emaLegalBasisCodeableConcept
type: StructureDefinition
node role: treeRoot
id:
  v: emaLegalBasisCodeableConcept
text:
  status:
    v: extensions
  div: Generated Narrative: StructureDefinition emaLegalBasisCodeableConcept Name Flags Card. Type Description & Constraints CodeableConcept 0..* EmaRefTermCodeableConceptRestrictions Concept - reference to a terminology or just text coding 0..* Coding Code defined by a terminology system Binding: XEVMPD medicinal product type (required) Documentation for this format
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics
  value: code
    v: can-bind
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics
  value: code
    v: do-translations
url:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaLegalBasisCodeableConcept
version:
  v: 1.2.0
name:
  v: EmaLegalBasisCodeableConcept
title:
  v: EMA Legal Basis CodeableConcept
status:
  v: draft
date:
  v: 2025-10-21T12:20:05+01:00
publisher:
  v: EMA
contact:
  name:
    v: EMA
  telecom:
    system:
      v: url
    value:
      v: https://support.ema.europa.eu/esc
description:
  v: EMA Legal Basis CodeableConcept
fhir version:
  v: 5.0.0
mapping:
  identity:
    v: v2
  uri:
    v: http://hl7.org/v2
  name:
    v: HL7 V2 Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
  name:
    v: RIM Mapping
mapping:
  identity:
    v: orim
  uri:
    v: http://hl7.org/orim
  name:
    v: Ontological RIM Mapping
kind:
  v: complex-type
abstract:
  v: false
type:
  v: CodeableConcept
base definition:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConceptRestrictions
  link: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConceptRestrictions
derivation:
  v: constraint
snapshot:
  extension:
    url:
      v: http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version
    value: string
      v: 1.2.0
  element:
    id:
      v: CodeableConcept
    path:
      v: CodeableConcept
    short:
      v: Concept - reference to a terminology or just text
    definition:
      v: A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.
    comment:
      v: Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: CodeableConcept
      min:
        v: 0
      max:
        v: *
    constraint:
      key:
        v: ele-1
      severity:
        v: error
      human:
        v: All FHIR elements must have a @value or children
      expression:
        v: hasValue() or (children().count() > id.count())
      source:
        v: http://hl7.org/fhir/StructureDefinition/Element
        link: http://hl7.org/fhir/StructureDefinition/Element
    is modifier:
      v: false
    mapping:
      identity:
        v: rim
      map:
        v: n/a,CD
    mapping:
      identity:
        v: v2
      map:
        v: CE/CNE/CWE
    mapping:
      identity:
        v: orim
      map:
        v: fhir:CodeableConcept rdfs:subClassOf dt:CD
  element:
    id:
      v: CodeableConcept.id
    path:
      v: CodeableConcept.id
    representation:
      v: xmlAttr
    short:
      v: Unique id for inter-element referencing
    definition:
      v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
    min:
      v: 0
    max:
      v: 1
    base:
      path:
        v: Element.id
      min:
        v: 0
      max:
        v: 1
    type:
      extension:
        value: url
      code:
        v: http://hl7.org/fhirpath/System.String
    condition:
      v: ele-1
    is modifier:
      v: false
    is summary:
      v: false
    mapping:
      identity:
        v: rim
      map:
        v: n/a
  element:
    id:
      v: CodeableConcept.extension
    path:
      v: CodeableConcept.extension
    slicing:
      description:
        v: Extensions are always sliced by (at least) url
      rules:
        v: open
    short:
      v: Extension
    definition:
      v: An Extension
    min:
      v: 0
    max:
      v: 0
    base:
      path:
        v: Element.extension
      min:
        v: 0
      max:
        v: *
    type:
      code:
        v: Extension
    constraint:
      key:
        v: ele-1
      severity:
        v: error

url
v: id

v: value

v: url

v: All FHIR elements must have a @value or children

v: hasValue() or (children().count() > id.count())

key:
  v: ext-1
severity:
  v: error
human:
  v: Must have either extensions or value[x], not both
expression:
  v: extension.exists() != value.exists()
source:
  v: http://hl7.org/fhir/StructureDefinition/Extension
  link: http://hl7.org/fhir/StructureDefinition/Extension

v: false

v: false

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

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

element:
  id:
    v: CodeableConcept
  path:
    v: CodeableConcept
element:
  id:
    v: CodeableConcept.coding
  path:
    v: CodeableConcept.coding
  binding:
    strength:
      v: required
    value set:
      v: http://ema.europa.eu/fhir/vs/marketingAuthorisationApplicationLegalBasis
      link: http://ema.europa.eu/fhir/vs/marketingAuthorisationApplicationLegalBasis