emaWriteApiMedicinalProductDefinitionRestrictions
type: StructureDefinition
node role: treeRoot
id:
  v: emaWriteApiMedicinalProductDefinitionRestrictions
text:
  status:
    v: extensions
  div: Generated Narrative: StructureDefinition emaWriteApiMedicinalProductDefinitionRestrictions Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> MedicinalProductDefinition MedicinalProductDefinition implicitRules 0..0 language 0..0 text 0..0 contained 0..0 modifierExtension 0..0 version 0..0 statusDate 0..0 description 0..0 route 0..0 specialMeasures 0..0 marketingStatus 0..0 packagedMedicinalProduct 0..0 ingredient 0..0 impurity 0..0 code 0..0 <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
url:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinitionRestrictions
version:
  v: 1.2.0
name:
  v: EmaWriteApiMedicinalProductDefinitionRestrictions
title:
  v: EMA Write API MedicinalProductDefinition Restrictions
status:
  v: draft
date:
  v: 2025-10-21T12:20:05+01:00
publisher:
  v: EMA
contact:
  name:
    v: EMA
  telecom:
    system:
      v: url
    value:
      v: https://support.ema.europa.eu/esc
description:
  v: Defines the restrictive rules a MedicinalProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application
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: MedicinalProductDefinition
base definition:
  v: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
  link: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
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: MedicinalProductDefinition
    path:
      v: MedicinalProductDefinition
    short:
      v: Detailed definition of a medicinal product
    definition:
      v: A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: MedicinalProductDefinition
      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
    is summary:
      v: false
    mapping:
      identity:
        v: rim
      map:
        v: Entity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
    mapping:
      identity:
        v: w5
      map:
        v: administrative.medication
    mapping:
      identity:
        v: idmp
      map:
        v: Medicinal Product and Investigational Medicinal Product
  element:
    id:
      v: MedicinalProductDefinition.id
    path:
      v: MedicinalProductDefinition.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:
        value: url
      code:
        v: http://hl7.org/fhirpath/System.String

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.

url
v: id

v: false

v: false

v: true

id:
  v: MedicinalProductDefinition.meta
path:
  v: MedicinalProductDefinition.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: MedicinalProductDefinition.implicitRules
path:
  v: MedicinalProductDefinition.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: 0
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: MedicinalProductDefinition.language
path:
  v: MedicinalProductDefinition.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: 0
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: MedicinalProductDefinition.text
path:
  v: MedicinalProductDefinition.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: 0
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: MedicinalProductDefinition.contained
path:
  v: MedicinalProductDefinition.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: 0
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: MedicinalProductDefinition.extension
path:
  v: MedicinalProductDefinition.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: MedicinalProductDefinition.modifierExtension
path:
  v: MedicinalProductDefinition.modifierExtension
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: 0
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

id:
  v: MedicinalProductDefinition.identifier
path:
  v: MedicinalProductDefinition.identifier
short:
  v: Business identifier for this product. Could be an MPID
definition:
  v: Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.
alias:
  v: MPID
min:
  v: 0
max:
  v: *
base:
  path:
    v: MedicinalProductDefinition.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: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.class
mapping:
  identity:
    v: idmp
  map:
    v: Medicinal Product.MPID, Investigational Medicinal Product.IMPID
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code

id:
  v: MedicinalProductDefinition.type
path:
  v: MedicinalProductDefinition.type
short:
  v: Regulatory type, e.g. Investigational or Authorized
definition:
  v: Regulatory type, e.g. Investigational or Authorized.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.type
  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: MedicinalProductType
  strength:
    v: example
  description:
    v: Overall defining type of this medicinal product.
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-type
    link: http://hl7.org/fhir/ValueSet/medicinal-product-type
mapping:
  identity:
    v: idmp
  map:
    v: (indicates if this is Medicinal Product or an Investigational Medicinal Product)
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.asSpecializedKind.generalizedMaterialKind.code

id:
  v: MedicinalProductDefinition.domain
path:
  v: MedicinalProductDefinition.domain
short:
  v: If this medicine applies to human or veterinary uses
definition:
  v: If this medicine applies to human or veterinary uses.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.domain
  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: MedicinalProductType
  strength:
    v: example
  description:
    v: Applicable domain for this product (e.g. human, veterinary).
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-domain
    link: http://hl7.org/fhir/ValueSet/medicinal-product-domain
mapping:
  identity:
    v: idmp
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{domain}'].value

id:
  v: MedicinalProductDefinition.version
path:
  v: MedicinalProductDefinition.version
short:
  v: A business identifier relating to a specific version of the product
definition:
  v: A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: MedicinalProductDefinition.version
  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: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Medicinal Product.Header.Version Number
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: MedicinalProductDefinition.status
path:
  v: MedicinalProductDefinition.status
short:
  v: The status within the lifecycle of this product record
definition:
  v: The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.status
  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: true
is modifier reason:
  v: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: PublicationStatus
  strength:
    v: preferred
  description:
    v: The lifecycle status of an artifact.
  value set:
    v: http://hl7.org/fhir/ValueSet/publication-status
    link: http://hl7.org/fhir/ValueSet/publication-status
mapping:
  identity:
    v: idmp
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: MedicinalProductDefinition.statusDate
path:
  v: MedicinalProductDefinition.statusDate
short:
  v: The date at which the given status became applicable
definition:
  v: The date at which the given status became applicable.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: MedicinalProductDefinition.statusDate
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
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
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: MedicinalProductDefinition.description
path:
  v: MedicinalProductDefinition.description
short:
  v: General description of this product
definition:
  v: General description of this product.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: MedicinalProductDefinition.description
  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: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].desc

id:
  v: MedicinalProductDefinition.combinedPharmaceuticalDoseForm
path:
  v: MedicinalProductDefinition.combinedPharmaceuticalDoseForm
short:
  v: The dose form for a single part product, or combined form of a multiple part product
definition:
  v: The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.combinedPharmaceuticalDoseForm
  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: CombinedDoseForm
  strength:
    v: example
  description:
    v: Dose forms for a product as a whole, considering all individual parts, but before any mixing
  value set:
    v: http://hl7.org/fhir/ValueSet/combined-dose-form
    link: http://hl7.org/fhir/ValueSet/combined-dose-form
mapping:
  identity:
    v: idmp
  map:
    v: Medicinal Product.Combined Pharmaceutical Dose Form
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode

id:
  v: MedicinalProductDefinition.route
path:
  v: MedicinalProductDefinition.route
short:
  v: The path by which the product is taken into or makes contact with the body
definition:
  v: The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: MedicinalProductDefinition.route
  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: SNOMEDCTRouteCodes
  strength:
    v: example
  description:
    v: A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
  value set:
    v: http://hl7.org/fhir/ValueSet/route-codes
    link: http://hl7.org/fhir/ValueSet/route-codes
mapping:
  identity:
    v: idmp
  map:
    v: Pharmaceutical Product.Route of Administration
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].productOf.reconstitution.consumable.administerableMaterial.consumedIn.substanceAdministration1.routeCode

id:
  v: MedicinalProductDefinition.indication
path:
  v: MedicinalProductDefinition.indication
short:
  v: Description of indication(s) for this product, used when structured indications are not required
definition:
  v: Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.indication
  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: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: (roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)
mapping:
  identity:
    v: rim

id:
  v: MedicinalProductDefinition.legalStatusOfSupply
path:
  v: MedicinalProductDefinition.legalStatusOfSupply
short:
  v: The legal status of supply of the medicinal product as classified by the regulator
definition:
  v: The legal status of supply of the medicinal product as classified by the regulator.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.legalStatusOfSupply
  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: LegalStatusOfSupply
  strength:
    v: example
  description:
    v: The prescription supply types appropriate to a medicinal product
  value set:
    v: http://hl7.org/fhir/ValueSet/legal-status-of-supply
    link: http://hl7.org/fhir/ValueSet/legal-status-of-supply
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorisation.Legal Status of Supply (moved here for practicality)
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].pertinentInformation.policy.code

id:
  v: MedicinalProductDefinition.additionalMonitoringIndicator
path:
  v: MedicinalProductDefinition.additionalMonitoringIndicator
short:
  v: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
definition:
  v: Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.additionalMonitoringIndicator
  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: AdditionalMonitoring
  strength:
    v: example
  description:
    v: Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
    link: http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
mapping:
  identity:
    v: idmp
  map:
    v: Medicinal Product.Additional Monitoring Indicator
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.policy.code

id:
  v: MedicinalProductDefinition.specialMeasures
path:
  v: MedicinalProductDefinition.specialMeasures
short:
  v: Whether the Medicinal Product is subject to special measures for regulatory reasons
definition:
  v: Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: MedicinalProductDefinition.specialMeasures
  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: SpecialMeasures
  strength:
    v: example
  description:
    v: Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
    link: http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
mapping:
  identity:
    v: idmp
  map:
    v: Medicinal Product.Special Measures
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.policy.code[@nullFlavor='OTH'].displayName

id:
  v: MedicinalProductDefinition.pediatricUseIndicator
path:
  v: MedicinalProductDefinition.pediatricUseIndicator
short:
  v: If authorised for use in children
definition:
  v: If authorised for use in children, or infants, neonates etc.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.pediatricUseIndicator
  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: PediatricUse
  strength:
    v: example
  description:
    v: Suitability for age groups, in particular children.
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
    link: http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
mapping:
  identity:
    v: idmp
  map:
    v: Medicinal Product.Pediatric Use Indicator
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.policy.code

id:
  v: MedicinalProductDefinition.classification
path:
  v: MedicinalProductDefinition.classification
short:
  v: Allows the product to be classified by various systems
definition:
  v: Allows the product to be classified by various systems, commonly WHO ATC.
min:
  v: 0
max:
  v: *
base:
  path:
    v: MedicinalProductDefinition.classification
  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: ProductClassification
  strength:
    v: example
  description:
    v: This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-classification
    link: http://hl7.org/fhir/ValueSet/medicinal-product-classification
mapping:
  identity:
    v: idmp
  map:
    v: Product Classification.Value
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code

id:
  v: MedicinalProductDefinition.marketingStatus
path:
  v: MedicinalProductDefinition.marketingStatus
short:
  v: Marketing status of the medicinal product, in contrast to marketing authorization
definition:
  v: Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization).
min:
  v: 0
max:
  v: 0
base:
  path:
    v: MedicinalProductDefinition.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: Marketing Status
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].statusCode

id:
  v: MedicinalProductDefinition.packagedMedicinalProduct
path:
  v: MedicinalProductDefinition.packagedMedicinalProduct
short:
  v: Package type for the product
definition:
  v: Package type for the product. See also the PackagedProductDefinition resource.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: MedicinalProductDefinition.packagedMedicinalProduct
  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: MedicinalProductPackageType
  strength:
    v: example
  description:
    v: Types of medicinal product packs
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-package-type
    link: http://hl7.org/fhir/ValueSet/medicinal-product-package-type
mapping:
  identity:
    v: idmp
  map:
    v: Packaged Medicinal Product
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.asContent.containerPackagedProduct.asContent.containerPackagedProduct.code

id:
  v: MedicinalProductDefinition.comprisedOf
path:
  v: MedicinalProductDefinition.comprisedOf
short:
  v: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
definition:
  v: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item).
min:
  v: 0
max:
  v: *
base:
  path:
    v: MedicinalProductDefinition.comprisedOf
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition
    link: http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/DeviceDefinition
    link: http://hl7.org/fhir/StructureDefinition/DeviceDefinition
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: Manufactured Item
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode

id:
  v: MedicinalProductDefinition.ingredient
path:
  v: MedicinalProductDefinition.ingredient
short:
  v: The ingredients of this medicinal product - when not detailed in other resources
definition:
  v: The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: MedicinalProductDefinition.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: Medicinal Product.Ingredient (see also FHIR Ingredient resource)
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].ingredient.ingredientSubstance.code

id:
  v: MedicinalProductDefinition.impurity
path:
  v: MedicinalProductDefinition.impurity
short:
  v: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
definition:
  v: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: MedicinalProductDefinition.impurity
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableReference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
    link: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
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: n/a
mapping:
  identity:
    v: rim
  map:
    v: (to do)

id:
  v: MedicinalProductDefinition.attachedDocument
path:
  v: MedicinalProductDefinition.attachedDocument
short:
  v: Additional documentation about the medicinal product
definition:
  v: Additional information or supporting documentation about the medicinal product.
min:
  v: 0
max:
  v: *
base:
  path:
    v: MedicinalProductDefinition.attachedDocument
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/DocumentReference
    link: http://hl7.org/fhir/StructureDefinition/DocumentReference
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: Attached Document
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.document

id:
  v: MedicinalProductDefinition.masterFile
path:
  v: MedicinalProductDefinition.masterFile
short:
  v: A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
definition:
  v: A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.
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  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/DocumentReference
    link: http://hl7.org/fhir/StructureDefinition/DocumentReference
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:
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  map:
    v: Master File
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.document

id:
  v: MedicinalProductDefinition.contact
path:
  v: MedicinalProductDefinition.contact
short:
  v: A product specific contact, person (in a role), or an organization
definition:
  v: A product specific contact, person (in a role), or an organization.
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  key:
    v: ele-1
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    v: All FHIR elements must have a @value or children
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    v: hasValue() or (children().count() > id.count())
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    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
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  v: false
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  v: false
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  v: true
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  map:
    v: n/a
mapping:
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  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty

id:
  v: MedicinalProductDefinition.contact.id
path:
  v: MedicinalProductDefinition.contact.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.
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  v: 0
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      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
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  v: ele-1
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  v: false
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  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: MedicinalProductDefinition.contact.extension
path:
  v: MedicinalProductDefinition.contact.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
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  v: *
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    v: 0
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  key:
    v: ele-1
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    v: error
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    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
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  key:
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    v: error
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    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
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    link: http://hl7.org/fhir/StructureDefinition/Extension
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  v: false
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  v: false
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  identity:
    v: rim
  map:
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id:
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path:
  v: MedicinalProductDefinition.contact.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).
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alias:
  v: user content
alias:
  v: modifiers
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  v: 0
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    v: *
type:
  code:
    v: Extension
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  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
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  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
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    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
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  v: true
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  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: MedicinalProductDefinition.contact.type
path:
  v: MedicinalProductDefinition.contact.type
short:
  v: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
definition:
  v: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.
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  v: 0
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  key:
    v: ele-1
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    v: error
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    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: ProductContactType
  strength:
    v: example
  description:
    v: Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
    link: http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
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    v: idmp
  map:
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    v: ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code

id:
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path:
  v: MedicinalProductDefinition.contact.contact
short:
  v: A product specific contact, person (in a role), or an organization
definition:
  v: A product specific contact, person (in a role), or an organization.
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    link: http://hl7.org/fhir/StructureDefinition/Organization
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/PractitionerRole
    link: http://hl7.org/fhir/StructureDefinition/PractitionerRole
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
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  v: false
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  v: true
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mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty

id:
  v: MedicinalProductDefinition.clinicalTrial
path:
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short:
  v: Clinical trials or studies that this product is involved in
definition:
  v: Clinical trials or studies that this product is involved in.
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type:
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    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ResearchStudy
    link: http://hl7.org/fhir/StructureDefinition/ResearchStudy
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: Investigational Medicinal Product.Clinical Trial Status
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram

id:
  v: MedicinalProductDefinition.code
path:
  v: MedicinalProductDefinition.code
short:
  v: A code that this product is known by, within some formal terminology
definition:
  v: A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.
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type:
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    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
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  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: MedicationFormalRepresentation
  strength:
    v: example
  description:
    v: A coded concept that defines the type of a medication.
  value set:
    v: http://hl7.org/fhir/ValueSet/medication-codes
    link: http://hl7.org/fhir/ValueSet/medication-codes
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    v: idmp
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    v: n/a
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  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code

id:
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path:
  v: MedicinalProductDefinition.name
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  v: The product's name, including full name and possibly coded parts
definition:
  v: The product's name, including full name and possibly coded parts.
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    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
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  v: false
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  v: true
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  identity:
    v: idmp
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    v: Medicinal Product Name
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id:
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path:
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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.
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      v: string
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    v: http://hl7.org/fhirpath/System.String
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    v: rim
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    v: n/a

id:
  v: MedicinalProductDefinition.name.extension
path:
  v: MedicinalProductDefinition.name.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:
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alias:
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    v: All FHIR elements must have a @value or children
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    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
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    v: ext-1
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    v: error
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    v: Must have either extensions or value[x], not both
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    link: http://hl7.org/fhir/StructureDefinition/Extension
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  v: false
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    v: rim
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id:
  v: MedicinalProductDefinition.name.modifierExtension
path:
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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).
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    v: error
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    v: All FHIR elements must have a @value or children
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    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
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    v: ext-1
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    v: error
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    v: Must have either extensions or value[x], not both
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    v: extension.exists() != value.exists()
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    link: http://hl7.org/fhir/StructureDefinition/Extension
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  v: true
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  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
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  v: true
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  identity:
    v: rim
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    v: N/A

id:
  v: MedicinalProductDefinition.name.productName
path:
  v: MedicinalProductDefinition.name.productName
short:
  v: The full product name
definition:
  v: The full product name.
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    v: All FHIR elements must have a @value or children
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    link: http://hl7.org/fhir/StructureDefinition/Element
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  v: false
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  v: false
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  v: true
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    v: Medicinal Product Name.Full Name
mapping:
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id:
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path:
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short:
  v: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
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  v: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.
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  key:
    v: ele-1
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    v: error
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    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
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  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ProductNameType
  strength:
    v: example
  description:
    v: Type of a name for a Medicinal Product.
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-name-type
    link: http://hl7.org/fhir/ValueSet/medicinal-product-name-type
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    v: idmp
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mapping:
  identity:
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id:
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path:
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short:
  v: Coding words or phrases of the name
definition:
  v: Coding words or phrases of the name.
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
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    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
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    v: idmp
  map:
    v: (any and all of the name parts e.g. Medicinal Product Name.Formulation Part)
mapping:
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    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix

id:
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path:
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  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.
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max:
  v: 1
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type:
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condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: MedicinalProductDefinition.name.part.extension
path:
  v: MedicinalProductDefinition.name.part.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: MedicinalProductDefinition.name.part.modifierExtension
path:
  v: MedicinalProductDefinition.name.part.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: MedicinalProductDefinition.name.part.part
path:
  v: MedicinalProductDefinition.name.part.part
short:
  v: A fragment of a product name
definition:
  v: A fragment of a product name.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.name.part.part
  min:
    v: 1
  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: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: (text of any of the name parts e.g. Medicinal Product Name.Formulation Part)
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix

id:
  v: MedicinalProductDefinition.name.part.type
path:
  v: MedicinalProductDefinition.name.part.type
short:
  v: Identifying type for this part of the name (e.g. strength part)
definition:
  v: Identifying type for this part of the name (e.g. strength part).
min:
  v: 1
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.name.part.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: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ProductNamePartType
  strength:
    v: example
  description:
    v: Type of part of a name for a Medicinal Product.
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
    link: http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
mapping:
  identity:
    v: idmp
  map:
    v: (which of the name parts this is e.g. Formulation Part)
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code

id:
  v: MedicinalProductDefinition.name.usage
path:
  v: MedicinalProductDefinition.name.usage
short:
  v: Country and jurisdiction where the name applies
definition:
  v: Country and jurisdiction where the name applies, and associated language.
min:
  v: 0
max:
  v: *
base:
  path:
    v: MedicinalProductDefinition.name.usage
  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: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Country / Language
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity

id:
  v: MedicinalProductDefinition.name.usage.id
path:
  v: MedicinalProductDefinition.name.usage.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: MedicinalProductDefinition.name.usage.extension
path:
  v: MedicinalProductDefinition.name.usage.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: MedicinalProductDefinition.name.usage.modifierExtension
path:
  v: MedicinalProductDefinition.name.usage.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: MedicinalProductDefinition.name.usage.country
path:
  v: MedicinalProductDefinition.name.usage.country
short:
  v: Country code for where this name applies
definition:
  v: Country code for where this name applies.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.name.usage.country
  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:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Country
  strength:
    v: example
  description:
    v: Jurisdiction codes
  value set:
    v: http://hl7.org/fhir/ValueSet/country
    link: http://hl7.org/fhir/ValueSet/country
mapping:
  identity:
    v: idmp
  map:
    v: Country / Language.Country
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code

id:
  v: MedicinalProductDefinition.name.usage.jurisdiction
path:
  v: MedicinalProductDefinition.name.usage.jurisdiction
short:
  v: Jurisdiction code for where this name applies
definition:
  v: Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.name.usage.jurisdiction
  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: Jurisdiction
  strength:
    v: example
  description:
    v: Jurisdiction codes
  value set:
    v: http://hl7.org/fhir/ValueSet/jurisdiction
    link: http://hl7.org/fhir/ValueSet/jurisdiction
mapping:
  identity:
    v: idmp
  map:
    v: Country / Language.Jurisdiction
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code

id:
  v: MedicinalProductDefinition.name.usage.language
path:
  v: MedicinalProductDefinition.name.usage.language
short:
  v: Language code for this name
definition:
  v: Language code for this name.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.name.usage.language
  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:
  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
mapping:
  identity:
    v: idmp
  map:
    v: Country / Language.Language
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.name.@xml:lang

id:
  v: MedicinalProductDefinition.crossReference
path:
  v: MedicinalProductDefinition.crossReference
short:
  v: Reference to another product, e.g. for linking authorised to investigational product
definition:
  v: Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.
min:
  v: 0
max:
  v: *
base:
  path:
    v: MedicinalProductDefinition.crossReference
  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: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Product Cross-Reference
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity

id:
  v: MedicinalProductDefinition.crossReference.id
path:
  v: MedicinalProductDefinition.crossReference.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: MedicinalProductDefinition.crossReference.extension
path:
  v: MedicinalProductDefinition.crossReference.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: MedicinalProductDefinition.crossReference.modifierExtension
path:
  v: MedicinalProductDefinition.crossReference.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: MedicinalProductDefinition.crossReference.product
path:
  v: MedicinalProductDefinition.crossReference.product
short:
  v: Reference to another product, e.g. for linking authorised to investigational product
definition:
  v: Reference to another product, e.g. for linking authorised to investigational product.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.crossReference.product
  min:
    v: 1
  max:
    v: 1
type:
  code:
    v: CodeableReference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
    link: http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
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: Product Cross-Reference
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code

id:
  v: MedicinalProductDefinition.crossReference.type
path:
  v: MedicinalProductDefinition.crossReference.type
short:
  v: The type of relationship, for instance branded to generic or virtual to actual product
definition:
  v: The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.crossReference.type
  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: ProductCrossReferenceType
  strength:
    v: example
  description:
    v: Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type
    link: http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type
mapping:
  identity:
    v: idmp
  map:
    v: Product Cross-Reference
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code

id:
  v: MedicinalProductDefinition.operation
path:
  v: MedicinalProductDefinition.operation
short:
  v: A manufacturing or administrative process for the medicinal product
definition:
  v: A manufacturing or administrative process or step associated with (or performed on) the medicinal product.
min:
  v: 0
max:
  v: *
base:
  path:
    v: MedicinalProductDefinition.operation
  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: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Manufacturing / Business Operation
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.action

id:
  v: MedicinalProductDefinition.operation.id
path:
  v: MedicinalProductDefinition.operation.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: MedicinalProductDefinition.operation.extension
path:
  v: MedicinalProductDefinition.operation.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: MedicinalProductDefinition.operation.modifierExtension
path:
  v: MedicinalProductDefinition.operation.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: MedicinalProductDefinition.operation.type
path:
  v: MedicinalProductDefinition.operation.type
short:
  v: The type of manufacturing operation e.g. manufacturing itself, re-packaging
definition:
  v: The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.operation.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableReference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ActivityDefinition
    link: http://hl7.org/fhir/StructureDefinition/ActivityDefinition
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/PlanDefinition
    link: http://hl7.org/fhir/StructureDefinition/PlanDefinition
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: Manufacturing / Business Operation.Operation Type
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.action.code

id:
  v: MedicinalProductDefinition.operation.effectiveDate
path:
  v: MedicinalProductDefinition.operation.effectiveDate
short:
  v: Date range of applicability
definition:
  v: Date range of applicability.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.operation.effectiveDate
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
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: Manufacturing / Business Operation.Effective Date
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime

id:
  v: MedicinalProductDefinition.operation.organization
path:
  v: MedicinalProductDefinition.operation.organization
short:
  v: The organization responsible for the particular process, e.g. the manufacturer or importer
definition:
  v: The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.
min:
  v: 0
max:
  v: *
base:
  path:
    v: MedicinalProductDefinition.operation.organization
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
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: Manufacturer / Establishment (Organisation)
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation

id:
  v: MedicinalProductDefinition.operation.confidentialityIndicator
path:
  v: MedicinalProductDefinition.operation.confidentialityIndicator
short:
  v: Specifies whether this process is considered proprietary or confidential
definition:
  v: Specifies whether this particular business or manufacturing process is considered proprietary or confidential.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.operation.confidentialityIndicator
  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: ProductConfidentiality
  strength:
    v: example
  description:
    v: Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
  value set:
    v: http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality
    link: http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality
mapping:
  identity:
    v: idmp
  map:
    v: Manufacturing / Business Operation.Confidentiality Indicator
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode

id:
  v: MedicinalProductDefinition.characteristic
path:
  v: MedicinalProductDefinition.characteristic
short:
  v: Key product features such as "sugar free", "modified release"
definition:
  v: Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".
min:
  v: 0
max:
  v: *
base:
  path:
    v: MedicinalProductDefinition.characteristic
  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: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Package Item (Container).Physical Characteristics
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.characteristic

id:
  v: MedicinalProductDefinition.characteristic.id
path:
  v: MedicinalProductDefinition.characteristic.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: MedicinalProductDefinition.characteristic.extension
path:
  v: MedicinalProductDefinition.characteristic.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: MedicinalProductDefinition.characteristic.modifierExtension
path:
  v: MedicinalProductDefinition.characteristic.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: MedicinalProductDefinition.characteristic.type
path:
  v: MedicinalProductDefinition.characteristic.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: MedicinalProductDefinition.characteristic.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: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ProductCharacteristic
  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
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}']

id:
  v: MedicinalProductDefinition.characteristic.value[x]
path:
  v: MedicinalProductDefinition.characteristic.value[x]
short:
  v: A value for the characteristic
definition:
  v: A value for the characteristic.text.
comment:
  v: Text, as markdown, is intended to be used only when the item cannot ever reasonably be coded. Otherwise, for cases where a code is not available, but is feasible, use CodeableConcept.text.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: MedicinalProductDefinition.characteristic.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
type:
  code:
    v: markdown
type:
  code:
    v: Quantity
type:
  code:
    v: integer
type:
  code:
    v: date
type:
  code:
    v: boolean
type:
  code:
    v: Attachment
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
mapping:
  identity:
    v: rim
  map:
    v: ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value

element:
  id:
    v: MedicinalProductDefinition.implicitRules
  path:
    v: MedicinalProductDefinition.implicitRules
  max:
    v: 0
element:
  id:
    v: MedicinalProductDefinition.language
  path:
    v: MedicinalProductDefinition.language
  max:
    v: 0
element:
  id:
    v: MedicinalProductDefinition.text
  path:
    v: MedicinalProductDefinition.text
  max:
    v: 0
element:
  id:
    v: MedicinalProductDefinition.contained
  path:
    v: MedicinalProductDefinition.contained
  max:
    v: 0
element:
  id:
    v: MedicinalProductDefinition.modifierExtension
  path:
    v: MedicinalProductDefinition.modifierExtension
  max:
    v: 0
element:
  id:
    v: MedicinalProductDefinition.version
  path:
    v: MedicinalProductDefinition.version
  max:
    v: 0
element:
  id:
    v: MedicinalProductDefinition.statusDate
  path:
    v: MedicinalProductDefinition.statusDate
  max:
    v: 0
element:
  id:
    v: MedicinalProductDefinition.description
  path:
    v: MedicinalProductDefinition.description
  max:
    v: 0
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