EMA Write PMS API Implementation Guide - Enrichments
1.2.0 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EMA Write API Regulated Authorization

Official URL: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiRegulatedAuthorization Version: 1.2.0
Draft as of 2025-08-08 Computable Name: EmaWriteApiRegulatedAuthorization

Defines the rules a Marketing or Manufacturing RegulatedAuthorization resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 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
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
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 Manufacturing Authorization.
extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier.
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension.
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension.
caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder.
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... extension:dateOfFirstAuthorisation 0..1 date Regulated Authorization - Date of First Authorisation
URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... extension:internationalBirthDate 0..1 date Regulated Authorization - International Birth Date
URL: http://ema.europa.eu/fhir/extension/internationalBirthDate
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... Slices for identifier Σ 0..2 Identifier Business identifier for the authorization, typically assigned by the authorizing body
Slice: Unordered, Open by value:system
ele-1: All FHIR elements must have a @value or children
.... identifier:marketingAuthorizationIdentifier Σ 0..1 EmaMarketingAuthorizationIdentifier Business identifier for the authorization, typically assigned by the authorizing body
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/MarketingAuthorizationNumber
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
.... identifier:manufacturingAuthorizationNumberIdentifier Σ 0..1 EmaManufacturingAuthNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
.... identifier:eudraGmpNumberIdentifier Σ 0..1 EmaEudraGmpNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/eudraGmpNumber
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
... subject Σ 1..1 Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) The product type, treatment, facility or activity that is being authorized
ele-1: All FHIR elements must have a @value or children
.... extension 0..0
.... coding Σ 1..1 EmaCoding Code defined by a terminology system
Binding: Marketing and Manufacturing types (required)
ele-1: All FHIR elements must have a @value or children
... status Σ 1..1 EmaRefTermCodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
Binding: Regulatory Entitlement Status (required)
ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
RegulatedAuthorization.typerequiredRegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementType
from this IG
RegulatedAuthorization.type.codingrequiredMarketingAndManufacturingTypesVs
http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes
from this IG
RegulatedAuthorization.statusrequiredRegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
from this IG

Constraints

IdGradePath(s)DetailsRequirements
caseIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the Date of First Authorisation extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists()
extensionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a holder.
: subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the International Birth Date extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marketingAuthorizationNumberIsMandatoryForMarktAutherrorRegulatedAuthorizationThe RegulatedAuthorization must have the Marketing Authorization Number identifier.
: (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (region.empty())
regulatorIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the regulator is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists()
statusDateIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (statusDate.empty())
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the validity period is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

This structure is derived from EmaWriteApiRegulatedAuthorizationRestrictions

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 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 Manufacturing Authorization.
extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier.
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension.
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension.
caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder.
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:dateOfFirstAuthorisation 0..1 date Regulated Authorization - Date of First Authorisation
URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
.... extension:internationalBirthDate 0..1 date Regulated Authorization - International Birth Date
URL: http://ema.europa.eu/fhir/extension/internationalBirthDate
... Slices for identifier 0..2 Identifier Business identifier for the authorization, typically assigned by the authorizing body
Slice: Unordered, Open by value:system
.... identifier:marketingAuthorizationIdentifier 0..1 EmaMarketingAuthorizationIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/MarketingAuthorizationNumber
.... identifier:manufacturingAuthorizationNumberIdentifier 0..1 EmaManufacturingAuthNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber
.... identifier:eudraGmpNumberIdentifier 0..1 EmaEudraGmpNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/eudraGmpNumber
... subject 1..1 Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) The product type, treatment, facility or activity that is being authorized
.... coding 1..1 EmaCoding Code defined by a terminology system
Binding: Marketing and Manufacturing types (required)
... status 1..1 EmaRefTermCodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
Binding: Regulatory Entitlement Status (required)
... holder
.... identifier 1..1 Identifier Logical reference, when literal reference is not known
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
..... value 1..1 string The value that is unique
... regulator
.... identifier
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
..... value 1..1 string The value that is unique
... case
.... Slices for date[x] 0..1 Period, dateTime Relevant date for this case
Slice: Unordered, Open by type:$this
..... date[x]:datePeriod 0..1 Period Relevant date for this case
.... application 0..1 BackboneElement Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
..... identifier 0..1 EmaApplicationIdentifierNumber Identifier by which this case can be referenced
..... type 0..1 CodeableConcept The defining type of case
Binding: Application Submission Type (required)
..... Slices for date[x] 1..1 dateTime Relevant date for this case
Slice: Unordered, Open by type:$this
...... date[x]:dateDateTime 1..1 dateTime Relevant date for this case

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
RegulatedAuthorization.typerequiredRegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementType
from this IG
RegulatedAuthorization.type.codingrequiredMarketingAndManufacturingTypesVs
http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes
from this IG
RegulatedAuthorization.statusrequiredRegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
from this IG
RegulatedAuthorization.case.application.typerequiredApplicationSubmissionTypeVs (a valid code from Application Submission Type)
http://ema.europa.eu/fhir/vs/applicationSubmissionType
from this IG

Constraints

IdGradePath(s)DetailsRequirements
caseIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the Date of First Authorisation extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists()
extensionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a holder.
: subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the International Birth Date extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marketingAuthorizationNumberIsMandatoryForMarktAutherrorRegulatedAuthorizationThe RegulatedAuthorization must have the Marketing Authorization Number identifier.
: (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (region.empty())
regulatorIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the regulator is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists()
statusDateIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (statusDate.empty())
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the validity period is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 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 Manufacturing Authorization.
extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier.
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension.
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension.
caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder.
... id Σ 0..1 id Logical id of this artifact
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:dateOfFirstAuthorisation 0..1 date Regulated Authorization - Date of First Authorisation
URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
.... extension:internationalBirthDate 0..1 date Regulated Authorization - International Birth Date
URL: http://ema.europa.eu/fhir/extension/internationalBirthDate
... Slices for identifier Σ 0..2 Identifier Business identifier for the authorization, typically assigned by the authorizing body
Slice: Unordered, Open by value:system
.... identifier:marketingAuthorizationIdentifier Σ 0..1 EmaMarketingAuthorizationIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/MarketingAuthorizationNumber
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:manufacturingAuthorizationNumberIdentifier Σ 0..1 EmaManufacturingAuthNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:eudraGmpNumberIdentifier Σ 0..1 EmaEudraGmpNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/eudraGmpNumber
..... value ΣC 1..1 string The value that is unique
Example General: 123456
... type Σ 1..1 EmaRefTermCodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: Regulatory Entitlement Type (required)
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..0
.... coding Σ 1..1 EmaCoding Code defined by a terminology system
Binding: Marketing and Manufacturing types (required)
... region Σ 0..* CodeableConcept The territory in which the authorization has been granted
Binding: JurisdictionValueSet (example): Jurisdiction codes


... status Σ 1..1 EmaRefTermCodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
Binding: Regulatory Entitlement Status (required)
... statusDate Σ 0..1 dateTime The date at which the current status was assigned
... validityPeriod Σ 0..1 Period 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
... holder Σ 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... display ΣC 0..1 string Text alternative for the resource
... regulator Σ 0..1 Reference(Organization) The regulatory authority or authorizing body granting the authorization
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 0..1 Identifier Logical reference, when literal reference is not known
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... display ΣC 0..1 string Text alternative for the resource
... attachedDocument Σ 0..* Reference(DocumentReference) Additional information or supporting documentation about the authorization
... case Σ 0..1 BackboneElement 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)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..1 Identifier Identifier by which this case can be referenced
.... type Σ 0..1 CodeableConcept The defining type of case
Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.

.... status Σ 0..1 CodeableConcept The status associated with the case
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... Slices for date[x] Σ 0..1 Relevant date for this case
Slice: Unordered, Open by type:$this
..... datePeriod Period
..... dateDateTime dateTime
..... date[x]:datePeriod Σ 0..1 Period Relevant date for this case
.... application Σ 0..1 BackboneElement Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... identifier Σ 0..1 EmaApplicationIdentifierNumber Identifier by which this case can be referenced
..... type Σ 0..1 CodeableConcept The defining type of case
Binding: Application Submission Type (required)
..... status Σ 0..1 CodeableConcept The status associated with the case
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... Slices for date[x] Σ 1..1 dateTime Relevant date for this case
Slice: Unordered, Closed by type:$this
...... date[x]:dateDateTime Σ 1..1 dateTime Relevant date for this case
..... application Σ 0..* See case (RegulatedAuthorization) Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
RegulatedAuthorization.typerequiredRegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementType
from this IG
RegulatedAuthorization.type.codingrequiredMarketingAndManufacturingTypesVs
http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes
from this IG
RegulatedAuthorization.regionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
RegulatedAuthorization.statusrequiredRegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
from this IG
RegulatedAuthorization.holder.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
RegulatedAuthorization.holder.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
RegulatedAuthorization.holder.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
RegulatedAuthorization.regulator.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
RegulatedAuthorization.regulator.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
RegulatedAuthorization.regulator.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
RegulatedAuthorization.case.typeexampleRegulatedAuthorizationCaseType
http://hl7.org/fhir/ValueSet/regulated-authorization-case-type
from the FHIR Standard
RegulatedAuthorization.case.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
RegulatedAuthorization.case.application.typerequiredApplicationSubmissionTypeVs (a valid code from Application Submission Type)
http://ema.europa.eu/fhir/vs/applicationSubmissionType
from this IG
RegulatedAuthorization.case.application.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
caseIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the Date of First Authorisation extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists()
extensionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a holder.
: subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the International Birth Date extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marketingAuthorizationNumberIsMandatoryForMarktAutherrorRegulatedAuthorizationThe RegulatedAuthorization must have the Marketing Authorization Number identifier.
: (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (region.empty())
regulatorIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the regulator is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists()
statusDateIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (statusDate.empty())
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the validity period is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

This structure is derived from EmaWriteApiRegulatedAuthorizationRestrictions

Summary

Mandatory: 3 elements(10 nested mandatory elements)

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of RegulatedAuthorization.identifier
  • The element 1 is sliced based on the value of RegulatedAuthorization.case.date[x]
  • The element 1 is sliced based on the value of RegulatedAuthorization.case.application.date[x]

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 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
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
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 Manufacturing Authorization.
extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier.
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension.
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension.
caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder.
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... extension:dateOfFirstAuthorisation 0..1 date Regulated Authorization - Date of First Authorisation
URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... extension:internationalBirthDate 0..1 date Regulated Authorization - International Birth Date
URL: http://ema.europa.eu/fhir/extension/internationalBirthDate
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... Slices for identifier Σ 0..2 Identifier Business identifier for the authorization, typically assigned by the authorizing body
Slice: Unordered, Open by value:system
ele-1: All FHIR elements must have a @value or children
.... identifier:marketingAuthorizationIdentifier Σ 0..1 EmaMarketingAuthorizationIdentifier Business identifier for the authorization, typically assigned by the authorizing body
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/MarketingAuthorizationNumber
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
.... identifier:manufacturingAuthorizationNumberIdentifier Σ 0..1 EmaManufacturingAuthNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
.... identifier:eudraGmpNumberIdentifier Σ 0..1 EmaEudraGmpNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/eudraGmpNumber
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
... subject Σ 1..1 Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) The product type, treatment, facility or activity that is being authorized
ele-1: All FHIR elements must have a @value or children
.... extension 0..0
.... coding Σ 1..1 EmaCoding Code defined by a terminology system
Binding: Marketing and Manufacturing types (required)
ele-1: All FHIR elements must have a @value or children
... status Σ 1..1 EmaRefTermCodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
Binding: Regulatory Entitlement Status (required)
ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
RegulatedAuthorization.typerequiredRegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementType
from this IG
RegulatedAuthorization.type.codingrequiredMarketingAndManufacturingTypesVs
http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes
from this IG
RegulatedAuthorization.statusrequiredRegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
from this IG

Constraints

IdGradePath(s)DetailsRequirements
caseIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the Date of First Authorisation extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists()
extensionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a holder.
: subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the International Birth Date extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marketingAuthorizationNumberIsMandatoryForMarktAutherrorRegulatedAuthorizationThe RegulatedAuthorization must have the Marketing Authorization Number identifier.
: (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (region.empty())
regulatorIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the regulator is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists()
statusDateIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (statusDate.empty())
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the validity period is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

Differential View

This structure is derived from EmaWriteApiRegulatedAuthorizationRestrictions

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 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 Manufacturing Authorization.
extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier.
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension.
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension.
caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder.
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:dateOfFirstAuthorisation 0..1 date Regulated Authorization - Date of First Authorisation
URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
.... extension:internationalBirthDate 0..1 date Regulated Authorization - International Birth Date
URL: http://ema.europa.eu/fhir/extension/internationalBirthDate
... Slices for identifier 0..2 Identifier Business identifier for the authorization, typically assigned by the authorizing body
Slice: Unordered, Open by value:system
.... identifier:marketingAuthorizationIdentifier 0..1 EmaMarketingAuthorizationIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/MarketingAuthorizationNumber
.... identifier:manufacturingAuthorizationNumberIdentifier 0..1 EmaManufacturingAuthNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber
.... identifier:eudraGmpNumberIdentifier 0..1 EmaEudraGmpNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/eudraGmpNumber
... subject 1..1 Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) The product type, treatment, facility or activity that is being authorized
.... coding 1..1 EmaCoding Code defined by a terminology system
Binding: Marketing and Manufacturing types (required)
... status 1..1 EmaRefTermCodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
Binding: Regulatory Entitlement Status (required)
... holder
.... identifier 1..1 Identifier Logical reference, when literal reference is not known
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
..... value 1..1 string The value that is unique
... regulator
.... identifier
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
..... value 1..1 string The value that is unique
... case
.... Slices for date[x] 0..1 Period, dateTime Relevant date for this case
Slice: Unordered, Open by type:$this
..... date[x]:datePeriod 0..1 Period Relevant date for this case
.... application 0..1 BackboneElement Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
..... identifier 0..1 EmaApplicationIdentifierNumber Identifier by which this case can be referenced
..... type 0..1 CodeableConcept The defining type of case
Binding: Application Submission Type (required)
..... Slices for date[x] 1..1 dateTime Relevant date for this case
Slice: Unordered, Open by type:$this
...... date[x]:dateDateTime 1..1 dateTime Relevant date for this case

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
RegulatedAuthorization.typerequiredRegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementType
from this IG
RegulatedAuthorization.type.codingrequiredMarketingAndManufacturingTypesVs
http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes
from this IG
RegulatedAuthorization.statusrequiredRegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
from this IG
RegulatedAuthorization.case.application.typerequiredApplicationSubmissionTypeVs (a valid code from Application Submission Type)
http://ema.europa.eu/fhir/vs/applicationSubmissionType
from this IG

Constraints

IdGradePath(s)DetailsRequirements
caseIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the Date of First Authorisation extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists()
extensionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a holder.
: subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the International Birth Date extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marketingAuthorizationNumberIsMandatoryForMarktAutherrorRegulatedAuthorizationThe RegulatedAuthorization must have the Marketing Authorization Number identifier.
: (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (region.empty())
regulatorIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the regulator is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists()
statusDateIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (statusDate.empty())
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the validity period is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization 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 Manufacturing Authorization.
extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier.
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension.
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension.
caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder.
... id Σ 0..1 id Logical id of this artifact
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:dateOfFirstAuthorisation 0..1 date Regulated Authorization - Date of First Authorisation
URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
.... extension:internationalBirthDate 0..1 date Regulated Authorization - International Birth Date
URL: http://ema.europa.eu/fhir/extension/internationalBirthDate
... Slices for identifier Σ 0..2 Identifier Business identifier for the authorization, typically assigned by the authorizing body
Slice: Unordered, Open by value:system
.... identifier:marketingAuthorizationIdentifier Σ 0..1 EmaMarketingAuthorizationIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/MarketingAuthorizationNumber
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:manufacturingAuthorizationNumberIdentifier Σ 0..1 EmaManufacturingAuthNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:eudraGmpNumberIdentifier Σ 0..1 EmaEudraGmpNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/eudraGmpNumber
..... value ΣC 1..1 string The value that is unique
Example General: 123456
... type Σ 1..1 EmaRefTermCodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: Regulatory Entitlement Type (required)
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..0
.... coding Σ 1..1 EmaCoding Code defined by a terminology system
Binding: Marketing and Manufacturing types (required)
... region Σ 0..* CodeableConcept The territory in which the authorization has been granted
Binding: JurisdictionValueSet (example): Jurisdiction codes


... status Σ 1..1 EmaRefTermCodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
Binding: Regulatory Entitlement Status (required)
... statusDate Σ 0..1 dateTime The date at which the current status was assigned
... validityPeriod Σ 0..1 Period 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
... holder Σ 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... display ΣC 0..1 string Text alternative for the resource
... regulator Σ 0..1 Reference(Organization) The regulatory authority or authorizing body granting the authorization
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
.... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier ΣC 0..1 Identifier Logical reference, when literal reference is not known
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

..... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://spor.ema.europa.eu/v1/locations
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... display ΣC 0..1 string Text alternative for the resource
... attachedDocument Σ 0..* Reference(DocumentReference) Additional information or supporting documentation about the authorization
... case Σ 0..1 BackboneElement 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)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..1 Identifier Identifier by which this case can be referenced
.... type Σ 0..1 CodeableConcept The defining type of case
Binding: RegulatedAuthorizationCaseType (example): The type of a case involved in an application.

.... status Σ 0..1 CodeableConcept The status associated with the case
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

.... Slices for date[x] Σ 0..1 Relevant date for this case
Slice: Unordered, Open by type:$this
..... datePeriod Period
..... dateDateTime dateTime
..... date[x]:datePeriod Σ 0..1 Period Relevant date for this case
.... application Σ 0..1 BackboneElement Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... identifier Σ 0..1 EmaApplicationIdentifierNumber Identifier by which this case can be referenced
..... type Σ 0..1 CodeableConcept The defining type of case
Binding: Application Submission Type (required)
..... status Σ 0..1 CodeableConcept The status associated with the case
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

..... Slices for date[x] Σ 1..1 dateTime Relevant date for this case
Slice: Unordered, Closed by type:$this
...... date[x]:dateDateTime Σ 1..1 dateTime Relevant date for this case
..... application Σ 0..* See case (RegulatedAuthorization) Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
RegulatedAuthorization.typerequiredRegulatoryEntitlementTypeVs (a valid code from Regulatory Entitlement)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementType
from this IG
RegulatedAuthorization.type.codingrequiredMarketingAndManufacturingTypesVs
http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes
from this IG
RegulatedAuthorization.regionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
RegulatedAuthorization.statusrequiredRegulatoryEntitlementStatusVs (a valid code from Regulatory Entitlement Status)
http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus
from this IG
RegulatedAuthorization.holder.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
RegulatedAuthorization.holder.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
RegulatedAuthorization.holder.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
RegulatedAuthorization.regulator.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
RegulatedAuthorization.regulator.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
RegulatedAuthorization.regulator.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
RegulatedAuthorization.case.typeexampleRegulatedAuthorizationCaseType
http://hl7.org/fhir/ValueSet/regulated-authorization-case-type
from the FHIR Standard
RegulatedAuthorization.case.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
RegulatedAuthorization.case.application.typerequiredApplicationSubmissionTypeVs (a valid code from Application Submission Type)
http://ema.europa.eu/fhir/vs/applicationSubmissionType
from this IG
RegulatedAuthorization.case.application.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
caseIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the Date of First Authorisation extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists()
extensionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a holder.
: subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have the International Birth Date extension.
: subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marketingAuthorizationNumberIsMandatoryForMarktAutherrorRegulatedAuthorizationThe RegulatedAuthorization must have the Marketing Authorization Number identifier.
: (type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (region.empty())
regulatorIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the regulator is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists()
statusDateIsEmptyForManAutherrorRegulatedAuthorizationThe RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization.
: (type.coding.exists(code = '200000051585')) implies (statusDate.empty())
validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpderrorRegulatedAuthorizationThe RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
: subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExistserrorRegulatedAuthorizationIf there is a Manufacturing Identifier, then the validity period is mandatory
: (type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

This structure is derived from EmaWriteApiRegulatedAuthorizationRestrictions

Summary

Mandatory: 3 elements(10 nested mandatory elements)

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of RegulatedAuthorization.identifier
  • The element 1 is sliced based on the value of RegulatedAuthorization.case.date[x]
  • The element 1 is sliced based on the value of RegulatedAuthorization.case.application.date[x]

 

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