Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Constraints: validityPeriodIsMandatoryIfManufacturingIdentifierExists, regionIsEmptyForManAuth, holderIsEmptyForManAuth, caseIsEmptyForManAuth, extensionIsEmptyForManAuth, dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd, interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd, caseIsMandatoryForMarktAuthIfSubjectIsMpd, holderIsMandatoryForMarktAuthIfSubjectIsMpd, validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd, marktAuthNumberIsMandatoryForMarktAuth
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
extension		0..0		Extension Slice: Unordered, Open by value:url
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
extension		0..0		Extension Slice: Unordered, Open by value:url
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
extension		0..0		Extension Slice: Unordered, Open by value:url
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
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
type	Σ	1..1	EmaRefTermCodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required)
extension		0..0		Extension Slice: Unordered, Open by value:url
coding	Σ	1..1	EmaCoding	Code defined by a terminology system Binding: Marketing and Manufacturing types (required)
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)
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
RegulatedAuthorization.​type	Base	required	Regulatory Entitlement Type	📦1.2.1	This IG
RegulatedAuthorization.​type.coding	Base	required	Marketing and Manufacturing types	📦1.2.1	This IG
RegulatedAuthorization.​status	Base	required	Regulatory Entitlement Status	📦1.2.1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
caseIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.	subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The 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()
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	RegulatedAuthorization	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	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()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
extensionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a holder.	subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have the International Birth Date extension.	subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marktAuthNumberIsMandatoryForMarktAuth	error	RegulatedAuthorization	The RegulatedAuthorization must have the Marketing Authorization Number identifier.	(type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (region.empty())
validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.	(type.coding.exists(code = '220000000061' or code = '220000000062') and subject.reference.startsWith('MedicinalProductDefinition/')) implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExists	error	RegulatedAuthorization	If there is a Manufacturing Identifier, then the validity period is mandatory	(type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Constraints: validityPeriodIsMandatoryIfManufacturingIdentifierExists, regionIsEmptyForManAuth, holderIsEmptyForManAuth, caseIsEmptyForManAuth, extensionIsEmptyForManAuth, dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd, interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd, caseIsMandatoryForMarktAuthIfSubjectIsMpd, holderIsMandatoryForMarktAuthIfSubjectIsMpd, validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd, marktAuthNumberIsMandatoryForMarktAuth
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
type		1..1	EmaRefTermCodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required)
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
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
RegulatedAuthorization.​type	Base	required	Regulatory Entitlement Type	📦1.2.1	This IG
RegulatedAuthorization.​type.coding	Base	required	Marketing and Manufacturing types	📦1.2.1	This IG
RegulatedAuthorization.​status	Base	required	Regulatory Entitlement Status	📦1.2.1	This IG
RegulatedAuthorization.​case.application.type	Base	required	Application Submission Type	📦1.2.1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
caseIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.	subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The 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()
extensionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a holder.	subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have the International Birth Date extension.	subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marktAuthNumberIsMandatoryForMarktAuth	error	RegulatedAuthorization	The RegulatedAuthorization must have the Marketing Authorization Number identifier.	(type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (region.empty())
validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.	(type.coding.exists(code = '220000000061' or code = '220000000062') and subject.reference.startsWith('MedicinalProductDefinition/')) implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExists	error	RegulatedAuthorization	If there is a Manufacturing Identifier, then the validity period is mandatory	(type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Constraints: validityPeriodIsMandatoryIfManufacturingIdentifierExists, regionIsEmptyForManAuth, holderIsEmptyForManAuth, caseIsEmptyForManAuth, extensionIsEmptyForManAuth, dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd, interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd, caseIsMandatoryForMarktAuthIfSubjectIsMpd, holderIsMandatoryForMarktAuthIfSubjectIsMpd, validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd, marktAuthNumberIsMandatoryForMarktAuth
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		Extension Slice: Unordered, Open by value:url
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		Extension Slice: Unordered, Open by value:url
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		Extension Slice: Unordered, Open by value:url
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
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
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		Extension Slice: Unordered, Open by value:url
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
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
RegulatedAuthorization.​type	Base	required	Regulatory Entitlement Type	📦1.2.1	This IG
RegulatedAuthorization.​type.coding	Base	required	Marketing and Manufacturing types	📦1.2.1	This IG
RegulatedAuthorization.​region	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
RegulatedAuthorization.​status	Base	required	Regulatory Entitlement Status	📦1.2.1	This IG
RegulatedAuthorization.​holder.type	Base	extensible	Resource Types	📍5.0.0	FHIR Std.
RegulatedAuthorization.​holder.identifier.use	Base	required	IdentifierUse	📍5.0.0	FHIR Std.
RegulatedAuthorization.​holder.identifier.type	Base	extensible	Identifier Type Codes	📍5.0.0	FHIR Std.
RegulatedAuthorization.​regulator.type	Base	extensible	Resource Types	📍5.0.0	FHIR Std.
RegulatedAuthorization.​regulator.identifier.​use	Base	required	IdentifierUse	📍5.0.0	FHIR Std.
RegulatedAuthorization.​regulator.identifier.​type	Base	extensible	Identifier Type Codes	📍5.0.0	FHIR Std.
RegulatedAuthorization.​case.type	Base	example	Regulated Authorization Case Type	📍5.0.0	FHIR Std.
RegulatedAuthorization.​case.status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
RegulatedAuthorization.​case.application.type	Base	required	Application Submission Type	📦1.2.1	This IG
RegulatedAuthorization.​case.application.status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
caseIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.	subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The 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()
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	RegulatedAuthorization	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	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()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
extensionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a holder.	subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have the International Birth Date extension.	subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marktAuthNumberIsMandatoryForMarktAuth	error	RegulatedAuthorization	The RegulatedAuthorization must have the Marketing Authorization Number identifier.	(type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (region.empty())
validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.	(type.coding.exists(code = '220000000061' or code = '220000000062') and subject.reference.startsWith('MedicinalProductDefinition/')) implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExists	error	RegulatedAuthorization	If there is a Manufacturing Identifier, then the validity period is mandatory	(type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

Summary

Mandatory: 3 elements(10 nested mandatory elements)

Structures

This structure refers to these other structures:

• EMA Marketing Authorization Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaMarketingAuthorizationIdentifier)
• EMA Manufacturing Authorization Number Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaManufacturingAuthNumberIdentifier)
• EMA Eudra GMP Number Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaEudraGmpNumberIdentifier)
• EMA Write API MedicinalProductDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition)
• EMA Write API PackagedProductDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiPackagedProductDefinition)
• EMA Write API ActivityDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition)
• EMA Generic ReferentialTerm CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept)
• EMA Application Identifier Number (http://ema.europa.eu/fhir/StructureDefinition/emaApplicationIdentifierNumber)

Extensions

This structure refers to these extensions:

• http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
• http://ema.europa.eu/fhir/extension/internationalBirthDate

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]

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Constraints: validityPeriodIsMandatoryIfManufacturingIdentifierExists, regionIsEmptyForManAuth, holderIsEmptyForManAuth, caseIsEmptyForManAuth, extensionIsEmptyForManAuth, dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd, interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd, caseIsMandatoryForMarktAuthIfSubjectIsMpd, holderIsMandatoryForMarktAuthIfSubjectIsMpd, validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd, marktAuthNumberIsMandatoryForMarktAuth
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
extension		0..0		Extension Slice: Unordered, Open by value:url
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
extension		0..0		Extension Slice: Unordered, Open by value:url
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
extension		0..0		Extension Slice: Unordered, Open by value:url
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
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
type	Σ	1..1	EmaRefTermCodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required)
extension		0..0		Extension Slice: Unordered, Open by value:url
coding	Σ	1..1	EmaCoding	Code defined by a terminology system Binding: Marketing and Manufacturing types (required)
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)
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
RegulatedAuthorization.​type	Base	required	Regulatory Entitlement Type	📦1.2.1	This IG
RegulatedAuthorization.​type.coding	Base	required	Marketing and Manufacturing types	📦1.2.1	This IG
RegulatedAuthorization.​status	Base	required	Regulatory Entitlement Status	📦1.2.1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
caseIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.	subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The 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()
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	RegulatedAuthorization	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	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()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
extensionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a holder.	subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have the International Birth Date extension.	subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marktAuthNumberIsMandatoryForMarktAuth	error	RegulatedAuthorization	The RegulatedAuthorization must have the Marketing Authorization Number identifier.	(type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (region.empty())
validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.	(type.coding.exists(code = '220000000061' or code = '220000000062') and subject.reference.startsWith('MedicinalProductDefinition/')) implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExists	error	RegulatedAuthorization	If there is a Manufacturing Identifier, then the validity period is mandatory	(type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Constraints: validityPeriodIsMandatoryIfManufacturingIdentifierExists, regionIsEmptyForManAuth, holderIsEmptyForManAuth, caseIsEmptyForManAuth, extensionIsEmptyForManAuth, dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd, interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd, caseIsMandatoryForMarktAuthIfSubjectIsMpd, holderIsMandatoryForMarktAuthIfSubjectIsMpd, validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd, marktAuthNumberIsMandatoryForMarktAuth
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
type		1..1	EmaRefTermCodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required)
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
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
RegulatedAuthorization.​type	Base	required	Regulatory Entitlement Type	📦1.2.1	This IG
RegulatedAuthorization.​type.coding	Base	required	Marketing and Manufacturing types	📦1.2.1	This IG
RegulatedAuthorization.​status	Base	required	Regulatory Entitlement Status	📦1.2.1	This IG
RegulatedAuthorization.​case.application.type	Base	required	Application Submission Type	📦1.2.1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
caseIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.	subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The 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()
extensionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a holder.	subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have the International Birth Date extension.	subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marktAuthNumberIsMandatoryForMarktAuth	error	RegulatedAuthorization	The RegulatedAuthorization must have the Marketing Authorization Number identifier.	(type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (region.empty())
validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.	(type.coding.exists(code = '220000000061' or code = '220000000062') and subject.reference.startsWith('MedicinalProductDefinition/')) implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExists	error	RegulatedAuthorization	If there is a Manufacturing Identifier, then the validity period is mandatory	(type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Constraints: validityPeriodIsMandatoryIfManufacturingIdentifierExists, regionIsEmptyForManAuth, holderIsEmptyForManAuth, caseIsEmptyForManAuth, extensionIsEmptyForManAuth, dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd, interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd, caseIsMandatoryForMarktAuthIfSubjectIsMpd, holderIsMandatoryForMarktAuthIfSubjectIsMpd, validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd, marktAuthNumberIsMandatoryForMarktAuth
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		Extension Slice: Unordered, Open by value:url
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		Extension Slice: Unordered, Open by value:url
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		Extension Slice: Unordered, Open by value:url
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
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
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		Extension Slice: Unordered, Open by value:url
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
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
RegulatedAuthorization.​type	Base	required	Regulatory Entitlement Type	📦1.2.1	This IG
RegulatedAuthorization.​type.coding	Base	required	Marketing and Manufacturing types	📦1.2.1	This IG
RegulatedAuthorization.​region	Base	example	Jurisdiction ValueSet	📍5.0.0	FHIR Std.
RegulatedAuthorization.​status	Base	required	Regulatory Entitlement Status	📦1.2.1	This IG
RegulatedAuthorization.​holder.type	Base	extensible	Resource Types	📍5.0.0	FHIR Std.
RegulatedAuthorization.​holder.identifier.use	Base	required	IdentifierUse	📍5.0.0	FHIR Std.
RegulatedAuthorization.​holder.identifier.type	Base	extensible	Identifier Type Codes	📍5.0.0	FHIR Std.
RegulatedAuthorization.​regulator.type	Base	extensible	Resource Types	📍5.0.0	FHIR Std.
RegulatedAuthorization.​regulator.identifier.​use	Base	required	IdentifierUse	📍5.0.0	FHIR Std.
RegulatedAuthorization.​regulator.identifier.​type	Base	extensible	Identifier Type Codes	📍5.0.0	FHIR Std.
RegulatedAuthorization.​case.type	Base	example	Regulated Authorization Case Type	📍5.0.0	FHIR Std.
RegulatedAuthorization.​case.status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.
RegulatedAuthorization.​case.application.type	Base	required	Application Submission Type	📦1.2.1	This IG
RegulatedAuthorization.​case.application.status	Base	preferred	PublicationStatus	📍5.0.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
caseIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (case.empty())
caseIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.	subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
dateOfFirstAuthIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The 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()
dom-2	error	RegulatedAuthorization	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	RegulatedAuthorization	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	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()
dom-4	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	RegulatedAuthorization	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	RegulatedAuthorization	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
extensionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (extension.empty())
holderIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (holder.empty())
holderIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a holder.	subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
interBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have the International Birth Date extension.	subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
marktAuthNumberIsMandatoryForMarktAuth	error	RegulatedAuthorization	The RegulatedAuthorization must have the Marketing Authorization Number identifier.	(type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
regionIsEmptyForManAuth	error	RegulatedAuthorization	The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.	(type.coding.exists(code = '200000051585')) implies (region.empty())
validityPeriodIsMandatoryForMarktAuthAndOrphanAuthIfSubjectIsMpd	error	RegulatedAuthorization	The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.	(type.coding.exists(code = '220000000061' or code = '220000000062') and subject.reference.startsWith('MedicinalProductDefinition/')) implies validityPeriod.exists()
validityPeriodIsMandatoryIfManufacturingIdentifierExists	error	RegulatedAuthorization	If there is a Manufacturing Identifier, then the validity period is mandatory	(type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()

Summary

Mandatory: 3 elements(10 nested mandatory elements)

Structures

This structure refers to these other structures:

• EMA Marketing Authorization Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaMarketingAuthorizationIdentifier)
• EMA Manufacturing Authorization Number Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaManufacturingAuthNumberIdentifier)
• EMA Eudra GMP Number Identifier (http://ema.europa.eu/fhir/StructureDefinition/emaEudraGmpNumberIdentifier)
• EMA Write API MedicinalProductDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition)
• EMA Write API PackagedProductDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiPackagedProductDefinition)
• EMA Write API ActivityDefinition (http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiActivityDefinition)
• EMA Generic ReferentialTerm CodeableConcept (http://ema.europa.eu/fhir/StructureDefinition/emaRefTermCodeableConcept)
• EMA Application Identifier Number (http://ema.europa.eu/fhir/StructureDefinition/emaApplicationIdentifierNumber)

Extensions

This structure refers to these extensions:

• http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation
• http://ema.europa.eu/fhir/extension/internationalBirthDate

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]