SPL Mapping FHIR R5 Implementation Guide
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SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 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

Logical Model: ProductSubmissionDocumentLogicalModel - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 1

Definitions for the ProductSubmissionDocumentLogicalModel logical model.

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

0. ProductSubmissionDocument
Definition

A document that contains information about a product being submitted for approval to the FDA.

ShortProduct Submission Document Logical Model
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. ProductSubmissionDocument.identifier
Definition

A unique identifier of this specific Product Submission document.

ShortDocument Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
4. ProductSubmissionDocument.splVersion
Definition

A date reference to the SPL version being used for this document.

ShortDocument SPL Version
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
6. ProductSubmissionDocument.submissionIdentifier
Definition

A unique identifier of the submission that remains constant across all versions/revisions of this document.

ShortSubmission Identifier
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
8. ProductSubmissionDocument.versionNumber
Definition

An integer that provides a sequence to the versions of the submission document.

ShortDocument Version Number
Control1..1
TypepositiveInt
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
10. ProductSubmissionDocument.type
Definition

A LOINC code that provides inforamtion on the Product Submission type.

ShortDocument Type
Control1..1
TypeCodeableConcept
12. ProductSubmissionDocument.title
Definition

The title for the document.

ShortDocument Title
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
14. ProductSubmissionDocument.labeler
Definition

Information about the labeler organization that authored the document.

ShortProduct Labeler
Control1..1
TypeBackboneElement
16. ProductSubmissionDocument.labeler.dunsNumber
Definition

The Duns & Broadstreet number for the labeler organization.

ShortProduct Labeler DUNS Number
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
18. ProductSubmissionDocument.labeler.name
Definition

The name of the labeler organization.

ShortProduct Labeler Name
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
20. ProductSubmissionDocument.labeler.registrant
Definition

Information about the registrant organization associated with the labeler.

ShortProduct Labeler Registrant
Control0..1
TypeBackboneElement
22. ProductSubmissionDocument.labeler.registrant.dunsNumber
Definition

The Duns & Broadstreet number for the registrant organization.

ShortRegistrant DUNS Number
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
24. ProductSubmissionDocument.labeler.registrant.name
Definition

The name of the registrant organization.

ShortRegistrant Name
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
26. ProductSubmissionDocument.labeler.registrant.establishment
Definition

Information about the establishment organization associated with active or new marketed products.

ShortProduct Establishment
Control1..*
TypeBackboneElement
28. ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber
Definition

The Duns & Broadstreet number for the establishment organization.

ShortEstablishment DUNS Number
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
30. ProductSubmissionDocument.labeler.registrant.establishment.name
Definition

The name of the establishment organization.

ShortEstablishment Name
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
32. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation
Definition

Various business operations that the Establishment organization performs.

ShortEstablishment Business Operations
Control1..*
TypeBackboneElement
34. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code
Definition

A code representing the specific business operation that the Establishment organization can perform.

ShortBusiness Operation Type
Control1..1
TypeCodeableConcept
36. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC
Definition

The NDC code of the specific product that this business operation is about.

ShortBusiness Operation Product NDC
Control0..1
TypeCodeableConcept
38. ProductSubmissionDocument.relatedDocument
Definition

Reference to other documents that contain relevant information about this product submission.

ShortReference to Related Document
Control0..*
TypeBackboneElement
40. ProductSubmissionDocument.relatedDocument.identifier
Definition

A unique identifier of this related document.

ShortRelated Document Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
42. ProductSubmissionDocument.relatedDocument.submissionIdentifier
Definition

A unique identifier of the submission of this related document.

ShortRelated Document Submission Identifier
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
44. ProductSubmissionDocument.relatedDocument.versionNumber
Definition

An integer that provides a sequence to the versions of the related document.

ShortRelated Document Version Number
Control1..1
TypepositiveInt
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
46. ProductSubmissionDocument.section
Definition

A logical grouping of Product Submission information.

ShortDocument Sections
Control1..*
TypeBackboneElement
48. ProductSubmissionDocument.section.identifier
Definition

An identifier for this section that can be used to reference it in the document.

ShortSection Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
50. ProductSubmissionDocument.section.effectiveTime
Definition

The date when this section was authored.

ShortSection Effective Time
Control1..1
Typedate
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
52. ProductSubmissionDocument.section.type
Definition

A code that identifies the content conveyed in this section.

ShortSection Type
Control1..1
TypeCodeableConcept
54. ProductSubmissionDocument.section.title
Definition

A header for the content contained in this section.

ShortSection Title
Control0..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
56. ProductSubmissionDocument.section.text
Definition

The human readable content of this section.

ShortSection Text
Control0..1
Typexhtml
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
58. ProductSubmissionDocument.section.highlights
Definition

Content that is not a complete rendering of the information in this section.

ShortSection Text Highlights
Control0..1
Typexhtml
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
60. ProductSubmissionDocument.section.image
Definition

References to images that are used in the human readable content of this section.

ShortSection Images
Control0..*
TypeBackboneElement
62. ProductSubmissionDocument.section.image.name
Definition

Title of the image.

ShortImage Title
Control1..1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
64. ProductSubmissionDocument.section.image.reference
Definition

Reference, either local or remote, to the image data.

ShortImage Reference
Control1..1
Typeurl
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
66. ProductSubmissionDocument.section.product
Definition

The complete definition of a medication being submitted in this document.

ShortSection Product Information
Control0..*
Typehttp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel
68. ProductSubmissionDocument.section.subsection
Definition

subsection

Shortsubsection
Control0..*
TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel#ProductSubmissionDocument.section

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

0. ProductSubmissionDocument
Definition

A document that contains information about a product being submitted for approval to the FDA.


Base definition for all elements in a resource.

ShortProduct Submission Document Logical ModelBase for all elements
Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
2. ProductSubmissionDocument.id
Definition

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

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

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

ShortAdditional content defined by implementations
Comments

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

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

    A unique identifier of this specific Product Submission document.

    ShortDocument Identifier
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control1..1
    Typestring
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    8. ProductSubmissionDocument.splVersion
    Definition

    A date reference to the SPL version being used for this document.

    ShortDocument SPL Version
    Control1..1
    Typedate
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    10. ProductSubmissionDocument.submissionIdentifier
    Definition

    A unique identifier of the submission that remains constant across all versions/revisions of this document.

    ShortSubmission Identifier
    Control1..1
    Typestring
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    12. ProductSubmissionDocument.versionNumber
    Definition

    An integer that provides a sequence to the versions of the submission document.

    ShortDocument Version Number
    Control1..1
    TypepositiveInt
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    14. ProductSubmissionDocument.type
    Definition

    A LOINC code that provides inforamtion on the Product Submission type.

    ShortDocument Type
    Control1..1
    TypeCodeableConcept
    16. ProductSubmissionDocument.title
    Definition

    The title for the document.

    ShortDocument Title
    Control0..1
    Typestring
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    18. ProductSubmissionDocument.labeler
    Definition

    Information about the labeler organization that authored the document.

    ShortProduct Labeler
    Control1..1
    TypeBackboneElement
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. ProductSubmissionDocument.labeler.id
    Definition

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

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

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

    ShortAdditional content defined by implementations
    Comments

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

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

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

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

      ShortExtensions that cannot be ignored even if unrecognized
      Comments

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

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

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

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

      The Duns & Broadstreet number for the labeler organization.

      ShortProduct Labeler DUNS Number
      Control1..1
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      28. ProductSubmissionDocument.labeler.name
      Definition

      The name of the labeler organization.

      ShortProduct Labeler Name
      Control1..1
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      30. ProductSubmissionDocument.labeler.registrant
      Definition

      Information about the registrant organization associated with the labeler.

      ShortProduct Labeler Registrant
      Control0..1
      TypeBackboneElement
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      32. ProductSubmissionDocument.labeler.registrant.id
      Definition

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

      ShortUnique id for inter-element referencing
      Control0..1
      This element is affected by the following invariants: ele-1
      Typeidstring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      34. ProductSubmissionDocument.labeler.registrant.extension
      Definition

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

      ShortAdditional content defined by implementations
      Comments

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

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

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

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

        ShortExtensions that cannot be ignored even if unrecognized
        Comments

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

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

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

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

        The Duns & Broadstreet number for the registrant organization.

        ShortRegistrant DUNS Number
        Control1..1
        Typestring
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        40. ProductSubmissionDocument.labeler.registrant.name
        Definition

        The name of the registrant organization.

        ShortRegistrant Name
        Control1..1
        Typestring
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        42. ProductSubmissionDocument.labeler.registrant.establishment
        Definition

        Information about the establishment organization associated with active or new marketed products.

        ShortProduct Establishment
        Control1..*
        TypeBackboneElement
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        44. ProductSubmissionDocument.labeler.registrant.establishment.id
        Definition

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

        ShortUnique id for inter-element referencing
        Control0..1
        This element is affected by the following invariants: ele-1
        Typeidstring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        46. ProductSubmissionDocument.labeler.registrant.establishment.extension
        Definition

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

        ShortAdditional content defined by implementations
        Comments

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

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

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

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

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

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

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

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

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

          The Duns & Broadstreet number for the establishment organization.

          ShortEstablishment DUNS Number
          Control1..1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          52. ProductSubmissionDocument.labeler.registrant.establishment.name
          Definition

          The name of the establishment organization.

          ShortEstablishment Name
          Control1..1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          54. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation
          Definition

          Various business operations that the Establishment organization performs.

          ShortEstablishment Business Operations
          Control1..*
          TypeBackboneElement
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.id
          Definition

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

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typeidstring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          58. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.extension
          Definition

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

          ShortAdditional content defined by implementations
          Comments

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

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

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

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

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

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            62. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code
            Definition

            A code representing the specific business operation that the Establishment organization can perform.

            ShortBusiness Operation Type
            Control1..1
            TypeCodeableConcept
            64. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC
            Definition

            The NDC code of the specific product that this business operation is about.

            ShortBusiness Operation Product NDC
            Control0..1
            TypeCodeableConcept
            66. ProductSubmissionDocument.relatedDocument
            Definition

            Reference to other documents that contain relevant information about this product submission.

            ShortReference to Related Document
            Control0..*
            TypeBackboneElement
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            68. ProductSubmissionDocument.relatedDocument.id
            Definition

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

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

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

            ShortAdditional content defined by implementations
            Comments

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

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

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              A unique identifier of this related document.

              ShortRelated Document Identifier
              NoteThis is a business identifier, not a resource identifier (see discussion)
              Control1..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              76. ProductSubmissionDocument.relatedDocument.submissionIdentifier
              Definition

              A unique identifier of the submission of this related document.

              ShortRelated Document Submission Identifier
              Control1..1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              78. ProductSubmissionDocument.relatedDocument.versionNumber
              Definition

              An integer that provides a sequence to the versions of the related document.

              ShortRelated Document Version Number
              Control1..1
              TypepositiveInt
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              80. ProductSubmissionDocument.section
              Definition

              A logical grouping of Product Submission information.

              ShortDocument Sections
              Control1..*
              TypeBackboneElement
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              82. ProductSubmissionDocument.section.id
              Definition

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

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

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

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

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

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

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

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

                An identifier for this section that can be used to reference it in the document.

                ShortSection Identifier
                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control1..1
                Typestring
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                90. ProductSubmissionDocument.section.effectiveTime
                Definition

                The date when this section was authored.

                ShortSection Effective Time
                Control1..1
                Typedate
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                92. ProductSubmissionDocument.section.type
                Definition

                A code that identifies the content conveyed in this section.

                ShortSection Type
                Control1..1
                TypeCodeableConcept
                94. ProductSubmissionDocument.section.title
                Definition

                A header for the content contained in this section.

                ShortSection Title
                Control0..1
                Typestring
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                96. ProductSubmissionDocument.section.text
                Definition

                The human readable content of this section.

                ShortSection Text
                Control0..1
                Typexhtml
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                98. ProductSubmissionDocument.section.highlights
                Definition

                Content that is not a complete rendering of the information in this section.

                ShortSection Text Highlights
                Control0..1
                Typexhtml
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                100. ProductSubmissionDocument.section.image
                Definition

                References to images that are used in the human readable content of this section.

                ShortSection Images
                Control0..*
                TypeBackboneElement
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                102. ProductSubmissionDocument.section.image.id
                Definition

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

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typeidstring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                104. ProductSubmissionDocument.section.image.extension
                Definition

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

                ShortAdditional content defined by implementations
                Comments

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

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

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

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

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

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

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

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

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

                  Title of the image.

                  ShortImage Title
                  Control1..1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  110. ProductSubmissionDocument.section.image.reference
                  Definition

                  Reference, either local or remote, to the image data.

                  ShortImage Reference
                  Control1..1
                  Typeurl
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  112. ProductSubmissionDocument.section.product
                  Definition

                  The complete definition of a medication being submitted in this document.

                  ShortSection Product Information
                  Control0..*
                  Typehttp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel
                  114. ProductSubmissionDocument.section.subsection
                  Definition

                  subsection

                  Shortsubsection
                  Control0..*
                  TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel#ProductSubmissionDocument.section

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

                  0. ProductSubmissionDocument
                  Definition

                  A document that contains information about a product being submitted for approval to the FDA.

                  ShortProduct Submission Document Logical Model
                  Control0..*
                  Is Modifierfalse
                  Logical ModelInstances of this logical model are not marked to be the target of a Reference
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  2. ProductSubmissionDocument.id
                  Definition

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

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

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

                  ShortAdditional content defined by implementations
                  Comments

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

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

                    A unique identifier of this specific Product Submission document.

                    ShortDocument Identifier
                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control1..1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    8. ProductSubmissionDocument.splVersion
                    Definition

                    A date reference to the SPL version being used for this document.

                    ShortDocument SPL Version
                    Control1..1
                    Typedate
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    10. ProductSubmissionDocument.submissionIdentifier
                    Definition

                    A unique identifier of the submission that remains constant across all versions/revisions of this document.

                    ShortSubmission Identifier
                    Control1..1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    12. ProductSubmissionDocument.versionNumber
                    Definition

                    An integer that provides a sequence to the versions of the submission document.

                    ShortDocument Version Number
                    Control1..1
                    TypepositiveInt
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    14. ProductSubmissionDocument.type
                    Definition

                    A LOINC code that provides inforamtion on the Product Submission type.

                    ShortDocument Type
                    Control1..1
                    TypeCodeableConcept
                    16. ProductSubmissionDocument.title
                    Definition

                    The title for the document.

                    ShortDocument Title
                    Control0..1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    18. ProductSubmissionDocument.labeler
                    Definition

                    Information about the labeler organization that authored the document.

                    ShortProduct Labeler
                    Control1..1
                    TypeBackboneElement
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    20. ProductSubmissionDocument.labeler.id
                    Definition

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

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

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

                    ShortAdditional content defined by implementations
                    Comments

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

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

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

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

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

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

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

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

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

                      The Duns & Broadstreet number for the labeler organization.

                      ShortProduct Labeler DUNS Number
                      Control1..1
                      Typestring
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      28. ProductSubmissionDocument.labeler.name
                      Definition

                      The name of the labeler organization.

                      ShortProduct Labeler Name
                      Control1..1
                      Typestring
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      30. ProductSubmissionDocument.labeler.registrant
                      Definition

                      Information about the registrant organization associated with the labeler.

                      ShortProduct Labeler Registrant
                      Control0..1
                      TypeBackboneElement
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      32. ProductSubmissionDocument.labeler.registrant.id
                      Definition

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

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

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

                      ShortAdditional content defined by implementations
                      Comments

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

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

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

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

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

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

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

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

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

                        The Duns & Broadstreet number for the registrant organization.

                        ShortRegistrant DUNS Number
                        Control1..1
                        Typestring
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        40. ProductSubmissionDocument.labeler.registrant.name
                        Definition

                        The name of the registrant organization.

                        ShortRegistrant Name
                        Control1..1
                        Typestring
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        42. ProductSubmissionDocument.labeler.registrant.establishment
                        Definition

                        Information about the establishment organization associated with active or new marketed products.

                        ShortProduct Establishment
                        Control1..*
                        TypeBackboneElement
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        44. ProductSubmissionDocument.labeler.registrant.establishment.id
                        Definition

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

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

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

                        ShortAdditional content defined by implementations
                        Comments

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

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

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

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

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

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

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

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

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

                          The Duns & Broadstreet number for the establishment organization.

                          ShortEstablishment DUNS Number
                          Control1..1
                          Typestring
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          52. ProductSubmissionDocument.labeler.registrant.establishment.name
                          Definition

                          The name of the establishment organization.

                          ShortEstablishment Name
                          Control1..1
                          Typestring
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          54. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation
                          Definition

                          Various business operations that the Establishment organization performs.

                          ShortEstablishment Business Operations
                          Control1..*
                          TypeBackboneElement
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          56. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.id
                          Definition

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

                          ShortUnique id for inter-element referencing
                          Control0..1
                          This element is affected by the following invariants: ele-1
                          Typeid
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          58. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.extension
                          Definition

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

                          ShortAdditional content defined by implementations
                          Comments

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

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

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

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

                            ShortExtensions that cannot be ignored even if unrecognized
                            Comments

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

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

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

                            Alternate Namesextensions, user content, modifiers
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            62. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code
                            Definition

                            A code representing the specific business operation that the Establishment organization can perform.

                            ShortBusiness Operation Type
                            Control1..1
                            TypeCodeableConcept
                            64. ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC
                            Definition

                            The NDC code of the specific product that this business operation is about.

                            ShortBusiness Operation Product NDC
                            Control0..1
                            TypeCodeableConcept
                            66. ProductSubmissionDocument.relatedDocument
                            Definition

                            Reference to other documents that contain relevant information about this product submission.

                            ShortReference to Related Document
                            Control0..*
                            TypeBackboneElement
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            68. ProductSubmissionDocument.relatedDocument.id
                            Definition

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

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

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

                            ShortAdditional content defined by implementations
                            Comments

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

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

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

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

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

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

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

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

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

                              A unique identifier of this related document.

                              ShortRelated Document Identifier
                              NoteThis is a business identifier, not a resource identifier (see discussion)
                              Control1..1
                              Typestring
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              76. ProductSubmissionDocument.relatedDocument.submissionIdentifier
                              Definition

                              A unique identifier of the submission of this related document.

                              ShortRelated Document Submission Identifier
                              Control1..1
                              Typestring
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              78. ProductSubmissionDocument.relatedDocument.versionNumber
                              Definition

                              An integer that provides a sequence to the versions of the related document.

                              ShortRelated Document Version Number
                              Control1..1
                              TypepositiveInt
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              80. ProductSubmissionDocument.section
                              Definition

                              A logical grouping of Product Submission information.

                              ShortDocument Sections
                              Control1..*
                              TypeBackboneElement
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              82. ProductSubmissionDocument.section.id
                              Definition

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

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

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

                              ShortAdditional content defined by implementations
                              Comments

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

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

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

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

                                ShortExtensions that cannot be ignored even if unrecognized
                                Comments

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

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

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

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

                                An identifier for this section that can be used to reference it in the document.

                                ShortSection Identifier
                                NoteThis is a business identifier, not a resource identifier (see discussion)
                                Control1..1
                                Typestring
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                90. ProductSubmissionDocument.section.effectiveTime
                                Definition

                                The date when this section was authored.

                                ShortSection Effective Time
                                Control1..1
                                Typedate
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                92. ProductSubmissionDocument.section.type
                                Definition

                                A code that identifies the content conveyed in this section.

                                ShortSection Type
                                Control1..1
                                TypeCodeableConcept
                                94. ProductSubmissionDocument.section.title
                                Definition

                                A header for the content contained in this section.

                                ShortSection Title
                                Control0..1
                                Typestring
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                96. ProductSubmissionDocument.section.text
                                Definition

                                The human readable content of this section.

                                ShortSection Text
                                Control0..1
                                Typexhtml
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                98. ProductSubmissionDocument.section.highlights
                                Definition

                                Content that is not a complete rendering of the information in this section.

                                ShortSection Text Highlights
                                Control0..1
                                Typexhtml
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                100. ProductSubmissionDocument.section.image
                                Definition

                                References to images that are used in the human readable content of this section.

                                ShortSection Images
                                Control0..*
                                TypeBackboneElement
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                102. ProductSubmissionDocument.section.image.id
                                Definition

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

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

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

                                ShortAdditional content defined by implementations
                                Comments

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

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

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

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

                                  ShortExtensions that cannot be ignored even if unrecognized
                                  Comments

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

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

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

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

                                  Title of the image.

                                  ShortImage Title
                                  Control1..1
                                  Typestring
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  110. ProductSubmissionDocument.section.image.reference
                                  Definition

                                  Reference, either local or remote, to the image data.

                                  ShortImage Reference
                                  Control1..1
                                  Typeurl
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  112. ProductSubmissionDocument.section.product
                                  Definition

                                  The complete definition of a medication being submitted in this document.

                                  ShortSection Product Information
                                  Control0..*
                                  Typehttp://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel
                                  114. ProductSubmissionDocument.section.subsection
                                  Definition

                                  subsection

                                  Shortsubsection
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel#ProductSubmissionDocument.section