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: BatchFormulaMedicinalProduct - Detailed Descriptions

Active as of 2024-12-04

Definitions for the pqcmc-batch-formula-product resource profile.

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

0. MedicinalProductDefinition
2. MedicinalProductDefinition.identifier
Shortoptional user designated identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
4. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
Definition

The form in which active and/or inert ingredient(s) are physically presented as indicated on the packaging according to the USP. [Source: NCI EVS - C42636] Examples: tablet, capsule, solution, cream, etc. that contains a drug substance generally, but not necessarily, in association with excipients. [Source: ICH Q1A(R2)] See also 21 CFR 314.3. Note: If there is a new dosage form that does not exist in the controlled terminology, then propose this new dosage form during sponsor meetings with FDA.

SME comment -- this is the marketed dosage form

ShortProduct Dosage Form
Control1..?
BindingThe codes SHALL be taken from Pharmaceutical Dosage Form Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology)
Must Supporttrue
6. MedicinalProductDefinition.route
Definition

Designation of the part of the body through which or into which, or the way in which, the medicinal product is intended to be introduced. In some cases a medicinal product can be intended for more than one route and/or method of administration. [Source: NCI E C38114]

ShortRoute of Administration
Control1..?
BindingThe codes SHALL be taken from Drug Route Of Administration Terminology
(required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology)
Must Supporttrue
8. MedicinalProductDefinition.comprisedOf
Control1..?
TypeReference(Literal Reference)(Drug Product Batch Formula)bundled
Must Supporttrue
10. MedicinalProductDefinition.name
Control0..2
Must Supporttrue
SlicingThis element introduces a set of slices on MedicinalProductDefinition.name. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
  • value @ type
  • 12. MedicinalProductDefinition.name.productName
    Must Supporttrue
    14. MedicinalProductDefinition.name.type
    Control1..?
    BindingThe codes SHALL be taken from Product Name Types Terminology
    (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs)
    Must Supporttrue
    16. MedicinalProductDefinition.name:Proprietary
    Slice NameProprietary
    Control0..1
    18. MedicinalProductDefinition.name:Proprietary.type
    Pattern Value{
      "coding" : [{
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "code" : "C71898",
        "display" : "Proprietary Name"
      }]
    }
    20. MedicinalProductDefinition.name:Proprietary.part
    Must Supporttrue
    SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
    • value @ type
    • 22. MedicinalProductDefinition.name:Proprietary.part.part
      Must Supporttrue
      24. MedicinalProductDefinition.name:Proprietary.part.type
      BindingThe codes SHALL be taken from PQCMC Name Part Terminology
      (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology)
      Must Supporttrue
      26. MedicinalProductDefinition.name:NonProprietary
      Slice NameNonProprietary
      Control1..1
      Invariantscmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once (defineVariable('system','http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2').select( defineVariable('strengthReferences',part.type.where(coding.exists(code = 'STR' and system = %system)).text).select( defineVariable('scientificNames',part.where(type.coding.exists(code = 'SCI' and system = %system)).part).select( %strengthReferences = %scientificNames and %scientificNames.distinct() = %scientificNames ))))
      28. MedicinalProductDefinition.name:NonProprietary.type
      Pattern Value{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C96971",
          "display" : "Nonproprietary Name"
        }]
      }
      30. MedicinalProductDefinition.name:NonProprietary.part
      Definition

      Name Parts are a means of specifying a range of acceptable forms of the name of a product. Note: The minimum is the scientific name.

      Control2..?
      Must Supporttrue
      SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
      • value @ type
      • 32. MedicinalProductDefinition.name:NonProprietary.part.part
        Must Supporttrue
        34. MedicinalProductDefinition.name:NonProprietary.part.type
        BindingThe codes SHALL be taken from PQCMC Name Part Terminology
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology)
        Must Supporttrue
        36. MedicinalProductDefinition.name:NonProprietary.part:Scientific
        Slice NameScientific
        Control1..*
        38. MedicinalProductDefinition.name:NonProprietary.part:Scientific.type
        Pattern Value{
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
            "code" : "SCI"
          }]
        }
        40. MedicinalProductDefinition.name:NonProprietary.part:Invented
        Slice NameInvented
        Control0..*
        42. MedicinalProductDefinition.name:NonProprietary.part:Invented.type
        Pattern Value{
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
            "code" : "INV"
          }]
        }
        44. MedicinalProductDefinition.name:NonProprietary.part:Formulation
        Slice NameFormulation
        Control0..*
        46. MedicinalProductDefinition.name:NonProprietary.part:Formulation.type
        Pattern Value{
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
            "code" : "FORMUL"
          }]
        }
        48. MedicinalProductDefinition.name:NonProprietary.part:Strength
        Slice NameStrength
        Control1..*
        50. MedicinalProductDefinition.name:NonProprietary.part:Strength.type
        Pattern Value{
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
            "code" : "STR"
          }]
        }
        52. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.text
        Control1..?
        Must Supporttrue
        54. MedicinalProductDefinition.name:NonProprietary.part:Container
        Slice NameContainer
        Control0..*
        56. MedicinalProductDefinition.name:NonProprietary.part:Container.type
        Pattern Value{
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
            "code" : "CON"
          }]
        }
        58. MedicinalProductDefinition.name:NonProprietary.part:Form
        Slice NameForm
        Control0..*
        60. MedicinalProductDefinition.name:NonProprietary.part:Form.type
        Pattern Value{
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
            "code" : "FRM"
          }]
        }
        62. MedicinalProductDefinition.name:NonProprietary.part:Device
        Slice NameDevice
        Control0..*
        64. MedicinalProductDefinition.name:NonProprietary.part:Device.type
        Pattern Value{
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
            "code" : "DEV"
          }]
        }

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

        0. MedicinalProductDefinition
        Definition

        A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).

        ShortDetailed definition of a medicinal product
        Control0..*
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
        dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id 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())
        2. MedicinalProductDefinition.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. MedicinalProductDefinition.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. MedicinalProductDefinition.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. MedicinalProductDefinition.identifier
        Definition

        Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

        Shortoptional user designated identifierBusiness identifier for this product. Could be an MPID
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1*
        TypeIdentifier
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Alternate NamesMPID
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        10. MedicinalProductDefinition.status
        Definition

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

        ShortThe status within the lifecycle of this product record
        Control0..1
        BindingThe codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status
        (preferred to http://hl7.org/fhir/ValueSet/publication-status)

        The lifecycle status of an artifact.

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

        The form in which active and/or inert ingredient(s) are physically presented as indicated on the packaging according to the USP. [Source: NCI EVS - C42636] Examples: tablet, capsule, solution, cream, etc. that contains a drug substance generally, but not necessarily, in association with excipients. [Source: ICH Q1A(R2)] See also 21 CFR 314.3. Note: If there is a new dosage form that does not exist in the controlled terminology, then propose this new dosage form during sponsor meetings with FDA.

        SME comment -- this is the marketed dosage form


        The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).

        ShortProduct Dosage FormThe dose form for a single part product, or combined form of a multiple part product
        Control10..1
        BindingThe codes SHALL be taken from For example codes, see Pharmaceutical Dosage Form Terminologyhttp://hl7.org/fhir/ValueSet/combined-dose-form
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        14. MedicinalProductDefinition.route
        Definition

        Designation of the part of the body through which or into which, or the way in which, the medicinal product is intended to be introduced. In some cases a medicinal product can be intended for more than one route and/or method of administration. [Source: NCI E C38114]


        The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.

        ShortRoute of AdministrationThe path by which the product is taken into or makes contact with the body
        Control10..*
        BindingThe codes SHALL be taken from For example codes, see Drug Route Of Administration Terminologyhttp://hl7.org/fhir/ValueSet/route-codes
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology)
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. MedicinalProductDefinition.comprisedOf
        Definition

        Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item).

        ShortTypes of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
        Control10..*
        TypeReference(Literal Reference)(Drug Product Batch Formula, ManufacturedItemDefinition, DeviceDefinition)bundled
        Is Modifierfalse
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        18. MedicinalProductDefinition.name
        Definition

        The product's name, including full name and possibly coded parts.

        ShortThe product's name, including full name and possibly coded parts
        Control1..2*
        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 MedicinalProductDefinition.name. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
        • value @ type
        • 20. MedicinalProductDefinition.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())
          22. MedicinalProductDefinition.name.productName
          Definition

          The full product name.

          ShortThe full product 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()))
          24. MedicinalProductDefinition.name.type
          Definition

          Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

          ShortType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
          Control10..1
          BindingThe codes SHALL be taken from For example codes, see Product Name Types Terminologyhttp://hl7.org/fhir/ValueSet/medicinal-product-name-type
          (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs)
          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          26. MedicinalProductDefinition.name:Proprietary
          Slice NameProprietary
          Definition

          The product's name, including full name and possibly coded parts.

          ShortThe product's name, including full name and possibly coded parts
          Control01..1*
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          28. MedicinalProductDefinition.name:Proprietary.modifierExtension
          Definition

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

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

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

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

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

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

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

          The full product name.

          ShortThe full product 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()))
          32. MedicinalProductDefinition.name:Proprietary.type
          Definition

          Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

          ShortType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
          Control0..1
          BindingFor example codes, see ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type
          (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-type)

          Type of a name for a Medicinal Product.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Pattern Value{
            "coding" : [{
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C71898",
              "display" : "Proprietary Name"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          34. MedicinalProductDefinition.name:Proprietary.part
          Definition

          Coding words or phrases of the name.

          ShortCoding words or phrases of the name
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          36. MedicinalProductDefinition.name:Proprietary.part.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. MedicinalProductDefinition.name:Proprietary.part.part
          Definition

          A fragment of a product name.

          ShortA fragment of a product 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()))
          40. MedicinalProductDefinition.name:Proprietary.part.type
          Definition

          Identifying type for this part of the name (e.g. strength part).

          ShortIdentifying type for this part of the name (e.g. strength part)
          Control1..1
          BindingThe codes SHALL be taken from For example codes, see PQCMC Name Part Terminologyhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
          (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology)
          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          42. MedicinalProductDefinition.name:NonProprietary
          Slice NameNonProprietary
          Definition

          The product's name, including full name and possibly coded parts.

          ShortThe product's name, including full name and possibly coded parts
          Control1..1*
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once (defineVariable('system','http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2').select( defineVariable('strengthReferences',part.type.where(coding.exists(code = 'STR' and system = %system)).text).select( defineVariable('scientificNames',part.where(type.coding.exists(code = 'SCI' and system = %system)).part).select( %strengthReferences = %scientificNames and %scientificNames.distinct() = %scientificNames ))))
          44. MedicinalProductDefinition.name:NonProprietary.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())
          46. MedicinalProductDefinition.name:NonProprietary.productName
          Definition

          The full product name.

          ShortThe full product 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()))
          48. MedicinalProductDefinition.name:NonProprietary.type
          Definition

          Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

          ShortType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
          Control0..1
          BindingFor example codes, see ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type
          (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-type)

          Type of a name for a Medicinal Product.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Pattern Value{
            "coding" : [{
              "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code" : "C96971",
              "display" : "Nonproprietary Name"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          50. MedicinalProductDefinition.name:NonProprietary.part
          Definition

          Name Parts are a means of specifying a range of acceptable forms of the name of a product. Note: The minimum is the scientific name.


          Coding words or phrases of the name.

          ShortCoding words or phrases of the name
          Control20..*
          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 MedicinalProductDefinition.name.part. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
          • value @ type
          • 52. MedicinalProductDefinition.name:NonProprietary.part.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())
            54. MedicinalProductDefinition.name:NonProprietary.part.part
            Definition

            A fragment of a product name.

            ShortA fragment of a product 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()))
            56. MedicinalProductDefinition.name:NonProprietary.part.type
            Definition

            Identifying type for this part of the name (e.g. strength part).

            ShortIdentifying type for this part of the name (e.g. strength part)
            Control1..1
            BindingThe codes SHALL be taken from For example codes, see PQCMC Name Part Terminologyhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
            (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology)
            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            58. MedicinalProductDefinition.name:NonProprietary.part:Scientific
            Slice NameScientific
            Definition

            Coding words or phrases of the name.

            ShortCoding words or phrases of the name
            Control10..*
            TypeBackboneElement
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            60. MedicinalProductDefinition.name:NonProprietary.part:Scientific.modifierExtension
            Definition

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

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

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

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

            A fragment of a product name.

            ShortA fragment of a product 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()))
            64. MedicinalProductDefinition.name:NonProprietary.part:Scientific.type
            Definition

            Identifying type for this part of the name (e.g. strength part).

            ShortIdentifying type for this part of the name (e.g. strength part)
            Control1..1
            BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

            Type of part of a name for a Medicinal Product.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "SCI"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            66. MedicinalProductDefinition.name:NonProprietary.part:Invented
            Slice NameInvented
            Definition

            Coding words or phrases of the name.

            ShortCoding words or phrases of the 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()))
            68. MedicinalProductDefinition.name:NonProprietary.part:Invented.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())
            70. MedicinalProductDefinition.name:NonProprietary.part:Invented.part
            Definition

            A fragment of a product name.

            ShortA fragment of a product 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()))
            72. MedicinalProductDefinition.name:NonProprietary.part:Invented.type
            Definition

            Identifying type for this part of the name (e.g. strength part).

            ShortIdentifying type for this part of the name (e.g. strength part)
            Control1..1
            BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

            Type of part of a name for a Medicinal Product.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "INV"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            74. MedicinalProductDefinition.name:NonProprietary.part:Formulation
            Slice NameFormulation
            Definition

            Coding words or phrases of the name.

            ShortCoding words or phrases of the 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()))
            76. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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. MedicinalProductDefinition.name:NonProprietary.part:Formulation.part
            Definition

            A fragment of a product name.

            ShortA fragment of a product 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()))
            80. MedicinalProductDefinition.name:NonProprietary.part:Formulation.type
            Definition

            Identifying type for this part of the name (e.g. strength part).

            ShortIdentifying type for this part of the name (e.g. strength part)
            Control1..1
            BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

            Type of part of a name for a Medicinal Product.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "FORMUL"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            82. MedicinalProductDefinition.name:NonProprietary.part:Strength
            Slice NameStrength
            Definition

            Coding words or phrases of the name.

            ShortCoding words or phrases of the name
            Control10..*
            TypeBackboneElement
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            84. MedicinalProductDefinition.name:NonProprietary.part:Strength.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())
            86. MedicinalProductDefinition.name:NonProprietary.part:Strength.part
            Definition

            A fragment of a product name.

            ShortA fragment of a product 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()))
            88. MedicinalProductDefinition.name:NonProprietary.part:Strength.type
            Definition

            Identifying type for this part of the name (e.g. strength part).

            ShortIdentifying type for this part of the name (e.g. strength part)
            Control1..1
            BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

            Type of part of a name for a Medicinal Product.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "STR"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            90. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.text
            Definition

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

            ShortPlain text representation of the concept
            Comments

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

            Control10..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supporttrue
            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()))
            92. MedicinalProductDefinition.name:NonProprietary.part:Container
            Slice NameContainer
            Definition

            Coding words or phrases of the name.

            ShortCoding words or phrases of the 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()))
            94. MedicinalProductDefinition.name:NonProprietary.part:Container.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())
            96. MedicinalProductDefinition.name:NonProprietary.part:Container.part
            Definition

            A fragment of a product name.

            ShortA fragment of a product 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()))
            98. MedicinalProductDefinition.name:NonProprietary.part:Container.type
            Definition

            Identifying type for this part of the name (e.g. strength part).

            ShortIdentifying type for this part of the name (e.g. strength part)
            Control1..1
            BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

            Type of part of a name for a Medicinal Product.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "CON"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            100. MedicinalProductDefinition.name:NonProprietary.part:Form
            Slice NameForm
            Definition

            Coding words or phrases of the name.

            ShortCoding words or phrases of the 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()))
            102. MedicinalProductDefinition.name:NonProprietary.part:Form.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())
            104. MedicinalProductDefinition.name:NonProprietary.part:Form.part
            Definition

            A fragment of a product name.

            ShortA fragment of a product 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()))
            106. MedicinalProductDefinition.name:NonProprietary.part:Form.type
            Definition

            Identifying type for this part of the name (e.g. strength part).

            ShortIdentifying type for this part of the name (e.g. strength part)
            Control1..1
            BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

            Type of part of a name for a Medicinal Product.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "FRM"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            108. MedicinalProductDefinition.name:NonProprietary.part:Device
            Slice NameDevice
            Definition

            Coding words or phrases of the name.

            ShortCoding words or phrases of the 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()))
            110. MedicinalProductDefinition.name:NonProprietary.part:Device.modifierExtension
            Definition

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

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

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

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

            A fragment of a product name.

            ShortA fragment of a product 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()))
            114. MedicinalProductDefinition.name:NonProprietary.part:Device.type
            Definition

            Identifying type for this part of the name (e.g. strength part).

            ShortIdentifying type for this part of the name (e.g. strength part)
            Control1..1
            BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

            Type of part of a name for a Medicinal Product.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                "code" : "DEV"
              }]
            }
            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. MedicinalProductDefinition
            Definition

            A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).

            ShortDetailed definition of a medicinal product
            Control0..*
            Is Modifierfalse
            Must Supportfalse
            Summaryfalse
            Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
            dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id 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())
            2. MedicinalProductDefinition.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. MedicinalProductDefinition.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. MedicinalProductDefinition.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. MedicinalProductDefinition.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. MedicinalProductDefinition.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. MedicinalProductDefinition.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. MedicinalProductDefinition.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. MedicinalProductDefinition.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. MedicinalProductDefinition.identifier
            Definition

            Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

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

            Regulatory type, e.g. Investigational or Authorized.

            ShortRegulatory type, e.g. Investigational or Authorized
            Control0..1
            BindingFor example codes, see MedicinalProductType
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-type)

            Overall defining type of this medicinal product.

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

            If this medicine applies to human or veterinary uses.

            ShortIf this medicine applies to human or veterinary uses
            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()))
            24. MedicinalProductDefinition.version
            Definition

            A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.

            ShortA business identifier relating to a specific version of the product
            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()))
            26. MedicinalProductDefinition.status
            Definition

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

            ShortThe status within the lifecycle of this product record
            Control0..1
            BindingThe codes SHOULD be taken from PublicationStatus
            (preferred to http://hl7.org/fhir/ValueSet/publication-status)

            The lifecycle status of an artifact.

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

            The date at which the given status became applicable.

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

            General description of this product.

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

            The form in which active and/or inert ingredient(s) are physically presented as indicated on the packaging according to the USP. [Source: NCI EVS - C42636] Examples: tablet, capsule, solution, cream, etc. that contains a drug substance generally, but not necessarily, in association with excipients. [Source: ICH Q1A(R2)] See also 21 CFR 314.3. Note: If there is a new dosage form that does not exist in the controlled terminology, then propose this new dosage form during sponsor meetings with FDA.

            SME comment -- this is the marketed dosage form

            ShortProduct Dosage Form
            Control1..1
            BindingThe codes SHALL be taken from Pharmaceutical Dosage Form Terminology
            (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology)
            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            34. MedicinalProductDefinition.route
            Definition

            Designation of the part of the body through which or into which, or the way in which, the medicinal product is intended to be introduced. In some cases a medicinal product can be intended for more than one route and/or method of administration. [Source: NCI E C38114]

            ShortRoute of Administration
            Control1..*
            BindingThe codes SHALL be taken from Drug Route Of Administration Terminology
            (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology)
            TypeCodeableConcept
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            36. MedicinalProductDefinition.indication
            Definition

            Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.

            ShortDescription of indication(s) for this product, used when structured indications are not required
            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()))
            38. MedicinalProductDefinition.legalStatusOfSupply
            Definition

            The legal status of supply of the medicinal product as classified by the regulator.

            ShortThe legal status of supply of the medicinal product as classified by the regulator
            Control0..1
            BindingFor example codes, see LegalStatusOfSupply
            (example to http://hl7.org/fhir/ValueSet/legal-status-of-supply)

            The prescription supply types appropriate to a medicinal product

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

            Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.

            ShortWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
            Control0..1
            BindingFor example codes, see AdditionalMonitoring
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring)

            Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).

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

            Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.

            ShortWhether the Medicinal Product is subject to special measures for regulatory reasons
            Control0..*
            BindingFor example codes, see SpecialMeasures
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-special-measures)

            Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.

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

            If authorised for use in children, or infants, neonates etc.

            ShortIf authorised for use in children
            Control0..1
            BindingFor example codes, see PediatricUse
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use)

            Suitability for age groups, in particular children.

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

            Allows the product to be classified by various systems, commonly WHO ATC.

            ShortAllows the product to be classified by various systems
            Control0..*
            BindingFor example codes, see ProductClassification
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

            This value set includes codes from the Anatomical Therapeutic Chemical Classification System - 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()))
            48. MedicinalProductDefinition.marketingStatus
            Definition

            Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization).

            ShortMarketing status of the medicinal product, in contrast to marketing authorization
            Control0..*
            TypeMarketingStatus
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            50. MedicinalProductDefinition.packagedMedicinalProduct
            Definition

            Package type for the product. See also the PackagedProductDefinition resource.

            ShortPackage type for the product
            Control0..*
            BindingFor example codes, see MedicinalProductPackageType
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-package-type)

            Types of medicinal product packs

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

            Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item).

            ShortTypes of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
            Control1..*
            TypeReference(Literal Reference)(Drug Product Batch Formula)bundled
            Is Modifierfalse
            Must Supporttrue
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            54. MedicinalProductDefinition.ingredient
            Definition

            The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.

            ShortThe ingredients of this medicinal product - when not detailed in other resources
            Control0..*
            BindingFor example codes, see SNOMEDCTSubstanceCodes
            (example to http://hl7.org/fhir/ValueSet/substance-codes)

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

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

            Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.

            ShortAny component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
            Control0..*
            BindingFor example codes, see SNOMEDCTSubstanceCodes
            (example to http://hl7.org/fhir/ValueSet/substance-codes)

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

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

            Additional information or supporting documentation about the medicinal product.

            ShortAdditional documentation about the medicinal product
            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()))
            60. MedicinalProductDefinition.masterFile
            Definition

            A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.

            ShortA master file for the medicinal product (e.g. Pharmacovigilance System Master File)
            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()))
            62. MedicinalProductDefinition.contact
            Definition

            A product specific contact, person (in a role), or an organization.

            ShortA product specific contact, person (in a role), or an organization
            Control0..*
            TypeBackboneElement
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            64. MedicinalProductDefinition.contact.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
            66. MedicinalProductDefinition.contact.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())
            68. MedicinalProductDefinition.contact.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())
            70. MedicinalProductDefinition.contact.type
            Definition

            Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.

            ShortAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
            Control0..1
            BindingFor example codes, see ProductContactType
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-contact-type)

            Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

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

            A product specific contact, person (in a role), or an organization.

            ShortA product specific contact, person (in a role), or an organization
            Control1..1
            TypeReference(Organization, PractitionerRole)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            74. MedicinalProductDefinition.clinicalTrial
            Definition

            Clinical trials or studies that this product is involved in.

            ShortClinical trials or studies that this product is involved in
            Control0..*
            TypeReference(ResearchStudy)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            76. MedicinalProductDefinition.code
            Definition

            A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.

            ShortA code that this product is known by, within some formal terminology
            Control0..*
            BindingFor example codes, see SNOMEDCTMedicationCodes
            (example to http://hl7.org/fhir/ValueSet/medication-codes)

            A coded concept that defines the type of a medication.

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

            The product's name, including full name and possibly coded parts.

            ShortThe product's name, including full name and possibly coded parts
            Control1..2
            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 MedicinalProductDefinition.name. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
            • value @ type
            • 80. MedicinalProductDefinition.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
              82. MedicinalProductDefinition.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())
              84. MedicinalProductDefinition.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())
              86. MedicinalProductDefinition.name.productName
              Definition

              The full product name.

              ShortThe full product 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()))
              88. MedicinalProductDefinition.name.type
              Definition

              Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

              ShortType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
              Control1..1
              BindingThe codes SHALL be taken from Product Name Types Terminology
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs)
              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              90. MedicinalProductDefinition.name.part
              Definition

              Coding words or phrases of the name.

              ShortCoding words or phrases of the 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()))
              92. MedicinalProductDefinition.name.part.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
              94. MedicinalProductDefinition.name.part.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())
              96. MedicinalProductDefinition.name.part.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. MedicinalProductDefinition.name.part.part
              Definition

              A fragment of a product name.

              ShortA fragment of a product 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()))
              100. MedicinalProductDefinition.name.part.type
              Definition

              Identifying type for this part of the name (e.g. strength part).

              ShortIdentifying type for this part of the name (e.g. strength part)
              Control1..1
              BindingFor example codes, see ProductNamePartType
              (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

              Type of part of a name for a Medicinal Product.

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

              Country and jurisdiction where the name applies, and associated language.

              ShortCountry and jurisdiction where the name applies
              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              104. MedicinalProductDefinition.name.usage.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
              106. MedicinalProductDefinition.name.usage.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())
              108. MedicinalProductDefinition.name.usage.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())
              110. MedicinalProductDefinition.name.usage.country
              Definition

              Country code for where this name applies.

              ShortCountry code for where this name applies
              Control1..1
              BindingFor example codes, see CountryValueSet
              (example to http://hl7.org/fhir/ValueSet/country)

              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()))
              112. MedicinalProductDefinition.name.usage.jurisdiction
              Definition

              Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).

              ShortJurisdiction code for where this name applies
              Control0..1
              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()))
              114. MedicinalProductDefinition.name.usage.language
              Definition

              Language code for this name.

              ShortLanguage code for this name
              Control1..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

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              116. MedicinalProductDefinition.name:Proprietary
              Slice NameProprietary
              Definition

              The product's name, including full name and possibly coded parts.

              ShortThe product's name, including full name and possibly coded parts
              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()))
              118. MedicinalProductDefinition.name:Proprietary.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
              120. MedicinalProductDefinition.name:Proprietary.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())
              122. MedicinalProductDefinition.name:Proprietary.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())
              124. MedicinalProductDefinition.name:Proprietary.productName
              Definition

              The full product name.

              ShortThe full product 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()))
              126. MedicinalProductDefinition.name:Proprietary.type
              Definition

              Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

              ShortType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
              Control0..1
              BindingFor example codes, see ProductNameType
              (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-type)

              Type of a name for a Medicinal Product.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Pattern Value{
                "coding" : [{
                  "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                  "code" : "C71898",
                  "display" : "Proprietary Name"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              128. MedicinalProductDefinition.name:Proprietary.part
              Definition

              Coding words or phrases of the name.

              ShortCoding words or phrases of the name
              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              130. MedicinalProductDefinition.name:Proprietary.part.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
              132. MedicinalProductDefinition.name:Proprietary.part.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())
              134. MedicinalProductDefinition.name:Proprietary.part.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())
              136. MedicinalProductDefinition.name:Proprietary.part.part
              Definition

              A fragment of a product name.

              ShortA fragment of a product 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()))
              138. MedicinalProductDefinition.name:Proprietary.part.type
              Definition

              Identifying type for this part of the name (e.g. strength part).

              ShortIdentifying type for this part of the name (e.g. strength part)
              Control1..1
              BindingThe codes SHALL be taken from PQCMC Name Part Terminology
              (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology)
              TypeCodeableConcept
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              140. MedicinalProductDefinition.name:Proprietary.usage
              Definition

              Country and jurisdiction where the name applies, and associated language.

              ShortCountry and jurisdiction where the name applies
              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              142. MedicinalProductDefinition.name:Proprietary.usage.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
              144. MedicinalProductDefinition.name:Proprietary.usage.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())
              146. MedicinalProductDefinition.name:Proprietary.usage.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())
              148. MedicinalProductDefinition.name:Proprietary.usage.country
              Definition

              Country code for where this name applies.

              ShortCountry code for where this name applies
              Control1..1
              BindingFor example codes, see CountryValueSet
              (example to http://hl7.org/fhir/ValueSet/country)

              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()))
              150. MedicinalProductDefinition.name:Proprietary.usage.jurisdiction
              Definition

              Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).

              ShortJurisdiction code for where this name applies
              Control0..1
              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()))
              152. MedicinalProductDefinition.name:Proprietary.usage.language
              Definition

              Language code for this name.

              ShortLanguage code for this name
              Control1..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

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              154. MedicinalProductDefinition.name:NonProprietary
              Slice NameNonProprietary
              Definition

              The product's name, including full name and possibly coded parts.

              ShortThe product's name, including full name and possibly coded parts
              Control1..1
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once (defineVariable('system','http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2').select( defineVariable('strengthReferences',part.type.where(coding.exists(code = 'STR' and system = %system)).text).select( defineVariable('scientificNames',part.where(type.coding.exists(code = 'SCI' and system = %system)).part).select( %strengthReferences = %scientificNames and %scientificNames.distinct() = %scientificNames ))))
              156. MedicinalProductDefinition.name:NonProprietary.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
              158. MedicinalProductDefinition.name:NonProprietary.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())
              160. MedicinalProductDefinition.name:NonProprietary.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())
              162. MedicinalProductDefinition.name:NonProprietary.productName
              Definition

              The full product name.

              ShortThe full product 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()))
              164. MedicinalProductDefinition.name:NonProprietary.type
              Definition

              Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

              ShortType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
              Control0..1
              BindingFor example codes, see ProductNameType
              (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-type)

              Type of a name for a Medicinal Product.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Pattern Value{
                "coding" : [{
                  "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                  "code" : "C96971",
                  "display" : "Nonproprietary Name"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              166. MedicinalProductDefinition.name:NonProprietary.part
              Definition

              Name Parts are a means of specifying a range of acceptable forms of the name of a product. Note: The minimum is the scientific name.

              ShortCoding words or phrases of the name
              Control2..*
              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 MedicinalProductDefinition.name.part. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
              • value @ type
              • 168. MedicinalProductDefinition.name:NonProprietary.part.id
                Definition

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

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

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

                ShortAdditional content defined by implementations
                Comments

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

                Control0..*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                172. MedicinalProductDefinition.name:NonProprietary.part.modifierExtension
                Definition

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

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

                ShortExtensions that cannot be ignored even if unrecognized
                Comments

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

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

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

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

                A fragment of a product name.

                ShortA fragment of a product 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()))
                176. MedicinalProductDefinition.name:NonProprietary.part.type
                Definition

                Identifying type for this part of the name (e.g. strength part).

                ShortIdentifying type for this part of the name (e.g. strength part)
                Control1..1
                BindingThe codes SHALL be taken from PQCMC Name Part Terminology
                (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology)
                TypeCodeableConcept
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                178. MedicinalProductDefinition.name:NonProprietary.part:Scientific
                Slice NameScientific
                Definition

                Coding words or phrases of the name.

                ShortCoding words or phrases of the name
                Control1..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                180. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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
                182. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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())
                184. MedicinalProductDefinition.name:NonProprietary.part:Scientific.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())
                186. MedicinalProductDefinition.name:NonProprietary.part:Scientific.part
                Definition

                A fragment of a product name.

                ShortA fragment of a product 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()))
                188. MedicinalProductDefinition.name:NonProprietary.part:Scientific.type
                Definition

                Identifying type for this part of the name (e.g. strength part).

                ShortIdentifying type for this part of the name (e.g. strength part)
                Control1..1
                BindingFor example codes, see ProductNamePartType
                (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                Type of part of a name for a Medicinal Product.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Pattern Value{
                  "coding" : [{
                    "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                    "code" : "SCI"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                190. MedicinalProductDefinition.name:NonProprietary.part:Invented
                Slice NameInvented
                Definition

                Coding words or phrases of the name.

                ShortCoding words or phrases of the 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()))
                192. MedicinalProductDefinition.name:NonProprietary.part:Invented.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
                194. MedicinalProductDefinition.name:NonProprietary.part:Invented.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())
                196. MedicinalProductDefinition.name:NonProprietary.part:Invented.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())
                198. MedicinalProductDefinition.name:NonProprietary.part:Invented.part
                Definition

                A fragment of a product name.

                ShortA fragment of a product 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()))
                200. MedicinalProductDefinition.name:NonProprietary.part:Invented.type
                Definition

                Identifying type for this part of the name (e.g. strength part).

                ShortIdentifying type for this part of the name (e.g. strength part)
                Control1..1
                BindingFor example codes, see ProductNamePartType
                (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                Type of part of a name for a Medicinal Product.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Pattern Value{
                  "coding" : [{
                    "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                    "code" : "INV"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                202. MedicinalProductDefinition.name:NonProprietary.part:Formulation
                Slice NameFormulation
                Definition

                Coding words or phrases of the name.

                ShortCoding words or phrases of the 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()))
                204. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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
                206. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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())
                208. MedicinalProductDefinition.name:NonProprietary.part:Formulation.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())
                210. MedicinalProductDefinition.name:NonProprietary.part:Formulation.part
                Definition

                A fragment of a product name.

                ShortA fragment of a product 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()))
                212. MedicinalProductDefinition.name:NonProprietary.part:Formulation.type
                Definition

                Identifying type for this part of the name (e.g. strength part).

                ShortIdentifying type for this part of the name (e.g. strength part)
                Control1..1
                BindingFor example codes, see ProductNamePartType
                (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                Type of part of a name for a Medicinal Product.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Pattern Value{
                  "coding" : [{
                    "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                    "code" : "FORMUL"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                214. MedicinalProductDefinition.name:NonProprietary.part:Strength
                Slice NameStrength
                Definition

                Coding words or phrases of the name.

                ShortCoding words or phrases of the name
                Control1..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                216. MedicinalProductDefinition.name:NonProprietary.part:Strength.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
                218. MedicinalProductDefinition.name:NonProprietary.part:Strength.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())
                220. MedicinalProductDefinition.name:NonProprietary.part:Strength.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())
                222. MedicinalProductDefinition.name:NonProprietary.part:Strength.part
                Definition

                A fragment of a product name.

                ShortA fragment of a product 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()))
                224. MedicinalProductDefinition.name:NonProprietary.part:Strength.type
                Definition

                Identifying type for this part of the name (e.g. strength part).

                ShortIdentifying type for this part of the name (e.g. strength part)
                Control1..1
                BindingFor example codes, see ProductNamePartType
                (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                Type of part of a name for a Medicinal Product.

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Pattern Value{
                  "coding" : [{
                    "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                    "code" : "STR"
                  }]
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                226. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.id
                Definition

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

                ShortUnique id for inter-element referencing
                Control0..1
                This element is affected by the following invariants: ele-1
                Typeid
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                228. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.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 MedicinalProductDefinition.name.part.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 230. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.coding
                  Definition

                  A reference to a code defined by a terminology system.

                  ShortCode defined by a terminology system
                  Comments

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

                  Control0..*
                  TypeCoding
                  Is Modifierfalse
                  Summarytrue
                  Requirements

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

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  232. MedicinalProductDefinition.name:NonProprietary.part:Strength.type.text
                  Definition

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

                  ShortPlain text representation of the concept
                  Comments

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

                  Control1..1
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  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()))
                  234. MedicinalProductDefinition.name:NonProprietary.part:Container
                  Slice NameContainer
                  Definition

                  Coding words or phrases of the name.

                  ShortCoding words or phrases of the 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()))
                  236. MedicinalProductDefinition.name:NonProprietary.part:Container.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
                  238. MedicinalProductDefinition.name:NonProprietary.part:Container.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())
                  240. MedicinalProductDefinition.name:NonProprietary.part:Container.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())
                  242. MedicinalProductDefinition.name:NonProprietary.part:Container.part
                  Definition

                  A fragment of a product name.

                  ShortA fragment of a product 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()))
                  244. MedicinalProductDefinition.name:NonProprietary.part:Container.type
                  Definition

                  Identifying type for this part of the name (e.g. strength part).

                  ShortIdentifying type for this part of the name (e.g. strength part)
                  Control1..1
                  BindingFor example codes, see ProductNamePartType
                  (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                  Type of part of a name for a Medicinal Product.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                      "code" : "CON"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  246. MedicinalProductDefinition.name:NonProprietary.part:Form
                  Slice NameForm
                  Definition

                  Coding words or phrases of the name.

                  ShortCoding words or phrases of the 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()))
                  248. MedicinalProductDefinition.name:NonProprietary.part:Form.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
                  250. MedicinalProductDefinition.name:NonProprietary.part:Form.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())
                  252. MedicinalProductDefinition.name:NonProprietary.part:Form.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())
                  254. MedicinalProductDefinition.name:NonProprietary.part:Form.part
                  Definition

                  A fragment of a product name.

                  ShortA fragment of a product 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()))
                  256. MedicinalProductDefinition.name:NonProprietary.part:Form.type
                  Definition

                  Identifying type for this part of the name (e.g. strength part).

                  ShortIdentifying type for this part of the name (e.g. strength part)
                  Control1..1
                  BindingFor example codes, see ProductNamePartType
                  (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                  Type of part of a name for a Medicinal Product.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                      "code" : "FRM"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  258. MedicinalProductDefinition.name:NonProprietary.part:Device
                  Slice NameDevice
                  Definition

                  Coding words or phrases of the name.

                  ShortCoding words or phrases of the 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()))
                  260. MedicinalProductDefinition.name:NonProprietary.part:Device.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
                  262. MedicinalProductDefinition.name:NonProprietary.part:Device.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())
                  264. MedicinalProductDefinition.name:NonProprietary.part:Device.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())
                  266. MedicinalProductDefinition.name:NonProprietary.part:Device.part
                  Definition

                  A fragment of a product name.

                  ShortA fragment of a product 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()))
                  268. MedicinalProductDefinition.name:NonProprietary.part:Device.type
                  Definition

                  Identifying type for this part of the name (e.g. strength part).

                  ShortIdentifying type for this part of the name (e.g. strength part)
                  Control1..1
                  BindingFor example codes, see ProductNamePartType
                  (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                  Type of part of a name for a Medicinal Product.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
                      "code" : "DEV"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  270. MedicinalProductDefinition.name:NonProprietary.usage
                  Definition

                  Country and jurisdiction where the name applies, and associated language.

                  ShortCountry and jurisdiction where the name applies
                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  272. MedicinalProductDefinition.name:NonProprietary.usage.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
                  274. MedicinalProductDefinition.name:NonProprietary.usage.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())
                  276. MedicinalProductDefinition.name:NonProprietary.usage.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())
                  278. MedicinalProductDefinition.name:NonProprietary.usage.country
                  Definition

                  Country code for where this name applies.

                  ShortCountry code for where this name applies
                  Control1..1
                  BindingFor example codes, see CountryValueSet
                  (example to http://hl7.org/fhir/ValueSet/country)

                  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()))
                  280. MedicinalProductDefinition.name:NonProprietary.usage.jurisdiction
                  Definition

                  Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).

                  ShortJurisdiction code for where this name applies
                  Control0..1
                  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()))
                  282. MedicinalProductDefinition.name:NonProprietary.usage.language
                  Definition

                  Language code for this name.

                  ShortLanguage code for this name
                  Control1..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

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

                  Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.

                  ShortReference to another product, e.g. for linking authorised to investigational product
                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  286. MedicinalProductDefinition.crossReference.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
                  288. MedicinalProductDefinition.crossReference.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())
                  290. MedicinalProductDefinition.crossReference.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())
                  292. MedicinalProductDefinition.crossReference.product
                  Definition

                  Reference to another product, e.g. for linking authorised to investigational product.

                  ShortReference to another product, e.g. for linking authorised to investigational product
                  Control1..1
                  TypeCodeableReference(MedicinalProductDefinition)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  294. MedicinalProductDefinition.crossReference.type
                  Definition

                  The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version.

                  ShortThe type of relationship, for instance branded to generic or virtual to actual product
                  Control0..1
                  BindingFor example codes, see ProductCrossReferenceType
                  (example to http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type)

                  Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

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

                  A manufacturing or administrative process or step associated with (or performed on) the medicinal product.

                  ShortA manufacturing or administrative process for the medicinal product
                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  298. MedicinalProductDefinition.operation.id
                  Definition

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

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

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

                  ShortAdditional content defined by implementations
                  Comments

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

                  Control0..*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  302. MedicinalProductDefinition.operation.modifierExtension
                  Definition

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

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

                  ShortExtensions that cannot be ignored even if unrecognized
                  Comments

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

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

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

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

                  The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.

                  ShortThe type of manufacturing operation e.g. manufacturing itself, re-packaging
                  Control0..1
                  TypeCodeableReference(ActivityDefinition, PlanDefinition)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  306. MedicinalProductDefinition.operation.effectiveDate
                  Definition

                  Date range of applicability.

                  ShortDate range of applicability
                  Control0..1
                  TypePeriod
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  308. MedicinalProductDefinition.operation.organization
                  Definition

                  The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.

                  ShortThe organization responsible for the particular process, e.g. the manufacturer or importer
                  Control0..*
                  TypeReference(Organization)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  310. MedicinalProductDefinition.operation.confidentialityIndicator
                  Definition

                  Specifies whether this particular business or manufacturing process is considered proprietary or confidential.

                  ShortSpecifies whether this process is considered proprietary or confidential
                  Control0..1
                  BindingFor example codes, see ProductConfidentiality
                  (example to http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality)

                  Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.

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

                  Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".

                  ShortKey product features such as "sugar free", "modified release"
                  Control0..*
                  TypeBackboneElement
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  314. MedicinalProductDefinition.characteristic.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
                  316. MedicinalProductDefinition.characteristic.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())
                  318. MedicinalProductDefinition.characteristic.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())
                  320. MedicinalProductDefinition.characteristic.type
                  Definition

                  A code expressing the type of characteristic.

                  ShortA code expressing the type of characteristic
                  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()))
                  322. MedicinalProductDefinition.characteristic.value[x]
                  Definition

                  A value for the characteristic.text.

                  ShortA value for the characteristic
                  Comments

                  Text, as markdown, is intended to be used only when the item cannot ever reasonably be coded. Otherwise, for cases where a code is not available, but is feasible, use CodeableConcept.text.

                  Control0..1
                  TypeChoice of: CodeableConcept, markdown, Quantity, integer, 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()))