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: SubmittedMedicinalPackaging - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 1

Definitions for the SubmittedMedicinalPackaging resource profile.

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

0. PackagedProductDefinition
2. PackagedProductDefinition.packageFor
Control1..1
TypeReference(SubmittedMedicinalProduct)
Must Supporttrue
4. PackagedProductDefinition.marketingStatus
Control0..1
Must Supporttrue
6. PackagedProductDefinition.marketingStatus.status
BindingThe codes SHALL be taken from SPL Marketing Statuses ValueSet
(required to http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses)
Must Supporttrue
8. PackagedProductDefinition.marketingStatus.dateRange
Control1..?
Must Supporttrue
10. PackagedProductDefinition.package
Control1..?
Must Supporttrue
12. PackagedProductDefinition.package.extension
SlicingThis element introduces a set of slices on PackagedProductDefinition.package.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 14. PackagedProductDefinition.package.extension:packageInstanceOf
    Slice NamepackageInstanceOf
    Control0..1
    TypeExtension(Packaged Product Reference) (Extension Type: Reference(SubmittedMedicinalPackaging))
    Must Supporttrue
    16. PackagedProductDefinition.package.identifier
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Must Supporttrue
    18. PackagedProductDefinition.package.type
    Control1..?
    Must Supporttrue
    20. PackagedProductDefinition.package.quantity
    Must Supporttrue
    22. PackagedProductDefinition.package.property
    Must Supporttrue
    24. PackagedProductDefinition.package.property.type
    Must Supporttrue
    Pattern Value{
      "coding" : [{
        "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
        "code" : "SPLCMBPRDTP"
      }]
    }
    26. PackagedProductDefinition.package.property.value[x]
    Control1..?
    BindingThe codes SHALL be taken from http://evs.nci.nih.gov/valueset/FDA/C102833
    (required to http://evs.nci.nih.gov/valueset/FDA/C102833)
    TypeCodeableConcept, date, boolean, Quantity, Attachment
    [x] NoteSee Choice of Data Types for further information about how to use [x]
    Must Supporttrue
    28. PackagedProductDefinition.package.containedItem
    Must Supporttrue
    30. PackagedProductDefinition.package.containedItem.item
    TypeCodeableReference(SubmittedManufacturedItem)
    Must Supporttrue
    32. PackagedProductDefinition.package.containedItem.amount
    Control1..?
    Must Supporttrue
    34. PackagedProductDefinition.package.package
    Must Supporttrue

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

    0. PackagedProductDefinition
    Definition

    A medically related item or items, in a container or package.

    ShortA medically related item or items, in a container or package
    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. PackagedProductDefinition.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. PackagedProductDefinition.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())
    6. PackagedProductDefinition.packageFor
    Definition

    The product that this is a pack for.

    ShortThe product that this is a pack for
    Control10..1*
    TypeReference(SubmittedMedicinalProduct, MedicinalProductDefinition)
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    8. PackagedProductDefinition.status
    Definition

    The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.

    ShortThe status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
    Control0..1
    BindingThe codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status
    (preferred to http://hl7.org/fhir/ValueSet/publication-status)

    The lifecycle status of an artifact.

    TypeCodeableConcept
    Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. PackagedProductDefinition.marketingStatus
    Definition

    Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.

    ShortAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
    Control0..1*
    TypeMarketingStatus
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. PackagedProductDefinition.marketingStatus.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())
    14. PackagedProductDefinition.marketingStatus.status
    Definition

    This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.

    ShortThis attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
    Control1..1
    BindingThe codes SHALL be taken from For codes, see SPL Marketing Statuses ValueSet
    (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses)
    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    16. PackagedProductDefinition.marketingStatus.dateRange
    Definition

    The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.

    ShortThe date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
    Control10..1
    TypePeriod
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. PackagedProductDefinition.package
    Definition

    A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item).

    ShortA packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
    Control10..1
    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)
    20. PackagedProductDefinition.package.extension
    Definition

    An Extension


    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.

    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
    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 PackagedProductDefinition.package.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 22. PackagedProductDefinition.package.extension:packageInstanceOf
      Slice NamepackageInstanceOf
      Definition

      A reference to a packaged product that is represented in a packaging element.

      ShortPackaged Product Reference
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Packaged Product Reference) (Extension Type: Reference(SubmittedMedicinalPackaging))
      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())
      24. PackagedProductDefinition.package.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. PackagedProductDefinition.package.identifier
      Definition

      An identifier that is specific to this particular part of the packaging. Including possibly Data Carrier Identifier (a GS1 barcode).

      ShortAn identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..*
      TypeIdentifier
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      28. PackagedProductDefinition.package.type
      Definition

      The physical type of the container of the items.

      ShortThe physical type of the container of the items
      Control10..1
      BindingFor example codes, see PackagingTypehttp://hl7.org/fhir/ValueSet/packaging-type
      (example to http://hl7.org/fhir/ValueSet/packaging-type)

      A high level categorisation of a package.

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      30. PackagedProductDefinition.package.quantity
      Definition

      The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1.

      ShortThe quantity of this level of packaging in the package that contains it (with the outermost level being 1)
      Control0..1
      Typeinteger
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      32. PackagedProductDefinition.package.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)
      34. PackagedProductDefinition.package.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())
      36. PackagedProductDefinition.package.property.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 Supporttrue
      Summarytrue
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
          "code" : "SPLCMBPRDTP"
        }]
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      38. PackagedProductDefinition.package.property.value[x]
      Definition

      A value for the characteristic.

      ShortA value for the characteristic
      Control10..1
      BindingThe codes SHALL be taken from For codes, see http://evs.nci.nih.gov/valueset/FDA/C102833
      (required to http://evs.nci.nih.gov/valueset/FDA/C102833)
      TypeCodeableConcept, date, boolean, Quantity, Attachment
      [x] NoteSee Choice of Data Types for further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      40. PackagedProductDefinition.package.containedItem
      Definition

      The item(s) within the packaging.

      ShortThe item(s) within the packaging
      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)
      42. PackagedProductDefinition.package.containedItem.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())
      44. PackagedProductDefinition.package.containedItem.item
      Definition

      The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package).

      ShortThe actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
      Control1..1
      TypeCodeableReference(SubmittedManufacturedItem, ManufacturedItemDefinition, DeviceDefinition, PackagedProductDefinition, BiologicallyDerivedProduct, NutritionProduct)
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      46. PackagedProductDefinition.package.containedItem.amount
      Definition

      The number of this type of item within this packaging.

      ShortThe number of this type of item within this packaging
      Control10..1
      TypeQuantity
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      48. PackagedProductDefinition.package.package
      Definition

      Allows containers (and parts of containers) parwithin containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition).

      ShortAllows containers (and parts of containers) within containers, still a single packaged product
      Control0..*
      TypeSee ttp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.package
      Is Modifierfalse
      Must Supporttrue
      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. PackagedProductDefinition
      Definition

      A medically related item or items, in a container or package.

      ShortA medically related item or items, in a container or package
      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. PackagedProductDefinition.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. PackagedProductDefinition.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. PackagedProductDefinition.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. PackagedProductDefinition.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. PackagedProductDefinition.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. PackagedProductDefinition.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. PackagedProductDefinition.extension
      Definition

      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.

      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
      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())
      16. PackagedProductDefinition.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())
      18. PackagedProductDefinition.identifier
      Definition

      A unique identifier for this package as whole. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

      ShortA unique identifier for this package as whole
      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()))
      20. PackagedProductDefinition.name
      Definition

      A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.

      ShortA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
      Control0..1
      Typestring
      Is Modifierfalse
      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()))
      22. PackagedProductDefinition.type
      Definition

      A high level category e.g. medicinal product, raw material, shipping/transport container, etc.

      ShortA high level category e.g. medicinal product, raw material, shipping container etc
      Control0..1
      BindingFor example codes, see PackageType
      (example to http://hl7.org/fhir/ValueSet/package-type)

      A high level categorisation of a package.

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

      The product that this is a pack for.

      ShortThe product that this is a pack for
      Control1..1
      TypeReference(SubmittedMedicinalProduct)
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      26. PackagedProductDefinition.status
      Definition

      The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.

      ShortThe status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
      Control0..1
      BindingThe codes SHOULD be taken from PublicationStatus
      (preferred to http://hl7.org/fhir/ValueSet/publication-status)

      The lifecycle status of an artifact.

      TypeCodeableConcept
      Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      28. PackagedProductDefinition.statusDate
      Definition

      The date at which the given status became applicable.

      ShortThe date at which the given status became applicable
      Control0..1
      TypedateTime
      Is Modifierfalse
      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()))
      30. PackagedProductDefinition.containedItemQuantity
      Definition

      A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource.

      ShortA total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size
      Control0..*
      TypeQuantity
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      32. PackagedProductDefinition.description
      Definition

      Textual description. Note that this is not the name of the package or product.

      ShortTextual description. Note that this is not the name of the package or product
      Control0..1
      Typemarkdown
      Is Modifierfalse
      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()))
      34. PackagedProductDefinition.legalStatusOfSupply
      Definition

      The legal status of supply of the packaged item as classified by the regulator.

      ShortThe legal status of supply of the packaged item as classified by the regulator
      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)
      36. PackagedProductDefinition.legalStatusOfSupply.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
      38. PackagedProductDefinition.legalStatusOfSupply.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())
      40. PackagedProductDefinition.legalStatusOfSupply.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())
      42. PackagedProductDefinition.legalStatusOfSupply.code
      Definition

      The actual status of supply. Conveys in what situation this package type may be supplied for use.

      ShortThe actual status of supply. In what situation this package type may be supplied for use
      Control0..1
      BindingFor example codes, see LegalStatusOfSupply
      (example to http://hl7.org/fhir/ValueSet/legal-status-of-supply)

      The prescription supply types appropriate to a medicinal product

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

      The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.

      ShortThe place where the legal status of supply applies
      Control0..1
      BindingFor example codes, see Jurisdiction ValueSet
      (example to http://hl7.org/fhir/ValueSet/jurisdiction)

      Jurisdiction codes

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

      Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.

      ShortAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
      Control0..1
      TypeMarketingStatus
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      48. PackagedProductDefinition.marketingStatus.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
      50. PackagedProductDefinition.marketingStatus.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 PackagedProductDefinition.marketingStatus.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 52. PackagedProductDefinition.marketingStatus.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. PackagedProductDefinition.marketingStatus.country
        Definition

        The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.

        ShortThe country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
        Control0..1
        TypeCodeableConcept
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        56. PackagedProductDefinition.marketingStatus.jurisdiction
        Definition

        Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified.

        ShortWhere a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
        Control0..1
        TypeCodeableConcept
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        58. PackagedProductDefinition.marketingStatus.status
        Definition

        This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.

        ShortThis attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
        Control1..1
        BindingThe codes SHALL be taken from SPL Marketing Statuses ValueSet
        (required to http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        60. PackagedProductDefinition.marketingStatus.dateRange
        Definition

        The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.

        ShortThe date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
        Control1..1
        TypePeriod
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        62. PackagedProductDefinition.marketingStatus.restoreDate
        Definition

        The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.

        ShortThe date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
        Control0..1
        TypedateTime
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        64. PackagedProductDefinition.characteristic
        Definition

        Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack".

        ShortAllows the key features to be recorded, such as "hospital pack", "nurse prescribable"
        Control0..*
        BindingFor example codes, see PackageCharacteristic
        (example to http://hl7.org/fhir/ValueSet/package-characteristic)

        A characteristic of a package.

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

        States whether a drug product is supplied with another item such as a diluent or adjuvant.

        ShortIf the drug product is supplied with another item such as a diluent or adjuvant
        Control0..1
        Typeboolean
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summarytrue
        Meaning if MissingIf this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        68. PackagedProductDefinition.manufacturer
        Definition

        Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.

        ShortManufacturer of this package type (multiple means these are all possible manufacturers)
        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()))
        70. PackagedProductDefinition.package
        Definition

        A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item).

        ShortA packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
        Control1..1
        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)
        72. PackagedProductDefinition.package.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
        74. PackagedProductDefinition.package.extension
        Definition

        An Extension

        ShortExtension
        Control0..*
        TypeExtension
        Is Modifierfalse
        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 PackagedProductDefinition.package.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 76. PackagedProductDefinition.package.extension:packageInstanceOf
          Slice NamepackageInstanceOf
          Definition

          A reference to a packaged product that is represented in a packaging element.

          ShortPackaged Product Reference
          Control0..1
          This element is affected by the following invariants: ele-1
          TypeExtension(Packaged Product Reference) (Extension Type: Reference(SubmittedMedicinalPackaging))
          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())
          78. PackagedProductDefinition.package.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())
          80. PackagedProductDefinition.package.identifier
          Definition

          An identifier that is specific to this particular part of the packaging. Including possibly Data Carrier Identifier (a GS1 barcode).

          ShortAn identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..*
          TypeIdentifier
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          82. PackagedProductDefinition.package.type
          Definition

          The physical type of the container of the items.

          ShortThe physical type of the container of the items
          Control1..1
          BindingFor example codes, see PackagingType
          (example to http://hl7.org/fhir/ValueSet/packaging-type)

          A high level categorisation of a package.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          84. PackagedProductDefinition.package.quantity
          Definition

          The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1.

          ShortThe quantity of this level of packaging in the package that contains it (with the outermost level being 1)
          Control0..1
          Typeinteger
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          86. PackagedProductDefinition.package.material
          Definition

          Material type of the package item.

          ShortMaterial type of the package item
          Control0..*
          BindingFor example codes, see PackageMaterial
          (example to http://hl7.org/fhir/ValueSet/package-material)

          A material used in the construction of packages and their components.

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

          A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve).

          ShortA possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
          Control0..*
          BindingFor example codes, see PackageMaterial
          (example to http://hl7.org/fhir/ValueSet/package-material)

          A material used in the construction of packages and their components.

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

          Shelf Life and storage information.

          ShortShelf Life and storage information
          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)
          92. PackagedProductDefinition.package.shelfLifeStorage.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
          94. PackagedProductDefinition.package.shelfLifeStorage.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())
          96. PackagedProductDefinition.package.shelfLifeStorage.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())
          98. PackagedProductDefinition.package.shelfLifeStorage.type
          Definition

          This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.

          ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
          Control0..1
          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          100. PackagedProductDefinition.package.shelfLifeStorage.period[x]
          Definition

          The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used.

          ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
          Control0..1
          TypeChoice of: Duration, string
          [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 Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          102. PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage
          Definition

          Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

          ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified
          Control0..*
          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          104. PackagedProductDefinition.package.manufacturer
          Definition

          Manufacturer of this package Item. When there are multiple it means these are all possible manufacturers.

          ShortManufacturer of this package Item (multiple means these are all possible manufacturers)
          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()))
          106. PackagedProductDefinition.package.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)
          108. PackagedProductDefinition.package.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
          110. PackagedProductDefinition.package.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())
          112. PackagedProductDefinition.package.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())
          114. PackagedProductDefinition.package.property.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 Supporttrue
          Summarytrue
          Pattern Value{
            "coding" : [{
              "system" : "http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes",
              "code" : "SPLCMBPRDTP"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          116. PackagedProductDefinition.package.property.value[x]
          Definition

          A value for the characteristic.

          ShortA value for the characteristic
          Control1..1
          BindingThe codes SHALL be taken from http://evs.nci.nih.gov/valueset/FDA/C102833
          (required to http://evs.nci.nih.gov/valueset/FDA/C102833)
          TypeCodeableConcept
          [x] NoteSee Choice of Data Types for further information about how to use [x]
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          118. PackagedProductDefinition.package.containedItem
          Definition

          The item(s) within the packaging.

          ShortThe item(s) within the packaging
          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)
          120. PackagedProductDefinition.package.containedItem.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
          122. PackagedProductDefinition.package.containedItem.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())
          124. PackagedProductDefinition.package.containedItem.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())
          126. PackagedProductDefinition.package.containedItem.item
          Definition

          The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.package.package).

          ShortThe actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
          Control1..1
          TypeCodeableReference(SubmittedManufacturedItem)
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          128. PackagedProductDefinition.package.containedItem.amount
          Definition

          The number of this type of item within this packaging.

          ShortThe number of this type of item within this packaging
          Control1..1
          TypeQuantity
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          130. PackagedProductDefinition.package.package
          Definition

          Allows containers (and parts of containers) parwithin containers, still a single packaged product. See also PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition).

          ShortAllows containers (and parts of containers) within containers, still a single packaged product
          Control0..*
          TypeSee ttp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.package
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))