pqcmc-product-batch-formula
type: StructureDefinition
node role: treeRoot
id:
  v: pqcmc-product-batch-formula
text:
  status:
    v: extensions
  div: Generated Narrative: StructureDefinition pqcmc-product-batch-formula Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> ManufacturedItemDefinition ManufacturedItemDefinition #xD; identifier S 0..1 Identifier optional user designated identifier #xD; status S 1..1 code draft | active | retired | unknown #xD; name S 1..1 string Product Non-proprietary Name #xD; manufacturedDoseForm 1..1 CodeableConcept Dose form as manufactured (before any necessary transformation) Binding: Manufactured Dose Form Terminology (required) #xD; manufacturer S 0..* LiteralReference(Basic Organization) {b} Manufacturer of the item, one of several possible #xD; Slices for property S 2..* BackboneElement General characteristics of this item Slice: Unordered, Closed by value:type.text #xD; property:All Slices Content/Rules for all slices #xD; type S 1..1 CodeableConcept A code expressing the type of characteristic #xD; text S 1..1 string Plain text representation of the concept #xD; property:BatchSize S 1..1 BackboneElement Batch Quantity #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Batch Quantity #xD; value[x] S 1..1 Quantity A value for the characteristic Binding: Units Of Measure (required) #xD; value S 1..1 decimal Numerical value (with implicit precision) #xD; code 0..1 code Quantity UOM #xD; property:BatchUtil S 1..* BackboneElement Batch Utilization #xD; type #xD; text 1..1 string Plain text representation of the concept Required Pattern: Batch Utilization #xD; value[x] S 1..1 CodeableConcept A value for the characteristic Binding: Batch utilization Terminology (required) #xD; <a href="StructureDefinition-pqcmc-product-batch-formula-definitions.html#ManufacturedItemDefinition.property:AddInfo" title="Slice AddInfo: A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on d…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
  value: code
    v: brr
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
  value: integer
    v: 2
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
      value: canonical
        v: http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda
        link: http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
  value: code
    v: trial-use
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
      value: canonical
        v: http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda
        link: http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda
url:
  v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula
identifier:
  system:
    v: urn:ietf:rfc:3986
  value:
    v: urn:oid:2.16.840.1.113883.4.642.40.36.42.47
version:
  v: 2.0.0
name:
  v: BatchFormula
title:
  v: Drug Product Batch Formula
status:
  v: active
date:
  v: 2025-07-03T13:07:08+00:00
publisher:
  v: HL7 International / Biomedical Research and Regulation
contact:
  name:
    v: HL7 International / Biomedical Research and Regulation
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/rcrim
  telecom:
    system:
      v: email
description:
  v: Listing of all components of the dosage form to be used in the manufacture, their amounts on a per batch basis, including overages, and reference to their quality standards.
jurisdiction:
  coding:
    system:
      v: urn:iso:std:iso:3166
    code:
      v: US
    display:
      v: United States of America
fhir version:
  v: 5.0.0
mapping:
  identity:
    v: w5
  uri:
    v: http://hl7.org/fhir/fivews
  name:
    v: FiveWs Pattern Mapping
mapping:
  identity:
    v: idmp
  uri:
    v: https://www.iso.org/obp/ui/#iso:std:iso:11615
  name:
    v: IDMP Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
  name:
    v: RIM Mapping
kind:
  v: resource
abstract:
  v: false
type:
  v: ManufacturedItemDefinition
base definition:
  v: http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition
  link: http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
    value: string
      v: 5.0.0
  element:
    id:
      v: ManufacturedItemDefinition
    path:
      v: ManufacturedItemDefinition
    short:
      v: The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
    definition:
      v: The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product.
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: ManufacturedItemDefinition
      min:
        v: 0
      max:
        v: *
    constraint:
      key:
        v: dom-2
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL NOT contain nested Resources
      expression:
        v: contained.contained.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-3
      severity:
        v: error
      human:
        v: 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
      expression:
        v: 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()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-4
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
      expression:
        v: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-5
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a security label
      expression:
        v: contained.meta.security.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      extension:
        value: boolean
      extension:
        value: markdown
      key:
        v: dom-6
      severity:
        v: warning
      human:
        v: A resource should have narrative for robust management
      expression:
        v: text.`div`.exists()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    must support:
      v: false
    is modifier:
      v: false

boolean
v: true

markdown
v: When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.

v: false

identity:
  v: rim
map:
  v: Entity, Role, or Act

identity:
  v: w5
map:
  v: administrative.medication

identity:
  v: idmp
map:
  v: Manufactured Item

id:
  v: ManufacturedItemDefinition.id
path:
  v: ManufacturedItemDefinition.id
short:
  v: Logical id of this artifact
definition:
  v: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
comment:
  v: 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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.meta
path:
  v: ManufacturedItemDefinition.meta
short:
  v: Metadata about the resource
definition:
  v: 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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.meta
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Meta
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.implicitRules
path:
  v: ManufacturedItemDefinition.implicitRules
short:
  v: A set of rules under which this content was created
definition:
  v: 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.
comment:
  v: 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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.implicitRules
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.language
path:
  v: ManufacturedItemDefinition.language
short:
  v: Language of the resource content
definition:
  v: The base language in which the resource is written.
comment:
  v: 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).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.language
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Language
  strength:
    v: required
  description:
    v: IETF language tag for a human language
  value set:
    v: http://hl7.org/fhir/ValueSet/all-languages|5.0.0
    link: 5.0
    link: .0
  additional:
    purpose:
      v: starter
    value set:
      v: http://hl7.org/fhir/ValueSet/languages
      link: http://hl7.org/fhir/ValueSet/languages

id:
  v: ManufacturedItemDefinition.text
path:
  v: ManufacturedItemDefinition.text
short:
  v: Text summary of the resource, for human interpretation
definition:
  v: 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.
comment:
  v: 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.
alias:
  v: narrative
alias:
  v: html
alias:
  v: xhtml
alias:
  v: display
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Narrative
condition:
  v: dom-6
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: Act.text?

id:
  v: ManufacturedItemDefinition.contained
path:
  v: ManufacturedItemDefinition.contained
short:
  v: Contained, inline Resources
definition:
  v: 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.
comment:
  v: 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.
alias:
  v: inline resources
alias:
  v: anonymous resources
alias:
  v: contained resources
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.contained
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Resource
condition:
  v: dom-2
condition:
  v: dom-4
condition:
  v: dom-3
condition:
  v: dom-5
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.extension
path:
  v: ManufacturedItemDefinition.extension
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.modifierExtension
path:
  v: ManufacturedItemDefinition.modifierExtension
short:
  v: Extensions that cannot be ignored
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: DomainResource.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.identifier
path:
  v: ManufacturedItemDefinition.identifier
short:
  v: optional user designated identifier
definition:
  v: Unique identifier.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.class
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.status
path:
  v: ManufacturedItemDefinition.status
short:
  v: draft | active | retired | unknown
definition:
  v: The status of this item. Enables tracking the life-cycle of the content.
comment:
  v: Allows filtering of manufactured items that are appropriate for use versus not.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.status
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not use a retired {{title}} without due consideration
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: PublicationStatus
  strength:
    v: required
  description:
    v: The lifecycle status of an artifact.
  value set:
    v: http://hl7.org/fhir/ValueSet/publication-status|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.name
path:
  v: ManufacturedItemDefinition.name
short:
  v: Product Non-proprietary Name
definition:
  v: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.name
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.class
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.manufacturedDoseForm
path:
  v: ManufacturedItemDefinition.manufacturedDoseForm
short:
  v: Dose form as manufactured (before any necessary transformation)
definition:
  v: Dose form as manufactured and before any transformation into the pharmaceutical product.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.manufacturedDoseForm
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology
mapping:
  identity:
    v: idmp
  map:
    v: Manufactured Item.Manufactured Dose Form

id:
  v: ManufacturedItemDefinition.unitOfPresentation
path:
  v: ManufacturedItemDefinition.unitOfPresentation
short:
  v: The “real-world” units in which the quantity of the item is described
definition:
  v: The “real-world” units in which the quantity of the manufactured item is described.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.unitOfPresentation
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: UnitOfPresentation
  strength:
    v: example
  description:
    v: The presentation type in which an administrable medicinal product is given to a patient.
  value set:
    v: http://hl7.org/fhir/ValueSet/unit-of-presentation
    link: http://hl7.org/fhir/ValueSet/unit-of-presentation
mapping:
  identity:
    v: idmp
  map:
    v: Manufactured Item.Unit of Presentation

id:
  v: ManufacturedItemDefinition.manufacturer
path:
  v: ManufacturedItemDefinition.manufacturer
short:
  v: Manufacturer of the item, one of several possible
definition:
  v: Manufacturer of the item, one of several possible.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.manufacturer
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference
  target profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
  aggregation:
    v: bundled
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Manufactured Item.Manufacturer / Establishment (Organisation)

id:
  v: ManufacturedItemDefinition.marketingStatus
path:
  v: ManufacturedItemDefinition.marketingStatus
short:
  v: Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
definition:
  v: Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.marketingStatus
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: MarketingStatus
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.ingredient
path:
  v: ManufacturedItemDefinition.ingredient
short:
  v: The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource
definition:
  v: The ingredients of this manufactured item. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.ingredient
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTSubstanceCodes
  strength:
    v: example
  description:
    v: This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/substance-codes
    link: http://hl7.org/fhir/ValueSet/substance-codes
mapping:
  identity:
    v: idmp
  map:
    v: Manufactured Item.Ingredient (see also FHIR Ingredient resource)

id:
  v: ManufacturedItemDefinition.property
path:
  v: ManufacturedItemDefinition.property
slicing:
  discriminator:
    type:
      v: value
    path:
      v: type.text
  description:
    v: Slice based on value
  rules:
    v: closed
short:
  v: General characteristics of this item
definition:
  v: General characteristics of this item.
min:
  v: 2
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.property
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Manufactured Item.Physical Characteristics

id:
  v: ManufacturedItemDefinition.property.id
path:
  v: ManufacturedItemDefinition.property.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property.extension
path:
  v: ManufacturedItemDefinition.property.extension
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property.modifierExtension
path:
  v: ManufacturedItemDefinition.property.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.property.type
path:
  v: ManufacturedItemDefinition.property.type
short:
  v: A code expressing the type of characteristic
definition:
  v: A code expressing the type of characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTCharacteristicCodes
  strength:
    v: example
  description:
    v: This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/product-characteristic-codes
    link: http://hl7.org/fhir/ValueSet/product-characteristic-codes
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, all attributes

id:
  v: ManufacturedItemDefinition.property.type.id
path:
  v: ManufacturedItemDefinition.property.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property.type.extension
path:
  v: ManufacturedItemDefinition.property.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property.type.coding
path:
  v: ManufacturedItemDefinition.property.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: ManufacturedItemDefinition.property.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.property.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: ManufacturedItemDefinition.property.value[x]
path:
  v: ManufacturedItemDefinition.property.value[x]
short:
  v: A value for the characteristic
definition:
  v: A value for the characteristic.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
type:
  code:
    v: Quantity
type:
  code:
    v: date
type:
  code:
    v: boolean
type:
  code:
    v: markdown
type:
  code:
    v: Attachment
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Binary
    link: http://hl7.org/fhir/StructureDefinition/Binary
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, attribute's value

id:
  v: ManufacturedItemDefinition.property:BatchSize
path:
  v: ManufacturedItemDefinition.property
slice name:
  v: BatchSize
short:
  v: Batch Quantity
definition:
  v: The amount of material in a specific batch size [Source: SME Defined] Example: 1000 kg
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Manufactured Item.Physical Characteristics

id:
  v: ManufacturedItemDefinition.property:BatchSize.id
path:
  v: ManufacturedItemDefinition.property.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:BatchSize.extension
path:
  v: ManufacturedItemDefinition.property.extension
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:BatchSize.modifierExtension
path:
  v: ManufacturedItemDefinition.property.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.property:BatchSize.type
path:
  v: ManufacturedItemDefinition.property.type
short:
  v: A code expressing the type of characteristic
definition:
  v: A code expressing the type of characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTCharacteristicCodes
  strength:
    v: example
  description:
    v: This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/product-characteristic-codes
    link: http://hl7.org/fhir/ValueSet/product-characteristic-codes
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, all attributes

id:
  v: ManufacturedItemDefinition.property:BatchSize.type.id
path:
  v: ManufacturedItemDefinition.property.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:BatchSize.type.extension
path:
  v: ManufacturedItemDefinition.property.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:BatchSize.type.coding
path:
  v: ManufacturedItemDefinition.property.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: ManufacturedItemDefinition.property:BatchSize.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.property.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
pattern: string
  v: Batch Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: ManufacturedItemDefinition.property:BatchSize.value[x]
path:
  v: ManufacturedItemDefinition.property.value[x]
short:
  v: A value for the characteristic
definition:
  v: A value for the characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, attribute's value

id:
  v: ManufacturedItemDefinition.property:BatchSize.value[x].id
path:
  v: ManufacturedItemDefinition.property.value[x].id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:BatchSize.value[x].extension
path:
  v: ManufacturedItemDefinition.property.value[x].extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:BatchSize.value[x].value
path:
  v: ManufacturedItemDefinition.property.value[x].value
short:
  v: Numerical value (with implicit precision)
definition:
  v: The value of the measured amount. The value includes an implicit precision in the presentation of the value.
comment:
  v: The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
requirements:
  v: Precision is handled implicitly in almost all cases of measurement.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: decimal
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: SN.2 / CQ - N/A
mapping:
  identity:
    v: rim
  map:
    v: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value

id:
  v: ManufacturedItemDefinition.property:BatchSize.value[x].comparator
path:
  v: ManufacturedItemDefinition.property.value[x].comparator
short:
  v: < | <= | >= | > | ad - how to understand the value
definition:
  v: How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
requirements:
  v: Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.comparator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
meaning when missing:
  v: If there is no comparator, then there is no modification of the value
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: QuantityComparator
  strength:
    v: required
  description:
    v: How the Quantity should be understood and represented.
  value set:
    v: http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: SN.1 / CQ.1
mapping:
  identity:
    v: rim
  map:
    v: IVL properties

id:
  v: ManufacturedItemDefinition.property:BatchSize.value[x].unit
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.property.value[x].unit
short:
  v: Unit representation
definition:
  v: A human-readable form of the unit.
requirements:
  v: There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.unit
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.unit

id:
  v: ManufacturedItemDefinition.property:BatchSize.value[x].system
path:
  v: ManufacturedItemDefinition.property.value[x].system
short:
  v: System that defines coded unit form
definition:
  v: The identification of the system that provides the coded form of the unit.
requirements:
  v: Need to know the system that defines the coded form of the unit.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: CO.codeSystem, PQ.translation.codeSystem

id:
  v: ManufacturedItemDefinition.property:BatchSize.value[x].code
path:
  v: ManufacturedItemDefinition.property.value[x].code
short:
  v: Quantity UOM
definition:
  v: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI EVS - C25709]
comment:
  v: The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
requirements:
  v: Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.code, MO.currency, PQ.translation.code

id:
  v: ManufacturedItemDefinition.property:BatchUtil
path:
  v: ManufacturedItemDefinition.property
slice name:
  v: BatchUtil
short:
  v: Batch Utilization
definition:
  v: A categorization of the batch that identifies its usage. [Source: SME Defined] Examples: commercial, development.
min:
  v: 1
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.property
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Manufactured Item.Physical Characteristics

id:
  v: ManufacturedItemDefinition.property:BatchUtil.id
path:
  v: ManufacturedItemDefinition.property.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:BatchUtil.extension
path:
  v: ManufacturedItemDefinition.property.extension
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:BatchUtil.modifierExtension
path:
  v: ManufacturedItemDefinition.property.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.property:BatchUtil.type
path:
  v: ManufacturedItemDefinition.property.type
short:
  v: A code expressing the type of characteristic
definition:
  v: A code expressing the type of characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTCharacteristicCodes
  strength:
    v: example
  description:
    v: This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/product-characteristic-codes
    link: http://hl7.org/fhir/ValueSet/product-characteristic-codes
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, all attributes

id:
  v: ManufacturedItemDefinition.property:BatchUtil.type.id
path:
  v: ManufacturedItemDefinition.property.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:BatchUtil.type.extension
path:
  v: ManufacturedItemDefinition.property.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:BatchUtil.type.coding
path:
  v: ManufacturedItemDefinition.property.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: ManufacturedItemDefinition.property:BatchUtil.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.property.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
pattern: string
  v: Batch Utilization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: ManufacturedItemDefinition.property:BatchUtil.value[x]
path:
  v: ManufacturedItemDefinition.property.value[x]
short:
  v: A value for the characteristic
definition:
  v: A value for the characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, attribute's value

id:
  v: ManufacturedItemDefinition.property:AddInfo
path:
  v: ManufacturedItemDefinition.property
slice name:
  v: AddInfo
short:
  v: Batch Formula Additional Information
definition:
  v: A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Manufactured Item.Physical Characteristics

id:
  v: ManufacturedItemDefinition.property:AddInfo.id
path:
  v: ManufacturedItemDefinition.property.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:AddInfo.extension
path:
  v: ManufacturedItemDefinition.property.extension
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:AddInfo.modifierExtension
path:
  v: ManufacturedItemDefinition.property.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.property:AddInfo.type
path:
  v: ManufacturedItemDefinition.property.type
short:
  v: A code expressing the type of characteristic
definition:
  v: A code expressing the type of characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTCharacteristicCodes
  strength:
    v: example
  description:
    v: This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/product-characteristic-codes
    link: http://hl7.org/fhir/ValueSet/product-characteristic-codes
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, all attributes

id:
  v: ManufacturedItemDefinition.property:AddInfo.type.id
path:
  v: ManufacturedItemDefinition.property.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:AddInfo.type.extension
path:
  v: ManufacturedItemDefinition.property.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.property:AddInfo.type.coding
path:
  v: ManufacturedItemDefinition.property.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: ManufacturedItemDefinition.property:AddInfo.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.property.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
pattern: string
  v: Batch Formula Additional Information
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: ManufacturedItemDefinition.property:AddInfo.value[x]
path:
  v: ManufacturedItemDefinition.property.value[x]
short:
  v: A value for the characteristic
definition:
  v: A value for the characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, attribute's value

id:
  v: ManufacturedItemDefinition.component
path:
  v: ManufacturedItemDefinition.component
short:
  v: Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup
definition:
  v: Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup.
min:
  v: 1
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.component
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Manufactured Item.Physical Characteristics

id:
  v: ManufacturedItemDefinition.component.id
path:
  v: ManufacturedItemDefinition.component.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.extension
path:
  v: ManufacturedItemDefinition.component.extension
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.modifierExtension
path:
  v: ManufacturedItemDefinition.component.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.component.type
path:
  v: ManufacturedItemDefinition.component.type
short:
  v: Product Part Type
definition:
  v: Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined] Example: Layer, Bead, Minitablet, Capsule Shell, Coating
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.component.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, all attributes

id:
  v: ManufacturedItemDefinition.component.function
path:
  v: ManufacturedItemDefinition.component.function
short:
  v: The function of this component within the item e.g. delivers active ingredient, masks taste
definition:
  v: The function of this component within the item e.g. delivers active ingredient, masks taste.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.component.function
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.amount
path:
  v: ManufacturedItemDefinition.component.amount
slicing:
  discriminator:
    type:
      v: value
    path:
      v: code
  description:
    v: Slice based on value of unit
  rules:
    v: closed
short:
  v: The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
definition:
  v: The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).
min:
  v: 2
max:
  v: 2
base:
  path:
    v: ManufacturedItemDefinition.component.amount
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.amount:perBatch
path:
  v: ManufacturedItemDefinition.component.amount
slice name:
  v: perBatch
short:
  v: Component Quantity Per Batch
definition:
  v: Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.component.amount
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.amount:perBatch.id
path:
  v: ManufacturedItemDefinition.component.amount.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.amount:perBatch.extension
path:
  v: ManufacturedItemDefinition.component.amount.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.amount:perBatch.value
path:
  v: ManufacturedItemDefinition.component.amount.value
short:
  v: Numerical value (with implicit precision)
definition:
  v: The value of the measured amount. The value includes an implicit precision in the presentation of the value.
comment:
  v: The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
requirements:
  v: Precision is handled implicitly in almost all cases of measurement.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: decimal
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: SN.2 / CQ - N/A
mapping:
  identity:
    v: rim
  map:
    v: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value

id:
  v: ManufacturedItemDefinition.component.amount:perBatch.comparator
path:
  v: ManufacturedItemDefinition.component.amount.comparator
short:
  v: < | <= | >= | > | ad - how to understand the value
definition:
  v: How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
requirements:
  v: Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.comparator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
meaning when missing:
  v: If there is no comparator, then there is no modification of the value
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: QuantityComparator
  strength:
    v: required
  description:
    v: How the Quantity should be understood and represented.
  value set:
    v: http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: SN.1 / CQ.1
mapping:
  identity:
    v: rim
  map:
    v: IVL properties

id:
  v: ManufacturedItemDefinition.component.amount:perBatch.unit
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.component.amount.unit
short:
  v: Unit representation
definition:
  v: A human-readable form of the unit.
requirements:
  v: There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.unit
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.unit

id:
  v: ManufacturedItemDefinition.component.amount:perBatch.system
path:
  v: ManufacturedItemDefinition.component.amount.system
short:
  v: System that defines coded unit form
definition:
  v: The identification of the system that provides the coded form of the unit.
requirements:
  v: Need to know the system that defines the coded form of the unit.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: CO.codeSystem, PQ.translation.codeSystem

id:
  v: ManufacturedItemDefinition.component.amount:perBatch.code
path:
  v: ManufacturedItemDefinition.component.amount.code
short:
  v: Coded form of the unit
definition:
  v: A computer processable form of the unit in some unit representation system.
comment:
  v: The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
requirements:
  v: Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.code, MO.currency, PQ.translation.code

id:
  v: ManufacturedItemDefinition.component.amount:percent
path:
  v: ManufacturedItemDefinition.component.amount
slice name:
  v: percent
short:
  v: The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
definition:
  v: The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume).
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.component.amount
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.amount:percent.id
path:
  v: ManufacturedItemDefinition.component.amount.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.amount:percent.extension
path:
  v: ManufacturedItemDefinition.component.amount.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.amount:percent.value
path:
  v: ManufacturedItemDefinition.component.amount.value
short:
  v: Numerical value (with implicit precision)
definition:
  v: The value of the measured amount. The value includes an implicit precision in the presentation of the value.
comment:
  v: The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
requirements:
  v: Precision is handled implicitly in almost all cases of measurement.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: decimal
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: SN.2 / CQ - N/A
mapping:
  identity:
    v: rim
  map:
    v: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value

id:
  v: ManufacturedItemDefinition.component.amount:percent.comparator
path:
  v: ManufacturedItemDefinition.component.amount.comparator
short:
  v: < | <= | >= | > | ad - how to understand the value
definition:
  v: How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
requirements:
  v: Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.comparator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
meaning when missing:
  v: If there is no comparator, then there is no modification of the value
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: QuantityComparator
  strength:
    v: required
  description:
    v: How the Quantity should be understood and represented.
  value set:
    v: http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: SN.1 / CQ.1
mapping:
  identity:
    v: rim
  map:
    v: IVL properties

id:
  v: ManufacturedItemDefinition.component.amount:percent.unit
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.component.amount.unit
short:
  v: Unit representation
definition:
  v: A human-readable form of the unit.
requirements:
  v: There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.unit
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.unit

id:
  v: ManufacturedItemDefinition.component.amount:percent.system
path:
  v: ManufacturedItemDefinition.component.amount.system
short:
  v: System that defines coded unit form
definition:
  v: The identification of the system that provides the coded form of the unit.
requirements:
  v: Need to know the system that defines the coded form of the unit.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: CO.codeSystem, PQ.translation.codeSystem

id:
  v: ManufacturedItemDefinition.component.amount:percent.code
path:
  v: ManufacturedItemDefinition.component.amount.code
short:
  v: Coded form of the unit
definition:
  v: A computer processable form of the unit in some unit representation system.
comment:
  v: The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
requirements:
  v: Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.code, MO.currency, PQ.translation.code

id:
  v: ManufacturedItemDefinition.component.constituent
path:
  v: ManufacturedItemDefinition.component.constituent
short:
  v: A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient)
definition:
  v: A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient).
min:
  v: 1
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.component.constituent
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.constituent.id
path:
  v: ManufacturedItemDefinition.component.constituent.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.constituent.extension
path:
  v: ManufacturedItemDefinition.component.constituent.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  ordered:
    v: false
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: ManufacturedItemDefinition.component.constituent.extension:additional-info
path:
  v: ManufacturedItemDefinition.component.constituent.extension
slice name:
  v: additional-info
short:
  v: Drug Product Constituent Additional Information
definition:
  v: A placeholder for providing any comments relevant to the constituent [Source: SME Defined] Examples: Water for wet granulation - removed during process; adjusted for loss on drying, etc.* property[
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false

id:
  v: ManufacturedItemDefinition.component.constituent.extension:ingredientOverage
path:
  v: ManufacturedItemDefinition.component.constituent.extension
slice name:
  v: ingredientOverage
short:
  v: Overage Extension
definition:
  v: Extension for measurements related to excess for ingredients in the batch formula.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
constraint:
  key:
    v: cmc-overage-percent-limit
  severity:
    v: error
  human:
    v: Overage percent must be less than 1.0
  expression:
    v: extension.where(url='proportionDecimal').single().value < 1
  source:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false

id:
  v: ManufacturedItemDefinition.component.constituent.extension:StrengthTextual
path:
  v: ManufacturedItemDefinition.component.constituent.extension
slice name:
  v: StrengthTextual
short:
  v: Product Batch Strength Textual Extension
definition:
  v: Extension for strength as a string for ingredients in the batch formula.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: true
is modifier:
  v: false
is summary:
  v: false

id:
  v: ManufacturedItemDefinition.component.constituent.modifierExtension
path:
  v: ManufacturedItemDefinition.component.constituent.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.component.constituent.amount
path:
  v: ManufacturedItemDefinition.component.constituent.amount
slicing:
  discriminator:
    type:
      v: value
    path:
      v: code
  description:
    v: Slice based on value of unit
  rules:
    v: closed
short:
  v: The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
definition:
  v: The measurable amount of the substance, expressable in different ways (e.g. by mass or volume).
min:
  v: 2
max:
  v: 2
base:
  path:
    v: ManufacturedItemDefinition.component.constituent.amount
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.constituent.amount:perBatch
path:
  v: ManufacturedItemDefinition.component.constituent.amount
slice name:
  v: perBatch
short:
  v: Component Quantity Per Batch
definition:
  v: Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.component.constituent.amount
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.constituent.amount:perBatch.id
path:
  v: ManufacturedItemDefinition.component.constituent.amount.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.constituent.amount:perBatch.extension
path:
  v: ManufacturedItemDefinition.component.constituent.amount.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.constituent.amount:perBatch.value
path:
  v: ManufacturedItemDefinition.component.constituent.amount.value
short:
  v: Numerical value (with implicit precision)
definition:
  v: The value of the measured amount. The value includes an implicit precision in the presentation of the value.
comment:
  v: The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
requirements:
  v: Precision is handled implicitly in almost all cases of measurement.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: decimal
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: SN.2 / CQ - N/A
mapping:
  identity:
    v: rim
  map:
    v: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value

id:
  v: ManufacturedItemDefinition.component.constituent.amount:perBatch.comparator
path:
  v: ManufacturedItemDefinition.component.constituent.amount.comparator
short:
  v: < | <= | >= | > | ad - how to understand the value
definition:
  v: How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
requirements:
  v: Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.comparator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
meaning when missing:
  v: If there is no comparator, then there is no modification of the value
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: QuantityComparator
  strength:
    v: required
  description:
    v: How the Quantity should be understood and represented.
  value set:
    v: http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: SN.1 / CQ.1
mapping:
  identity:
    v: rim
  map:
    v: IVL properties

id:
  v: ManufacturedItemDefinition.component.constituent.amount:perBatch.unit
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.component.constituent.amount.unit
short:
  v: Unit representation
definition:
  v: A human-readable form of the unit.
requirements:
  v: There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.unit
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.unit

id:
  v: ManufacturedItemDefinition.component.constituent.amount:perBatch.system
path:
  v: ManufacturedItemDefinition.component.constituent.amount.system
short:
  v: System that defines coded unit form
definition:
  v: The identification of the system that provides the coded form of the unit.
requirements:
  v: Need to know the system that defines the coded form of the unit.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: CO.codeSystem, PQ.translation.codeSystem

id:
  v: ManufacturedItemDefinition.component.constituent.amount:perBatch.code
path:
  v: ManufacturedItemDefinition.component.constituent.amount.code
short:
  v: Coded form of the unit
definition:
  v: A computer processable form of the unit in some unit representation system.
comment:
  v: The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
requirements:
  v: Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.code, MO.currency, PQ.translation.code

id:
  v: ManufacturedItemDefinition.component.constituent.amount:percent
path:
  v: ManufacturedItemDefinition.component.constituent.amount
slice name:
  v: percent
short:
  v: Quantity Percent
definition:
  v: Quantity expressed as Volume To Volume: The percentage of the component in the batch [Source: SME Defined] Quantity UOM: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI E - C25709]
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.component.constituent.amount
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Quantity
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.constituent.amount:percent.id
path:
  v: ManufacturedItemDefinition.component.constituent.amount.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.constituent.amount:percent.extension
path:
  v: ManufacturedItemDefinition.component.constituent.amount.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.constituent.amount:percent.value
path:
  v: ManufacturedItemDefinition.component.constituent.amount.value
short:
  v: Numerical value (with implicit precision)
definition:
  v: The value of the measured amount. The value includes an implicit precision in the presentation of the value.
comment:
  v: The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
requirements:
  v: Precision is handled implicitly in almost all cases of measurement.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: decimal
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: SN.2 / CQ - N/A
mapping:
  identity:
    v: rim
  map:
    v: PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value

id:
  v: ManufacturedItemDefinition.component.constituent.amount:percent.comparator
path:
  v: ManufacturedItemDefinition.component.constituent.amount.comparator
short:
  v: < | <= | >= | > | ad - how to understand the value
definition:
  v: How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
requirements:
  v: Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.comparator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
meaning when missing:
  v: If there is no comparator, then there is no modification of the value
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: QuantityComparator
  strength:
    v: required
  description:
    v: How the Quantity should be understood and represented.
  value set:
    v: http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: SN.1 / CQ.1
mapping:
  identity:
    v: rim
  map:
    v: IVL properties

id:
  v: ManufacturedItemDefinition.component.constituent.amount:percent.unit
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.component.constituent.amount.unit
short:
  v: Unit representation
definition:
  v: A human-readable form of the unit.
requirements:
  v: There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.unit
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.unit

id:
  v: ManufacturedItemDefinition.component.constituent.amount:percent.system
path:
  v: ManufacturedItemDefinition.component.constituent.amount.system
short:
  v: System that defines coded unit form
definition:
  v: The identification of the system that provides the coded form of the unit.
requirements:
  v: Need to know the system that defines the coded form of the unit.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Quantity.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: CO.codeSystem, PQ.translation.codeSystem

id:
  v: ManufacturedItemDefinition.component.constituent.amount:percent.code
path:
  v: ManufacturedItemDefinition.component.constituent.amount.code
short:
  v: Coded form of the unit
definition:
  v: A computer processable form of the unit in some unit representation system.
comment:
  v: The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
requirements:
  v: Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Quantity.code
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
condition:
  v: qty-3
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-percentage-units
mapping:
  identity:
    v: v2
  map:
    v: (see OBX.6 etc.) / CQ.2
mapping:
  identity:
    v: rim
  map:
    v: PQ.code, MO.currency, PQ.translation.code

id:
  v: ManufacturedItemDefinition.component.constituent.location
path:
  v: ManufacturedItemDefinition.component.constituent.location
short:
  v: Product Part Ingredient Physical Location
definition:
  v: Identifies where the ingredient physically resides within the product part. [Source: SME Defined] Examples: Intragranular, Extra granular, Blend
min:
  v: 0
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.component.constituent.location
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location

id:
  v: ManufacturedItemDefinition.component.constituent.function
path:
  v: ManufacturedItemDefinition.component.constituent.function
short:
  v: The function of this constituent within the component e.g. binder
definition:
  v: The function of this constituent within the component e.g. binder.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.component.constituent.function
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.constituent.hasIngredient
path:
  v: ManufacturedItemDefinition.component.constituent.hasIngredient
short:
  v: The ingredient that is the constituent of the given component
definition:
  v: The ingredient that is the constituent of the given component.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.component.constituent.hasIngredient
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableReference
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference
  target profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
  aggregation:
    v: bundled
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.property
path:
  v: ManufacturedItemDefinition.component.property
slicing:
  discriminator:
    type:
      v: value
    path:
      v: type.text
  description:
    v: Slice based on value
  rules:
    v: closed
short:
  v: General characteristics of this component
definition:
  v: General characteristics of this component.
min:
  v: 1
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.component.property
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.property.id
path:
  v: ManufacturedItemDefinition.component.property.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property.extension
path:
  v: ManufacturedItemDefinition.component.property.extension
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property.modifierExtension
path:
  v: ManufacturedItemDefinition.component.property.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.component.property.type
path:
  v: ManufacturedItemDefinition.component.property.type
short:
  v: A code expressing the type of characteristic
definition:
  v: A code expressing the type of characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTCharacteristicCodes
  strength:
    v: example
  description:
    v: This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/product-characteristic-codes
    link: http://hl7.org/fhir/ValueSet/product-characteristic-codes
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, all attributes

id:
  v: ManufacturedItemDefinition.component.property.type.id
path:
  v: ManufacturedItemDefinition.component.property.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property.type.extension
path:
  v: ManufacturedItemDefinition.component.property.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property.type.coding
path:
  v: ManufacturedItemDefinition.component.property.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: ManufacturedItemDefinition.component.property.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.component.property.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: ManufacturedItemDefinition.component.property.value[x]
path:
  v: ManufacturedItemDefinition.component.property.value[x]
short:
  v: A value for the characteristic
definition:
  v: A value for the characteristic.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
type:
  code:
    v: Quantity
type:
  code:
    v: date
type:
  code:
    v: boolean
type:
  code:
    v: markdown
type:
  code:
    v: Attachment
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Binary
    link: http://hl7.org/fhir/StructureDefinition/Binary
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, attribute's value

id:
  v: ManufacturedItemDefinition.component.property:PPiD
path:
  v: ManufacturedItemDefinition.component.property
slice name:
  v: PPiD
short:
  v: Product Part Identifier
definition:
  v: A submitter designated identifier that uniquely identifies the part within the drug product. [Source: SME Defined] Examples: 1, A1, Red bead, Blue minitablet
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.component.property
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.property:PPiD.id
path:
  v: ManufacturedItemDefinition.component.property.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:PPiD.extension
path:
  v: ManufacturedItemDefinition.component.property.extension
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:PPiD.modifierExtension
path:
  v: ManufacturedItemDefinition.component.property.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.component.property:PPiD.type
path:
  v: ManufacturedItemDefinition.component.property.type
short:
  v: A code expressing the type of characteristic
definition:
  v: A code expressing the type of characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTCharacteristicCodes
  strength:
    v: example
  description:
    v: This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/product-characteristic-codes
    link: http://hl7.org/fhir/ValueSet/product-characteristic-codes
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, all attributes

id:
  v: ManufacturedItemDefinition.component.property:PPiD.type.id
path:
  v: ManufacturedItemDefinition.component.property.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:PPiD.type.extension
path:
  v: ManufacturedItemDefinition.component.property.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:PPiD.type.coding
path:
  v: ManufacturedItemDefinition.component.property.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: ManufacturedItemDefinition.component.property:PPiD.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.component.property.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
pattern: string
  v: Product Part Identifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: ManufacturedItemDefinition.component.property:PPiD.value[x]
path:
  v: ManufacturedItemDefinition.component.property.value[x]
short:
  v: A value for the characteristic
definition:
  v: A value for the characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, attribute's value

id:
  v: ManufacturedItemDefinition.component.property:PPiDref
path:
  v: ManufacturedItemDefinition.component.property
slice name:
  v: PPiDref
short:
  v: Product Part Identifier Reference
definition:
  v: Identifies the parent or outer-level product part. [Source: SME Defined] Example: A bead (Product Part Identifier = “B1”) has a seal coating (Product Part Identifier = “SCoat”) and is contained in a Hard HPMC capsule shell (Product Part Identifier “Cap Shell”). For the seal coating, Product Part Identifier Reference = “B1”, because the seal coat is applied to the bead.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.component.property
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.property:PPiDref.id
path:
  v: ManufacturedItemDefinition.component.property.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:PPiDref.extension
path:
  v: ManufacturedItemDefinition.component.property.extension
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:PPiDref.modifierExtension
path:
  v: ManufacturedItemDefinition.component.property.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.component.property:PPiDref.type
path:
  v: ManufacturedItemDefinition.component.property.type
short:
  v: A code expressing the type of characteristic
definition:
  v: A code expressing the type of characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTCharacteristicCodes
  strength:
    v: example
  description:
    v: This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/product-characteristic-codes
    link: http://hl7.org/fhir/ValueSet/product-characteristic-codes
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, all attributes

id:
  v: ManufacturedItemDefinition.component.property:PPiDref.type.id
path:
  v: ManufacturedItemDefinition.component.property.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:PPiDref.type.extension
path:
  v: ManufacturedItemDefinition.component.property.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:PPiDref.type.coding
path:
  v: ManufacturedItemDefinition.component.property.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: ManufacturedItemDefinition.component.property:PPiDref.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.component.property.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
pattern: string
  v: Product Part Identifier Reference
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: ManufacturedItemDefinition.component.property:PPiDref.value[x]
path:
  v: ManufacturedItemDefinition.component.property.value[x]
short:
  v: A value for the characteristic
definition:
  v: A value for the characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, attribute's value

id:
  v: ManufacturedItemDefinition.component.property:AddInfo
path:
  v: ManufacturedItemDefinition.component.property
slice name:
  v: AddInfo
short:
  v: Product Part Additional Information
definition:
  v: A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.component.property
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

id:
  v: ManufacturedItemDefinition.component.property:AddInfo.id
path:
  v: ManufacturedItemDefinition.component.property.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:AddInfo.extension
path:
  v: ManufacturedItemDefinition.component.property.extension
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:AddInfo.modifierExtension
path:
  v: ManufacturedItemDefinition.component.property.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: 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).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: 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](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: ManufacturedItemDefinition.component.property:AddInfo.type
path:
  v: ManufacturedItemDefinition.component.property.type
short:
  v: A code expressing the type of characteristic
definition:
  v: A code expressing the type of characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.type
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: SNOMEDCTCharacteristicCodes
  strength:
    v: example
  description:
    v: This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/product-characteristic-codes
    link: http://hl7.org/fhir/ValueSet/product-characteristic-codes
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, all attributes

id:
  v: ManufacturedItemDefinition.component.property:AddInfo.type.id
path:
  v: ManufacturedItemDefinition.component.property.type.id
representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:AddInfo.type.extension
path:
  v: ManufacturedItemDefinition.component.property.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: 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.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: ManufacturedItemDefinition.component.property:AddInfo.type.coding
path:
  v: ManufacturedItemDefinition.component.property.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 0
max:
  v: *
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.1-8, C*E.10-22
mapping:
  identity:
    v: rim
  map:
    v: union(., ./translation)
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding

id:
  v: ManufacturedItemDefinition.component.property:AddInfo.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: ManufacturedItemDefinition.component.property.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: CodeableConcept.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
pattern: string
  v: Product Part Additional Information
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: C*E.9. But note many systems use C*E.2 for this
mapping:
  identity:
    v: rim
  map:
    v: ./originalText[mediaType/code="text/plain"]/data
mapping:
  identity:
    v: orim
  map:
    v: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText

id:
  v: ManufacturedItemDefinition.component.property:AddInfo.value[x]
path:
  v: ManufacturedItemDefinition.component.property.value[x]
short:
  v: A value for the characteristic
definition:
  v: A value for the characteristic.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: ManufacturedItemDefinition.property.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Physical Characteristics, attribute's value

id:
  v: ManufacturedItemDefinition.component.component
path:
  v: ManufacturedItemDefinition.component.component
short:
  v: A component that this component contains or is made from
definition:
  v: A component that this component contains or is made from.
min:
  v: 0
max:
  v: *
base:
  path:
    v: ManufacturedItemDefinition.component.component
  min:
    v: 0
  max:
    v: *
content reference:
  v: http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition#ManufacturedItemDefinition.component
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: true
is modifier:
  v: false
is summary:
  v: true

element:
  id:
    v: ManufacturedItemDefinition.identifier
  path:
    v: ManufacturedItemDefinition.identifier
  short:
    v: optional user designated identifier
  max:
    v: 1
  must support:
    v: true
element:
  id:
    v: ManufacturedItemDefinition.status
  path:
    v: ManufacturedItemDefinition.status
  must support:
    v: true
element:
  id:
    v: ManufacturedItemDefinition.name
  path:
    v: ManufacturedItemDefinition.name
  short:
    v: Product Non-proprietary Name
  definition:
    v: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional. [Source: SME Defined]
  min:
    v: 1
  must support:
    v: true
element:
  id:
    v: ManufacturedItemDefinition.manufacturedDoseForm
  path:
    v: ManufacturedItemDefinition.manufacturedDoseForm
  binding:
    strength:
      v: required
    value set:
      v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology
      link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology
element:
  id:
    v: ManufacturedItemDefinition.manufacturer
  path:
    v: ManufacturedItemDefinition.manufacturer
  type:
    code:
      v: Reference
    profile:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference
      link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference
    target profile:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
      link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    aggregation:
      v: bundled
  must support:
    v: true
element:
  id:
    v: ManufacturedItemDefinition.property
  path:
    v: ManufacturedItemDefinition.property
  slicing:
    discriminator:
      type:
        v: value
      path:
        v: type.text
    description:
      v: Slice based on value
    rules:
      v: closed
  min:
    v: 2
  must support:
    v: true
element:
  id:
    v: ManufacturedItemDefinition.property.type
  path:
    v: ManufacturedItemDefinition.property.type
  must support:
    v: true
element:
  id:
    v: ManufacturedItemDefinition.property.type.text
  path:
    v: ManufacturedItemDefinition.property.type.text
  min:
    v: 1
  must support:
    v: true
element:
  id:
    v: ManufacturedItemDefinition.property:BatchSize
  path:
    v: ManufacturedItemDefinition.property
  slice name:
    v: BatchSize
  short:
    v: Batch Quantity
  definition:
    v: The amount of material in a specific batch size [Source: SME Defined] Example: 1000 kg
  min:
    v: 1
  max:
    v: 1
  must support:
    v: true
element:
  id:
    v: ManufacturedItemDefinition.property:BatchSize.type.text
  path:
    v: ManufacturedItemDefinition.property.type.text
  pattern: string
    v: Batch Quantity
element:
  id:
    v: ManufacturedItemDefinition.property:BatchSize.value[x]
  path:
    v: ManufacturedItemDefinition.property.value[x]
  min:
    v: 1
  type:
    code:
      v: Quantity
  must support:
    v: true
  binding:
    strength:
      v: required
    value set:
      v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure
      link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure
element:
  id:
    v: ManufacturedItemDefinition.property:BatchSize.value[x].value
  path:
    v: ManufacturedItemDefinition.property.value[x].value
  min:
    v: 1
  must support:
    v: true
element:
  id:
    v: ManufacturedItemDefinition.property:BatchSize.value[x].code
  path:
    v: ManufacturedItemDefinition.property.value[x].code
  short:
    v: Quantity UOM
  definition:
    v: A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. [Source: NCI EVS - C25709]
element:
  id:
    v: ManufacturedItemDefinition.property:BatchUtil
  path:
    v: ManufacturedItemDefinition.property
  slice name:
    v: BatchUtil
  short:
    v: Batch Utilization
  definition:
    v: A categorization of the batch that identifies its usage. [Source: SME Defined] Examples: commercial, development.
  min:
    v: 1
  max:
    v: *
  must support:
    v: true
element:
  id:
    v: ManufacturedItemDefinition.property:BatchUtil.type.text
  path:
    v: ManufacturedItemDefinition.property.type.text
  pattern: string
    v: Batch Utilization
element:
  id:
    v: ManufacturedItemDefinition.property:BatchUtil.value[x]
  path:
    v: ManufacturedItemDefinition.property.value[x]
  min:
    v: 1
  type:
    code:
      v: CodeableConcept
  must support:
    v: true
  binding:
    strength:
      v: required
    value set:
      v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology
      link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-batch-utilization-terminology
element:
  id:
    v: ManufacturedItemDefinition.property:AddInfo
  path:
    v: ManufacturedItemDefinition.property

v: AddInfo

v: Batch Formula Additional Information

v: A placeholder for providing any comments that are relevant to the drug product component. [Source: SME Defined] Examples: removed during process, adjusted for loss on drying. Implementation note: This is represented in markdown. For multiple comments utilize markdwon formating for separation of notes.

v: 0

v: 1

v: true

id:
  v: ManufacturedItemDefinition.property:AddInfo.type.text
path:
  v: ManufacturedItemDefinition.property.type.text
pattern: string
  v: Batch Formula Additional Information

id:
  v: ManufacturedItemDefinition.property:AddInfo.value[x]
path:
  v: ManufacturedItemDefinition.property.value[x]
min:
  v: 1
type:
  code:
    v: markdown
must support:
  v: true

id:
  v: ManufacturedItemDefinition.component
path:
  v: ManufacturedItemDefinition.component
min:
  v: 1
must support:
  v: true

id:
  v: ManufacturedItemDefinition.component.type
path:
  v: ManufacturedItemDefinition.component.type
short:
  v: Product Part Type
definition:
  v: Identifies the kind of element, based on the design the applicant develops to achieve the desired drug product and overall release profile. [Source: SME Defined] Example: Layer, Bead, Minitablet, Capsule Shell, Coating
must support:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type

id:
  v: ManufacturedItemDefinition.component.amount
path:
  v: ManufacturedItemDefinition.component.amount
slicing:
  discriminator:
    type:
      v: value
    path:
      v: code
  description:
    v: Slice based on value of unit
  rules:
    v: closed
min:
  v: 2
max:
  v: 2

id:
  v: ManufacturedItemDefinition.component.amount:perBatch
path:
  v: ManufacturedItemDefinition.component.amount
slice name:
  v: perBatch
short:
  v: Component Quantity Per Batch
definition:
  v: Specifies the amount of the component per batch size of the drug product. [Source: SME Defined]
min:
  v: 1
max:
  v: 1
must support:
  v: true

id:
  v: ManufacturedItemDefinition.component.amount:perBatch.value
path:
  v: ManufacturedItemDefinition.component.amount.value
min:
  v: 1
must support:
  v: true

id:
  v: ManufacturedItemDefinition.component.amount:perBatch.unit
path:
  v: ManufacturedItemDefinition.component.amount.unit
min:
  v: 1
must support:
  v: true

id:
  v: ManufacturedItemDefinition.component.amount:perBatch.code
path:
  v: ManufacturedItemDefinition.component.amount.code
min:
  v: 1
must support:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units
    link: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-non-percentage-units

id:
  v: ManufacturedItemDefinition.component.amount:percent
path:
  v: ManufacturedItemDefinition.component.amount
slice name:
  v: percent
min:
  v: 1
max:
  v: 1
must support:
  v: true

id:
  v: ManufacturedItemDefinition.component.amount:percent.value
path:
  v: ManufacturedItemDefinition.component.amount.value
min:
  v: 1
must support:
  v: true

id:
  v: ManufacturedItemDefinition.component.amount:percent.unit
path:
  v: ManufacturedItemDefinition.component.amount.unit
min:
  v: 1
must support:
  v: true

id:
  v: ManufacturedItemDefinition.component.amount:percent.code