emaWriteApiRegulatedAuthorization
type: StructureDefinition
node role: treeRoot
id:
  v: emaWriteApiRegulatedAuthorization
text:
  status:
    v: extensions
  div: Generated Narrative: StructureDefinition emaWriteApiRegulatedAuthorization Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> RegulatedAuthorization <a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( regulatorIsMandatoryIfManufacturingIdentifierExists, validityPeriodIsMandatoryIfManufacturingIdentifierExists, regionIsEmptyForManAuth, statusDateIsEmptyForManAuth, holderIsEmptyForManAuth, caseIsEmptyForManAuth, extensionIsEmptyForManAuth, manAuthNumberIsMandatoryForCertainManufacturingActivities, marketingAuthorizationNumberIsMandatoryForMarktAuth, validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd, dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd, internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd, caseIsMandatoryForMarktAuthIfSubjectIsMpd, holderIsMandatoryForMarktAuthIfSubjectIsMpd )">C 0..* EmaWriteApiRegulatedAuthorizationRestrictions Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product regulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory validityPeriodIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the validity period is mandatory regionIsEmptyForManAuth: The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. statusDateIsEmptyForManAuth: The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. holderIsEmptyForManAuth: The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. caseIsEmptyForManAuth: The RegulatedAuthorization must not have a Case if it is a Ma…
url:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
version:
  v: 1.2.0
name:
  v: EmaWriteApiRegulatedAuthorization
title:
  v: EMA Write API Regulated Authorization
status:
  v: draft
date:
  v: 2025-10-21T12:20:05+01:00
publisher:
  v: EMA
contact:
  name:
    v: EMA
  telecom:
    system:
      v: url
    value:
      v: https://support.ema.europa.eu/esc
description:
  v: Defines the rules a Marketing or Manufacturing RegulatedAuthorization resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application
fhir version:
  v: 5.0.0
mapping:
  identity:
    v: w5
  uri:
    v: http://hl7.org/fhir/fivews
  name:
    v: FiveWs Pattern Mapping
mapping:
  identity:
    v: idmp
  uri:
    v: https://www.iso.org/obp/ui/#iso:std:iso:11615
  name:
    v: IDMP Mapping
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
  name:
    v: RIM Mapping
kind:
  v: resource
abstract:
  v: false
type:
  v: RegulatedAuthorization
base definition:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorizationRestrictions
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorizationRestrictions
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: RegulatedAuthorization
    path:
      v: RegulatedAuthorization
    short:
      v: Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
    definition:
      v: Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.
    min:
      v: 0
    max:
      v: *
    base:
      path:
        v: RegulatedAuthorization
      min:
        v: 0
      max:
        v: *
    constraint:
      key:
        v: dom-2
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL NOT contain nested Resources
      expression:
        v: contained.contained.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-3
      severity:
        v: error
      human:
        v: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
      expression:
        v: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-4
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
      expression:
        v: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: dom-5
      severity:
        v: error
      human:
        v: If a resource is contained in another resource, it SHALL NOT have a security label
      expression:
        v: contained.meta.security.empty()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      extension:
        value: boolean
      extension:
        value: markdown
      key:
        v: dom-6
      severity:
        v: warning
      human:
        v: A resource should have narrative for robust management
      expression:
        v: text.`div`.exists()
      source:
        v: http://hl7.org/fhir/StructureDefinition/DomainResource
        link: http://hl7.org/fhir/StructureDefinition/DomainResource
    constraint:
      key:
        v: regulatorIsMandatoryIfManufacturingIdentifierExists
      severity:
        v: error
      human:
        v: If there is a Manufacturing Identifier, then the regulator is mandatory
      expression:
        v: (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists()
      source:
        v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
        link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
    constraint:
      key:
        v: validityPeriodIsMandatoryIfManufacturingIdentifierExists
      severity:
        v: error
      human:
        v: If there is a Manufacturing Identifier, then the validity period is mandatory
      expression:
        v: (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()
      source:
        v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
        link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
    constraint:
      key:
        v: regionIsEmptyForManAuth
      severity:
        v: error
      human:
        v: The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.
      expression:
        v: (type.coding.exists(code = '200000051585')) implies (region.empty())
      source:
        v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
        link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
    constraint:
      key:
        v: statusDateIsEmptyForManAuth
      severity:
        v: error
      human:
        v: The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization.
      expression:
        v: (type.coding.exists(code = '200000051585')) implies (statusDate.empty())
      source:
        v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
        link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

boolean
v: true

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

key:
  v: holderIsEmptyForManAuth
severity:
  v: error
human:
  v: The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.
expression:
  v: (type.coding.exists(code = '200000051585')) implies (holder.empty())
source:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

key:
  v: caseIsEmptyForManAuth
severity:
  v: error
human:
  v: The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.
expression:
  v: (type.coding.exists(code = '200000051585')) implies (case.empty())
source:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

key:
  v: extensionIsEmptyForManAuth
severity:
  v: error
human:
  v: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
expression:
  v: (type.coding.exists(code = '200000051585')) implies (extension.empty())
source:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

key:
  v: manAuthNumberIsMandatoryForCertainManufacturingActivities
severity:
  v: error
human:
  v: The RegulatedAuthorization's Manufacturing Authorization Number identifier is mandatory when the subject references an ActivityDefinition whose code is among the following ones: 100000163737, 100000163709, 100000163618, 100000160477, 100000160476, 100000160464, 100000160463, 100000160462, 100000160461, 100000160460, 100000160459, 100000160458, 100000160457, 100000160456, 100000160414, 100000160413, 100000160412, 100000160411, 100000160410, 100000160409, 100000160408, 100000160407.
expression:
  v: (subject.resolve().ofType(ActivityDefinition).code.coding.where(code = '100000163737' or code = '100000163709' or code = '100000163618' or code = '100000160477' or code = '100000160476' or code = '100000160464' or code = '100000160463' or code = '100000160462' or code = '100000160461' or code = '100000160460' or code = '100000160459' or code = '100000160458' or code = '100000160457' or code = '100000160456' or code = '100000160414' or code = '100000160413' or code = '100000160412' or code = '100000160411' or code = '100000160410' or code = '100000160409' or code = '100000160408' or code = '100000160407').exists()) implies identifier.where(system = 'http://ema.europa.eu/fhir/manufacturingAuthorizationNumber').exists()
source:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

key:
  v: marketingAuthorizationNumberIsMandatoryForMarktAuth
severity:
  v: error
human:
  v: The RegulatedAuthorization must have the Marketing Authorization Number identifier.
expression:
  v: (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
source:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

key:
  v: validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd
severity:
  v: error
human:
  v: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
expression:
  v: subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists()
source:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

key:
  v: dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd
severity:
  v: error
human:
  v: The RegulatedAuthorization must have the Date of First Authorisation extension.
expression:
  v: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists()
source:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

key:
  v: internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd
severity:
  v: error
human:
  v: The RegulatedAuthorization must have the International Birth Date extension.
expression:
  v: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
source:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

key:
  v: caseIsMandatoryForMarktAuthIfSubjectIsMpd
severity:
  v: error
human:
  v: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
expression:
  v: subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
source:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

key:
  v: holderIsMandatoryForMarktAuthIfSubjectIsMpd
severity:
  v: error
human:
  v: The RegulatedAuthorization must have a holder.
expression:
  v: subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
source:
  v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization

v: false

v: false

v: false

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

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

identity:
  v: idmp
map:
  v: Marketing Authorization, Clinical Trial Authorization

id:
  v: RegulatedAuthorization.id
path:
  v: RegulatedAuthorization.id
short:
  v: Logical id of this artifact
definition:
  v: The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
comment:
  v: Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Resource.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: id
  code:
    v: http://hl7.org/fhirpath/System.String
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: RegulatedAuthorization.meta
path:
  v: RegulatedAuthorization.meta
short:
  v: Metadata about the resource
definition:
  v: The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Resource.meta
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Meta
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true

id:
  v: RegulatedAuthorization.implicitRules
path:
  v: RegulatedAuthorization.implicitRules
short:
  v: A set of rules under which this content was created
definition:
  v: A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
comment:
  v: Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Resource.implicitRules
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
is summary:
  v: true

id:
  v: RegulatedAuthorization.language
path:
  v: RegulatedAuthorization.language
short:
  v: Language of the resource content
definition:
  v: The base language in which the resource is written.
comment:
  v: Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Resource.language
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Language
  strength:
    v: required
  description:
    v: IETF language tag for a human language
  value set:
    v: http://hl7.org/fhir/ValueSet/all-languages|5.0.0
    link: 5.0
    link: .0
  additional:
    purpose:
      v: starter
    value set:
      v: http://hl7.org/fhir/ValueSet/languages
      link: http://hl7.org/fhir/ValueSet/languages

id:
  v: RegulatedAuthorization.text
path:
  v: RegulatedAuthorization.text
short:
  v: Text summary of the resource, for human interpretation
definition:
  v: A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
comment:
  v: Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
alias:
  v: narrative
alias:
  v: html
alias:
  v: xhtml
alias:
  v: display
min:
  v: 0
max:
  v: 0
base:
  path:
    v: DomainResource.text
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Narrative
condition:
  v: dom-6
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: Act.text?

id:
  v: RegulatedAuthorization.contained
path:
  v: RegulatedAuthorization.contained
short:
  v: Contained, inline Resources
definition:
  v: These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
comment:
  v: This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
alias:
  v: inline resources
alias:
  v: anonymous resources
alias:
  v: contained resources
min:
  v: 0
max:
  v: 0
base:
  path:
    v: DomainResource.contained
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Resource
condition:
  v: dom-2
condition:
  v: dom-4
condition:
  v: dom-3
condition:
  v: dom-5
must support:
  v: false
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: N/A

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

id:
  v: RegulatedAuthorization.extension:dateOfFirstAuthorisation
path:
  v: RegulatedAuthorization.extension
slice name:
  v: dateOfFirstAuthorisation
short:
  v: Regulated Authorization - Date of First Authorisation
definition:
  v: The Regulated Authorization's Date of First Authorisation
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
  profile:
    v: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
    link: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: false
is modifier:
  v: false

id:
  v: RegulatedAuthorization.extension:internationalBirthDate
path:
  v: RegulatedAuthorization.extension
slice name:
  v: internationalBirthDate
short:
  v: Regulated Authorization - International Birth Date
definition:
  v: The Regulated Authorization's International Birth Date
min:
  v: 0
max:
  v: 1
base:
  path:
    v: DomainResource.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
  profile:
    v: http://ema.europa.eu/fhir/extension/internationalBirthDate
    link: http://ema.europa.eu/fhir/extension/internationalBirthDate
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: false
is modifier:
  v: false

id:
  v: RegulatedAuthorization.modifierExtension
path:
  v: RegulatedAuthorization.modifierExtension
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: 0
base:
  path:
    v: DomainResource.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
must support:
  v: false
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
is summary:
  v: true

id:
  v: RegulatedAuthorization.identifier
path:
  v: RegulatedAuthorization.identifier
slicing:
  discriminator:
    type:
      v: value
    path:
      v: system
  description:
    v: Slice based on the system of the identifier
  rules:
    v: open
short:
  v: Business identifier for the authorization, typically assigned by the authorizing body
definition:
  v: Business identifier for the authorization, typically assigned by the authorizing body.
min:
  v: 0
max:
  v: 2
base:
  path:
    v: RegulatedAuthorization.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.class
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Marketing Authorization Number

id:
  v: RegulatedAuthorization.identifier:marketingAuthorizationIdentifier
path:
  v: RegulatedAuthorization.identifier
slice name:
  v: marketingAuthorizationIdentifier
short:
  v: Business identifier for the authorization, typically assigned by the authorizing body
definition:
  v: Business identifier for the authorization, typically assigned by the authorizing body.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaMarketingAuthorizationIdentifier
    link: http://ema.europa.eu/fhir/StructureDefinition/emaMarketingAuthorizationIdentifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.class
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Marketing Authorization Number

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

id:
  v: RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.extension
path:
  v: RegulatedAuthorization.identifier.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  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
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.use
path:
  v: RegulatedAuthorization.identifier.use
short:
  v: usual | official | temp | secondary | old (If known)
definition:
  v: The purpose of this identifier.
comment:
  v: Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
requirements:
  v: Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.use
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierUse
  strength:
    v: required
  description:
    v: Identifies the purpose for this identifier, if known .
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.type
path:
  v: RegulatedAuthorization.identifier.type
short:
  v: Description of identifier
definition:
  v: A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
comment:
  v: 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:
  v: Allows users to make use of identifiers when the identifier system is not known.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierType
  strength:
    v: extensible
  description:
    v: A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-type
    link: http://hl7.org/fhir/ValueSet/identifier-type
mapping:
  identity:
    v: v2
  map:
    v: CX.5
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.system
path:
  v: RegulatedAuthorization.identifier.system
short:
  v: The namespace for the identifier value
definition:
  v: Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
comment:
  v: Identifier.system is always case sensitive.
requirements:
  v: 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.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
pattern: uri
  v: http://ema.europa.eu/fhir/MarketingAuthorizationNumber
example:
  label:
    v: General
  value: uri
    v: http://www.acme.com/identifiers/patient
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: CX.4 / EI-2-4
mapping:
  identity:
    v: rim
  map:
    v: II.root or Role.id.root
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierType

id:
  v: RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.value
path:
  v: RegulatedAuthorization.identifier.value
short:
  v: The value that is unique
definition:
  v: The portion of the identifier typically relevant to the user and which is unique within the context of the system.
comment:
  v: 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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-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.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
example:
  label:
    v: General
  value: string
    v: 123456
condition:
  v: ident-1
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: CX.1 / EI.1
mapping:
  identity:
    v: rim
  map:
    v: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
mapping:
  identity:
    v: servd
  map:
    v: ./Value

id:
  v: RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.period
path:
  v: RegulatedAuthorization.identifier.period
short:
  v: Time period when id is/was valid for use
definition:
  v: Time period during which identifier is/was valid for use.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: CX.7 + CX.8
mapping:
  identity:
    v: rim
  map:
    v: Role.effectiveTime or implied by context
mapping:
  identity:
    v: servd
  map:
    v: ./StartDate and ./EndDate

id:
  v: RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.assigner
path:
  v: RegulatedAuthorization.identifier.assigner
short:
  v: Organization that issued id (may be just text)
definition:
  v: Organization that issued/manages the identifier.
comment:
  v: 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.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.assigner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / (CX.4,CX.9,CX.10)
mapping:
  identity:
    v: rim
  map:
    v: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierIssuingAuthority

id:
  v: RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier
path:
  v: RegulatedAuthorization.identifier
slice name:
  v: manufacturingAuthorizationNumberIdentifier
short:
  v: Business identifier for the authorization, typically assigned by the authorizing body
definition:
  v: Business identifier for the authorization, typically assigned by the authorizing body.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaManufacturingAuthNumberIdentifier
    link: http://ema.europa.eu/fhir/StructureDefinition/emaManufacturingAuthNumberIdentifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.class
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Marketing Authorization Number

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

id:
  v: RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.extension
path:
  v: RegulatedAuthorization.identifier.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  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
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.use
path:
  v: RegulatedAuthorization.identifier.use
short:
  v: usual | official | temp | secondary | old (If known)
definition:
  v: The purpose of this identifier.
comment:
  v: Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
requirements:
  v: Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.use
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierUse
  strength:
    v: required
  description:
    v: Identifies the purpose for this identifier, if known .
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.type
path:
  v: RegulatedAuthorization.identifier.type
short:
  v: Description of identifier
definition:
  v: A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
comment:
  v: 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:
  v: Allows users to make use of identifiers when the identifier system is not known.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierType
  strength:
    v: extensible
  description:
    v: A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-type
    link: http://hl7.org/fhir/ValueSet/identifier-type
mapping:
  identity:
    v: v2
  map:
    v: CX.5
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.system
path:
  v: RegulatedAuthorization.identifier.system
short:
  v: The namespace for the identifier value
definition:
  v: Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
comment:
  v: Identifier.system is always case sensitive.
requirements:
  v: 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.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
pattern: uri
  v: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber
example:
  label:
    v: General
  value: uri
    v: http://www.acme.com/identifiers/patient
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: CX.4 / EI-2-4
mapping:
  identity:
    v: rim
  map:
    v: II.root or Role.id.root
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierType

id:
  v: RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.value
path:
  v: RegulatedAuthorization.identifier.value
short:
  v: The value that is unique
definition:
  v: The portion of the identifier typically relevant to the user and which is unique within the context of the system.
comment:
  v: 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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-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.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
example:
  label:
    v: General
  value: string
    v: 123456
condition:
  v: ident-1
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: CX.1 / EI.1
mapping:
  identity:
    v: rim
  map:
    v: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
mapping:
  identity:
    v: servd
  map:
    v: ./Value

id:
  v: RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.period
path:
  v: RegulatedAuthorization.identifier.period
short:
  v: Time period when id is/was valid for use
definition:
  v: Time period during which identifier is/was valid for use.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: CX.7 + CX.8
mapping:
  identity:
    v: rim
  map:
    v: Role.effectiveTime or implied by context
mapping:
  identity:
    v: servd
  map:
    v: ./StartDate and ./EndDate

id:
  v: RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.assigner
path:
  v: RegulatedAuthorization.identifier.assigner
short:
  v: Organization that issued id (may be just text)
definition:
  v: Organization that issued/manages the identifier.
comment:
  v: 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.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.assigner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / (CX.4,CX.9,CX.10)
mapping:
  identity:
    v: rim
  map:
    v: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierIssuingAuthority

id:
  v: RegulatedAuthorization.identifier:eudraGmpNumberIdentifier
path:
  v: RegulatedAuthorization.identifier
slice name:
  v: eudraGmpNumberIdentifier
short:
  v: Business identifier for the authorization, typically assigned by the authorizing body
definition:
  v: Business identifier for the authorization, typically assigned by the authorizing body.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.identifier
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Identifier
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaEudraGmpNumberIdentifier
    link: http://ema.europa.eu/fhir/StructureDefinition/emaEudraGmpNumberIdentifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: w5
  map:
    v: FiveWs.class
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Marketing Authorization Number

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

id:
  v: RegulatedAuthorization.identifier:eudraGmpNumberIdentifier.extension
path:
  v: RegulatedAuthorization.identifier.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  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
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: RegulatedAuthorization.identifier:eudraGmpNumberIdentifier.use
path:
  v: RegulatedAuthorization.identifier.use
short:
  v: usual | official | temp | secondary | old (If known)
definition:
  v: The purpose of this identifier.
comment:
  v: Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
requirements:
  v: Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.use
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierUse
  strength:
    v: required
  description:
    v: Identifies the purpose for this identifier, if known .
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: RegulatedAuthorization.identifier:eudraGmpNumberIdentifier.type
path:
  v: RegulatedAuthorization.identifier.type
short:
  v: Description of identifier
definition:
  v: A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
comment:
  v: 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:
  v: Allows users to make use of identifiers when the identifier system is not known.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierType
  strength:
    v: extensible
  description:
    v: A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-type
    link: http://hl7.org/fhir/ValueSet/identifier-type
mapping:
  identity:
    v: v2
  map:
    v: CX.5
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: RegulatedAuthorization.identifier:eudraGmpNumberIdentifier.system
path:
  v: RegulatedAuthorization.identifier.system
short:
  v: The namespace for the identifier value
definition:
  v: Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
comment:
  v: Identifier.system is always case sensitive.
requirements:
  v: 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.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
pattern: uri
  v: http://ema.europa.eu/fhir/eudraGmpNumber
example:
  label:
    v: General
  value: uri
    v: http://www.acme.com/identifiers/patient
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: CX.4 / EI-2-4
mapping:
  identity:
    v: rim
  map:
    v: II.root or Role.id.root
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierType

id:
  v: RegulatedAuthorization.identifier:eudraGmpNumberIdentifier.value
path:
  v: RegulatedAuthorization.identifier.value
short:
  v: The value that is unique
definition:
  v: The portion of the identifier typically relevant to the user and which is unique within the context of the system.
comment:
  v: 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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-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.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
example:
  label:
    v: General
  value: string
    v: 123456
condition:
  v: ident-1
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: CX.1 / EI.1
mapping:
  identity:
    v: rim
  map:
    v: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
mapping:
  identity:
    v: servd
  map:
    v: ./Value

id:
  v: RegulatedAuthorization.identifier:eudraGmpNumberIdentifier.period
path:
  v: RegulatedAuthorization.identifier.period
short:
  v: Time period when id is/was valid for use
definition:
  v: Time period during which identifier is/was valid for use.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: CX.7 + CX.8
mapping:
  identity:
    v: rim
  map:
    v: Role.effectiveTime or implied by context
mapping:
  identity:
    v: servd
  map:
    v: ./StartDate and ./EndDate

id:
  v: RegulatedAuthorization.identifier:eudraGmpNumberIdentifier.assigner
path:
  v: RegulatedAuthorization.identifier.assigner
short:
  v: Organization that issued id (may be just text)
definition:
  v: Organization that issued/manages the identifier.
comment:
  v: 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.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Identifier.assigner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / (CX.4,CX.9,CX.10)
mapping:
  identity:
    v: rim
  map:
    v: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierIssuingAuthority

id:
  v: RegulatedAuthorization.subject
path:
  v: RegulatedAuthorization.subject
short:
  v: The product type, treatment, facility or activity that is being authorized
definition:
  v: The product type, treatment, facility or activity that is being authorized.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.subject
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition
    link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition
  target profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiPackagedProductDefinition
    link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiPackagedProductDefinition
  target profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition
    link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: (the link to Medicinal Product or Packaged Medicinal Product)

id:
  v: RegulatedAuthorization.type
path:
  v: RegulatedAuthorization.type
short:
  v: Overall type of this authorization, for example drug marketing approval, orphan drug designation
definition:
  v: Overall type of this authorization, for example drug marketing approval, orphan drug designation.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept
    link: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://ema.europa.eu/fhir/vs/regulatoryEntitlementType
    link: http://ema.europa.eu/fhir/vs/regulatoryEntitlementType
mapping:
  identity:
    v: idmp
  map:
    v: n/a

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

id:
  v: RegulatedAuthorization.type.extension
path:
  v: RegulatedAuthorization.type.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: 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
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false

id:
  v: RegulatedAuthorization.type.coding
path:
  v: RegulatedAuthorization.type.coding
short:
  v: Code defined by a terminology system
definition:
  v: A reference to a code defined by a terminology system.
comment:
  v: Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
requirements:
  v: Allows for alternative encodings within a code system, and translations to other code systems.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: CodeableConcept.coding
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Coding
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaCoding
    link: http://ema.europa.eu/fhir/StructureDefinition/emaCoding
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/marketingAndManufacturingTypes
    link: http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes
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: RegulatedAuthorization.type.text
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: RegulatedAuthorization.type.text
short:
  v: Plain text representation of the concept
definition:
  v: A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
comment:
  v: Very often the text is the same as a displayName of one of the codings.
requirements:
  v: The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
min:
  v: 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

id:
  v: RegulatedAuthorization.description
path:
  v: RegulatedAuthorization.description
short:
  v: General textual supporting information
definition:
  v: General textual supporting information.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: RegulatedAuthorization.description
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: markdown
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: RegulatedAuthorization.region
path:
  v: RegulatedAuthorization.region
short:
  v: The territory in which the authorization has been granted
definition:
  v: The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.
min:
  v: 0
max:
  v: *
base:
  path:
    v: RegulatedAuthorization.region
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: Jurisdiction
  strength:
    v: example
  description:
    v: Jurisdiction codes
  value set:
    v: http://hl7.org/fhir/ValueSet/jurisdiction
    link: http://hl7.org/fhir/ValueSet/jurisdiction
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Country

id:
  v: RegulatedAuthorization.status
path:
  v: RegulatedAuthorization.status
short:
  v: The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
definition:
  v: The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.status
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept
    link: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
    link: http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Authorization Status

id:
  v: RegulatedAuthorization.statusDate
path:
  v: RegulatedAuthorization.statusDate
short:
  v: The date at which the current status was assigned
definition:
  v: The date at which the current status was assigned.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.statusDate
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: dateTime
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Authorization Status Date

id:
  v: RegulatedAuthorization.validityPeriod
path:
  v: RegulatedAuthorization.validityPeriod
short:
  v: The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
definition:
  v: The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.validityPeriod
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End

id:
  v: RegulatedAuthorization.indication
path:
  v: RegulatedAuthorization.indication
short:
  v: Condition for which the use of the regulated product applies
definition:
  v: Condition for which the use of the regulated product applies.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: RegulatedAuthorization.indication
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableReference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition
    link: http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: RegulatedAuthorization.intendedUse
path:
  v: RegulatedAuthorization.intendedUse
short:
  v: The intended use of the product, e.g. prevention, treatment
definition:
  v: The intended use of the product, e.g. prevention, treatment, diagnosis.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: RegulatedAuthorization.intendedUse
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: ProductIntendedUse
  strength:
    v: preferred
  description:
    v: The overall intended use of a product.
  value set:
    v: http://hl7.org/fhir/ValueSet/product-intended-use
    link: http://hl7.org/fhir/ValueSet/product-intended-use
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: RegulatedAuthorization.basis
path:
  v: RegulatedAuthorization.basis
short:
  v: The legal/regulatory framework or reasons under which this authorization is granted
definition:
  v: The legal or regulatory framework against which this authorization is granted, or other reasons for it.
min:
  v: 0
max:
  v: 0
base:
  path:
    v: RegulatedAuthorization.basis
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: RegulatedAuthorizationBasis
  strength:
    v: example
  description:
    v: A legal or regulatory framework against which an authorization is granted, or other reasons for it.
  value set:
    v: http://hl7.org/fhir/ValueSet/regulated-authorization-basis
    link: http://hl7.org/fhir/ValueSet/regulated-authorization-basis
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Status Reasons.Legal Grounds

id:
  v: RegulatedAuthorization.holder
path:
  v: RegulatedAuthorization.holder
short:
  v: The organization that has been granted this authorization, by the regulator
definition:
  v: The organization that has been granted this authorization, by some authoritative body (the 'regulator').
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.holder
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Marketing Authorization Holder (Organisation)

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

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

id:
  v: RegulatedAuthorization.holder.reference
path:
  v: RegulatedAuthorization.holder.reference
short:
  v: Literal reference, Relative, internal or absolute URL
definition:
  v: 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:
  v: 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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.reference
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
condition:
  v: ref-2
condition:
  v: ref-1
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: rim
  map:
    v: N/A

id:
  v: RegulatedAuthorization.holder.type
path:
  v: RegulatedAuthorization.holder.type
short:
  v: Type the reference refers to (e.g. "Patient") - must be a resource in resources
definition:
  v: 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:
  v: 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 known RESTful URL) or by resolving the target of the reference.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: FHIRResourceTypeExt
  strength:
    v: extensible
  description:
    v: Aa resource (or, for logical models, the URI of the logical model).
  value set:
    v: http://hl7.org/fhir/ValueSet/resource-types
    link: http://hl7.org/fhir/ValueSet/resource-types
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: RegulatedAuthorization.holder.identifier
path:
  v: RegulatedAuthorization.holder.identifier
short:
  v: Logical reference, when literal reference is not known
definition:
  v: 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:
  v: 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). This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Reference.identifier
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Identifier
condition:
  v: ref-2
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: rim
  map:
    v: .identifier

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

id:
  v: RegulatedAuthorization.holder.identifier.extension
path:
  v: RegulatedAuthorization.holder.identifier.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: RegulatedAuthorization.holder.identifier.use
path:
  v: RegulatedAuthorization.holder.identifier.use
short:
  v: usual | official | temp | secondary | old (If known)
definition:
  v: The purpose of this identifier.
comment:
  v: Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
requirements:
  v: Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.use
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierUse
  strength:
    v: required
  description:
    v: Identifies the purpose for this identifier, if known .
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: RegulatedAuthorization.holder.identifier.type
path:
  v: RegulatedAuthorization.holder.identifier.type
short:
  v: Description of identifier
definition:
  v: A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
comment:
  v: 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:
  v: Allows users to make use of identifiers when the identifier system is not known.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierType
  strength:
    v: extensible
  description:
    v: A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-type
    link: http://hl7.org/fhir/ValueSet/identifier-type
mapping:
  identity:
    v: v2
  map:
    v: CX.5
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: RegulatedAuthorization.holder.identifier.system
path:
  v: RegulatedAuthorization.holder.identifier.system
short:
  v: The namespace for the identifier value
definition:
  v: Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
comment:
  v: Identifier.system is always case sensitive.
requirements:
  v: 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.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
pattern: uri
  v: http://spor.ema.europa.eu/v1/locations
example:
  label:
    v: General
  value: uri
    v: http://www.acme.com/identifiers/patient
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: CX.4 / EI-2-4
mapping:
  identity:
    v: rim
  map:
    v: II.root or Role.id.root
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierType

id:
  v: RegulatedAuthorization.holder.identifier.value
path:
  v: RegulatedAuthorization.holder.identifier.value
short:
  v: The value that is unique
definition:
  v: The portion of the identifier typically relevant to the user and which is unique within the context of the system.
comment:
  v: 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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-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.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
example:
  label:
    v: General
  value: string
    v: 123456
condition:
  v: ident-1
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: CX.1 / EI.1
mapping:
  identity:
    v: rim
  map:
    v: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
mapping:
  identity:
    v: servd
  map:
    v: ./Value

id:
  v: RegulatedAuthorization.holder.identifier.period
path:
  v: RegulatedAuthorization.holder.identifier.period
short:
  v: Time period when id is/was valid for use
definition:
  v: Time period during which identifier is/was valid for use.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: CX.7 + CX.8
mapping:
  identity:
    v: rim
  map:
    v: Role.effectiveTime or implied by context
mapping:
  identity:
    v: servd
  map:
    v: ./StartDate and ./EndDate

id:
  v: RegulatedAuthorization.holder.identifier.assigner
path:
  v: RegulatedAuthorization.holder.identifier.assigner
short:
  v: Organization that issued id (may be just text)
definition:
  v: Organization that issued/manages the identifier.
comment:
  v: 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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.assigner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / (CX.4,CX.9,CX.10)
mapping:
  identity:
    v: rim
  map:
    v: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierIssuingAuthority

id:
  v: RegulatedAuthorization.holder.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: RegulatedAuthorization.holder.display
short:
  v: Text alternative for the resource
definition:
  v: Plain text narrative that identifies the resource in addition to the resource reference.
comment:
  v: 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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.display
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
condition:
  v: ref-2
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: rim
  map:
    v: N/A

id:
  v: RegulatedAuthorization.regulator
path:
  v: RegulatedAuthorization.regulator
short:
  v: The regulatory authority or authorizing body granting the authorization
definition:
  v: The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.regulator
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Medicines Regulatory Agency (Organisation)

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

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

id:
  v: RegulatedAuthorization.regulator.reference
path:
  v: RegulatedAuthorization.regulator.reference
short:
  v: Literal reference, Relative, internal or absolute URL
definition:
  v: 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:
  v: 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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.reference
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
condition:
  v: ref-2
condition:
  v: ref-1
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: rim
  map:
    v: N/A

id:
  v: RegulatedAuthorization.regulator.type
path:
  v: RegulatedAuthorization.regulator.type
short:
  v: Type the reference refers to (e.g. "Patient") - must be a resource in resources
definition:
  v: 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:
  v: 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 known RESTful URL) or by resolving the target of the reference.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: FHIRResourceTypeExt
  strength:
    v: extensible
  description:
    v: Aa resource (or, for logical models, the URI of the logical model).
  value set:
    v: http://hl7.org/fhir/ValueSet/resource-types
    link: http://hl7.org/fhir/ValueSet/resource-types
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: RegulatedAuthorization.regulator.identifier
path:
  v: RegulatedAuthorization.regulator.identifier
short:
  v: Logical reference, when literal reference is not known
definition:
  v: 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:
  v: 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). This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.identifier
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Identifier
condition:
  v: ref-2
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: rim
  map:
    v: .identifier

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

id:
  v: RegulatedAuthorization.regulator.identifier.extension
path:
  v: RegulatedAuthorization.regulator.identifier.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: RegulatedAuthorization.regulator.identifier.use
path:
  v: RegulatedAuthorization.regulator.identifier.use
short:
  v: usual | official | temp | secondary | old (If known)
definition:
  v: The purpose of this identifier.
comment:
  v: Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
requirements:
  v: Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.use
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: code
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: true
is modifier reason:
  v: This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierUse
  strength:
    v: required
  description:
    v: Identifies the purpose for this identifier, if known .
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    link: 5.0
    link: .0
mapping:
  identity:
    v: v2
  map:
    v: N/A
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: RegulatedAuthorization.regulator.identifier.type
path:
  v: RegulatedAuthorization.regulator.identifier.type
short:
  v: Description of identifier
definition:
  v: A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
comment:
  v: 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:
  v: Allows users to make use of identifiers when the identifier system is not known.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: IdentifierType
  strength:
    v: extensible
  description:
    v: A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
  value set:
    v: http://hl7.org/fhir/ValueSet/identifier-type
    link: http://hl7.org/fhir/ValueSet/identifier-type
mapping:
  identity:
    v: v2
  map:
    v: CX.5
mapping:
  identity:
    v: rim
  map:
    v: Role.code or implied by context

id:
  v: RegulatedAuthorization.regulator.identifier.system
path:
  v: RegulatedAuthorization.regulator.identifier.system
short:
  v: The namespace for the identifier value
definition:
  v: Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
comment:
  v: Identifier.system is always case sensitive.
requirements:
  v: 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.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.system
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: uri
pattern: uri
  v: http://spor.ema.europa.eu/v1/locations
example:
  label:
    v: General
  value: uri
    v: http://www.acme.com/identifiers/patient
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: CX.4 / EI-2-4
mapping:
  identity:
    v: rim
  map:
    v: II.root or Role.id.root
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierType

id:
  v: RegulatedAuthorization.regulator.identifier.value
path:
  v: RegulatedAuthorization.regulator.identifier.value
short:
  v: The value that is unique
definition:
  v: The portion of the identifier typically relevant to the user and which is unique within the context of the system.
comment:
  v: 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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-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.
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Identifier.value
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
example:
  label:
    v: General
  value: string
    v: 123456
condition:
  v: ident-1
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: CX.1 / EI.1
mapping:
  identity:
    v: rim
  map:
    v: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
mapping:
  identity:
    v: servd
  map:
    v: ./Value

id:
  v: RegulatedAuthorization.regulator.identifier.period
path:
  v: RegulatedAuthorization.regulator.identifier.period
short:
  v: Time period when id is/was valid for use
definition:
  v: Time period during which identifier is/was valid for use.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.period
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Period
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: CX.7 + CX.8
mapping:
  identity:
    v: rim
  map:
    v: Role.effectiveTime or implied by context
mapping:
  identity:
    v: servd
  map:
    v: ./StartDate and ./EndDate

id:
  v: RegulatedAuthorization.regulator.identifier.assigner
path:
  v: RegulatedAuthorization.regulator.identifier.assigner
short:
  v: Organization that issued id (may be just text)
definition:
  v: Organization that issued/manages the identifier.
comment:
  v: 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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Identifier.assigner
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/Organization
    link: http://hl7.org/fhir/StructureDefinition/Organization
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: v2
  map:
    v: CX.4 / (CX.4,CX.9,CX.10)
mapping:
  identity:
    v: rim
  map:
    v: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
mapping:
  identity:
    v: servd
  map:
    v: ./IdentifierIssuingAuthority

id:
  v: RegulatedAuthorization.regulator.display
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable
  value: boolean
    v: true
path:
  v: RegulatedAuthorization.regulator.display
short:
  v: Text alternative for the resource
definition:
  v: Plain text narrative that identifies the resource in addition to the resource reference.
comment:
  v: 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.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Reference.display
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
condition:
  v: ref-2
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: rim
  map:
    v: N/A

id:
  v: RegulatedAuthorization.attachedDocument
path:
  v: RegulatedAuthorization.attachedDocument
short:
  v: Additional information or supporting documentation about the authorization
definition:
  v: Additional information or supporting documentation about the authorization.
min:
  v: 0
max:
  v: *
base:
  path:
    v: RegulatedAuthorization.attachedDocument
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Reference
  target profile:
    v: http://hl7.org/fhir/StructureDefinition/DocumentReference
    link: http://hl7.org/fhir/StructureDefinition/DocumentReference
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: RegulatedAuthorization.case
path:
  v: RegulatedAuthorization.case
short:
  v: The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
definition:
  v: The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.case
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: BackboneElement
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application

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

id:
  v: RegulatedAuthorization.case.extension
path:
  v: RegulatedAuthorization.case.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
min:
  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: RegulatedAuthorization.case.modifierExtension
path:
  v: RegulatedAuthorization.case.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
alias:
  v: extensions
alias:
  v: user content
alias:
  v: modifiers
min:
  v: 0
max:
  v: *
base:
  path:
    v: BackboneElement.modifierExtension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
constraint:
  key:
    v: ext-1
  severity:
    v: error
  human:
    v: Must have either extensions or value[x], not both
  expression:
    v: extension.exists() != value.exists()
  source:
    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
is modifier:
  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: RegulatedAuthorization.case.identifier
path:
  v: RegulatedAuthorization.case.identifier
short:
  v: Identifier by which this case can be referenced
definition:
  v: Identifier by which this case can be referenced.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.case.identifier
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: Identifier
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number

id:
  v: RegulatedAuthorization.case.type
path:
  v: RegulatedAuthorization.case.type
short:
  v: The defining type of case
definition:
  v: The defining type of case.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.case.type
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: RegulatedAuthorizationCaseType
  strength:
    v: example
  description:
    v: The type of a case involved in an application.
  value set:
    v: http://hl7.org/fhir/ValueSet/regulated-authorization-case-type
    link: http://hl7.org/fhir/ValueSet/regulated-authorization-case-type
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type

id:
  v: RegulatedAuthorization.case.status
path:
  v: RegulatedAuthorization.case.status
short:
  v: The status associated with the case
definition:
  v: The status associated with the case.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.case.status
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: PublicationStatus
  strength:
    v: preferred
  description:
    v: The lifecycle status of an artifact.
  value set:
    v: http://hl7.org/fhir/ValueSet/publication-status
    link: http://hl7.org/fhir/ValueSet/publication-status
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: RegulatedAuthorization.case.date[x]
path:
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slicing:
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    path:
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short:
  v: Relevant date for this case
definition:
  v: Relevant date for this case.
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max:
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base:
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    v: RegulatedAuthorization.case.date[x]
  min:
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type:
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    v: Period
type:
  code:
    v: dateTime
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date

id:
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path:
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type:
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constraint:
  key:
    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date

id:
  v: RegulatedAuthorization.case.application
path:
  v: RegulatedAuthorization.case.application
short:
  v: Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
definition:
  v: A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.
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max:
  v: 1
base:
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    v: 0
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    v: *
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  code:
    v: BackboneElement
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  key:
    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
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    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
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  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Marketing Authorization Application

id:
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path:
  v: RegulatedAuthorization.case.application.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
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    v: 0
  max:
    v: 1
type:
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    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
    value: url
      v: string
  code:
    v: http://hl7.org/fhirpath/System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
  v: RegulatedAuthorization.case.application.extension
path:
  v: RegulatedAuthorization.case.application.extension
short:
  v: Additional content defined by implementations
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
alias:
  v: extensions
alias:
  v: user content
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  v: 0
max:
  v: *
base:
  path:
    v: Element.extension
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    v: 0
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    v: Extension
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  key:
    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
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  key:
    v: ext-1
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    v: error
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    v: Must have either extensions or value[x], not both
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    link: http://hl7.org/fhir/StructureDefinition/Extension
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  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
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path:
  v: RegulatedAuthorization.case.application.modifierExtension
short:
  v: Extensions that cannot be ignored even if unrecognized
definition:
  v: May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
comment:
  v: There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
requirements:
  v: Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).
alias:
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alias:
  v: user content
alias:
  v: modifiers
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  v: 0
max:
  v: *
base:
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    v: *
type:
  code:
    v: Extension
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
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  key:
    v: ext-1
  severity:
    v: error
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    v: Must have either extensions or value[x], not both
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    v: extension.exists() != value.exists()
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    v: http://hl7.org/fhir/StructureDefinition/Extension
    link: http://hl7.org/fhir/StructureDefinition/Extension
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  v: true
is modifier reason:
  v: Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: RegulatedAuthorization.case.application.identifier
path:
  v: RegulatedAuthorization.case.application.identifier
short:
  v: Identifier by which this case can be referenced
definition:
  v: Identifier by which this case can be referenced.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: RegulatedAuthorization.case.identifier
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    v: 0
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    v: 1
type:
  code:
    v: Identifier
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaApplicationIdentifierNumber
    link: http://ema.europa.eu/fhir/StructureDefinition/emaApplicationIdentifierNumber
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number

id:
  v: RegulatedAuthorization.case.application.type
path:
  v: RegulatedAuthorization.case.application.type
short:
  v: The defining type of case
definition:
  v: The defining type of case.
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  v: 0
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  v: 1
base:
  path:
    v: RegulatedAuthorization.case.type
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    v: 1
type:
  code:
    v: CodeableConcept
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://ema.europa.eu/fhir/vs/applicationSubmissionType
    link: http://ema.europa.eu/fhir/vs/applicationSubmissionType
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type

id:
  v: RegulatedAuthorization.case.application.status
path:
  v: RegulatedAuthorization.case.application.status
short:
  v: The status associated with the case
definition:
  v: The status associated with the case.
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  v: 0
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  v: 1
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    v: RegulatedAuthorization.case.status
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type:
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    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
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    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
is modifier:
  v: false
is summary:
  v: true
binding:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName
    value: string
      v: PublicationStatus
  strength:
    v: preferred
  description:
    v: The lifecycle status of an artifact.
  value set:
    v: http://hl7.org/fhir/ValueSet/publication-status
    link: http://hl7.org/fhir/ValueSet/publication-status
mapping:
  identity:
    v: idmp
  map:
    v: n/a

id:
  v: RegulatedAuthorization.case.application.date[x]
path:
  v: RegulatedAuthorization.case.application.date[x]
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      v: type
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definition:
  v: Relevant date for this case.
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base:
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type:
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    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
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    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
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  v: false
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  v: false
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    v: idmp
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    v: Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date

id:
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  v: Relevant date for this case
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type:
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    v: ele-1
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    v: error
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    v: All FHIR elements must have a @value or children
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    v: hasValue() or (children().count() > id.count())
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    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
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  v: false
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  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
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    v: Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date

id:
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path:
  v: RegulatedAuthorization.case.application.application
short:
  v: Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
definition:
  v: A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.
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content reference:
  v: http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization#RegulatedAuthorization.case
constraint:
  key:
    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    link: http://hl7.org/fhir/StructureDefinition/Element
must support:
  v: false
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  v: false
is summary:
  v: true
mapping:
  identity:
    v: idmp
  map:
    v: Marketing Authorization.Marketing Authorization Application

element:
  id:
    v: RegulatedAuthorization
  path:
    v: RegulatedAuthorization
  constraint:
    key:
      v: regulatorIsMandatoryIfManufacturingIdentifierExists
    severity:
      v: error
    human:
      v: If there is a Manufacturing Identifier, then the regulator is mandatory
    expression:
      v: (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists()
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: validityPeriodIsMandatoryIfManufacturingIdentifierExists
    severity:
      v: error
    human:
      v: If there is a Manufacturing Identifier, then the validity period is mandatory
    expression:
      v: (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: regionIsEmptyForManAuth
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.
    expression:
      v: (type.coding.exists(code = '200000051585')) implies (region.empty())
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: statusDateIsEmptyForManAuth
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization.
    expression:
      v: (type.coding.exists(code = '200000051585')) implies (statusDate.empty())
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: holderIsEmptyForManAuth
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.
    expression:
      v: (type.coding.exists(code = '200000051585')) implies (holder.empty())
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: caseIsEmptyForManAuth
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.
    expression:
      v: (type.coding.exists(code = '200000051585')) implies (case.empty())
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: extensionIsEmptyForManAuth
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
    expression:
      v: (type.coding.exists(code = '200000051585')) implies (extension.empty())
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: manAuthNumberIsMandatoryForCertainManufacturingActivities
    severity:
      v: error
    human:
      v: The RegulatedAuthorization's Manufacturing Authorization Number identifier is mandatory when the subject references an ActivityDefinition whose code is among the following ones: 100000163737, 100000163709, 100000163618, 100000160477, 100000160476, 100000160464, 100000160463, 100000160462, 100000160461, 100000160460, 100000160459, 100000160458, 100000160457, 100000160456, 100000160414, 100000160413, 100000160412, 100000160411, 100000160410, 100000160409, 100000160408, 100000160407.
    expression:
      v: (subject.resolve().ofType(ActivityDefinition).code.coding.where(code = '100000163737' or code = '100000163709' or code = '100000163618' or code = '100000160477' or code = '100000160476' or code = '100000160464' or code = '100000160463' or code = '100000160462' or code = '100000160461' or code = '100000160460' or code = '100000160459' or code = '100000160458' or code = '100000160457' or code = '100000160456' or code = '100000160414' or code = '100000160413' or code = '100000160412' or code = '100000160411' or code = '100000160410' or code = '100000160409' or code = '100000160408' or code = '100000160407').exists()) implies identifier.where(system = 'http://ema.europa.eu/fhir/manufacturingAuthorizationNumber').exists()
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: marketingAuthorizationNumberIsMandatoryForMarktAuth
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must have the Marketing Authorization Number identifier.
    expression:
      v: (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
    expression:
      v: subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists()
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must have the Date of First Authorisation extension.
    expression:
      v: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists()
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must have the International Birth Date extension.
    expression:
      v: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: caseIsMandatoryForMarktAuthIfSubjectIsMpd
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
    expression:
      v: subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
  constraint:
    key:
      v: holderIsMandatoryForMarktAuthIfSubjectIsMpd
    severity:
      v: error
    human:
      v: The RegulatedAuthorization must have a holder.
    expression:
      v: subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
    source:
      v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
      link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization
element:
  id:
    v: RegulatedAuthorization.extension
  path:
    v: RegulatedAuthorization.extension
  slicing:
    discriminator:
      type:
        v: value
      path:
        v: url
    ordered:
      v: false
    rules:
      v: open
element:
  id:
    v: RegulatedAuthorization.extension:dateOfFirstAuthorisation
  path:
    v: RegulatedAuthorization.extension
  slice name:
    v: dateOfFirstAuthorisation
  min:
    v: 0
  max:
    v: 1
  type:
    code:
      v: Extension

id:
  v: RegulatedAuthorization.extension:internationalBirthDate
path:
  v: RegulatedAuthorization.extension
slice name:
  v: internationalBirthDate
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Extension
  profile:
    v: http://ema.europa.eu/fhir/extension/internationalBirthDate
    link: http://ema.europa.eu/fhir/extension/internationalBirthDate

id:
  v: RegulatedAuthorization.identifier
path:
  v: RegulatedAuthorization.identifier
slicing:
  discriminator:
    type:
      v: value
    path:
      v: system
  description:
    v: Slice based on the system of the identifier
  rules:
    v: open
max:
  v: 2

id:
  v: RegulatedAuthorization.identifier:marketingAuthorizationIdentifier
path:
  v: RegulatedAuthorization.identifier
slice name:
  v: marketingAuthorizationIdentifier
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Identifier
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaMarketingAuthorizationIdentifier
    link: http://ema.europa.eu/fhir/StructureDefinition/emaMarketingAuthorizationIdentifier

id:
  v: RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.system
path:
  v: RegulatedAuthorization.identifier.system
min:
  v: 1
pattern: uri
  v: http://ema.europa.eu/fhir/MarketingAuthorizationNumber

id:
  v: RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier
path:
  v: RegulatedAuthorization.identifier
slice name:
  v: manufacturingAuthorizationNumberIdentifier
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Identifier
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaManufacturingAuthNumberIdentifier
    link: http://ema.europa.eu/fhir/StructureDefinition/emaManufacturingAuthNumberIdentifier

id:
  v: RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.system
path:
  v: RegulatedAuthorization.identifier.system
min:
  v: 1
pattern: uri
  v: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber

id:
  v: RegulatedAuthorization.identifier:eudraGmpNumberIdentifier
path:
  v: RegulatedAuthorization.identifier
slice name:
  v: eudraGmpNumberIdentifier
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Identifier
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaEudraGmpNumberIdentifier
    link: http://ema.europa.eu/fhir/StructureDefinition/emaEudraGmpNumberIdentifier

id:
  v: RegulatedAuthorization.identifier:eudraGmpNumberIdentifier.system
path:
  v: RegulatedAuthorization.identifier.system
min:
  v: 1
pattern: uri
  v: http://ema.europa.eu/fhir/eudraGmpNumber

id:
  v: RegulatedAuthorization.subject
path:
  v: RegulatedAuthorization.subject
min:
  v: 1
max:
  v: 1
type:
  code:
    v: Reference
  target profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition
    link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition
  target profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiPackagedProductDefinition
    link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiPackagedProductDefinition
  target profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition
    link: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition

id:
  v: RegulatedAuthorization.type
path:
  v: RegulatedAuthorization.type
min:
  v: 1
type:
  code:
    v: CodeableConcept
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept
    link: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept
binding:
  strength:
    v: required
  value set:
    v: http://ema.europa.eu/fhir/vs/regulatoryEntitlementType
    link: http://ema.europa.eu/fhir/vs/regulatoryEntitlementType

id:
  v: RegulatedAuthorization.type.coding
path:
  v: RegulatedAuthorization.type.coding
binding:
  strength:
    v: required
  value set:
    v: http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes
    link: http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes

id:
  v: RegulatedAuthorization.status
path:
  v: RegulatedAuthorization.status
min:
  v: 1
type:
  code:
    v: CodeableConcept
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept
    link: http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept
binding:
  strength:
    v: required
  value set:
    v: http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
    link: http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus

id:
  v: RegulatedAuthorization.holder.identifier
path:
  v: RegulatedAuthorization.holder.identifier
min:
  v: 1

id:
  v: RegulatedAuthorization.holder.identifier.system
path:
  v: RegulatedAuthorization.holder.identifier.system
min:
  v: 1
pattern: uri
  v: http://spor.ema.europa.eu/v1/locations

id:
  v: RegulatedAuthorization.holder.identifier.value
path:
  v: RegulatedAuthorization.holder.identifier.value
min:
  v: 1

id:
  v: RegulatedAuthorization.regulator.identifier.system
path:
  v: RegulatedAuthorization.regulator.identifier.system
min:
  v: 1
pattern: uri
  v: http://spor.ema.europa.eu/v1/locations

id:
  v: RegulatedAuthorization.regulator.identifier.value
path:
  v: RegulatedAuthorization.regulator.identifier.value
min:
  v: 1

id:
  v: RegulatedAuthorization.case.date[x]
path:
  v: RegulatedAuthorization.case.date[x]
slicing:
  discriminator:
    type:
      v: type
    path:
      v: $this
  ordered:
    v: false
  rules:
    v: open

id:
  v: RegulatedAuthorization.case.date[x]:datePeriod
path:
  v: RegulatedAuthorization.case.date[x]
slice name:
  v: datePeriod
min:
  v: 0
max:
  v: 1
type:
  code:
    v: Period

id:
  v: RegulatedAuthorization.case.application
path:
  v: RegulatedAuthorization.case.application
max:
  v: 1
type:
  code:
    v: BackboneElement

id:
  v: RegulatedAuthorization.case.application.identifier
path:
  v: RegulatedAuthorization.case.application.identifier
type:
  code:
    v: Identifier
  profile:
    v: http://ema.europa.eu/fhir/StructureDefinition/emaApplicationIdentifierNumber
    link: http://ema.europa.eu/fhir/StructureDefinition/emaApplicationIdentifierNumber

id:
  v: RegulatedAuthorization.case.application.type
path:
  v: RegulatedAuthorization.case.application.type
binding:
  strength:
    v: required
  value set:
    v: http://ema.europa.eu/fhir/vs/applicationSubmissionType
    link: http://ema.europa.eu/fhir/vs/applicationSubmissionType

id:
  v: RegulatedAuthorization.case.application.date[x]
path:
  v: RegulatedAuthorization.case.application.date[x]
slicing:
  discriminator:
    type:
      v: type
    path:
      v: $this
  ordered:
    v: false
  rules:
    v: open
min:
  v: 1

id:
  v: RegulatedAuthorization.case.application.date[x]:dateDateTime
path:
  v: RegulatedAuthorization.case.application.date[x]
slice name:
  v: dateDateTime
min:
  v: 1
max:
  v: 1
type:
  code:
    v: dateTime