Summary
Diagnostics
Care Provision
Request & Response
Medications
Workflow
Entities
Management
Individuals
General
Billing
Support
Payment
Security
Other
Conformance
Documents
Terminology
Definitional Artifacts
Evidence-Based Medicine
Quality Reporting & Testing
Medication Definition
Public Health & Research
Complex
Primitive
ActivityDefinition
CapabilityStatement
ChargeItemDefinition
Claim
CodeSystem
Composition
ConceptMap
CoverageEligibilityRequest
Encounter
Group
Library
List
Measure
MedicinalProduct
MessageHeader
NamingSystem
Observation
Patient
PlanDefinition
Resource
StructureDefinition
StructureMap
ValueSet
default
Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).
MedicinalProduct
Path
MedicinalProduct
Id
MedicinalProduct
Cardinality
0 - *
Definition
Detailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use).
Comment
Constraint
dom-2 [error]
If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3 [error]
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
dom-4 [error]
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5 [error]
If a resource is contained in another resource, it SHALL NOT have a security label
dom-6 [warning]
A resource should have narrative for robust management
Path
MedicinalProduct.identifier
Id
MedicinalProduct.identifier
Type
Cardinality
0 - *
Definition
Business identifier for this product. Could be an MPID.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.assigner.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.assigner.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.assigner.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.assigner.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.assigner.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.assigner.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.type
Id
MedicinalProduct.type
Type
Cardinality
0 - 1
Definition
Regulatory type, e.g. Investigational or Authorized.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.domain
Id
MedicinalProduct.domain
Type
Cardinality
0 - 1
Definition
If this medicine applies to human or veterinary uses.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.domain.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.domain.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.domain.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.domain.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.domain.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
combinedPharmaceuticalDoseForm
The dose form for a single part product, or combined form of a multiple part product
Path
MedicinalProduct.combinedPharmaceuticalDoseForm
Id
MedicinalProduct.combinedPharmaceuticalDoseForm
Type
Cardinality
0 - 1
Definition
The dose form for a single part product, or combined form of a multiple part product.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.combinedPharmaceuticalDoseForm.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.combinedPharmaceuticalDoseForm.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.combinedPharmaceuticalDoseForm.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.combinedPharmaceuticalDoseForm.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.combinedPharmaceuticalDoseForm.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.combinedPharmaceuticalDoseForm.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
legalStatusOfSupply
The legal status of supply of the medicinal product as classified by the regulator
Path
MedicinalProduct.legalStatusOfSupply
Id
MedicinalProduct.legalStatusOfSupply
Type
Cardinality
0 - 1
Definition
The legal status of supply of the medicinal product as classified by the regulator.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.legalStatusOfSupply.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.legalStatusOfSupply.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.legalStatusOfSupply.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.legalStatusOfSupply.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.legalStatusOfSupply.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.legalStatusOfSupply.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
additionalMonitoringIndicator
Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Path
MedicinalProduct.additionalMonitoringIndicator
Id
MedicinalProduct.additionalMonitoringIndicator
Type
Cardinality
0 - 1
Definition
Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.additionalMonitoringIndicator.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.additionalMonitoringIndicator.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.additionalMonitoringIndicator.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.additionalMonitoringIndicator.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.additionalMonitoringIndicator.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.additionalMonitoringIndicator.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
specialMeasures
Whether the Medicinal Product is subject to special measures for regulatory reasons
Path
MedicinalProduct.specialMeasures
Id
MedicinalProduct.specialMeasures
Type
Cardinality
0 - *
Definition
Whether the Medicinal Product is subject to special measures for regulatory reasons.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.paediatricUseIndicator
Id
MedicinalProduct.paediatricUseIndicator
Type
Cardinality
0 - 1
Definition
If authorised for use in children.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.paediatricUseIndicator.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.paediatricUseIndicator.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.paediatricUseIndicator.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.paediatricUseIndicator.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.paediatricUseIndicator.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.paediatricUseIndicator.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.productClassification
Id
MedicinalProduct.productClassification
Type
Cardinality
0 - *
Definition
Allows the product to be classified by various systems.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.productClassification.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.productClassification.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.productClassification.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.productClassification.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.productClassification.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.productClassification.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
marketingStatus
Marketing status of the medicinal product, in contrast to marketing authorizaton
Path
MedicinalProduct.marketingStatus
Id
MedicinalProduct.marketingStatus
Type
Cardinality
0 - *
Definition
Marketing status of the medicinal product, in contrast to marketing authorizaton.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
country
The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
Path
MedicinalProduct.marketingStatus.MarketingStatus.country
Id
MarketingStatus.country
Type
Cardinality
1 - 1
Definition
The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.country.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.country.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.country.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.country.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.country.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.country.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
jurisdiction
Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
Path
MedicinalProduct.marketingStatus.MarketingStatus.jurisdiction
Id
MarketingStatus.jurisdiction
Type
Cardinality
0 - 1
Definition
Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.jurisdiction.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.jurisdiction.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.jurisdiction.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.jurisdiction.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.jurisdiction.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.jurisdiction.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
status
This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
Path
MedicinalProduct.marketingStatus.MarketingStatus.status
Id
MarketingStatus.status
Type
Cardinality
1 - 1
Definition
This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.status.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.status.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.status.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.status.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.status.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.status.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
dateRange
The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
Path
MedicinalProduct.marketingStatus.MarketingStatus.dateRange
Id
MarketingStatus.dateRange
Type
Cardinality
1 - 1
Definition
The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.marketingStatus.MarketingStatus.dateRange.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.marketingStatus.MarketingStatus.dateRange.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
restoreDate
The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
Path
MedicinalProduct.marketingStatus.MarketingStatus.restoreDate
Id
MarketingStatus.restoreDate
Type
Cardinality
0 - 1
Definition
The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct
Id
MedicinalProduct.pharmaceuticalProduct
Type
Cardinality
0 - *
Definition
Pharmaceutical aspects of product.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.pharmaceuticalProduct.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.pharmaceuticalProduct.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct
Id
MedicinalProduct.packagedMedicinalProduct
Type
Cardinality
0 - *
Definition
Package representation for the product.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.packagedMedicinalProduct.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.packagedMedicinalProduct.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument
Id
MedicinalProduct.attachedDocument
Type
Cardinality
0 - *
Definition
Supporting documentation, typically for regulatory submission.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.attachedDocument.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.attachedDocument.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
masterFile
A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
Path
MedicinalProduct.masterFile
Id
MedicinalProduct.masterFile
Type
Cardinality
0 - *
Definition
A master file for to the medicinal product (e.g. Pharmacovigilance System Master File).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.masterFile.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.masterFile.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact
Id
MedicinalProduct.contact
Type
Cardinality
0 - *
Definition
A product specific contact, person (in a role), or an organization.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.contact.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.contact.Reference.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.contact.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.contact.Reference.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.contact.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial
Id
MedicinalProduct.clinicalTrial
Type
Cardinality
0 - *
Definition
Clinical trials or studies that this product is involved in.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.clinicalTrial.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.clinicalTrial.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name
Id
MedicinalProduct.name
Type
Cardinality
1 - *
Definition
The product's name, including full name and possibly coded parts.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.productName
Id
MedicinalProduct.name.productName
Type
Cardinality
1 - 1
Definition
The full product name.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.namePart
Id
MedicinalProduct.name.namePart
Type
Cardinality
0 - *
Definition
Coding words or phrases of the name.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.namePart.part
Id
MedicinalProduct.name.namePart.part
Type
Cardinality
1 - 1
Definition
A fragment of a product name.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.namePart.type
Id
MedicinalProduct.name.namePart.type
Type
Cardinality
1 - 1
Definition
Idenifying type for this part of the name (e.g. strength part).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.namePart.type.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.namePart.type.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.namePart.type.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.namePart.type.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.namePart.type.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.countryLanguage
Id
MedicinalProduct.name.countryLanguage
Type
Cardinality
0 - *
Definition
Country where the name applies.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.countryLanguage.country
Id
MedicinalProduct.name.countryLanguage.country
Type
Cardinality
1 - 1
Definition
Country code for where this name applies.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.countryLanguage.country.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.countryLanguage.jurisdiction
Id
MedicinalProduct.name.countryLanguage.jurisdiction
Type
Cardinality
0 - 1
Definition
Jurisdiction code for where this name applies.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.name.countryLanguage.jurisdiction.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
crossReference
Reference to another product, e.g. for linking authorised to investigational product
Path
MedicinalProduct.crossReference
Id
MedicinalProduct.crossReference
Type
Cardinality
0 - *
Definition
Reference to another product, e.g. for linking authorised to investigational product.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.crossReference.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.crossReference.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.crossReference.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.assigner.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.assigner.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.assigner.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.assigner.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.assigner.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.assigner.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.crossReference.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
manufacturingBusinessOperation
An operation applied to the product, for manufacturing or adminsitrative purpose
Path
MedicinalProduct.manufacturingBusinessOperation
Id
MedicinalProduct.manufacturingBusinessOperation
Type
Cardinality
0 - *
Definition
An operation applied to the product, for manufacturing or adminsitrative purpose.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.operationType
Id
MedicinalProduct.manufacturingBusinessOperation.operationType
Type
Cardinality
0 - 1
Definition
The type of manufacturing operation.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.operationType.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.operationType.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.operationType.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.operationType.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.operationType.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.operationType.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber
Id
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber
Type
Cardinality
0 - 1
Definition
Regulatory authorization reference number.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.authorisationReferenceNumber.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.effectiveDate
Id
MedicinalProduct.manufacturingBusinessOperation.effectiveDate
Type
Cardinality
0 - 1
Definition
Regulatory authorization date.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator
Id
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator
Type
Cardinality
0 - 1
Definition
To indicate if this proces is commercially confidential.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.confidentialityIndicator.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer
Id
MedicinalProduct.manufacturingBusinessOperation.manufacturer
Type
Cardinality
0 - *
Definition
The manufacturer or establishment associated with the process.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.manufacturer.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.regulator
Id
MedicinalProduct.manufacturingBusinessOperation.regulator
Type
Cardinality
0 - 1
Definition
A regulator which oversees the operation.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.regulator.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.manufacturingBusinessOperation.regulator.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.regulator.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.regulator.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.regulator.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.regulator.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.regulator.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.regulator.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.regulator.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.manufacturingBusinessOperation.regulator.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
specialDesignation
Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
Path
MedicinalProduct.specialDesignation
Id
MedicinalProduct.specialDesignation
Type
Cardinality
0 - *
Definition
Indicates if the medicinal product has an orphan designation for the treatment of a rare disease.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier
Id
MedicinalProduct.specialDesignation.identifier
Type
Cardinality
0 - *
Definition
Identifier for the designation, or procedure number.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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](extension-rendered-value.html). 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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.specialDesignation.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.
Comment
The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
MedicinalProduct.specialDesignation.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-1
Path
MedicinalProduct.specialDesignation.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
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).
Comment
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.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
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.
Comment
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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.type
Id
MedicinalProduct.specialDesignation.type
Type
Cardinality
0 - 1
Definition
The type of special designation, e.g. orphan drug, minor use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.intendedUse
Id
MedicinalProduct.specialDesignation.intendedUse
Type
Cardinality
0 - 1
Definition
The intended use of the product, e.g. prevention, treatment.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.intendedUse.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.intendedUse.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.intendedUse.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.intendedUse.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.intendedUse.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.intendedUse.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.indication[x]
Id
MedicinalProduct.specialDesignation.indication[x]
Type
Cardinality
0 - 1
Definition
Condition for which the medicinal use applies.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.indication[x].CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.indication[x].CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.indication[x].CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.indication[x].CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.indication[x].CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.indication[x].CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.status
Id
MedicinalProduct.specialDesignation.status
Type
Cardinality
0 - 1
Definition
For example granted, pending, expired or withdrawn.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.status.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.status.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.status.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.status.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.status.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.status.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.date
Id
MedicinalProduct.specialDesignation.date
Type
Cardinality
0 - 1
Definition
Date when the designation was granted.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.species
Id
MedicinalProduct.specialDesignation.species
Type
Cardinality
0 - 1
Definition
Animal species for which this applies.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.species.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.species.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.species.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.species.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.species.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProduct.specialDesignation.species.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children