Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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: DrugSubstanceCharacterisation - Detailed Descriptions

Active as of 2024-12-04

Definitions for the pqcmc-drug-substance-characterisation resource profile.

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

0. SubstanceDefinition
Invariantscmc-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' ((classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'https://www.uniprot.org') ).exists()))
cmc-name-isbt: Name.type ISBT 128 required for blood products. (classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'))
cmc-substance-characterisation-content-required: Drug Substance Characterisation must contain at least one characterisation or at least one relationship (characterization.exists() or relationship.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 controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model. [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]

ShortSubstance Type
Control1..1
BindingThe codes SHALL be taken from Substance Classification
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification)
Must Supporttrue
6. SubstanceDefinition.manufacturer
Control0..1
TypeReference(Literal Reference)(Basic Organization)bundled
Must Supporttrue
8. SubstanceDefinition.supplier
Control0..1
TypeReference(Literal Reference)(Basic Organization)bundled
Must Supporttrue
10. SubstanceDefinition.characterization
Must Supporttrue
12. 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
14. SubstanceDefinition.characterization.description
ShortAnalysis Narrative Text and Table
Must Supporttrue
16. 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
  • 18. 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)
    20. 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)
    22. SubstanceDefinition.code
    Control1..?
    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
    • 24. 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
      26. SubstanceDefinition.code:unii.code
      Control1..?
      Must Supporttrue
      28. SubstanceDefinition.code:unii.code.coding
      Control1..1
      Must Supporttrue
      30. SubstanceDefinition.code:unii.code.coding.system
      Control1..?
      Must Supporttrue
      Pattern Valuehttp://fdasis.nlm.nih.gov
      32. 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
      34. SubstanceDefinition.code:uniProt.code
      Control1..?
      Must Supporttrue
      36. SubstanceDefinition.code:uniProt.code.coding
      Control1..1
      Must Supporttrue
      38. SubstanceDefinition.code:uniProt.code.coding.system
      Control1..?
      Must Supporttrue
      Pattern Valuehttps://www.uniprot.org
      40. 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
      • 42. 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)
        44. SubstanceDefinition.name.preferred
        ShortTrue when the name type is Substance Name
        Must Supporttrue
        46. SubstanceDefinition.name:sub
        Slice Namesub
        Control0..1
        Must Supporttrue
        48. SubstanceDefinition.name:sub.name
        Definition

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

        ShortGeneric Name
        Must Supporttrue
        50. 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"
          }]
        }
        52. SubstanceDefinition.name:sub.preferred
        Must Supporttrue
        54. SubstanceDefinition.name:gsrs
        Slice Namegsrs
        Control0..1
        Must Supporttrue
        56. SubstanceDefinition.name:gsrs.name
        Definition

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

        ShortGSRS Preferred Term
        Must Supporttrue
        58. 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"
          }]
        }
        60. SubstanceDefinition.name:gsrs.preferred
        Must Supporttrue
        62. SubstanceDefinition.name:isbt
        Slice Nameisbt
        Control0..1
        Must Supporttrue
        64. 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
        66. 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"
          }]
        }
        68. SubstanceDefinition.name:isbt.preferred
        Must Supporttrue
        70. SubstanceDefinition.relationship
        ShortReference to Drug Substance Impurity
        Must Supporttrue
        72. SubstanceDefinition.relationship.substanceDefinition[x]
        Control1..?
        TypeReference(Literal Reference)(Drug Substance Impurity)bundled, CodeableConcept
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Must Supporttrue

        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-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' ((classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'https://www.uniprot.org') ).exists()))
        cmc-name-isbt: Name.type ISBT 128 required for blood products. (classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'))
        cmc-substance-characterisation-content-required: Drug Substance Characterisation must contain at least one characterisation or at least one relationship (characterization.exists() or relationship.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 controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model. [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]


        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).

        ShortSubstance TypeA 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..1*
        BindingThe codes SHALL be taken from For codes, see Substance Classification
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification)
        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.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..1*
        TypeReference(Literal Reference)(Basic Organization, Organization)bundled
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        14. 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..1*
        TypeReference(Literal Reference)(Basic Organization, Organization)bundled
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. 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()))
        18. 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())
        20. 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()))
        22. 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()))
        24. 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
        • 26. 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()))
          28. 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()))
          30. SubstanceDefinition.code
          Definition

          Codes associated with the substance.

          ShortCodes associated with the 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()))
          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
          • 32. 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())
            34. 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()))
            36. 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())
            38. 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()))
            40. 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()))
            42. 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()))
            44. 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()))
            46. 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())
            48. 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()))
            50. 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()))
            52. 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()))
            54. 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
            • 56. 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())
              58. 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()))
              60. 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()))
              62. 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()))
              64. 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()))
              66. 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())
              68. 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()))
              70. 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()))
              72. 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()))
              74. 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()))
              76. 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())
              78. 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()))
              80. 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()))
              82. 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()))
              84. 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()))
              86. 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())
              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/]


              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()))
              90. 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()))
              92. 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()))
              94. SubstanceDefinition.relationship
              Definition

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

              ShortReference to Drug Substance ImpurityA link between this substance and another
              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              96. 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())
              98. 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
              Control10..1
              TypeReference(Literal Reference)(Drug Substance Impurity, SubstanceDefinition)bundled, CodeableConcept
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              100. 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 SubstanceRelationshipTypehttp://hl7.org/fhir/ValueSet/substance-relationship-type
              (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()))

              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-when-unii-required: A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein' ((classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists() implies code.where( code.coding.exists(system = 'http://fdasis.nlm.nih.gov') ).exists()) and (classification.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and code = 'C17021' ).exists() implies code.where( code.coding.exists(system = 'https://www.uniprot.org') ).exists()))
              cmc-name-isbt: Name.type ISBT 128 required for blood products. (classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'))
              cmc-substance-characterisation-content-required: Drug Substance Characterisation must contain at least one characterisation or at least one relationship (characterization.exists() or relationship.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 controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model. [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]

              ShortSubstance Type
              Control1..1
              BindingThe codes SHALL be taken from Substance Classification
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification)
              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..1
              TypeReference(Literal Reference)(Basic Organization)bundled
              Is Modifierfalse
              Must Supporttrue
              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..1
              TypeReference(Literal Reference)(Basic Organization)bundled
              Is Modifierfalse
              Must Supporttrue
              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 Supportfalse
                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 method used to elucidate the structure of the drug substance. Examples: X-ray, NMR, Peptide mapping, Ligand binding assay.

                ShortThe method used to find the structure e.g. X-ray, NMR
                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
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                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.

                ShortA 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()))
                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)
                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
                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.code
                Definition

                Codes associated with the substance.

                ShortCodes associated with the substance
                Control1..*
                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
                • 152. 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
                  154. 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())
                  156. 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())
                  158. 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()))
                  160. 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()))
                  162. 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()))
                  164. 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()))
                  166. 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()))
                  168. 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()))
                  170. 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
                  172. 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())
                  174. 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())
                  176. 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()))
                  178. 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
                  180. 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
                  • 182. 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()))
                    184. 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
                    186. 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
                    • 188. 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()))
                      190. 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()))
                      192. 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()))
                      194. 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()))
                      196. 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()))
                      198. 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()))
                      200. 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()))
                      202. 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()))
                      204. 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()))
                      206. 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()))
                      208. 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()))
                      210. 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
                      212. 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())
                      214. 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())
                      216. 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()))
                      218. 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
                      220. 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
                      • 222. 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()))
                        224. 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
                        226. 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
                        • 228. 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()))
                          230. 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()))
                          232. 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()))
                          234. 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()))
                          236. 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()))
                          238. 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()))
                          240. 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()))
                          242. 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()))
                          244. 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()))
                          246. 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()))
                          248. 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
                          • 250. 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
                            252. 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())
                            254. 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())
                            256. 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()))
                            258. 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()))
                            260. 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()))
                            262. 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()))
                            264. 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()))
                            266. 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()))
                            268. 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()))
                            270. 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()))
                            272. 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()))
                            274. 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()))
                            276. 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
                            278. 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())
                            280. 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())
                            282. 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()))
                            284. 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()))
                            286. 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()))
                            288. 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()))
                            290. 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()))
                            292. 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
                            294. 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())
                            296. 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())
                            298. 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()))
                            300. 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()))
                            302. 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()))
                            304. 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()))
                            306. 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()))
                            308. 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()))
                            310. 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()))
                            312. 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()))
                            314. 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()))
                            316. 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()))
                            318. 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
                            320. 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())
                            322. 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())
                            324. 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()))
                            326. 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()))
                            328. 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()))
                            330. 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()))
                            332. 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()))
                            334. 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
                            336. 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())
                            338. 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())
                            340. 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()))
                            342. 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()))
                            344. 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()))
                            346. 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()))
                            348. 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()))
                            350. 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()))
                            352. 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()))
                            354. 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()))
                            356. 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()))
                            358. 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()))
                            360. 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
                            362. 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())
                            364. 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())
                            366. 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()))
                            368. 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()))
                            370. 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()))
                            372. 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()))
                            374. 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()))
                            376. 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
                            378. 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())
                            380. 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())
                            382. 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()))
                            384. 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()))
                            386. 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()))
                            388. 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()))
                            390. 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()))
                            392. 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()))
                            394. 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()))
                            396. 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()))
                            398. 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()))
                            400. 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()))
                            402. 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
                            404. 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())
                            406. 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())
                            408. 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()))
                            410. 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()))
                            412. 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()))
                            414. 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()))
                            416. SubstanceDefinition.relationship
                            Definition

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

                            ShortReference to Drug Substance Impurity
                            Control0..*
                            TypeBackboneElement
                            Is Modifierfalse
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            418. 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
                            420. 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())
                            422. 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())
                            424. 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
                            Control1..1
                            TypeReference(Literal Reference)(Drug Substance Impurity)bundled
                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                            Is Modifierfalse
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            426. 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()))
                            428. 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()))
                            430. 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()))
                            432. 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()))
                            434. 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()))
                            436. 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()))
                            438. 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()))
                            440. 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()))
                            442. 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()))
                            444. 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()))
                            446. 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
                            448. 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())
                            450. 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())
                            452. 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()))
                            454. 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()))
                            456. 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()))
                            458. 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()))
                            460. 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()))