Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot United States of America flag

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Resource Profile: ImpuritySubstance - Detailed Descriptions

Active as of 2024-12-04

Definitions for the pqcmc-drug-product-substance-impurity resource profile.

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

0. SubstanceDefinition
Invariantscmc-impurity-unii-required: If Product Impurity Chemical Structure Data File is not present, then a unii is required (structure.representation.type.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C103240' ).exists().not() implies ( code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists() ))
2. SubstanceDefinition.identifier
Shortoptional user designated identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
4. SubstanceDefinition.classification
Definition

A categorization of impurities based on its origin. [Source: SME Defined] Examples: Degradation Product, Inorganic, Process Related/Process, Product Related, Leachables.

ShortImpurity Classification
Control1..?
BindingThe codes SHALL be taken from Impurity Classification Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology)
Must Supporttrue
6. SubstanceDefinition.characterization
Must Supporttrue
8. SubstanceDefinition.characterization.technique
Definition

The technique used to elucidate the structure ore characterization of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc.

ShortSubstance Characterisation Technique
TypeCodeableConcept(Text Only Codeable Concept)
Must Supporttrue
10. SubstanceDefinition.characterization.description
ShortAnalysis Narrative Text and Table
Must Supporttrue
12. SubstanceDefinition.characterization.file
ShortImpurity Analysis Graphic | Impurity Analytical Instrument Data File
Must Supporttrue
SlicingThis element introduces a set of slices on SubstanceDefinition.characterization.file. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • profile @ $this
  • 14. SubstanceDefinition.characterization.file:AnalysisGraphic
    Slice NameAnalysisGraphic
    Definition

    Analysis Graphic: The pictorial representation of the data. [Source: SME Defined] Examples: spectrum, chromatogram. Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the instrumental output for the molecule -- CH3OHA pictorial representation of the structure of the drug substance. Required for Small Molecules. [Source: SME Defined]

    ShortAnalysis Graphic
    Control0..*
    TypeAttachment(Analysis Graphic)
    16. SubstanceDefinition.characterization.file:AnalyticalInstrumentData
    Slice NameAnalyticalInstrumentData
    Definition

    Impurity Analytical Instrument Data File: The transport format for data exchange. [Source: SME Defined] Example: JCAMP, ADX, ADF.

    ShortAnalytical Instrument Data File
    Control0..*
    TypeAttachment(Analytical Instrument Data)
    18. SubstanceDefinition.structure
    Must Supporttrue
    20. SubstanceDefinition.structure.technique
    Definition

    The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.

    ShortImpurity Substance Characterisation Technique
    TypeCodeableConcept(Text Only Codeable Concept)
    Must Supporttrue
    22. SubstanceDefinition.structure.representation
    ShortImpurity Structure Graphic | Impurity Structure Data File
    Must Supporttrue
    SlicingThis element introduces a set of slices on SubstanceDefinition.structure.representation. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
    • value @ type
    • 24. SubstanceDefinition.structure.representation.type
      Control1..?
      BindingThe codes SHALL be taken from Representation Types
      (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types)
      Must Supporttrue
      26. SubstanceDefinition.structure.representation:graphic
      Slice Namegraphic
      ShortA graphical, displayable depiction of the structure (e.g. an SVG, PNG)
      Control0..1
      28. SubstanceDefinition.structure.representation:graphic.type
      ShortGraphic
      Pattern Value{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C54273"
        }]
      }
      30. SubstanceDefinition.structure.representation:graphic.document
      Definition

      A pictorial representation of the structure of the impurity substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.

      ShortImpurity Structure Graphic
      Control1..?
      TypeReference(Literal Reference)(Graphic Reference)bundled
      32. SubstanceDefinition.structure.representation:structureFile
      Slice NamestructureFile
      Shortmachine-readable representation -- attached file
      Control0..*
      34. SubstanceDefinition.structure.representation:structureFile.type
      ShortStructure File
      Pattern Value{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C103240"
        }]
      }
      36. SubstanceDefinition.structure.representation:structureFile.document
      ShortImpurity Chemical Structure Data (files, e.g. .SDF, .CIF)
      Control1..?
      TypeReference(Literal Reference)(Structure Data Reference)bundled
      Must Supporttrue
      38. SubstanceDefinition.structure.representation:structureString
      Slice NamestructureString
      Shortmachine-readable representation -- plain text
      Control0..*
      40. SubstanceDefinition.structure.representation:structureString.type
      ShortStructure Textual
      Pattern Value{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C45253"
        }]
      }
      42. SubstanceDefinition.structure.representation:structureString.representation
      Definition

      A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SMILES, INCHI

      ShortImpurity Chemical Structure Data (short, plain text representations, e.g. SMILES)
      Control1..?
      Must Supporttrue
      44. SubstanceDefinition.structure.representation:structureString.format
      ShortDrug Substance Impurity Method Type
      Control1..?
      BindingThe codes SHALL be taken from Chemical Structure Data File Type Terminology
      (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology)
      Must Supporttrue
      46. SubstanceDefinition.code
      Must Supporttrue
      SlicingThis element introduces a set of slices on SubstanceDefinition.code. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ code.coding.system
      • 48. SubstanceDefinition.code:unii
        Slice Nameunii
        Definition

        The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/] Example: 362O9ITL9D Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/

        ShortUNII
        Control0..1
        50. SubstanceDefinition.code:unii.code
        Control1..?
        Must Supporttrue
        52. SubstanceDefinition.code:unii.code.coding
        Control1..1
        Must Supporttrue
        54. SubstanceDefinition.code:unii.code.coding.system
        Control1..?
        Must Supporttrue
        Pattern Valuehttp://fdasis.nlm.nih.gov
        56. SubstanceDefinition.code:uniProt
        Slice NameuniProt
        Definition

        The UniProt ID is an index to the UniProt knowledgebase, a large resource of protein sequences and associated detailed annotation. It is accessible at https://www.uniprot.org/

        ShortUniProt ID
        Control0..1
        58. SubstanceDefinition.code:uniProt.code
        Control1..?
        Must Supporttrue
        60. SubstanceDefinition.code:uniProt.code.coding
        Control1..1
        Must Supporttrue
        62. SubstanceDefinition.code:uniProt.code.coding.system
        Control1..?
        Must Supporttrue
        Pattern Valuehttps://www.uniprot.org
        64. SubstanceDefinition.name
        Definition

        Substance Name is identified by its Substance Type. Substance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF

        ShortSubstance Name
        Control1..?
        Must Supporttrue
        Invariantscmc-name-preferred: Name.preferred: at most one = true (select(preferred = true).count() < 2)
        SlicingThis element introduces a set of slices on SubstanceDefinition.name. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
        • value @ type
        • 66. SubstanceDefinition.name.type
          BindingThe codes SHALL be taken from Substance Name Type
          (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type)
          68. SubstanceDefinition.name.preferred
          ShortTrue when the name type is Substance Name
          Must Supporttrue
          70. SubstanceDefinition.name:sub
          Slice Namesub
          Control0..1
          Must Supporttrue
          72. SubstanceDefinition.name:sub.name
          Definition

          A non-branded nor registered name that meant for common use.

          ShortGeneric Name
          Must Supporttrue
          74. SubstanceDefinition.name:sub.type
          Control1..?
          Must Supporttrue
          Pattern Value{
            "coding" : [{
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C97054",
              "display" : "Generic Name"
            }]
          }
          76. SubstanceDefinition.name:sub.preferred
          Must Supporttrue
          78. SubstanceDefinition.name:gsrs
          Slice Namegsrs
          Control0..1
          Must Supporttrue
          80. SubstanceDefinition.name:gsrs.name
          Definition

          Default display name identified within FDA Global Substance Registration System (GSRS).

          ShortGSRS Preferred Term
          Must Supporttrue
          82. SubstanceDefinition.name:gsrs.type
          Control1..?
          Must Supporttrue
          Pattern Value{
            "coding" : [{
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C203355",
              "display" : "GSRS Preferred Term"
            }]
          }
          84. SubstanceDefinition.name:gsrs.preferred
          Must Supporttrue
          86. SubstanceDefinition.name:isbt
          Slice Nameisbt
          Control0..1
          Must Supporttrue
          88. SubstanceDefinition.name:isbt.name
          Definition

          It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]

          ShortISBT-128 DIN
          Must Supporttrue
          90. SubstanceDefinition.name:isbt.type
          Control1..?
          Must Supporttrue
          Pattern Value{
            "coding" : [{
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C95517",
              "display" : "ISBT-128 DIN"
            }]
          }
          92. SubstanceDefinition.name:isbt.preferred
          Must Supporttrue
          94. SubstanceDefinition.name:comp
          Slice Namecomp
          Control0..1
          Must Supporttrue
          96. SubstanceDefinition.name:comp.name
          Definition

          An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]

          ShortCompany ID/Code
          Must Supporttrue
          98. SubstanceDefinition.name:comp.type
          Control1..?
          Must Supporttrue
          Pattern Value{
            "coding" : [{
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C203354",
              "display" : "Company ID/Code"
            }]
          }

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

          0. SubstanceDefinition
          Definition

          The detailed description of a substance, typically at a level beyond what is used for prescribing.

          ShortThe detailed description of a substance, typically at a level beyond what is used for prescribing
          Control0..*
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
          dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
          dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
          dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
          dom-6: A resource should have narrative for robust management (text.`div`.exists())
          cmc-impurity-unii-required: If Product Impurity Chemical Structure Data File is not present, then a unii is required (structure.representation.type.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C103240' ).exists().not() implies ( code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists() ))
          2. SubstanceDefinition.implicitRules
          Definition

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

          ShortA set of rules under which this content was created
          Comments

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

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

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

          ShortContained, inline Resources
          Comments

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

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

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

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

          ShortExtensions that cannot be ignored
          Comments

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

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

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

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

          Identifier by which this substance is known.

          Shortoptional user designated identifierIdentifier by which this substance is known
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..1*
          TypeIdentifier
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          10. SubstanceDefinition.classification
          Definition

          A categorization of impurities based on its origin. [Source: SME Defined] Examples: Degradation Product, Inorganic, Process Related/Process, Product Related, Leachables.


          A high level categorization, e.g. polymer or nucleic acid, or food, chemical, biological, or a lower level such as the general types of polymer (linear or branch chain) or type of impurity (process related or contaminant).

          ShortImpurity ClassificationA categorization, high level e.g. polymer or nucleic acid, or food, chemical, biological, or lower e.g. polymer linear or branch chain, or type of impurity
          Control10..*
          BindingThe codes SHALL be taken from For codes, see Impurity Classification Terminology
          (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology)
          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          12. SubstanceDefinition.characterization
          Definition

          General specifications for this substance.

          ShortGeneral specifications for this substance
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          14. SubstanceDefinition.characterization.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())
          16. SubstanceDefinition.characterization.technique
          Definition

          The technique used to elucidate the structure ore characterization of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc.


          The method used to elucidate the characterization of the drug substance. Example: HPLC.

          ShortSubstance Characterisation TechniqueThe method used to find the characterization e.g. HPLC
          Comments

          Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

          Control0..1
          BindingFor example codes, see StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-technique
          (example to http://hl7.org/fhir/ValueSet/substance-structure-technique)

          The method used to elucidate the characterization of the drug substance.

          TypeCodeableConcept(Text Only Codeable Concept)
          Is Modifierfalse
          Must Supporttrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          18. SubstanceDefinition.characterization.description
          Definition

          The description or justification in support of the interpretation of the data file.

          ShortAnalysis Narrative Text and TableThe description or justification in support of the interpretation of the data file
          Control0..1
          Typemarkdown
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          20. SubstanceDefinition.characterization.file
          Definition

          The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis.

          ShortImpurity Analysis Graphic | Impurity Analytical Instrument Data FileThe data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis
          Control0..*
          TypeAttachment
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on SubstanceDefinition.characterization.file. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • profile @ $this
          • 22. SubstanceDefinition.characterization.file:AnalysisGraphic
            Slice NameAnalysisGraphic
            Definition

            Analysis Graphic: The pictorial representation of the data. [Source: SME Defined] Examples: spectrum, chromatogram. Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the instrumental output for the molecule -- CH3OHA pictorial representation of the structure of the drug substance. Required for Small Molecules. [Source: SME Defined]


            The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis.

            ShortAnalysis GraphicThe data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis
            Comments

            When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as "Signed Procedure Consent".

            Control0..*
            TypeAttachment(Analysis Graphic)
            Is Modifierfalse
            Must Supportfalse
            Invariantsatt-1: If the Attachment has data, it SHALL have a contentType (data.empty() or contentType.exists())
            ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            24. SubstanceDefinition.characterization.file:AnalyticalInstrumentData
            Slice NameAnalyticalInstrumentData
            Definition

            Impurity Analytical Instrument Data File: The transport format for data exchange. [Source: SME Defined] Example: JCAMP, ADX, ADF.


            The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis.

            ShortAnalytical Instrument Data FileThe data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis
            Comments

            When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as "Signed Procedure Consent".

            Control0..*
            TypeAttachment(Analytical Instrument Data)
            Is Modifierfalse
            Must Supportfalse
            Invariantsatt-1: If the Attachment has data, it SHALL have a contentType (data.empty() or contentType.exists())
            ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            26. SubstanceDefinition.structure
            Definition

            Structural information.

            ShortStructural information
            Control0..1
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            28. SubstanceDefinition.structure.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())
            30. SubstanceDefinition.structure.technique
            Definition

            The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.


            The method used to elucidate the structure of the drug substance. Examples: X-ray, NMR, Peptide mapping, Ligand binding assay.

            ShortImpurity Substance Characterisation TechniqueThe method used to find the structure e.g. X-ray, NMR
            Comments

            Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

            Control0..*
            BindingFor example codes, see StructureTechniquehttp://hl7.org/fhir/ValueSet/substance-structure-technique
            (example to http://hl7.org/fhir/ValueSet/substance-structure-technique)

            The method used to elucidate the structure of the drug substance.

            TypeCodeableConcept(Text Only Codeable Concept)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            32. SubstanceDefinition.structure.representation
            Definition

            A depiction of the structure of the substance.

            ShortImpurity Structure Graphic | Impurity Structure Data FileA depiction of the structure of the substance
            Control0..*
            TypeBackboneElement
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on SubstanceDefinition.structure.representation. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
            • value @ type
            • 34. SubstanceDefinition.structure.representation.modifierExtension
              Definition

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              The kind of structural representation (e.g. full, partial).

              ShortThe kind of structural representation (e.g. full, partial)
              Control10..1
              BindingThe codes SHALL be taken from For example codes, see Representation Typeshttp://hl7.org/fhir/ValueSet/substance-representation-type
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types)
              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              38. SubstanceDefinition.structure.representation:graphic
              Slice Namegraphic
              Definition

              A depiction of the structure of the substance.

              ShortA graphical, displayable depiction of the structure (e.g. an SVG, PNG)A depiction of the structure of the substance
              Control0..1*
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              40. SubstanceDefinition.structure.representation:graphic.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())
              42. SubstanceDefinition.structure.representation:graphic.type
              Definition

              The kind of structural representation (e.g. full, partial).

              ShortGraphicThe kind of structural representation (e.g. full, partial)
              Control0..1
              BindingFor example codes, see SubstanceRepresentationTypehttp://hl7.org/fhir/ValueSet/substance-representation-type
              (example to http://hl7.org/fhir/ValueSet/substance-representation-type)

              A format of a substance representation.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Pattern Value{
                "coding" : [{
                  "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                  "code" : "C54273"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              44. SubstanceDefinition.structure.representation:graphic.document
              Definition

              A pictorial representation of the structure of the impurity substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.


              An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.

              ShortImpurity Structure GraphicAn attachment with the structural representation e.g. a structure graphic or AnIML file
              Control10..1
              TypeReference(Literal Reference)(Graphic Reference, DocumentReference)bundled
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              46. SubstanceDefinition.structure.representation:structureFile
              Slice NamestructureFile
              Definition

              A depiction of the structure of the substance.

              Shortmachine-readable representation -- attached fileA depiction of the structure of the substance
              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              48. SubstanceDefinition.structure.representation:structureFile.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. SubstanceDefinition.structure.representation:structureFile.type
              Definition

              The kind of structural representation (e.g. full, partial).

              ShortStructure FileThe kind of structural representation (e.g. full, partial)
              Control0..1
              BindingFor example codes, see SubstanceRepresentationTypehttp://hl7.org/fhir/ValueSet/substance-representation-type
              (example to http://hl7.org/fhir/ValueSet/substance-representation-type)

              A format of a substance representation.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Pattern Value{
                "coding" : [{
                  "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                  "code" : "C103240"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              52. SubstanceDefinition.structure.representation:structureFile.document
              Definition

              An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.

              ShortImpurity Chemical Structure Data (files, e.g. .SDF, .CIF)An attachment with the structural representation e.g. a structure graphic or AnIML file
              Control10..1
              TypeReference(Literal Reference)(Structure Data Reference, DocumentReference)bundled
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              54. SubstanceDefinition.structure.representation:structureString
              Slice NamestructureString
              Definition

              A depiction of the structure of the substance.

              Shortmachine-readable representation -- plain textA depiction of the structure of the substance
              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              56. SubstanceDefinition.structure.representation:structureString.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())
              58. SubstanceDefinition.structure.representation:structureString.type
              Definition

              The kind of structural representation (e.g. full, partial).

              ShortStructure TextualThe kind of structural representation (e.g. full, partial)
              Control0..1
              BindingFor example codes, see SubstanceRepresentationTypehttp://hl7.org/fhir/ValueSet/substance-representation-type
              (example to http://hl7.org/fhir/ValueSet/substance-representation-type)

              A format of a substance representation.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Pattern Value{
                "coding" : [{
                  "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                  "code" : "C45253"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              60. SubstanceDefinition.structure.representation:structureString.representation
              Definition

              A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SMILES, INCHI


              The structural representation as a text string in a standard format.

              ShortImpurity Chemical Structure Data (short, plain text representations, e.g. SMILES)The structural representation as a text string in a standard format
              Control10..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              62. SubstanceDefinition.structure.representation:structureString.format
              Definition

              The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.

              ShortDrug Substance Impurity Method TypeThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
              Control10..1
              BindingThe codes SHALL be taken from For example codes, see Chemical Structure Data File Type Terminologyhttp://hl7.org/fhir/ValueSet/substance-representation-format
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology)
              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              64. SubstanceDefinition.code
              Definition

              Codes associated with the substance.

              ShortCodes associated with the substance
              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on SubstanceDefinition.code. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ code.coding.system
              • 66. SubstanceDefinition.code.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())
                68. SubstanceDefinition.code:unii
                Slice Nameunii
                Definition

                The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/] Example: 362O9ITL9D Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/


                Codes associated with the substance.

                ShortUNIICodes associated with the substance
                Control0..1*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                70. SubstanceDefinition.code:unii.modifierExtension
                Definition

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

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

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

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

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

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

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

                The specific code.

                ShortThe specific code
                Control10..1
                TypeCodeableConcept
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                74. SubstanceDefinition.code:unii.code.coding
                Definition

                A reference to a code defined by a terminology system.

                ShortCode defined by a terminology system
                Comments

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

                Control10..1*
                TypeCoding
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

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

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                76. SubstanceDefinition.code:unii.code.coding.system
                Definition

                The identification of the code system that defines the meaning of the symbol in the code.

                ShortIdentity of the terminology system
                Comments

                The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

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

                Need to be unambiguous about the source of the definition of the symbol.

                Pattern Valuehttp://fdasis.nlm.nih.gov
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                78. SubstanceDefinition.code:uniProt
                Slice NameuniProt
                Definition

                The UniProt ID is an index to the UniProt knowledgebase, a large resource of protein sequences and associated detailed annotation. It is accessible at https://www.uniprot.org/


                Codes associated with the substance.

                ShortUniProt IDCodes associated with the substance
                Control0..1*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                80. SubstanceDefinition.code:uniProt.modifierExtension
                Definition

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

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

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

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

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

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

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

                The specific code.

                ShortThe specific code
                Control10..1
                TypeCodeableConcept
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                84. SubstanceDefinition.code:uniProt.code.coding
                Definition

                A reference to a code defined by a terminology system.

                ShortCode defined by a terminology system
                Comments

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

                Control10..1*
                TypeCoding
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Requirements

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

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                86. SubstanceDefinition.code:uniProt.code.coding.system
                Definition

                The identification of the code system that defines the meaning of the symbol in the code.

                ShortIdentity of the terminology system
                Comments

                The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

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

                Need to be unambiguous about the source of the definition of the symbol.

                Pattern Valuehttps://www.uniprot.org
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                88. SubstanceDefinition.name
                Definition

                Substance Name is identified by its Substance Type. Substance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF


                Names applicable to this substance.

                ShortSubstance NameNames applicable to this substance
                Control10..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                cmc-name-preferred: Name.preferred: at most one = true (select(preferred = true).count() < 2)
                SlicingThis element introduces a set of slices on SubstanceDefinition.name. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                • value @ type
                • 90. SubstanceDefinition.name.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())
                  92. SubstanceDefinition.name.name
                  Definition

                  The actual name.

                  ShortThe actual name
                  Control1..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  94. SubstanceDefinition.name.type
                  Definition

                  Name type, for example 'systematic', 'scientific, 'brand'.

                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                  Control0..1
                  BindingThe codes SHALL be taken from For example codes, see Substance Name Typehttp://hl7.org/fhir/ValueSet/substance-name-type
                  (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type)
                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  96. SubstanceDefinition.name.preferred
                  Definition

                  If this is the preferred name for this substance.

                  ShortTrue when the name type is Substance NameIf this is the preferred name for this substance
                  Control0..1
                  Typeboolean
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  98. SubstanceDefinition.name:sub
                  Slice Namesub
                  Definition

                  Names applicable to this substance.

                  ShortNames applicable to this substance
                  Control0..1*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  100. SubstanceDefinition.name:sub.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())
                  102. SubstanceDefinition.name:sub.name
                  Definition

                  A non-branded nor registered name that meant for common use.


                  The actual name.

                  ShortGeneric NameThe actual name
                  Control1..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  104. SubstanceDefinition.name:sub.type
                  Definition

                  Name type, for example 'systematic', 'scientific, 'brand'.

                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                  Control10..1
                  BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
                  (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                  The type of a name given to a substance.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C97054",
                      "display" : "Generic Name"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  106. SubstanceDefinition.name:sub.preferred
                  Definition

                  If this is the preferred name for this substance.

                  ShortIf this is the preferred name for this substance
                  Control0..1
                  Typeboolean
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  108. SubstanceDefinition.name:gsrs
                  Slice Namegsrs
                  Definition

                  Names applicable to this substance.

                  ShortNames applicable to this substance
                  Control0..1*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  110. SubstanceDefinition.name:gsrs.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())
                  112. SubstanceDefinition.name:gsrs.name
                  Definition

                  Default display name identified within FDA Global Substance Registration System (GSRS).


                  The actual name.

                  ShortGSRS Preferred TermThe actual name
                  Control1..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  114. SubstanceDefinition.name:gsrs.type
                  Definition

                  Name type, for example 'systematic', 'scientific, 'brand'.

                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                  Control10..1
                  BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
                  (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                  The type of a name given to a substance.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C203355",
                      "display" : "GSRS Preferred Term"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  116. SubstanceDefinition.name:gsrs.preferred
                  Definition

                  If this is the preferred name for this substance.

                  ShortIf this is the preferred name for this substance
                  Control0..1
                  Typeboolean
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  118. SubstanceDefinition.name:isbt
                  Slice Nameisbt
                  Definition

                  Names applicable to this substance.

                  ShortNames applicable to this substance
                  Control0..1*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  120. SubstanceDefinition.name:isbt.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())
                  122. SubstanceDefinition.name:isbt.name
                  Definition

                  It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]


                  The actual name.

                  ShortISBT-128 DINThe actual name
                  Control1..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  124. SubstanceDefinition.name:isbt.type
                  Definition

                  Name type, for example 'systematic', 'scientific, 'brand'.

                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                  Control10..1
                  BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
                  (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                  The type of a name given to a substance.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C95517",
                      "display" : "ISBT-128 DIN"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  126. SubstanceDefinition.name:isbt.preferred
                  Definition

                  If this is the preferred name for this substance.

                  ShortIf this is the preferred name for this substance
                  Control0..1
                  Typeboolean
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  128. SubstanceDefinition.name:comp
                  Slice Namecomp
                  Definition

                  Names applicable to this substance.

                  ShortNames applicable to this substance
                  Control0..1*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  130. SubstanceDefinition.name:comp.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())
                  132. SubstanceDefinition.name:comp.name
                  Definition

                  An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]


                  The actual name.

                  ShortCompany ID/CodeThe actual name
                  Control1..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  134. SubstanceDefinition.name:comp.type
                  Definition

                  Name type, for example 'systematic', 'scientific, 'brand'.

                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                  Control10..1
                  BindingFor example codes, see SubstanceNameTypehttp://hl7.org/fhir/ValueSet/substance-name-type
                  (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                  The type of a name given to a substance.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                      "code" : "C203354",
                      "display" : "Company ID/Code"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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

                  0. SubstanceDefinition
                  Definition

                  The detailed description of a substance, typically at a level beyond what is used for prescribing.

                  ShortThe detailed description of a substance, typically at a level beyond what is used for prescribing
                  Control0..*
                  Is Modifierfalse
                  Must Supportfalse
                  Summaryfalse
                  Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                  dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
                  dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
                  dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                  dom-6: A resource should have narrative for robust management (text.`div`.exists())
                  cmc-impurity-unii-required: If Product Impurity Chemical Structure Data File is not present, then a unii is required (structure.representation.type.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C103240' ).exists().not() implies ( code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists() ))
                  2. SubstanceDefinition.id
                  Definition

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

                  ShortLogical id of this artifact
                  Comments

                  Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

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

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

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

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

                  ShortA set of rules under which this content was created
                  Comments

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

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

                  The base language in which the resource is written.

                  ShortLanguage of the resource content
                  Comments

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

                  Control0..1
                  BindingThe codes SHALL be taken from AllLanguages
                  (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                  IETF language tag for a human language

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

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

                  ShortText summary of the resource, for human interpretation
                  Comments

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

                  Control0..1
                  This element is affected by the following invariants: dom-6
                  TypeNarrative
                  Is Modifierfalse
                  Must Supportfalse
                  Summaryfalse
                  Alternate Namesnarrative, html, xhtml, display
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  12. SubstanceDefinition.contained
                  Definition

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

                  ShortContained, inline Resources
                  Comments

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

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

                  May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and 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
                  Must Supportfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  16. SubstanceDefinition.modifierExtension
                  Definition

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

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

                  ShortExtensions that cannot be ignored
                  Comments

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

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

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

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

                  Identifier by which this substance is known.

                  Shortoptional user designated identifier
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..1
                  TypeIdentifier
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  20. SubstanceDefinition.version
                  Definition

                  A business level version identifier of the substance.

                  ShortA business level version identifier of the substance
                  NoteThis is a business version Id, not a resource version Id (see discussion)
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  22. SubstanceDefinition.status
                  Definition

                  Status of substance within the catalogue e.g. active, retired.

                  ShortStatus of substance within the catalogue e.g. active, retired
                  Control0..1
                  BindingThe codes SHOULD be taken from PublicationStatus
                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                  The lifecycle status of an artifact.

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

                  A categorization of impurities based on its origin. [Source: SME Defined] Examples: Degradation Product, Inorganic, Process Related/Process, Product Related, Leachables.

                  ShortImpurity Classification
                  Control1..*
                  BindingThe codes SHALL be taken from Impurity Classification Terminology
                  (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-impurity-classification-terminology)
                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  26. SubstanceDefinition.domain
                  Definition

                  If the substance applies to human or veterinary use.

                  ShortIf the substance applies to human or veterinary use
                  Control0..1
                  BindingFor example codes, see MedicinalProductDomain
                  (example to http://hl7.org/fhir/ValueSet/medicinal-product-domain)

                  Applicable domain for this product (e.g. human, veterinary).

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

                  The quality standard, established benchmark, to which substance complies (e.g. USP/NF, Ph. Eur, JP, BP, Company Standard).

                  ShortThe quality standard, established benchmark, to which substance complies (e.g. USP/NF, BP)
                  Control0..*
                  BindingFor example codes, see SubstanceGrade
                  (example to http://hl7.org/fhir/ValueSet/substance-grade)

                  The quality standard, established benchmark, to which a substance complies

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

                  Textual description of the substance.

                  ShortTextual description of the substance
                  Control0..1
                  Typemarkdown
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  32. SubstanceDefinition.informationSource
                  Definition

                  Supporting literature.

                  ShortSupporting literature
                  Control0..*
                  TypeReference(Citation)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  34. SubstanceDefinition.note
                  Definition

                  Textual comment about the substance's catalogue or registry record.

                  ShortTextual comment about the substance's catalogue or registry record
                  Control0..*
                  TypeAnnotation
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  36. SubstanceDefinition.manufacturer
                  Definition

                  The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive.

                  ShortThe entity that creates, makes, produces or fabricates the substance
                  Control0..*
                  TypeReference(Organization)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  38. SubstanceDefinition.supplier
                  Definition

                  An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor.

                  ShortAn entity that is the source for the substance. It may be different from the manufacturer
                  Control0..*
                  TypeReference(Organization)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  40. SubstanceDefinition.moiety
                  Definition

                  Moiety, for structural modifications.

                  ShortMoiety, for structural modifications
                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  42. SubstanceDefinition.moiety.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
                  44. SubstanceDefinition.moiety.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())
                  46. SubstanceDefinition.moiety.modifierExtension
                  Definition

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

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

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

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

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

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

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

                  Role that the moiety is playing.

                  ShortRole that the moiety is playing
                  Control0..1
                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  50. SubstanceDefinition.moiety.identifier
                  Definition

                  Identifier by which this moiety substance is known.

                  ShortIdentifier by which this moiety substance is known
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..1
                  TypeIdentifier
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  52. SubstanceDefinition.moiety.name
                  Definition

                  Textual name for this moiety substance.

                  ShortTextual name for this moiety substance
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  54. SubstanceDefinition.moiety.stereochemistry
                  Definition

                  Stereochemistry type.

                  ShortStereochemistry type
                  Control0..1
                  BindingFor example codes, see Stereochemistry
                  (example to http://hl7.org/fhir/ValueSet/substance-stereochemistry)

                  The optical rotation type of a substance.

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

                  Optical activity type.

                  ShortOptical activity type
                  Control0..1
                  BindingFor example codes, see OpticalActivity
                  (example to http://hl7.org/fhir/ValueSet/substance-optical-activity)

                  The optical rotation type of a substance.

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

                  Molecular formula for this moiety of this substance, typically using the Hill system.

                  ShortMolecular formula for this moiety (e.g. with the Hill system)
                  Control0..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  60. SubstanceDefinition.moiety.amount[x]
                  Definition

                  Quantitative value for this moiety.

                  ShortQuantitative value for this moiety
                  Control0..1
                  TypeChoice of: Quantity, string
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  62. SubstanceDefinition.moiety.measurementType
                  Definition

                  The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio.

                  ShortThe measurement type of the quantitative value
                  Control0..1
                  BindingFor example codes, see SubstanceAmountType
                  (example to http://hl7.org/fhir/ValueSet/substance-amount-type)

                  The relationship between two substance types.

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

                  General specifications for this substance.

                  ShortGeneral specifications for this substance
                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  66. SubstanceDefinition.characterization.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
                  68. SubstanceDefinition.characterization.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())
                  70. SubstanceDefinition.characterization.modifierExtension
                  Definition

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

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

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

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

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

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

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

                  The technique used to elucidate the structure ore characterization of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc.

                  ShortSubstance Characterisation Technique
                  Comments

                  Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                  Control0..1
                  BindingFor example codes, see StructureTechnique
                  (example to http://hl7.org/fhir/ValueSet/substance-structure-technique)

                  The method used to elucidate the characterization of the drug substance.

                  TypeCodeableConcept(Text Only Codeable Concept)
                  Is Modifierfalse
                  Must Supporttrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  74. SubstanceDefinition.characterization.form
                  Definition

                  Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form.

                  ShortDescribes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form
                  Control0..1
                  BindingFor example codes, see SubstanceForm
                  (example to http://hl7.org/fhir/ValueSet/substance-form)
                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  76. SubstanceDefinition.characterization.description
                  Definition

                  The description or justification in support of the interpretation of the data file.

                  ShortAnalysis Narrative Text and Table
                  Control0..1
                  Typemarkdown
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  78. SubstanceDefinition.characterization.file
                  Definition

                  The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis.

                  ShortImpurity Analysis Graphic | Impurity Analytical Instrument Data File
                  Control0..*
                  TypeAttachment
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  SlicingThis element introduces a set of slices on SubstanceDefinition.characterization.file. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • profile @ $this
                  • 80. SubstanceDefinition.characterization.file:AnalysisGraphic
                    Slice NameAnalysisGraphic
                    Definition

                    Analysis Graphic: The pictorial representation of the data. [Source: SME Defined] Examples: spectrum, chromatogram. Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the instrumental output for the molecule -- CH3OHA pictorial representation of the structure of the drug substance. Required for Small Molecules. [Source: SME Defined]

                    ShortAnalysis Graphic
                    Comments

                    When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as "Signed Procedure Consent".

                    Control0..*
                    TypeAttachment(Analysis Graphic)
                    Is Modifierfalse
                    Must Supportfalse
                    Invariantsatt-1: If the Attachment has data, it SHALL have a contentType (data.empty() or contentType.exists())
                    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    82. SubstanceDefinition.characterization.file:AnalyticalInstrumentData
                    Slice NameAnalyticalInstrumentData
                    Definition

                    Impurity Analytical Instrument Data File: The transport format for data exchange. [Source: SME Defined] Example: JCAMP, ADX, ADF.

                    ShortAnalytical Instrument Data File
                    Comments

                    When providing a summary view (for example with Observation.value[x]) Attachment should be represented with a brief display text such as "Signed Procedure Consent".

                    Control0..*
                    TypeAttachment(Analytical Instrument Data)
                    Is Modifierfalse
                    Must Supportfalse
                    Invariantsatt-1: If the Attachment has data, it SHALL have a contentType (data.empty() or contentType.exists())
                    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    84. SubstanceDefinition.property
                    Definition

                    General specifications for this substance.

                    ShortGeneral specifications for this substance
                    Control0..*
                    TypeBackboneElement
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    86. SubstanceDefinition.property.id
                    Definition

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

                    ShortUnique id for inter-element referencing
                    Control0..1
                    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
                    88. SubstanceDefinition.property.extension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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())
                    90. SubstanceDefinition.property.modifierExtension
                    Definition

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

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

                    ShortExtensions that cannot be ignored even if unrecognized
                    Comments

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

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

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

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

                    A code expressing the type of property.

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

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

                    TypeCodeableConcept
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    94. SubstanceDefinition.property.value[x]
                    Definition

                    A value for the property.

                    ShortA value for the property
                    Control0..1
                    TypeChoice of: CodeableConcept, Quantity, date, boolean, Attachment
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    96. SubstanceDefinition.referenceInformation
                    Definition

                    General information detailing this substance.

                    ShortGeneral information detailing this substance
                    Control0..1
                    TypeReference(SubstanceReferenceInformation)
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    98. SubstanceDefinition.molecularWeight
                    Definition

                    The average mass of a molecule of a compound compared to 1/12 the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms.

                    ShortThe average mass of a molecule of a compound
                    Control0..*
                    TypeBackboneElement
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    100. SubstanceDefinition.molecularWeight.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
                    102. SubstanceDefinition.molecularWeight.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())
                    104. SubstanceDefinition.molecularWeight.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())
                    106. SubstanceDefinition.molecularWeight.method
                    Definition

                    The method by which the molecular weight was determined.

                    ShortThe method by which the weight was determined
                    Control0..1
                    BindingFor example codes, see WeightMethod
                    (example to http://hl7.org/fhir/ValueSet/substance-weight-method)

                    The method by which the substance weight was measured.

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

                    Type of molecular weight such as exact, average (also known as. number average), weight average.

                    ShortType of molecular weight e.g. exact, average, weight average
                    Control0..1
                    BindingFor example codes, see WeightType
                    (example to http://hl7.org/fhir/ValueSet/substance-weight-type)

                    The type of substance weight measurement.

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

                    Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field.

                    ShortUsed to capture quantitative values for a variety of elements
                    Control1..1
                    TypeQuantity
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    112. SubstanceDefinition.structure
                    Definition

                    Structural information.

                    ShortStructural information
                    Control0..1
                    TypeBackboneElement
                    Is Modifierfalse
                    Must Supporttrue
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    114. SubstanceDefinition.structure.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
                    116. SubstanceDefinition.structure.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())
                    118. SubstanceDefinition.structure.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())
                    120. SubstanceDefinition.structure.stereochemistry
                    Definition

                    Stereochemistry type.

                    ShortStereochemistry type
                    Control0..1
                    BindingFor example codes, see Stereochemistry
                    (example to http://hl7.org/fhir/ValueSet/substance-stereochemistry)

                    The optical rotation type of a substance.

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

                    Optical activity type.

                    ShortOptical activity type
                    Control0..1
                    BindingFor example codes, see OpticalActivity
                    (example to http://hl7.org/fhir/ValueSet/substance-optical-activity)

                    The optical rotation type of a substance.

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

                    An expression which states the number and type of atoms present in a molecule of a substance.

                    ShortAn expression which states the number and type of atoms present in a molecule of a substance
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    126. SubstanceDefinition.structure.molecularFormulaByMoiety
                    Definition

                    Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot.

                    ShortSpecified per moiety according to the Hill system
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    128. SubstanceDefinition.structure.molecularWeight
                    Definition

                    The molecular weight or weight range (for proteins, polymers or nucleic acids).

                    ShortThe molecular weight or weight range
                    Control0..1
                    TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.molecularWeight
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    130. SubstanceDefinition.structure.technique
                    Definition

                    The technique used to elucidate the structure or characterisation of the drug substance. [Source: SME Defined] Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.

                    ShortImpurity Substance Characterisation Technique
                    Comments

                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                    Control0..*
                    BindingFor example codes, see StructureTechnique
                    (example to http://hl7.org/fhir/ValueSet/substance-structure-technique)

                    The method used to elucidate the structure of the drug substance.

                    TypeCodeableConcept(Text Only Codeable Concept)
                    Is Modifierfalse
                    Must Supporttrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    132. SubstanceDefinition.structure.sourceDocument
                    Definition

                    The source of information about the structure.

                    ShortSource of information for the structure
                    Control0..*
                    TypeReference(DocumentReference)
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    134. SubstanceDefinition.structure.representation
                    Definition

                    A depiction of the structure of the substance.

                    ShortImpurity Structure Graphic | Impurity Structure Data File
                    Control0..*
                    TypeBackboneElement
                    Is Modifierfalse
                    Must Supporttrue
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    SlicingThis element introduces a set of slices on SubstanceDefinition.structure.representation. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                    • value @ type
                    • 136. SubstanceDefinition.structure.representation.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
                      138. SubstanceDefinition.structure.representation.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())
                      140. SubstanceDefinition.structure.representation.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())
                      142. SubstanceDefinition.structure.representation.type
                      Definition

                      The kind of structural representation (e.g. full, partial).

                      ShortThe kind of structural representation (e.g. full, partial)
                      Control1..1
                      BindingThe codes SHALL be taken from Representation Types
                      (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types)
                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      144. SubstanceDefinition.structure.representation.representation
                      Definition

                      The structural representation as a text string in a standard format.

                      ShortThe structural representation as a text string in a standard format
                      Control0..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      146. SubstanceDefinition.structure.representation.format
                      Definition

                      The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.

                      ShortThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
                      Control0..1
                      BindingFor example codes, see SubstanceRepresentationFormat
                      (example to http://hl7.org/fhir/ValueSet/substance-representation-format)

                      A format of a substance representation.

                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      148. SubstanceDefinition.structure.representation.document
                      Definition

                      An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.

                      ShortAn attachment with the structural representation e.g. a structure graphic or AnIML file
                      Control0..1
                      TypeReference(DocumentReference)
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      150. SubstanceDefinition.structure.representation:graphic
                      Slice Namegraphic
                      Definition

                      A depiction of the structure of the substance.

                      ShortA graphical, displayable depiction of the structure (e.g. an SVG, PNG)
                      Control0..1
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      152. SubstanceDefinition.structure.representation:graphic.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
                      154. SubstanceDefinition.structure.representation:graphic.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())
                      156. SubstanceDefinition.structure.representation:graphic.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())
                      158. SubstanceDefinition.structure.representation:graphic.type
                      Definition

                      The kind of structural representation (e.g. full, partial).

                      ShortGraphic
                      Control0..1
                      BindingFor example codes, see SubstanceRepresentationType
                      (example to http://hl7.org/fhir/ValueSet/substance-representation-type)

                      A format of a substance representation.

                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Pattern Value{
                        "coding" : [{
                          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                          "code" : "C54273"
                        }]
                      }
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      160. SubstanceDefinition.structure.representation:graphic.representation
                      Definition

                      The structural representation as a text string in a standard format.

                      ShortThe structural representation as a text string in a standard format
                      Control0..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      162. SubstanceDefinition.structure.representation:graphic.format
                      Definition

                      The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.

                      ShortThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
                      Control0..1
                      BindingFor example codes, see SubstanceRepresentationFormat
                      (example to http://hl7.org/fhir/ValueSet/substance-representation-format)

                      A format of a substance representation.

                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      164. SubstanceDefinition.structure.representation:graphic.document
                      Definition

                      A pictorial representation of the structure of the impurity substance. [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for use in eCTD' Example: This is the representation of the molecule CH3OH, or the sequence SHLVEALALVAGERG.

                      ShortImpurity Structure Graphic
                      Control1..1
                      TypeReference(Literal Reference)(Graphic Reference)bundled
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      166. SubstanceDefinition.structure.representation:structureFile
                      Slice NamestructureFile
                      Definition

                      A depiction of the structure of the substance.

                      Shortmachine-readable representation -- attached file
                      Control0..*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      168. SubstanceDefinition.structure.representation:structureFile.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
                      170. SubstanceDefinition.structure.representation:structureFile.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())
                      172. SubstanceDefinition.structure.representation:structureFile.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())
                      174. SubstanceDefinition.structure.representation:structureFile.type
                      Definition

                      The kind of structural representation (e.g. full, partial).

                      ShortStructure File
                      Control0..1
                      BindingFor example codes, see SubstanceRepresentationType
                      (example to http://hl7.org/fhir/ValueSet/substance-representation-type)

                      A format of a substance representation.

                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Pattern Value{
                        "coding" : [{
                          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                          "code" : "C103240"
                        }]
                      }
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      176. SubstanceDefinition.structure.representation:structureFile.representation
                      Definition

                      The structural representation as a text string in a standard format.

                      ShortThe structural representation as a text string in a standard format
                      Control0..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      178. SubstanceDefinition.structure.representation:structureFile.format
                      Definition

                      The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.

                      ShortThe format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)
                      Control0..1
                      BindingFor example codes, see SubstanceRepresentationFormat
                      (example to http://hl7.org/fhir/ValueSet/substance-representation-format)

                      A format of a substance representation.

                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      180. SubstanceDefinition.structure.representation:structureFile.document
                      Definition

                      An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.

                      ShortImpurity Chemical Structure Data (files, e.g. .SDF, .CIF)
                      Control1..1
                      TypeReference(Literal Reference)(Structure Data Reference)bundled
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      182. SubstanceDefinition.structure.representation:structureString
                      Slice NamestructureString
                      Definition

                      A depiction of the structure of the substance.

                      Shortmachine-readable representation -- plain text
                      Control0..*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      184. SubstanceDefinition.structure.representation:structureString.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
                      186. SubstanceDefinition.structure.representation:structureString.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())
                      188. SubstanceDefinition.structure.representation:structureString.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())
                      190. SubstanceDefinition.structure.representation:structureString.type
                      Definition

                      The kind of structural representation (e.g. full, partial).

                      ShortStructure Textual
                      Control0..1
                      BindingFor example codes, see SubstanceRepresentationType
                      (example to http://hl7.org/fhir/ValueSet/substance-representation-type)

                      A format of a substance representation.

                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Pattern Value{
                        "coding" : [{
                          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                          "code" : "C45253"
                        }]
                      }
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      192. SubstanceDefinition.structure.representation:structureString.representation
                      Definition

                      A machine-readable representation of the structure of the chemical. [Source: SME Defined] Examples: SMILES, INCHI

                      ShortImpurity Chemical Structure Data (short, plain text representations, e.g. SMILES)
                      Control1..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      194. SubstanceDefinition.structure.representation:structureString.format
                      Definition

                      The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document.

                      ShortDrug Substance Impurity Method Type
                      Control1..1
                      BindingThe codes SHALL be taken from Chemical Structure Data File Type Terminology
                      (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology)
                      TypeCodeableConcept
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      196. SubstanceDefinition.structure.representation:structureString.document
                      Definition

                      An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file.

                      ShortAn attachment with the structural representation e.g. a structure graphic or AnIML file
                      Control0..1
                      TypeReference(DocumentReference)
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      198. SubstanceDefinition.code
                      Definition

                      Codes associated with the substance.

                      ShortCodes associated with the substance
                      Control0..*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      SlicingThis element introduces a set of slices on SubstanceDefinition.code. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ code.coding.system
                      • 200. SubstanceDefinition.code.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
                        202. SubstanceDefinition.code.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())
                        204. SubstanceDefinition.code.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())
                        206. SubstanceDefinition.code.code
                        Definition

                        The specific code.

                        ShortThe specific code
                        Control0..1
                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        208. SubstanceDefinition.code.status
                        Definition

                        Status of the code assignment, for example 'provisional', 'approved'.

                        ShortStatus of the code assignment, for example 'provisional', 'approved'
                        Control0..1
                        BindingThe codes SHOULD be taken from PublicationStatus
                        (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                        The lifecycle status of an artifact.

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

                        The date at which the code status was changed as part of the terminology maintenance.

                        ShortThe date at which the code status was changed
                        Control0..1
                        TypedateTime
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        212. SubstanceDefinition.code.note
                        Definition

                        Any comment can be provided in this field, if necessary.

                        ShortAny comment can be provided in this field
                        Control0..*
                        TypeAnnotation
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        214. SubstanceDefinition.code.source
                        Definition

                        Supporting literature.

                        ShortSupporting literature
                        Control0..*
                        TypeReference(DocumentReference)
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        216. SubstanceDefinition.code:unii
                        Slice Nameunii
                        Definition

                        The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/] Example: 362O9ITL9D Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/

                        ShortUNII
                        Control0..1
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        218. SubstanceDefinition.code:unii.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
                        220. SubstanceDefinition.code:unii.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())
                        222. SubstanceDefinition.code:unii.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())
                        224. SubstanceDefinition.code:unii.code
                        Definition

                        The specific code.

                        ShortThe specific code
                        Control1..1
                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supporttrue
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        226. SubstanceDefinition.code:unii.code.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
                        228. SubstanceDefinition.code:unii.code.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 SubstanceDefinition.code.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 230. SubstanceDefinition.code:unii.code.coding
                          Definition

                          A reference to a code defined by a terminology system.

                          ShortCode defined by a terminology system
                          Comments

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

                          Control1..1
                          TypeCoding
                          Is Modifierfalse
                          Must Supporttrue
                          Summarytrue
                          Requirements

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

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          232. SubstanceDefinition.code:unii.code.coding.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
                          234. SubstanceDefinition.code:unii.code.coding.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 SubstanceDefinition.code.code.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 236. SubstanceDefinition.code:unii.code.coding.system
                            Definition

                            The identification of the code system that defines the meaning of the symbol in the code.

                            ShortIdentity of the terminology system
                            Comments

                            The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                            Control1..1
                            Typeuri
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Requirements

                            Need to be unambiguous about the source of the definition of the symbol.

                            Pattern Valuehttp://fdasis.nlm.nih.gov
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            238. SubstanceDefinition.code:unii.code.coding.version
                            Definition

                            The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                            ShortVersion of the system - if relevant
                            Comments

                            Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                            NoteThis is a business version Id, not a resource version Id (see discussion)
                            Control0..1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            240. SubstanceDefinition.code:unii.code.coding.code
                            Definition

                            A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                            ShortSymbol in syntax defined by the system
                            Control0..1
                            This element is affected by the following invariants: cod-1
                            Typecode
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            Need to refer to a particular code in the system.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            242. SubstanceDefinition.code:unii.code.coding.display
                            Definition

                            A representation of the meaning of the code in the system, following the rules of the system.

                            ShortRepresentation defined by the system
                            Control0..1
                            This element is affected by the following invariants: cod-1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            244. SubstanceDefinition.code:unii.code.coding.userSelected
                            Definition

                            Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                            ShortIf this coding was chosen directly by the user
                            Comments

                            Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                            Control0..1
                            Typeboolean
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

                            This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            246. SubstanceDefinition.code:unii.code.text
                            Definition

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

                            ShortPlain text representation of the concept
                            Comments

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

                            Control0..1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Summarytrue
                            Requirements

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

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            248. SubstanceDefinition.code:unii.status
                            Definition

                            Status of the code assignment, for example 'provisional', 'approved'.

                            ShortStatus of the code assignment, for example 'provisional', 'approved'
                            Control0..1
                            BindingThe codes SHOULD be taken from PublicationStatus
                            (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                            The lifecycle status of an artifact.

                            TypeCodeableConcept
                            Is Modifierfalse
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            250. SubstanceDefinition.code:unii.statusDate
                            Definition

                            The date at which the code status was changed as part of the terminology maintenance.

                            ShortThe date at which the code status was changed
                            Control0..1
                            TypedateTime
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            252. SubstanceDefinition.code:unii.note
                            Definition

                            Any comment can be provided in this field, if necessary.

                            ShortAny comment can be provided in this field
                            Control0..*
                            TypeAnnotation
                            Is Modifierfalse
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            254. SubstanceDefinition.code:unii.source
                            Definition

                            Supporting literature.

                            ShortSupporting literature
                            Control0..*
                            TypeReference(DocumentReference)
                            Is Modifierfalse
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            256. SubstanceDefinition.code:uniProt
                            Slice NameuniProt
                            Definition

                            The UniProt ID is an index to the UniProt knowledgebase, a large resource of protein sequences and associated detailed annotation. It is accessible at https://www.uniprot.org/

                            ShortUniProt ID
                            Control0..1
                            TypeBackboneElement
                            Is Modifierfalse
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            258. SubstanceDefinition.code:uniProt.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
                            260. SubstanceDefinition.code:uniProt.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())
                            262. SubstanceDefinition.code:uniProt.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())
                            264. SubstanceDefinition.code:uniProt.code
                            Definition

                            The specific code.

                            ShortThe specific code
                            Control1..1
                            TypeCodeableConcept
                            Is Modifierfalse
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            266. SubstanceDefinition.code:uniProt.code.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
                            268. SubstanceDefinition.code:uniProt.code.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 SubstanceDefinition.code.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 270. SubstanceDefinition.code:uniProt.code.coding
                              Definition

                              A reference to a code defined by a terminology system.

                              ShortCode defined by a terminology system
                              Comments

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

                              Control1..1
                              TypeCoding
                              Is Modifierfalse
                              Must Supporttrue
                              Summarytrue
                              Requirements

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

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              272. SubstanceDefinition.code:uniProt.code.coding.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
                              274. SubstanceDefinition.code:uniProt.code.coding.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 SubstanceDefinition.code.code.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 276. SubstanceDefinition.code:uniProt.code.coding.system
                                Definition

                                The identification of the code system that defines the meaning of the symbol in the code.

                                ShortIdentity of the terminology system
                                Comments

                                The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                                Control1..1
                                Typeuri
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supporttrue
                                Summarytrue
                                Requirements

                                Need to be unambiguous about the source of the definition of the symbol.

                                Pattern Valuehttps://www.uniprot.org
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                278. SubstanceDefinition.code:uniProt.code.coding.version
                                Definition

                                The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                ShortVersion of the system - if relevant
                                Comments

                                Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                NoteThis is a business version Id, not a resource version Id (see discussion)
                                Control0..1
                                Typestring
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                280. SubstanceDefinition.code:uniProt.code.coding.code
                                Definition

                                A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                ShortSymbol in syntax defined by the system
                                Control0..1
                                This element is affected by the following invariants: cod-1
                                Typecode
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

                                Need to refer to a particular code in the system.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                282. SubstanceDefinition.code:uniProt.code.coding.display
                                Definition

                                A representation of the meaning of the code in the system, following the rules of the system.

                                ShortRepresentation defined by the system
                                Control0..1
                                This element is affected by the following invariants: cod-1
                                Typestring
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

                                Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                284. SubstanceDefinition.code:uniProt.code.coding.userSelected
                                Definition

                                Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                ShortIf this coding was chosen directly by the user
                                Comments

                                Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                                Control0..1
                                Typeboolean
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

                                This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                286. SubstanceDefinition.code:uniProt.code.text
                                Definition

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

                                ShortPlain text representation of the concept
                                Comments

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

                                Control0..1
                                Typestring
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

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

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                288. SubstanceDefinition.code:uniProt.status
                                Definition

                                Status of the code assignment, for example 'provisional', 'approved'.

                                ShortStatus of the code assignment, for example 'provisional', 'approved'
                                Control0..1
                                BindingThe codes SHOULD be taken from PublicationStatus
                                (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                The lifecycle status of an artifact.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                290. SubstanceDefinition.code:uniProt.statusDate
                                Definition

                                The date at which the code status was changed as part of the terminology maintenance.

                                ShortThe date at which the code status was changed
                                Control0..1
                                TypedateTime
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                292. SubstanceDefinition.code:uniProt.note
                                Definition

                                Any comment can be provided in this field, if necessary.

                                ShortAny comment can be provided in this field
                                Control0..*
                                TypeAnnotation
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                294. SubstanceDefinition.code:uniProt.source
                                Definition

                                Supporting literature.

                                ShortSupporting literature
                                Control0..*
                                TypeReference(DocumentReference)
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                296. SubstanceDefinition.name
                                Definition

                                Substance Name is identified by its Substance Type. Substance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined] Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF

                                ShortSubstance Name
                                Control1..*
                                TypeBackboneElement
                                Is Modifierfalse
                                Must Supporttrue
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                cmc-name-preferred: Name.preferred: at most one = true (select(preferred = true).count() < 2)
                                SlicingThis element introduces a set of slices on SubstanceDefinition.name. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                • value @ type
                                • 298. SubstanceDefinition.name.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
                                  300. SubstanceDefinition.name.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())
                                  302. SubstanceDefinition.name.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())
                                  304. SubstanceDefinition.name.name
                                  Definition

                                  The actual name.

                                  ShortThe actual name
                                  Control1..1
                                  Typestring
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  306. SubstanceDefinition.name.type
                                  Definition

                                  Name type, for example 'systematic', 'scientific, 'brand'.

                                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                                  Control0..1
                                  BindingThe codes SHALL be taken from Substance Name Type
                                  (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type)
                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  308. SubstanceDefinition.name.status
                                  Definition

                                  The status of the name, for example 'current', 'proposed'.

                                  ShortThe status of the name e.g. 'current', 'proposed'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

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

                                  If this is the preferred name for this substance.

                                  ShortTrue when the name type is Substance Name
                                  Control0..1
                                  Typeboolean
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  312. SubstanceDefinition.name.language
                                  Definition

                                  Human language that the name is written in.

                                  ShortHuman language that the name is written in
                                  Control0..*
                                  BindingThe codes SHALL be taken from AllLanguages
                                  (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                  IETF language tag for a human language

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

                                  The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                  ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                  Control0..*
                                  BindingFor example codes, see SubstanceNameDomain
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                  The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

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

                                  The jurisdiction where this name applies.

                                  ShortThe jurisdiction where this name applies
                                  Control0..*
                                  BindingFor example codes, see JurisdictionValueSet
                                  (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                  Jurisdiction codes

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

                                  A synonym of this particular name, by which the substance is also known.

                                  ShortA synonym of this particular name, by which the substance is also known
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  320. SubstanceDefinition.name.translation
                                  Definition

                                  A translation for this name into another human language.

                                  ShortA translation for this name into another human language
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  322. SubstanceDefinition.name.official
                                  Definition

                                  Details of the official nature of this name.

                                  ShortDetails of the official nature of this name
                                  Control0..*
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  324. SubstanceDefinition.name.official.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
                                  326. SubstanceDefinition.name.official.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())
                                  328. SubstanceDefinition.name.official.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())
                                  330. SubstanceDefinition.name.official.authority
                                  Definition

                                  Which authority uses this official name.

                                  ShortWhich authority uses this official name
                                  Control0..1
                                  BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                  (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                  An authority that officates substance names.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  332. SubstanceDefinition.name.official.status
                                  Definition

                                  The status of the official name, for example 'draft', 'active', 'retired'.

                                  ShortThe status of the official name, for example 'draft', 'active'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  334. SubstanceDefinition.name.official.date
                                  Definition

                                  Date of the official name change.

                                  ShortDate of official name change
                                  Control0..1
                                  TypedateTime
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  336. SubstanceDefinition.name.source
                                  Definition

                                  Supporting literature.

                                  ShortSupporting literature
                                  Control0..*
                                  TypeReference(DocumentReference)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  338. SubstanceDefinition.name:sub
                                  Slice Namesub
                                  Definition

                                  Names applicable to this substance.

                                  ShortNames applicable to this substance
                                  Control0..1
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  340. SubstanceDefinition.name:sub.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
                                  342. SubstanceDefinition.name:sub.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())
                                  344. SubstanceDefinition.name:sub.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())
                                  346. SubstanceDefinition.name:sub.name
                                  Definition

                                  A non-branded nor registered name that meant for common use.

                                  ShortGeneric Name
                                  Control1..1
                                  Typestring
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  348. SubstanceDefinition.name:sub.type
                                  Definition

                                  Name type, for example 'systematic', 'scientific, 'brand'.

                                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                                  Control1..1
                                  BindingFor example codes, see SubstanceNameType
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                  The type of a name given to a substance.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Pattern Value{
                                    "coding" : [{
                                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                      "code" : "C97054",
                                      "display" : "Generic Name"
                                    }]
                                  }
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  350. SubstanceDefinition.name:sub.status
                                  Definition

                                  The status of the name, for example 'current', 'proposed'.

                                  ShortThe status of the name e.g. 'current', 'proposed'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  352. SubstanceDefinition.name:sub.preferred
                                  Definition

                                  If this is the preferred name for this substance.

                                  ShortIf this is the preferred name for this substance
                                  Control0..1
                                  Typeboolean
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  354. SubstanceDefinition.name:sub.language
                                  Definition

                                  Human language that the name is written in.

                                  ShortHuman language that the name is written in
                                  Control0..*
                                  BindingThe codes SHALL be taken from AllLanguages
                                  (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                  IETF language tag for a human language

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  356. SubstanceDefinition.name:sub.domain
                                  Definition

                                  The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                  ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                  Control0..*
                                  BindingFor example codes, see SubstanceNameDomain
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                  The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

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

                                  The jurisdiction where this name applies.

                                  ShortThe jurisdiction where this name applies
                                  Control0..*
                                  BindingFor example codes, see JurisdictionValueSet
                                  (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                  Jurisdiction codes

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  360. SubstanceDefinition.name:sub.synonym
                                  Definition

                                  A synonym of this particular name, by which the substance is also known.

                                  ShortA synonym of this particular name, by which the substance is also known
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  362. SubstanceDefinition.name:sub.translation
                                  Definition

                                  A translation for this name into another human language.

                                  ShortA translation for this name into another human language
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  364. SubstanceDefinition.name:sub.official
                                  Definition

                                  Details of the official nature of this name.

                                  ShortDetails of the official nature of this name
                                  Control0..*
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  366. SubstanceDefinition.name:sub.official.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
                                  368. SubstanceDefinition.name:sub.official.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())
                                  370. SubstanceDefinition.name:sub.official.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())
                                  372. SubstanceDefinition.name:sub.official.authority
                                  Definition

                                  Which authority uses this official name.

                                  ShortWhich authority uses this official name
                                  Control0..1
                                  BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                  (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                  An authority that officates substance names.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  374. SubstanceDefinition.name:sub.official.status
                                  Definition

                                  The status of the official name, for example 'draft', 'active', 'retired'.

                                  ShortThe status of the official name, for example 'draft', 'active'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  376. SubstanceDefinition.name:sub.official.date
                                  Definition

                                  Date of the official name change.

                                  ShortDate of official name change
                                  Control0..1
                                  TypedateTime
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  378. SubstanceDefinition.name:sub.source
                                  Definition

                                  Supporting literature.

                                  ShortSupporting literature
                                  Control0..*
                                  TypeReference(DocumentReference)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  380. SubstanceDefinition.name:gsrs
                                  Slice Namegsrs
                                  Definition

                                  Names applicable to this substance.

                                  ShortNames applicable to this substance
                                  Control0..1
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  382. SubstanceDefinition.name:gsrs.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
                                  384. SubstanceDefinition.name:gsrs.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())
                                  386. SubstanceDefinition.name:gsrs.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())
                                  388. SubstanceDefinition.name:gsrs.name
                                  Definition

                                  Default display name identified within FDA Global Substance Registration System (GSRS).

                                  ShortGSRS Preferred Term
                                  Control1..1
                                  Typestring
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  390. SubstanceDefinition.name:gsrs.type
                                  Definition

                                  Name type, for example 'systematic', 'scientific, 'brand'.

                                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                                  Control1..1
                                  BindingFor example codes, see SubstanceNameType
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                  The type of a name given to a substance.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Pattern Value{
                                    "coding" : [{
                                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                      "code" : "C203355",
                                      "display" : "GSRS Preferred Term"
                                    }]
                                  }
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  392. SubstanceDefinition.name:gsrs.status
                                  Definition

                                  The status of the name, for example 'current', 'proposed'.

                                  ShortThe status of the name e.g. 'current', 'proposed'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  394. SubstanceDefinition.name:gsrs.preferred
                                  Definition

                                  If this is the preferred name for this substance.

                                  ShortIf this is the preferred name for this substance
                                  Control0..1
                                  Typeboolean
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  396. SubstanceDefinition.name:gsrs.language
                                  Definition

                                  Human language that the name is written in.

                                  ShortHuman language that the name is written in
                                  Control0..*
                                  BindingThe codes SHALL be taken from AllLanguages
                                  (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                  IETF language tag for a human language

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  398. SubstanceDefinition.name:gsrs.domain
                                  Definition

                                  The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                  ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                  Control0..*
                                  BindingFor example codes, see SubstanceNameDomain
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                  The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

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

                                  The jurisdiction where this name applies.

                                  ShortThe jurisdiction where this name applies
                                  Control0..*
                                  BindingFor example codes, see JurisdictionValueSet
                                  (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                  Jurisdiction codes

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  402. SubstanceDefinition.name:gsrs.synonym
                                  Definition

                                  A synonym of this particular name, by which the substance is also known.

                                  ShortA synonym of this particular name, by which the substance is also known
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  404. SubstanceDefinition.name:gsrs.translation
                                  Definition

                                  A translation for this name into another human language.

                                  ShortA translation for this name into another human language
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  406. SubstanceDefinition.name:gsrs.official
                                  Definition

                                  Details of the official nature of this name.

                                  ShortDetails of the official nature of this name
                                  Control0..*
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  408. SubstanceDefinition.name:gsrs.official.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
                                  410. SubstanceDefinition.name:gsrs.official.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())
                                  412. SubstanceDefinition.name:gsrs.official.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())
                                  414. SubstanceDefinition.name:gsrs.official.authority
                                  Definition

                                  Which authority uses this official name.

                                  ShortWhich authority uses this official name
                                  Control0..1
                                  BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                  (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                  An authority that officates substance names.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  416. SubstanceDefinition.name:gsrs.official.status
                                  Definition

                                  The status of the official name, for example 'draft', 'active', 'retired'.

                                  ShortThe status of the official name, for example 'draft', 'active'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  418. SubstanceDefinition.name:gsrs.official.date
                                  Definition

                                  Date of the official name change.

                                  ShortDate of official name change
                                  Control0..1
                                  TypedateTime
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  420. SubstanceDefinition.name:gsrs.source
                                  Definition

                                  Supporting literature.

                                  ShortSupporting literature
                                  Control0..*
                                  TypeReference(DocumentReference)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  422. SubstanceDefinition.name:isbt
                                  Slice Nameisbt
                                  Definition

                                  Names applicable to this substance.

                                  ShortNames applicable to this substance
                                  Control0..1
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  424. SubstanceDefinition.name:isbt.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
                                  426. SubstanceDefinition.name:isbt.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())
                                  428. SubstanceDefinition.name:isbt.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())
                                  430. SubstanceDefinition.name:isbt.name
                                  Definition

                                  It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]

                                  ShortISBT-128 DIN
                                  Control1..1
                                  Typestring
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  432. SubstanceDefinition.name:isbt.type
                                  Definition

                                  Name type, for example 'systematic', 'scientific, 'brand'.

                                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                                  Control1..1
                                  BindingFor example codes, see SubstanceNameType
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                  The type of a name given to a substance.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Pattern Value{
                                    "coding" : [{
                                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                      "code" : "C95517",
                                      "display" : "ISBT-128 DIN"
                                    }]
                                  }
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  434. SubstanceDefinition.name:isbt.status
                                  Definition

                                  The status of the name, for example 'current', 'proposed'.

                                  ShortThe status of the name e.g. 'current', 'proposed'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  436. SubstanceDefinition.name:isbt.preferred
                                  Definition

                                  If this is the preferred name for this substance.

                                  ShortIf this is the preferred name for this substance
                                  Control0..1
                                  Typeboolean
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  438. SubstanceDefinition.name:isbt.language
                                  Definition

                                  Human language that the name is written in.

                                  ShortHuman language that the name is written in
                                  Control0..*
                                  BindingThe codes SHALL be taken from AllLanguages
                                  (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                  IETF language tag for a human language

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  440. SubstanceDefinition.name:isbt.domain
                                  Definition

                                  The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                  ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                  Control0..*
                                  BindingFor example codes, see SubstanceNameDomain
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                  The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

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

                                  The jurisdiction where this name applies.

                                  ShortThe jurisdiction where this name applies
                                  Control0..*
                                  BindingFor example codes, see JurisdictionValueSet
                                  (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                  Jurisdiction codes

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  444. SubstanceDefinition.name:isbt.synonym
                                  Definition

                                  A synonym of this particular name, by which the substance is also known.

                                  ShortA synonym of this particular name, by which the substance is also known
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  446. SubstanceDefinition.name:isbt.translation
                                  Definition

                                  A translation for this name into another human language.

                                  ShortA translation for this name into another human language
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  448. SubstanceDefinition.name:isbt.official
                                  Definition

                                  Details of the official nature of this name.

                                  ShortDetails of the official nature of this name
                                  Control0..*
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  450. SubstanceDefinition.name:isbt.official.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
                                  452. SubstanceDefinition.name:isbt.official.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())
                                  454. SubstanceDefinition.name:isbt.official.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())
                                  456. SubstanceDefinition.name:isbt.official.authority
                                  Definition

                                  Which authority uses this official name.

                                  ShortWhich authority uses this official name
                                  Control0..1
                                  BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                  (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                  An authority that officates substance names.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  458. SubstanceDefinition.name:isbt.official.status
                                  Definition

                                  The status of the official name, for example 'draft', 'active', 'retired'.

                                  ShortThe status of the official name, for example 'draft', 'active'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  460. SubstanceDefinition.name:isbt.official.date
                                  Definition

                                  Date of the official name change.

                                  ShortDate of official name change
                                  Control0..1
                                  TypedateTime
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  462. SubstanceDefinition.name:isbt.source
                                  Definition

                                  Supporting literature.

                                  ShortSupporting literature
                                  Control0..*
                                  TypeReference(DocumentReference)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  464. SubstanceDefinition.name:comp
                                  Slice Namecomp
                                  Definition

                                  Names applicable to this substance.

                                  ShortNames applicable to this substance
                                  Control0..1
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  466. SubstanceDefinition.name:comp.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
                                  468. SubstanceDefinition.name:comp.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())
                                  470. SubstanceDefinition.name:comp.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())
                                  472. SubstanceDefinition.name:comp.name
                                  Definition

                                  An internal identifier assigned by the sponsor to this drug substance. [Source: SME Defined]

                                  ShortCompany ID/Code
                                  Control1..1
                                  Typestring
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supporttrue
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  474. SubstanceDefinition.name:comp.type
                                  Definition

                                  Name type, for example 'systematic', 'scientific, 'brand'.

                                  ShortName type e.g. 'systematic', 'scientific, 'brand'
                                  Control1..1
                                  BindingFor example codes, see SubstanceNameType
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-type)

                                  The type of a name given to a substance.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supporttrue
                                  Summarytrue
                                  Pattern Value{
                                    "coding" : [{
                                      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                                      "code" : "C203354",
                                      "display" : "Company ID/Code"
                                    }]
                                  }
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  476. SubstanceDefinition.name:comp.status
                                  Definition

                                  The status of the name, for example 'current', 'proposed'.

                                  ShortThe status of the name e.g. 'current', 'proposed'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  478. SubstanceDefinition.name:comp.preferred
                                  Definition

                                  If this is the preferred name for this substance.

                                  ShortIf this is the preferred name for this substance
                                  Control0..1
                                  Typeboolean
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  480. SubstanceDefinition.name:comp.language
                                  Definition

                                  Human language that the name is written in.

                                  ShortHuman language that the name is written in
                                  Control0..*
                                  BindingThe codes SHALL be taken from AllLanguages
                                  (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                  IETF language tag for a human language

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  482. SubstanceDefinition.name:comp.domain
                                  Definition

                                  The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive.

                                  ShortThe use context of this name e.g. as an active ingredient or as a food colour additive
                                  Control0..*
                                  BindingFor example codes, see SubstanceNameDomain
                                  (example to http://hl7.org/fhir/ValueSet/substance-name-domain)

                                  The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive.

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

                                  The jurisdiction where this name applies.

                                  ShortThe jurisdiction where this name applies
                                  Control0..*
                                  BindingFor example codes, see JurisdictionValueSet
                                  (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                  Jurisdiction codes

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  486. SubstanceDefinition.name:comp.synonym
                                  Definition

                                  A synonym of this particular name, by which the substance is also known.

                                  ShortA synonym of this particular name, by which the substance is also known
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  488. SubstanceDefinition.name:comp.translation
                                  Definition

                                  A translation for this name into another human language.

                                  ShortA translation for this name into another human language
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  490. SubstanceDefinition.name:comp.official
                                  Definition

                                  Details of the official nature of this name.

                                  ShortDetails of the official nature of this name
                                  Control0..*
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  492. SubstanceDefinition.name:comp.official.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
                                  494. SubstanceDefinition.name:comp.official.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())
                                  496. SubstanceDefinition.name:comp.official.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())
                                  498. SubstanceDefinition.name:comp.official.authority
                                  Definition

                                  Which authority uses this official name.

                                  ShortWhich authority uses this official name
                                  Control0..1
                                  BindingThe codes SHOULD be taken from SubstanceNameAuthority
                                  (preferred to http://hl7.org/fhir/ValueSet/substance-name-authority)

                                  An authority that officates substance names.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  500. SubstanceDefinition.name:comp.official.status
                                  Definition

                                  The status of the official name, for example 'draft', 'active', 'retired'.

                                  ShortThe status of the official name, for example 'draft', 'active'
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  502. SubstanceDefinition.name:comp.official.date
                                  Definition

                                  Date of the official name change.

                                  ShortDate of official name change
                                  Control0..1
                                  TypedateTime
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  504. SubstanceDefinition.name:comp.source
                                  Definition

                                  Supporting literature.

                                  ShortSupporting literature
                                  Control0..*
                                  TypeReference(DocumentReference)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  506. SubstanceDefinition.relationship
                                  Definition

                                  A link between this substance and another, with details of the relationship.

                                  ShortA link between this substance and another
                                  Control0..*
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  508. SubstanceDefinition.relationship.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
                                  510. SubstanceDefinition.relationship.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())
                                  512. SubstanceDefinition.relationship.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())
                                  514. SubstanceDefinition.relationship.substanceDefinition[x]
                                  Definition

                                  A pointer to another substance, as a resource or just a representational code.

                                  ShortA pointer to another substance, as a resource or a representational code
                                  Control0..1
                                  TypeChoice of: Reference(SubstanceDefinition), CodeableConcept
                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  516. SubstanceDefinition.relationship.type
                                  Definition

                                  For example "salt to parent", "active moiety", "starting material", "polymorph", "impurity of".

                                  ShortFor example "salt to parent", "active moiety"
                                  Control1..1
                                  BindingFor example codes, see SubstanceRelationshipType
                                  (example to http://hl7.org/fhir/ValueSet/substance-relationship-type)

                                  The relationship between two substance types.

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

                                  For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships.

                                  ShortFor example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships
                                  Control0..1
                                  Typeboolean
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Meaning if MissingIf this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  520. SubstanceDefinition.relationship.amount[x]
                                  Definition

                                  A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other.

                                  ShortA numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other
                                  Control0..1
                                  TypeChoice of: Quantity, Ratio, string
                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  522. SubstanceDefinition.relationship.ratioHighLimitAmount
                                  Definition

                                  For use when the numeric has an uncertain range.

                                  ShortFor use when the numeric has an uncertain range
                                  Control0..1
                                  TypeRatio
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  524. SubstanceDefinition.relationship.comparator
                                  Definition

                                  An operator for the amount, for example "average", "approximately", "less than".

                                  ShortAn operator for the amount, for example "average", "approximately", "less than"
                                  Control0..1
                                  BindingFor example codes, see SubstanceAmountType
                                  (example to http://hl7.org/fhir/ValueSet/substance-amount-type)

                                  The relationship between two substance types.

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

                                  Supporting literature.

                                  ShortSupporting literature
                                  Control0..*
                                  TypeReference(DocumentReference)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  528. SubstanceDefinition.nucleicAcid
                                  Definition

                                  Data items specific to nucleic acids.

                                  ShortData items specific to nucleic acids
                                  Control0..1
                                  TypeReference(SubstanceNucleicAcid)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  530. SubstanceDefinition.polymer
                                  Definition

                                  Data items specific to polymers.

                                  ShortData items specific to polymers
                                  Control0..1
                                  TypeReference(SubstancePolymer)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  532. SubstanceDefinition.protein
                                  Definition

                                  Data items specific to proteins.

                                  ShortData items specific to proteins
                                  Control0..1
                                  TypeReference(SubstanceProtein)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  534. SubstanceDefinition.sourceMaterial
                                  Definition

                                  Material or taxonomic/anatomical source for the substance.

                                  ShortMaterial or taxonomic/anatomical source
                                  Control0..1
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  536. SubstanceDefinition.sourceMaterial.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
                                  538. SubstanceDefinition.sourceMaterial.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())
                                  540. SubstanceDefinition.sourceMaterial.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())
                                  542. SubstanceDefinition.sourceMaterial.type
                                  Definition

                                  A classification that provides the origin of the raw material. Example: cat hair would be an Animal source type.

                                  ShortClassification of the origin of the raw material. e.g. cat hair is an Animal source type
                                  Control0..1
                                  BindingFor example codes, see SourceMaterialType
                                  (example to http://hl7.org/fhir/ValueSet/substance-source-material-type)

                                  A classification that provides the origin of the substance raw material.

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

                                  The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

                                  ShortThe genus of an organism e.g. the Latin epithet of the plant/animal scientific name
                                  Control0..1
                                  BindingFor example codes, see SourceMaterialGenus
                                  (example to http://hl7.org/fhir/ValueSet/substance-source-material-genus)

                                  The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name.

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

                                  The species of an organism, typically referring to the Latin epithet of the species of the plant/animal.

                                  ShortThe species of an organism e.g. the Latin epithet of the species of the plant/animal
                                  Control0..1
                                  BindingFor example codes, see SourceMaterialSpecies
                                  (example to http://hl7.org/fhir/ValueSet/substance-source-material-species)

                                  A species of origin a substance raw material.

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

                                  An anatomical origin of the source material within an organism.

                                  ShortAn anatomical origin of the source material within an organism
                                  Control0..1
                                  BindingFor example codes, see SourceMaterialPart
                                  (example to http://hl7.org/fhir/ValueSet/substance-source-material-part)

                                  An anatomical origin of the source material within an organism.

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

                                  The country or countries where the material is harvested.

                                  ShortThe country or countries where the material is harvested
                                  Control0..*
                                  BindingThe codes SHALL be taken from CountryValueSet
                                  (required to http://hl7.org/fhir/ValueSet/country|5.0.0)

                                  Jurisdiction codes

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