Control0..1
                BindingThe codes SHALL be taken from http://evs.nci.nih.gov/valueset/FDA/C54454
                (required to http://evs.nci.nih.gov/valueset/FDA/C54454)
                TypeCodeableConcept
                [x] NoteSee Choice of Data Types for further information about how to use [x]
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                100. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                102. ManufacturedItemDefinition.property:Size.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
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                104. ManufacturedItemDefinition.property:Size.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 manageable, 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())
                106. 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 manageable, 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())
                108. ManufacturedItemDefinition.property:Size.type
                Definition

                A code expressing the type of characteristic.

                ShortA code expressing the type of characteristic
                Control1..1
                BindingFor example codes, see product-characteristic-codes
                (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

                This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                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()))
                110. ManufacturedItemDefinition.property:Size.value[x]
                Definition

                A value for the characteristic.

                ShortA value for the characteristic
                Control0..1
                TypeQuantity
                [x] NoteSee Choice of Data Types for further information about how to use [x]
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                112. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                114. ManufacturedItemDefinition.property:Flavor.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
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                116. ManufacturedItemDefinition.property:Flavor.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 manageable, 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())
                118. 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 manageable, 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())
                120. ManufacturedItemDefinition.property:Flavor.type
                Definition

                A code expressing the type of characteristic.

                ShortA code expressing the type of characteristic
                Control1..1
                BindingFor example codes, see product-characteristic-codes
                (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

                This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                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()))
                122. ManufacturedItemDefinition.property:Flavor.value[x]
                Definition

                A value for the characteristic.

                ShortA value for the characteristic
                Control0..1
                BindingThe codes SHALL be taken from http://evs.nci.nih.gov/valueset/FDA/C73339
                (required to http://evs.nci.nih.gov/valueset/FDA/C73339)
                TypeCodeableConcept
                [x] NoteSee Choice of Data Types for further information about how to use [x]
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                124. 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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                126. ManufacturedItemDefinition.property:Image.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
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                128. ManufacturedItemDefinition.property:Image.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 manageable, 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())
                130. 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 manageable, 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())
                132. ManufacturedItemDefinition.property:Image.type
                Definition

                A code expressing the type of characteristic.

                ShortA code expressing the type of characteristic
                Control1..1
                BindingFor example codes, see product-characteristic-codes
                (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

                This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                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()))
                134. ManufacturedItemDefinition.property:Image.value[x]
                Definition

                A value for the characteristic.

                ShortA value for the characteristic
                Control0..1
                TypeAttachment
                [x] NoteSee Choice of Data Types for further information about how to use [x]
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))