Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	IDMP RegulatedAuthorization 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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
subject	Σ	0..*	Reference(IDMP MedicinalProductDefinition | IDMP PackagedProductDefinition | CH IDMP ManufacturedItemDefinition | IDMP Ingredient)	The product type, treatment, facility or activity that is being authorized ele-1: All FHIR elements must have a @value or children
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: CH - Authorisation Type (required) ele-1: All FHIR elements must have a @value or children
Slices for coding	Σ	0..1	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system ele-1: All FHIR elements must have a @value or children
coding:CH	Σ	0..1	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
system	Σ	1..1	uri	Identity of the terminology system ele-1: All FHIR elements must have a @value or children Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
code	ΣC	1..1	code	Symbol in syntax defined by the system ele-1: All FHIR elements must have a @value or children
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: urn:iso:std:iso:3166
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CH
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: CH SMC - Authorisation Status (required) ele-1: All FHIR elements must have a @value or children
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system ele-1: All FHIR elements must have a @value or children
coding:SMC	Σ	0..1	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
system	Σ	1..1	uri	Identity of the terminology system ele-1: All FHIR elements must have a @value or children Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
code	ΣC	1..1	code	Symbol in syntax defined by the system ele-1: All FHIR elements must have a @value or children
coding:FOPH	Σ	0..1	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
system	Σ	1..1	uri	Identity of the terminology system ele-1: All FHIR elements must have a @value or children Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status
code	ΣC	1..1	code	Symbol in syntax defined by the system ele-1: All FHIR elements must have a @value or children
holder	Σ	0..1	Reference(Organization) {c}	The organization that has been granted this authorization, by the regulator ele-1: All FHIR elements must have a @value or children
regulator	Σ	0..1	Reference(Organization) {c}	The regulatory authority or authorizing body granting the authorization ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
RegulatedAuthorization.type	required	ChAuthorisationTypeVS (a valid code from CH - Authorisation Type) http://fhir.ch/ig/ch-epl/ValueSet/ch-authorisation-type from this IG
RegulatedAuthorization.region	example	Pattern: CH http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	required	ChSMCAuthorisationStatusVS (a valid code from CH SMC - Authorisation Status) http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-authorisation-status from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	IDMP RegulatedAuthorization
subject		0..*	Reference(IDMP MedicinalProductDefinition | IDMP PackagedProductDefinition | CH IDMP ManufacturedItemDefinition | IDMP Ingredient)	The product type, treatment, facility or activity that is being authorized
type		0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: CH - Authorisation Type (required)
Slices for coding		0..1	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:CH		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
code		1..1	code	Symbol in syntax defined by the system
region		0..*	CodeableConcept	The territory in which the authorization has been granted Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: urn:iso:std:iso:3166
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CH
status		0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: CH SMC - Authorisation Status (required)
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:SMC		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
code		1..1	code	Symbol in syntax defined by the system
coding:FOPH		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status
code		1..1	code	Symbol in syntax defined by the system
holder		0..1	Reference(Organization) {c}	The organization that has been granted this authorization, by the regulator
regulator		0..1	Reference(Organization) {c}	The regulatory authority or authorizing body granting the authorization
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
RegulatedAuthorization.type	required	ChAuthorisationTypeVS (a valid code from CH - Authorisation Type) http://fhir.ch/ig/ch-epl/ValueSet/ch-authorisation-type from this IG
RegulatedAuthorization.status	required	ChSMCAuthorisationStatusVS (a valid code from CH SMC - Authorisation Status) http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-authorisation-status from this IG

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	IDMP RegulatedAuthorization
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
subject	Σ	0..*	Reference(IDMP MedicinalProductDefinition | IDMP PackagedProductDefinition | CH IDMP ManufacturedItemDefinition | IDMP Ingredient)	The product type, treatment, facility or activity that is being authorized
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: CH - Authorisation Type (required)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..1	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:CH	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: urn:iso:std:iso:3166
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CH
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: CH SMC - Authorisation Status (required)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:SMC	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:FOPH	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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
indication	Σ	0..*	CodeableReference(ClinicalUseDefinition)	Condition for which the use of the regulated product applies
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product.
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
holder	Σ	0..1	Reference(Organization) {c}	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization) {c}	The regulatory authority or authorizing body granting the authorization
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.
date[x]	Σ	0..1		Relevant date for this case
datePeriod			Period
dateDateTime			dateTime
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	Conformance	ValueSet / Code	URI
RegulatedAuthorization.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
RegulatedAuthorization.type	required	ChAuthorisationTypeVS (a valid code from CH - Authorisation Type) http://fhir.ch/ig/ch-epl/ValueSet/ch-authorisation-type from this IG
RegulatedAuthorization.region	example	Pattern: CH http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	required	ChSMCAuthorisationStatusVS (a valid code from CH SMC - Authorisation Status) http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-authorisation-status from this IG
RegulatedAuthorization.intendedUse	preferred	ProductIntendedUse http://hl7.org/fhir/ValueSet/product-intended-use from the FHIR Standard
RegulatedAuthorization.basis	example	RegulatedAuthorizationBasis http://hl7.org/fhir/ValueSet/regulated-authorization-basis from the FHIR Standard
RegulatedAuthorization.case.type	example	RegulatedAuthorizationCaseType http://hl7.org/fhir/ValueSet/regulated-authorization-case-type from the FHIR Standard
RegulatedAuthorization.case.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Summary

Mandatory: 0 element(7 nested mandatory elements)

Structures

This structure refers to these other structures:

• IDMP MedicinalProductDefinition (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition)
• IDMP PackagedProductDefinition (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition)
• CH IDMP ManufacturedItemDefinition (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition)
• IDMP Ingredient (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of RegulatedAuthorization.type.coding
• The element 1 is sliced based on the value of RegulatedAuthorization.status.coding

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	IDMP RegulatedAuthorization 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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
subject	Σ	0..*	Reference(IDMP MedicinalProductDefinition | IDMP PackagedProductDefinition | CH IDMP ManufacturedItemDefinition | IDMP Ingredient)	The product type, treatment, facility or activity that is being authorized ele-1: All FHIR elements must have a @value or children
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: CH - Authorisation Type (required) ele-1: All FHIR elements must have a @value or children
Slices for coding	Σ	0..1	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system ele-1: All FHIR elements must have a @value or children
coding:CH	Σ	0..1	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
system	Σ	1..1	uri	Identity of the terminology system ele-1: All FHIR elements must have a @value or children Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
code	ΣC	1..1	code	Symbol in syntax defined by the system ele-1: All FHIR elements must have a @value or children
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: urn:iso:std:iso:3166
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CH
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: CH SMC - Authorisation Status (required) ele-1: All FHIR elements must have a @value or children
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system ele-1: All FHIR elements must have a @value or children
coding:SMC	Σ	0..1	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
system	Σ	1..1	uri	Identity of the terminology system ele-1: All FHIR elements must have a @value or children Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
code	ΣC	1..1	code	Symbol in syntax defined by the system ele-1: All FHIR elements must have a @value or children
coding:FOPH	Σ	0..1	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
system	Σ	1..1	uri	Identity of the terminology system ele-1: All FHIR elements must have a @value or children Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status
code	ΣC	1..1	code	Symbol in syntax defined by the system ele-1: All FHIR elements must have a @value or children
holder	Σ	0..1	Reference(Organization) {c}	The organization that has been granted this authorization, by the regulator ele-1: All FHIR elements must have a @value or children
regulator	Σ	0..1	Reference(Organization) {c}	The regulatory authority or authorizing body granting the authorization ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
RegulatedAuthorization.type	required	ChAuthorisationTypeVS (a valid code from CH - Authorisation Type) http://fhir.ch/ig/ch-epl/ValueSet/ch-authorisation-type from this IG
RegulatedAuthorization.region	example	Pattern: CH http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	required	ChSMCAuthorisationStatusVS (a valid code from CH SMC - Authorisation Status) http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-authorisation-status from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	IDMP RegulatedAuthorization
subject		0..*	Reference(IDMP MedicinalProductDefinition | IDMP PackagedProductDefinition | CH IDMP ManufacturedItemDefinition | IDMP Ingredient)	The product type, treatment, facility or activity that is being authorized
type		0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: CH - Authorisation Type (required)
Slices for coding		0..1	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:CH		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
code		1..1	code	Symbol in syntax defined by the system
region		0..*	CodeableConcept	The territory in which the authorization has been granted Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: urn:iso:std:iso:3166
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CH
status		0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: CH SMC - Authorisation Status (required)
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:SMC		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
code		1..1	code	Symbol in syntax defined by the system
coding:FOPH		0..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status
code		1..1	code	Symbol in syntax defined by the system
holder		0..1	Reference(Organization) {c}	The organization that has been granted this authorization, by the regulator
regulator		0..1	Reference(Organization) {c}	The regulatory authority or authorizing body granting the authorization
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
RegulatedAuthorization.type	required	ChAuthorisationTypeVS (a valid code from CH - Authorisation Type) http://fhir.ch/ig/ch-epl/ValueSet/ch-authorisation-type from this IG
RegulatedAuthorization.status	required	ChSMCAuthorisationStatusVS (a valid code from CH SMC - Authorisation Status) http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-authorisation-status from this IG

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	IDMP RegulatedAuthorization
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
subject	Σ	0..*	Reference(IDMP MedicinalProductDefinition | IDMP PackagedProductDefinition | CH IDMP ManufacturedItemDefinition | IDMP Ingredient)	The product type, treatment, facility or activity that is being authorized
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: CH - Authorisation Type (required)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	0..1	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:CH	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: JurisdictionValueSet (example): Jurisdiction codes Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: urn:iso:std:iso:3166
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CH
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: CH SMC - Authorisation Status (required)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:SMC	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
coding:FOPH	Σ	0..1	Coding	Code defined by a terminology system
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status
version	Σ	0..1	string	Version of the system - if relevant
code	ΣC	1..1	code	Symbol in syntax defined by the system
display	ΣC	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
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
indication	Σ	0..*	CodeableReference(ClinicalUseDefinition)	Condition for which the use of the regulated product applies
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment Binding: ProductIntendedUse (preferred): The overall intended use of a product.
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
holder	Σ	0..1	Reference(Organization) {c}	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization) {c}	The regulatory authority or authorizing body granting the authorization
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.
date[x]	Σ	0..1		Relevant date for this case
datePeriod			Period
dateDateTime			dateTime
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	Conformance	ValueSet / Code	URI
RegulatedAuthorization.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
RegulatedAuthorization.type	required	ChAuthorisationTypeVS (a valid code from CH - Authorisation Type) http://fhir.ch/ig/ch-epl/ValueSet/ch-authorisation-type from this IG
RegulatedAuthorization.region	example	Pattern: CH http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	required	ChSMCAuthorisationStatusVS (a valid code from CH SMC - Authorisation Status) http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-authorisation-status from this IG
RegulatedAuthorization.intendedUse	preferred	ProductIntendedUse http://hl7.org/fhir/ValueSet/product-intended-use from the FHIR Standard
RegulatedAuthorization.basis	example	RegulatedAuthorizationBasis http://hl7.org/fhir/ValueSet/regulated-authorization-basis from the FHIR Standard
RegulatedAuthorization.case.type	example	RegulatedAuthorizationCaseType http://hl7.org/fhir/ValueSet/regulated-authorization-case-type from the FHIR Standard
RegulatedAuthorization.case.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Summary

Mandatory: 0 element(7 nested mandatory elements)

Structures

This structure refers to these other structures:

• IDMP MedicinalProductDefinition (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition)
• IDMP PackagedProductDefinition (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition)
• CH IDMP ManufacturedItemDefinition (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-manufactureditemdefinition)
• IDMP Ingredient (http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-ingredient)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of RegulatedAuthorization.type.coding
• The element 1 is sliced based on the value of RegulatedAuthorization.status.coding