Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-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: DrugProductContainerClosure - Detailed Descriptions

Active as of 2024-04-04

Definitions for the pqcmc-drugproduct-container-closure resource profile.

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

0. MedicinalProductDefinition
2. MedicinalProductDefinition.meta
4. MedicinalProductDefinition.meta.profile
Control1..1
Must Supporttrue
6. MedicinalProductDefinition.extension
Control1..?
SlicingThis element introduces a set of slices on MedicinalProductDefinition.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. MedicinalProductDefinition.extension:containerClosure
    Slice NamecontainerClosure
    Control1..*
    TypeExtension(Container Closure) (Complex Extension)
    Must Supporttrue
    10. MedicinalProductDefinition.identifier
    Shortoptional user designated identifier
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..1
    12. MedicinalProductDefinition.name
    Control0..2
    Must Supporttrue
    SlicingThis element introduces a set of slices on MedicinalProductDefinition.name. The slices are unordered and Open, and can be differentiated using the following discriminators:
    • value @ type
    • 14. MedicinalProductDefinition.name.productName
      Must Supporttrue
      16. MedicinalProductDefinition.name.type
      Control1..?
      Must Supporttrue
      18. MedicinalProductDefinition.name.usage
      20. MedicinalProductDefinition.name.usage.jurisdiction
      Control0..0
      22. MedicinalProductDefinition.name:Proprietary
      Slice NameProprietary
      Control0..1
      24. MedicinalProductDefinition.name:Proprietary.type
      Pattern Value{
        "coding" : [{
          "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types",
          "code" : "PROP",
          "display" : "Proprietary"
        }]
      }
      26. MedicinalProductDefinition.name:Proprietary.part
      Must Supporttrue
      SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part. The slices are unordered and Open, and can be differentiated using the following discriminators:
      • value @ type
      • 28. MedicinalProductDefinition.name:Proprietary.part.part
        Must Supporttrue
        30. MedicinalProductDefinition.name:Proprietary.part.type
        BindingThe codes SHALL be taken from Name Part Terminology
        (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology)
        Must Supporttrue
        32. MedicinalProductDefinition.name:Proprietary.usage
        34. MedicinalProductDefinition.name:Proprietary.usage.jurisdiction
        Control0..0
        36. MedicinalProductDefinition.name:NonProprietary
        Slice NameNonProprietary
        Control1..1
        38. MedicinalProductDefinition.name:NonProprietary.type
        Pattern Value{
          "coding" : [{
            "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types",
            "code" : "NON",
            "display" : "Non-Proprietary"
          }]
        }
        40. 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 are unordered and Open, and can be differentiated using the following discriminators:
        • value @ type
        • 42. MedicinalProductDefinition.name:NonProprietary.part.part
          Must Supporttrue
          44. MedicinalProductDefinition.name:NonProprietary.part.type
          BindingThe codes SHALL be taken from Name Part Terminology
          (required to http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology)
          Must Supporttrue
          46. MedicinalProductDefinition.name:NonProprietary.part:Scientific
          Slice NameScientific
          Control1..*
          48. MedicinalProductDefinition.name:NonProprietary.part:Scientific.type
          Pattern Value{
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
              "code" : "SCI"
            }]
          }
          50. MedicinalProductDefinition.name:NonProprietary.part:Invented
          Slice NameInvented
          Control0..*
          52. MedicinalProductDefinition.name:NonProprietary.part:Invented.type
          Pattern Value{
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
              "code" : "INV"
            }]
          }
          54. MedicinalProductDefinition.name:NonProprietary.part:Formulation
          Slice NameFormulation
          Control0..*
          56. MedicinalProductDefinition.name:NonProprietary.part:Formulation.type
          Pattern Value{
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
              "code" : "FORMUL"
            }]
          }
          58. MedicinalProductDefinition.name:NonProprietary.part:Strength
          Slice NameStrength
          Control1..*
          60. MedicinalProductDefinition.name:NonProprietary.part:Strength.type
          Pattern Value{
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
              "code" : "STR"
            }]
          }
          62. MedicinalProductDefinition.name:NonProprietary.part:Container
          Slice NameContainer
          Control0..*
          64. MedicinalProductDefinition.name:NonProprietary.part:Container.type
          Pattern Value{
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
              "code" : "CON"
            }]
          }
          66. MedicinalProductDefinition.name:NonProprietary.part:Form
          Slice NameForm
          Control0..*
          68. MedicinalProductDefinition.name:NonProprietary.part:Form.type
          Pattern Value{
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
              "code" : "FRM"
            }]
          }
          70. MedicinalProductDefinition.name:NonProprietary.part:Device
          Slice NameDevice
          Control0..*
          72. MedicinalProductDefinition.name:NonProprietary.part:Device.type
          Pattern Value{
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
              "code" : "DEV"
            }]
          }
          74. MedicinalProductDefinition.name:NonProprietary.usage
          76. MedicinalProductDefinition.name:NonProprietary.usage.jurisdiction
          Control0..0

          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.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()))
          4. MedicinalProductDefinition.meta.profile
          Definition

          A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

          ShortProfiles this resource claims to conform to
          Comments

          It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

          Control10..1*
          Typecanonical(StructureDefinition)
          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()))
          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.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
          10. MedicinalProductDefinition.extension
          Definition

          An Extension


          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.

          ShortExtensionAdditional content defined by implementations
          Comments

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

          Control10..*
          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())
          SlicingThis element introduces a set of slices on MedicinalProductDefinition.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 12. MedicinalProductDefinition.extension:containerClosure
            Slice NamecontainerClosure
            Definition

            The packaging information including a brief description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance or drug product during their use in the clinical trials.

            ShortContainer Closure System Information
            Control1..*
            TypeExtension(Container Closure) (Complex Extension)
            Is Modifierfalse
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            14. 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())
            16. 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 Supportfalse
            Summarytrue
            Alternate NamesMPID
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            18. 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()))
            20. 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 are unordered and Open, and can be differentiated using the following discriminators:
            • value @ type
            • 22. 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())
              24. 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()))
              26. 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
              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 Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              28. 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()))
              30. 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())
              32. 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()))
              34. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types",
                  "code" : "PROP",
                  "display" : "Proprietary"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              36. 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()))
              38. 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())
              40. 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()))
              42. 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 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()))
              44. 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()))
              46. 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())
              48. 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()))
              50. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types",
                  "code" : "NON",
                  "display" : "Non-Proprietary"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              52. 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 are unordered and Open, and can be differentiated using the following discriminators:
              • value @ type
              • 54. 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())
                56. 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()))
                58. 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 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()))
                60. 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()))
                62. 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())
                64. 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()))
                66. 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()))
                68. 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()))
                70. 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())
                72. 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()))
                74. 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()))
                76. 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()))
                78. 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())
                80. 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()))
                82. 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()))
                84. 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()))
                86. 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())
                88. 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()))
                90. 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()))
                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.meta.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
                8. MedicinalProductDefinition.meta.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.meta.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 10. MedicinalProductDefinition.meta.versionId
                  Definition

                  The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

                  ShortVersion specific identifier
                  Comments

                  The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

                  Control0..1
                  Typeid
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  12. MedicinalProductDefinition.meta.lastUpdated
                  Definition

                  When the resource last changed - e.g. when the version changed.

                  ShortWhen the resource version last changed
                  Comments

                  This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

                  Control0..1
                  Typeinstant
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  14. MedicinalProductDefinition.meta.source
                  Definition

                  A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

                  ShortIdentifies where the resource comes from
                  Comments

                  The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference.

                  This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

                  Control0..1
                  Typeuri
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  16. MedicinalProductDefinition.meta.profile
                  Definition

                  A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

                  ShortProfiles this resource claims to conform to
                  Comments

                  It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

                  Control1..1
                  Typecanonical(StructureDefinition)
                  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()))
                  18. MedicinalProductDefinition.meta.security
                  Definition

                  Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

                  ShortSecurity Labels applied to this resource
                  Comments

                  The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

                  Control0..*
                  BindingUnless not suitable, these codes SHALL be taken from AllSecurityLabels
                  (extensible to http://hl7.org/fhir/ValueSet/security-labels)

                  Security Labels from the Healthcare Privacy and Security Classification System.

                  TypeCoding
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  20. MedicinalProductDefinition.meta.tag
                  Definition

                  Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

                  ShortTags applied to this resource
                  Comments

                  The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

                  Control0..*
                  BindingFor example codes, see CommonTags
                  (example to http://hl7.org/fhir/ValueSet/common-tags)

                  Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

                  TypeCoding
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  22. 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()))
                  24. 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()))
                  26. 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()))
                  28. 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
                  30. MedicinalProductDefinition.extension
                  Definition

                  An Extension

                  ShortExtension
                  Control1..*
                  TypeExtension
                  Is Modifierfalse
                  Must Supportfalse
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on MedicinalProductDefinition.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 32. MedicinalProductDefinition.extension:containerClosure
                    Slice NamecontainerClosure
                    Definition

                    The packaging information including a brief description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance or drug product during their use in the clinical trials.

                    ShortContainer Closure System Information
                    Control1..*
                    TypeExtension(Container Closure) (Complex Extension)
                    Is Modifierfalse
                    Must Supporttrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    34. 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())
                    36. 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 Supportfalse
                    Summarytrue
                    Alternate NamesMPID
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    38. 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()))
                    40. 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()))
                    42. 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 versionId, 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()))
                    44. 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()))
                    46. 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()))
                    48. 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()))
                    50. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
                    Definition

                    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).

                    ShortThe dose form for a single part product, or combined form of a multiple part product
                    Control0..1
                    BindingFor example codes, see CombinedDoseForm
                    (example to http://hl7.org/fhir/ValueSet/combined-dose-form)

                    Dose forms for a product as a whole, considering all individual parts, but before any mixing

                    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.route
                    Definition

                    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.

                    ShortThe path by which the product is taken into or makes contact with the body
                    Control0..*
                    BindingFor example codes, see SNOMEDCTRouteCodes
                    (example to http://hl7.org/fhir/ValueSet/route-codes)

                    A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    54. 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()))
                    56. 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()))
                    58. 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()))
                    60. 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()))
                    62. 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()))
                    64. 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()))
                    66. 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()))
                    68. 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()))
                    70. 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
                    Control0..*
                    TypeReference(ManufacturedItemDefinition, DeviceDefinition)
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    72. 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()))
                    74. 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()))
                    76. 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()))
                    78. 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()))
                    80. 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()))
                    82. 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
                    84. 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())
                    86. 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())
                    88. 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()))
                    90. 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()))
                    92. 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()))
                    94. 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()))
                    96. 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 are unordered and Open, and can be differentiated using the following discriminators:
                    • value @ type
                    • 98. 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
                      100. 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())
                      102. 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())
                      104. 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()))
                      106. 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
                      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 Supporttrue
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      108. 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()))
                      110. 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
                      112. 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())
                      114. 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())
                      116. 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()))
                      118. 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()))
                      120. 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()))
                      122. 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
                      124. 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())
                      126. 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())
                      128. 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()))
                      130. 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..0
                      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()))
                      132. 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()))
                      134. 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()))
                      136. 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
                      138. 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())
                      140. 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())
                      142. 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()))
                      144. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types",
                          "code" : "PROP",
                          "display" : "Proprietary"
                        }]
                      }
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      146. 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()))
                      148. 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
                      150. 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())
                      152. 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())
                      154. 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()))
                      156. 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 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()))
                      158. 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()))
                      160. 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
                      162. 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())
                      164. 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())
                      166. 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()))
                      168. 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..0
                      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()))
                      170. 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()))
                      172. 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()))
                      174. 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
                      176. 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())
                      178. 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())
                      180. 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()))
                      182. 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types",
                          "code" : "NON",
                          "display" : "Non-Proprietary"
                        }]
                      }
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      184. 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 are unordered and Open, and can be differentiated using the following discriminators:
                      • value @ type
                      • 186. 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
                        188. 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())
                        190. 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())
                        192. 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()))
                        194. 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 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()))
                        196. 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()))
                        198. 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
                        200. 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())
                        202. 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())
                        204. 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()))
                        206. 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()))
                        208. 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()))
                        210. 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
                        212. 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())
                        214. 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())
                        216. 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()))
                        218. 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()))
                        220. 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()))
                        222. 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
                        224. 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())
                        226. 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())
                        228. 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()))
                        230. 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()))
                        232. 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()))
                        234. 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
                        236. 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())
                        238. 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())
                        240. 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()))
                        242. 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()))
                        244. 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()))
                        246. 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
                        248. 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())
                        250. 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())
                        252. 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()))
                        254. 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()))
                        256. 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()))
                        258. 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
                        260. 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())
                        262. 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())
                        264. 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()))
                        266. 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()))
                        268. 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()))
                        270. 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
                        272. 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())
                        274. 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())
                        276. 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()))
                        278. 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()))
                        280. 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()))
                        282. 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
                        284. 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())
                        286. 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())
                        288. 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()))
                        290. 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..0
                        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()))
                        292. 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()))
                        294. 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()))
                        296. 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
                        298. 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())
                        300. 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())
                        302. 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()))
                        304. 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()))
                        306. 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()))
                        308. 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
                        310. 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())
                        312. 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())
                        314. 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()))
                        316. 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()))
                        318. 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()))
                        320. 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()))
                        322. 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()))
                        324. 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
                        326. 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())
                        328. 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())
                        330. 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()))
                        332. 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] NoteSee Choice of Data Types for further information about how to use [x]
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))