Profile_R5_MedicinalProductDefinition_R4_MedicinalProduct - Definitions - Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1.0

Is Modifier false

Summary true

4. MedicinalProduct.meta

Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

Short Metadata about the resource

Control 0..1

Meta

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

6. MedicinalProduct.implicitRules

Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Short A set of rules under which this content was created

Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control 0..1

Is Modifier true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

8. MedicinalProduct.language

Definition

The base language in which the resource is written.

Short Language of the resource content

Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control 0..1

The codes SHOULD be taken from CommonLanguages

(preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

A human language.

Additional Bindings

Purpose

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary false

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

10. MedicinalProduct.text

Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Short Text summary of the resource, for human interpretation

Comments

Contained resources do not have 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.

Control 0..1

Narrative

Is Modifier false

Summary false

Alternate Names narrative, html, xhtml, display

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

12. MedicinalProduct.contained

Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Short Contained, inline Resources

Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Control 0..*

Resource

Is Modifier false

Summary false

Alternate Names inline resources, anonymous resources, contained resources

14. MedicinalProduct.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())

This element introduces a set of slices on MedicinalProduct.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

16. MedicinalProduct.extension:version

Slice Name version

Definition

R5: MedicinalProductDefinition.version (new:string)

Short R5: A business identifier relating to a specific version of the product (new)

Comments

Element MedicinalProductDefinition.version has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.version has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: A business identifier relating to a specific version of the product (new)) (Extension Type: string)

Is Modifier false

Summary false

18. MedicinalProduct.extension:statusDate

Slice Name statusDate

Definition

R5: MedicinalProductDefinition.statusDate (new:dateTime)

Short R5: The date at which the given status became applicable (new)

Comments

Element MedicinalProductDefinition.statusDate has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.statusDate has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: The date at which the given status became applicable (new)) (Extension Type: dateTime)

Is Modifier false

Summary false

20. MedicinalProduct.extension:description

Slice Name description

Definition

R5: MedicinalProductDefinition.description (new:markdown)

Short R5: General description of this product (new)

Comments

Element MedicinalProductDefinition.description has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.description has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: General description of this product (new)) (Extension Type: markdown)

Is Modifier false

Summary false

22. MedicinalProduct.extension:route

Slice Name route

Definition

R5: MedicinalProductDefinition.route (new:CodeableConcept)

Short R5: The path by which the product is taken into or makes contact with the body (new)

Comments

Element MedicinalProductDefinition.route has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.route has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: The path by which the product is taken into or makes contact with the body (new)) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

24. MedicinalProduct.extension:indication

Slice Name indication

Definition

R5: MedicinalProductDefinition.indication (new:markdown)

Short R5: Description of indication(s) for this product, used when structured indications are not required (new)

Comments

Element MedicinalProductDefinition.indication has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.indication has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Description of indication(s) for this product, used when structured indications are not required (new)) (Extension Type: markdown)

Is Modifier false

Summary false

26. MedicinalProduct.extension:pediatricUseIndicator

Slice Name pediatricUseIndicator

Definition

R5: MedicinalProductDefinition.pediatricUseIndicator (new:CodeableConcept)

Short R5: If authorised for use in children (new)

Comments

Element MedicinalProductDefinition.pediatricUseIndicator has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.pediatricUseIndicator has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: If authorised for use in children (new)) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

28. MedicinalProduct.extension:classification

Slice Name classification

Definition

R5: MedicinalProductDefinition.classification (new:CodeableConcept)

Short R5: Allows the product to be classified by various systems (new)

Comments

Element MedicinalProductDefinition.classification has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.classification has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Allows the product to be classified by various systems (new)) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

30. MedicinalProduct.extension:comprisedOf

Slice Name comprisedOf

Definition

R5: MedicinalProductDefinition.comprisedOf (new:Reference(ManufacturedItemDefinition,DeviceDefinition))

Short R5: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes (new)

Comments

Element MedicinalProductDefinition.comprisedOf has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.comprisedOf has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes (new)) (Extension Type: Reference(Cross-version Profile for R5.ManufacturedItemDefinition for use in FHIR R4, Basic, Cross-version Profile for R5.DeviceDefinition for use in FHIR R4, DeviceDefinition))

Is Modifier false

Summary false

32. MedicinalProduct.extension:ingredient

Slice Name ingredient

Definition

R5: MedicinalProductDefinition.ingredient (new:CodeableConcept)

Short R5: The ingredients of this medicinal product - when not detailed in other resources (new)

Comments

Element MedicinalProductDefinition.ingredient has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.ingredient has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: The ingredients of this medicinal product - when not detailed in other resources (new)) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

34. MedicinalProduct.extension:impurity

Slice Name impurity

Definition

R5: MedicinalProductDefinition.impurity (new:CodeableReference(SubstanceDefinition))

Short R5: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new)

Comments

Element MedicinalProductDefinition.impurity has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.impurity has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product (new)) (Complex Extension)

Is Modifier false

36. MedicinalProduct.extension:code

Slice Name code

Definition

R5: MedicinalProductDefinition.code (new:Coding)

Short R5: A code that this product is known by, within some formal terminology (new)

Comments

Element MedicinalProductDefinition.code has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.code has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: A code that this product is known by, within some formal terminology (new)) (Extension Type: Coding)

Is Modifier false

Summary false

38. MedicinalProduct.extension:operation

Slice Name operation

Definition

R5: MedicinalProductDefinition.operation (new:BackboneElement)

Short R5: A manufacturing or administrative process for the medicinal product (new)

Comments

Element MedicinalProductDefinition.operation has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.operation has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: A manufacturing or administrative process for the medicinal product (new)) (Complex Extension)

Is Modifier false

40. MedicinalProduct.extension:characteristic

Slice Name characteristic

Definition

R5: MedicinalProductDefinition.characteristic (new:BackboneElement)

Short R5: Key product features such as "sugar free", "modified release" (new)

Comments

Element MedicinalProductDefinition.characteristic has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.characteristic has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: Key product features such as "sugar free", "modified release" (new)) (Complex Extension)

Is Modifier false

42. MedicinalProduct.modifierExtension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them

Summary false

This element introduces a set of slices on MedicinalProduct.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

44. MedicinalProduct.modifierExtension:status

Slice Name status

Definition

R5: MedicinalProductDefinition.status (new:CodeableConcept)

Short R5: The status within the lifecycle of this product record (new)

Comments

Element MedicinalProductDefinition.status has a context of MedicinalProduct based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.status has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: The status within the lifecycle of this product record (new)) (Extension Type: CodeableConcept)

Is Modifier true because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid

Summary false

46. MedicinalProduct.identifier

Definition

Business identifier for this product. Could be an MPID.

Short Business identifier for this product. Could be an MPID

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..*

Is Modifier false

Summary true

Alternate Names MPID

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

48. MedicinalProduct.type

Definition

Regulatory type, e.g. Investigational or Authorized.

Short Regulatory type, e.g. Investigational or Authorized

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

50. MedicinalProduct.domain

Definition

If this medicine applies to human or veterinary uses.

Short If this medicine applies to human or veterinary uses

Control 0..1

Coding

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

52. MedicinalProduct.domain.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

54. MedicinalProduct.domain.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on MedicinalProduct.domain.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

56. MedicinalProduct.domain.extension:domain

Slice Name domain

Definition

R5: MedicinalProductDefinition.domain additional types (CodeableConcept) additional types from child elements (text)

Short R5: domain additional types

Comments

Element MedicinalProductDefinition.domain is mapped to FHIR R4 element MedicinalProduct.domain as SourceIsBroaderThanTarget. The mappings for MedicinalProductDefinition.domain do not cover the following types: CodeableConcept. The mappings for MedicinalProductDefinition.domain do not cover the following types based on type expansion: text.

Control 0..1

Type Extension(R5: domain additional types) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

58. MedicinalProduct.domain.system

Definition

The identification of the code system that defines the meaning of the symbol in the code.

Short Identity of the terminology system

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

Need to be unambiguous about the source of the definition of the symbol.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

60. MedicinalProduct.domain.version

Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Short Version of the system - if relevant

Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

Note This is a business version Id, not a resource version Id (see discussion)

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

62. MedicinalProduct.domain.code

Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Short Symbol in syntax defined by the system

Control 0..1

code

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

Need to refer to a particular code in the system.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

64. MedicinalProduct.domain.display

Definition

A representation of the meaning of the code in the system, following the rules of the system.

Short Representation defined by the system

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

66. MedicinalProduct.domain.userSelected

Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

Short If this coding was chosen directly by the user

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

Control 0..1

boolean

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

68. MedicinalProduct.combinedPharmaceuticalDoseForm

Definition

The dose form for a single part product, or combined form of a multiple part product.

Short The dose form for a single part product, or combined form of a multiple part product

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

70. MedicinalProduct.legalStatusOfSupply

Definition

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

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

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

72. MedicinalProduct.additionalMonitoringIndicator

Definition

Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.

Short Whether the Medicinal Product is subject to additional monitoring for regulatory reasons

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

74. MedicinalProduct.specialMeasures

Definition

Whether the Medicinal Product is subject to special measures for regulatory reasons.

Short Whether the Medicinal Product is subject to special measures for regulatory reasons

Control 0..*

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

76. MedicinalProduct.specialMeasures.id

Definition

unique id for the element within a resource (for internal references)

Short xml:id (or equivalent in JSON)

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

78. MedicinalProduct.specialMeasures.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on MedicinalProduct.specialMeasures.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

80. MedicinalProduct.specialMeasures.extension:specialMeasures

Slice Name specialMeasures

Definition

R5: MedicinalProductDefinition.specialMeasures additional types (CodeableConcept) additional types from child elements (coding)

Short R5: specialMeasures additional types

Comments

Element MedicinalProductDefinition.specialMeasures is mapped to FHIR R4 element MedicinalProduct.specialMeasures as SourceIsBroaderThanTarget. The mappings for MedicinalProductDefinition.specialMeasures do not cover the following types: CodeableConcept. The mappings for MedicinalProductDefinition.specialMeasures do not cover the following types based on type expansion: coding.

Control 0..*
This element is affected by the following invariants: ele-1

Type Extension(R5: specialMeasures additional types) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

82. MedicinalProduct.specialMeasures.value

Definition

The actual value

Short Primitive value for string

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

Max Length: 1048576

84. MedicinalProduct.paediatricUseIndicator

Definition

If authorised for use in children.

Short If authorised for use in children

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

86. MedicinalProduct.productClassification

Definition

Allows the product to be classified by various systems.

Short Allows the product to be classified by various systems

Control 0..*

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

88. MedicinalProduct.marketingStatus

Definition

Marketing status of the medicinal product, in contrast to marketing authorizaton.

Short Marketing status of the medicinal product, in contrast to marketing authorizaton

Control 0..*

MarketingStatus

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

90. MedicinalProduct.pharmaceuticalProduct

Definition

Pharmaceutical aspects of product.

Short Pharmaceutical aspects of product

Control 0..*

Type Reference(MedicinalProductPharmaceutical)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

92. MedicinalProduct.packagedMedicinalProduct

Definition

Package representation for the product.

Short Package representation for the product

Control 0..*

Type Reference(MedicinalProductPackaged)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

94. MedicinalProduct.packagedMedicinalProduct.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

96. MedicinalProduct.packagedMedicinalProduct.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on MedicinalProduct.packagedMedicinalProduct.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

98. MedicinalProduct.packagedMedicinalProduct.extension:packagedMedicinalProduct

Slice Name packagedMedicinalProduct

Definition

R5: MedicinalProductDefinition.packagedMedicinalProduct additional types (CodeableConcept) additional types from child elements (coding, text)

Short R5: Package type for the product additional types

Comments

Element MedicinalProductDefinition.packagedMedicinalProduct is mapped to FHIR R4 element MedicinalProduct.packagedMedicinalProduct as SourceIsBroaderThanTarget. The mappings for MedicinalProductDefinition.packagedMedicinalProduct do not cover the following types: CodeableConcept. The mappings for MedicinalProductDefinition.packagedMedicinalProduct do not cover the following types based on type expansion: coding, text.

Control 0..*

Type Extension(R5: Package type for the product additional types) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

100. MedicinalProduct.packagedMedicinalProduct.reference

Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

Short Literal reference, Relative, internal or absolute URL

Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

102. MedicinalProduct.packagedMedicinalProduct.type

Definition

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

Short Type the reference refers to (e.g. "Patient")

Comments

This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

Control 0..1

Unless not suitable, these codes SHALL be taken from ResourceType

(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

Aa resource (or, for logical models, the URI of the logical model).

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

104. MedicinalProduct.packagedMedicinalProduct.identifier

Definition

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

Short Logical reference, when literal reference is not known

Comments

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

106. MedicinalProduct.packagedMedicinalProduct.display

Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Short Text alternative for the resource

Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

108. MedicinalProduct.attachedDocument

Definition

Supporting documentation, typically for regulatory submission.

Short Supporting documentation, typically for regulatory submission

Control 0..*

Type Reference(DocumentReference)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

110. MedicinalProduct.attachedDocument.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

112. MedicinalProduct.attachedDocument.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on MedicinalProduct.attachedDocument.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

114. MedicinalProduct.attachedDocument.extension:attachedDocument

Slice Name attachedDocument

Definition

R5: MedicinalProductDefinition.attachedDocument additional types from child elements (display, identifier, reference, type)

Short R5: Additional documentation about the medicinal product additional types

Comments

Element MedicinalProductDefinition.attachedDocument is mapped to FHIR R4 element MedicinalProduct.attachedDocument as SourceIsBroaderThanTarget. The mappings for MedicinalProductDefinition.attachedDocument do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element MedicinalProductDefinition.attachedDocument with unmapped reference targets: DocumentReference.

Control 0..1

Type Extension(Alternate Reference) (Extension Type: Reference(Resource))

Is Modifier false

Summary false

116. MedicinalProduct.attachedDocument.reference

Definition

Short Literal reference, Relative, internal or absolute URL

Comments

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

118. MedicinalProduct.attachedDocument.type

Definition

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

Short Type the reference refers to (e.g. "Patient")

Comments

Control 0..1

Unless not suitable, these codes SHALL be taken from ResourceType

(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

Aa resource (or, for logical models, the URI of the logical model).

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

120. MedicinalProduct.attachedDocument.identifier

Definition

Short Logical reference, when literal reference is not known

Comments

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

122. MedicinalProduct.attachedDocument.display

Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Short Text alternative for the resource

Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

124. MedicinalProduct.masterFile

Definition

A master file for to the medicinal product (e.g. Pharmacovigilance System Master File).

Short A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)

Control 0..*

Type Reference(DocumentReference)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

126. MedicinalProduct.masterFile.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

128. MedicinalProduct.masterFile.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on MedicinalProduct.masterFile.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

130. MedicinalProduct.masterFile.extension:masterFile

Slice Name masterFile

Definition

R5: MedicinalProductDefinition.masterFile additional types from child elements (display, identifier, reference, type)

Short R5: A master file for the medicinal product (e.g. Pharmacovigilance System Master File) additional types

Comments

Element MedicinalProductDefinition.masterFile is mapped to FHIR R4 element MedicinalProduct.masterFile as SourceIsBroaderThanTarget. The mappings for MedicinalProductDefinition.masterFile do not cover the following types based on type expansion: display, identifier, reference, type. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element MedicinalProductDefinition.masterFile with unmapped reference targets: DocumentReference.

Control 0..1

Type Extension(Alternate Reference) (Extension Type: Reference(Resource))

Is Modifier false

Summary false

132. MedicinalProduct.masterFile.reference

Definition

Short Literal reference, Relative, internal or absolute URL

Comments

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

134. MedicinalProduct.masterFile.type

Definition

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

Short Type the reference refers to (e.g. "Patient")

Comments

Control 0..1

Unless not suitable, these codes SHALL be taken from ResourceType

(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

Aa resource (or, for logical models, the URI of the logical model).

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

136. MedicinalProduct.masterFile.identifier

Definition

Short Logical reference, when literal reference is not known

Comments

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

138. MedicinalProduct.masterFile.display

Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Short Text alternative for the resource

Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

140. MedicinalProduct.contact

Definition

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

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

Control 0..*

Type Reference(Organization, PractitionerRole)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

142. MedicinalProduct.contact.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

144. MedicinalProduct.contact.extension

Definition

An Extension

Short Extension

Control 1..*

Is Modifier false

Summary false

This element introduces a set of slices on MedicinalProduct.contact.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

146. MedicinalProduct.contact.extension:type

Slice Name type

Definition

R5: MedicinalProductDefinition.contact.type (new:CodeableConcept)

Short R5: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information (new)

Comments

Element MedicinalProductDefinition.contact.type has a context of MedicinalProduct.contact based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.contact.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..1

Type Extension(R5: Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information (new)) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

148. MedicinalProduct.contact.extension:contact

Slice Name contact

Definition

R5: MedicinalProductDefinition.contact.contact (new:Reference(Organization,PractitionerRole))

Short R5: A product specific contact, person (in a role), or an organization (new)

Comments

Element MedicinalProductDefinition.contact.contact has a context of MedicinalProduct.contact based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.contact.contact has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 1..1

Type Extension(R5: A product specific contact, person (in a role), or an organization (new)) (Extension Type: Reference(Cross-version Profile for R5.Organization for use in FHIR R4, Organization, Cross-version Profile for R5.PractitionerRole for use in FHIR R4, PractitionerRole))

Is Modifier false

Summary false

150. MedicinalProduct.contact.reference

Definition

Short Literal reference, Relative, internal or absolute URL

Comments

Control 0..1
This element is affected by the following invariants: ref-1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

152. MedicinalProduct.contact.type

Definition

The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

Short Type the reference refers to (e.g. "Patient")

Comments

Control 0..1

Unless not suitable, these codes SHALL be taken from ResourceType

(extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

Aa resource (or, for logical models, the URI of the logical model).

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

154. MedicinalProduct.contact.identifier

Definition

Short Logical reference, when literal reference is not known

Comments

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

156. MedicinalProduct.contact.display

Definition

Plain text narrative that identifies the resource in addition to the resource reference.

Short Text alternative for the resource

Comments

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

158. MedicinalProduct.clinicalTrial

Definition

Clinical trials or studies that this product is involved in.

Short Clinical trials or studies that this product is involved in

Control 0..*

Type Reference(ResearchStudy)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

160. MedicinalProduct.name

Definition

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

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

Control 1..*

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

162. MedicinalProduct.name.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

164. MedicinalProduct.name.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on MedicinalProduct.name.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

166. MedicinalProduct.name.extension:type

Slice Name type

Definition

R5: MedicinalProductDefinition.name.type (new:CodeableConcept)

Short R5: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary (new)

Comments

Element MedicinalProductDefinition.name.type has a context of MedicinalProduct.name based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.name.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..1
This element is affected by the following invariants: ele-1

Type Extension(R5: Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary (new)) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

168. MedicinalProduct.name.modifierExtension

Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, 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).

Short Extensions that cannot be ignored even if unrecognized

Comments

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

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them

Summary true

Requirements

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

Alternate Names extensions, user content, modifiers

170. MedicinalProduct.name.productName

Definition

The full product name.

Short The full product name

Control 1..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

172. MedicinalProduct.name.namePart

Definition

Coding words or phrases of the name.

Short Coding words or phrases of the name

Control 0..*

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

174. MedicinalProduct.name.namePart.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

176. MedicinalProduct.name.namePart.extension

Definition

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, 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.

Short Additional content defined by implementations

Comments

Control 0..*

Is Modifier false

Summary false

Alternate Names extensions, user content

178. MedicinalProduct.name.namePart.modifierExtension

Definition

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

Short Extensions that cannot be ignored even if unrecognized

Comments

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them

Summary true

Requirements

Alternate Names extensions, user content, modifiers

180. MedicinalProduct.name.namePart.part

Definition

A fragment of a product name.

Short A fragment of a product name

Control 1..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

182. MedicinalProduct.name.namePart.type

Definition

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

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

Control 1..1

Coding

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

184. MedicinalProduct.name.namePart.type.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

186. MedicinalProduct.name.namePart.type.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on MedicinalProduct.name.namePart.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

188. MedicinalProduct.name.namePart.type.extension:type

Slice Name type

Definition

R5: MedicinalProductDefinition.name.part.type additional types (CodeableConcept) additional types from child elements (text)

Short R5: Identifying type for this part of the name (e.g. strength part) additional types

Comments

Element MedicinalProductDefinition.name.part.type is mapped to FHIR R4 element MedicinalProduct.name.namePart.type as SourceIsBroaderThanTarget. The mappings for MedicinalProductDefinition.name.part.type do not cover the following types: CodeableConcept. The mappings for MedicinalProductDefinition.name.part.type do not cover the following types based on type expansion: text.

Control 1..1

Type Extension(R5: Identifying type for this part of the name (e.g. strength part) additional types) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

190. MedicinalProduct.name.namePart.type.system

Definition

The identification of the code system that defines the meaning of the symbol in the code.

Short Identity of the terminology system

Comments

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

Need to be unambiguous about the source of the definition of the symbol.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

192. MedicinalProduct.name.namePart.type.version

Definition

Short Version of the system - if relevant

Comments

Note This is a business version Id, not a resource version Id (see discussion)

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

194. MedicinalProduct.name.namePart.type.code

Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Short Symbol in syntax defined by the system

Control 0..1

code

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

Need to refer to a particular code in the system.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

196. MedicinalProduct.name.namePart.type.display

Definition

A representation of the meaning of the code in the system, following the rules of the system.

Short Representation defined by the system

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

198. MedicinalProduct.name.namePart.type.userSelected

Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

Short If this coding was chosen directly by the user

Comments

Control 0..1

boolean

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

200. MedicinalProduct.name.countryLanguage

Definition

Country where the name applies.

Short Country where the name applies

Control 0..*

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

202. MedicinalProduct.name.countryLanguage.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

204. MedicinalProduct.name.countryLanguage.extension

Definition

Short Additional content defined by implementations

Comments

Control 0..*

Is Modifier false

Summary false

Alternate Names extensions, user content

206. MedicinalProduct.name.countryLanguage.modifierExtension

Definition

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

Short Extensions that cannot be ignored even if unrecognized

Comments

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them

Summary true

Requirements

Alternate Names extensions, user content, modifiers

208. MedicinalProduct.name.countryLanguage.country

Definition

Country code for where this name applies.

Short Country code for where this name applies

Control 1..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

210. MedicinalProduct.name.countryLanguage.jurisdiction

Definition

Jurisdiction code for where this name applies.

Short Jurisdiction code for where this name applies

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

212. MedicinalProduct.name.countryLanguage.language

Definition

Language code for this name.

Short Language code for this name

Control 1..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

214. MedicinalProduct.name.countryLanguage.language.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

216. MedicinalProduct.name.countryLanguage.language.extension

Definition

An Extension

Short Extension

Control 0..*

Is Modifier false

Summary false

This element introduces a set of slices on MedicinalProduct.name.countryLanguage.language.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

218. MedicinalProduct.name.countryLanguage.language.extension:language

Slice Name language

Definition

R5: MedicinalProductDefinition.name.usage.language

Short R5: language

Comments

Element MedicinalProductDefinition.name.usage.language is mapped to FHIR R4 element MedicinalProduct.name.countryLanguage.language as Equivalent.

Control 1..1

Type Extension(R5: language) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

220. MedicinalProduct.name.countryLanguage.language.coding

Definition

A reference to a code defined by a terminology system.

Short Code defined by a terminology system

Comments

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

Control 0..*

Coding

Is Modifier false

Summary true

Requirements

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

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

222. MedicinalProduct.name.countryLanguage.language.text

Definition

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

Short Plain text representation of the concept

Comments

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

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

224. MedicinalProduct.crossReference

Definition

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

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

Control 0..*

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

226. MedicinalProduct.crossReference.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

228. MedicinalProduct.crossReference.extension

Definition

An Extension

Short Extension

Control 1..*

Is Modifier false

Summary false

This element introduces a set of slices on MedicinalProduct.crossReference.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:

value @ url

230. MedicinalProduct.crossReference.extension:product

Slice Name product

Definition

R5: MedicinalProductDefinition.crossReference.product (new:CodeableReference(MedicinalProductDefinition))

Short R5: Reference to another product, e.g. for linking authorised to investigational product (new)

Comments

Element MedicinalProductDefinition.crossReference.product has a context of MedicinalProduct.crossReference based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.crossReference.product has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 1..1

Type Extension(R5: Reference to another product, e.g. for linking authorised to investigational product (new)) (Complex Extension)

Is Modifier false

232. MedicinalProduct.crossReference.extension:type

Slice Name type

Definition

R5: MedicinalProductDefinition.crossReference.type (new:CodeableConcept)

Short R5: The type of relationship, for instance branded to generic or virtual to actual product (new)

Comments

Element MedicinalProductDefinition.crossReference.type has a context of MedicinalProduct.crossReference based on following the parent source element upwards and mapping to MedicinalProduct. Element MedicinalProductDefinition.crossReference.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control 0..1

Type Extension(R5: The type of relationship, for instance branded to generic or virtual to actual product (new)) (Extension Type: CodeableConcept)

Is Modifier false

Summary false

234. MedicinalProduct.crossReference.use

Definition

The purpose of this identifier.

Short usual | official | temp | secondary | old (If known)

Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control 0..1

The codes SHALL be taken from IdentifierUse
(required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

Identifies the purpose for this identifier, if known .

code

Is Modifier true because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

236. MedicinalProduct.crossReference.type

Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

Short Description of identifier

Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

Control 0..1

Unless not suitable, these codes SHALL be taken from Identifier Type Codes
(extensible to http://hl7.org/fhir/ValueSet/identifier-type|4.0.1)

A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

Is Modifier false

Summary true

Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

238. MedicinalProduct.crossReference.system

Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

Short The namespace for the identifier value

Comments

Identifier.system is always case sensitive.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Example General: http://www.acme.com/identifiers/patient

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

240. MedicinalProduct.crossReference.value

Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

Short The value that is unique

Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Control 0..1

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Example General: 123456

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

242. MedicinalProduct.crossReference.period

Definition

Time period during which identifier is/was valid for use.

Short Time period when id is/was valid for use

Control 0..1

Period

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

244. MedicinalProduct.crossReference.assigner

Definition

Organization that issued/manages the identifier.

Short Organization that issued id (may be just text)

Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

Control 0..1

Type Reference(Organization)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

246. MedicinalProduct.manufacturingBusinessOperation

Definition

An operation applied to the product, for manufacturing or adminsitrative purpose.

Short An operation applied to the product, for manufacturing or adminsitrative purpose

Control 0..*

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

248. MedicinalProduct.manufacturingBusinessOperation.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

250. MedicinalProduct.manufacturingBusinessOperation.extension

Definition

Short Additional content defined by implementations

Comments

Control 0..*

Is Modifier false

Summary false

Alternate Names extensions, user content

252. MedicinalProduct.manufacturingBusinessOperation.modifierExtension

Definition

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

Short Extensions that cannot be ignored even if unrecognized

Comments

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them

Summary true

Requirements

Alternate Names extensions, user content, modifiers

254. MedicinalProduct.manufacturingBusinessOperation.operationType

Definition

The type of manufacturing operation.

Short The type of manufacturing operation

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

256. MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber

Definition

Regulatory authorization reference number.

Short Regulatory authorization reference number

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

258. MedicinalProduct.manufacturingBusinessOperation.effectiveDate

Definition

Regulatory authorization date.

Short Regulatory authorization date

Control 0..1

dateTime

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

260. MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator

Definition

To indicate if this proces is commercially confidential.

Short To indicate if this proces is commercially confidential

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

262. MedicinalProduct.manufacturingBusinessOperation.manufacturer

Definition

The manufacturer or establishment associated with the process.

Short The manufacturer or establishment associated with the process

Control 0..*

Type Reference(Organization)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

264. MedicinalProduct.manufacturingBusinessOperation.regulator

Definition

A regulator which oversees the operation.

Short A regulator which oversees the operation

Control 0..1

Type Reference(Organization)

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

266. MedicinalProduct.specialDesignation

Definition

Indicates if the medicinal product has an orphan designation for the treatment of a rare disease.

Short Indicates if the medicinal product has an orphan designation for the treatment of a rare disease

Control 0..*

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

268. MedicinalProduct.specialDesignation.id

Definition

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

Short Unique id for inter-element referencing

Control 0..1

Is Modifier false

XML Format In the XML format, this property is represented as an attribute.

Summary false

270. MedicinalProduct.specialDesignation.extension

Definition

Short Additional content defined by implementations

Comments

Control 0..*

Is Modifier false

Summary false

Alternate Names extensions, user content

272. MedicinalProduct.specialDesignation.modifierExtension

Definition

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

Short Extensions that cannot be ignored even if unrecognized

Comments

Control 0..*

Is Modifier true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them

Summary true

Requirements

Alternate Names extensions, user content, modifiers

274. MedicinalProduct.specialDesignation.identifier

Definition

Identifier for the designation, or procedure number.

Short Identifier for the designation, or procedure number

Note This is a business identifier, not a resource identifier (see discussion)

Control 0..*

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

276. MedicinalProduct.specialDesignation.type

Definition

The type of special designation, e.g. orphan drug, minor use.

Short The type of special designation, e.g. orphan drug, minor use

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

278. MedicinalProduct.specialDesignation.intendedUse

Definition

The intended use of the product, e.g. prevention, treatment.

Short The intended use of the product, e.g. prevention, treatment

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

280. MedicinalProduct.specialDesignation.indication[x]

Definition

Condition for which the medicinal use applies.

Short Condition for which the medicinal use applies

Control 0..1

Type Choice of: CodeableConcept, Reference(MedicinalProductIndication)

[x] Note SeeChoice of Data Typesfor further information about how to use [x]

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

282. MedicinalProduct.specialDesignation.status

Definition

For example granted, pending, expired or withdrawn.

Short For example granted, pending, expired or withdrawn

Control 0..1

Is Modifier false

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

284. MedicinalProduct.specialDesignation.date

Definition

Date when the designation was granted.

Short Date when the designation was granted

Control 0..1

dateTime

Is Modifier false

Primitive Value This primitive element may be present, or absent, or replaced by an extension

Summary true

Invariants ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

286. MedicinalProduct.specialDesignation.species

Definition

Animal species for which this applies.

Short Animal species for which this applies

Control 0..1