SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.5 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: SubmittedMedicinalProductMarketing

Details around the marketing of a submitted medicinal product.

Usage:

• Use this Resource Profile: ProductSubmissionBundle
• Examples for this Resource Profile: RegulatedAuthorization/AllopurinolMarketing, RegulatedAuthorization/Enbrel010Marketing, RegulatedAuthorization/Enbrel021Marketing, RegulatedAuthorization/Enbrel032Marketing... Show 12 more, RegulatedAuthorization/Enbrel044Marketing, RegulatedAuthorization/Enbrel055Marketing, RegulatedAuthorization/Enbrel425Marketing, RegulatedAuthorization/Enbrel425Part1Marketing, RegulatedAuthorization/Enbrel425Part2Marketing, RegulatedAuthorization/Enbrel435Marketing, RegulatedAuthorization/Enbrel445Marketing, RegulatedAuthorization/Enbrel446Marketing, RegulatedAuthorization/Enbrel455Marketing, RegulatedAuthorization/Enbrel456Marketing, RegulatedAuthorization/LantusSyringeMarketing and RegulatedAuthorization/LantusVialMarketing

Formal Views of Profile Content

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

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
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
identifier	SΣ	0..1	Identifier	Business identifier for the authorization, typically assigned by the authorizing body ele-1: All FHIR elements must have a @value or children
subject	SΣ	1..1	Reference(SubmittedMedicinalProduct)	The product type, treatment, facility or activity that is being authorized ele-1: All FHIR elements must have a @value or children
type	SΣ	1..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: SPL Marketing Categories (required) ele-1: All FHIR elements must have a @value or children
region	SΣ	1..1	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: USA
statusDate	SΣ	0..1	dateTime	The date at which the current status was assigned 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	SPLMarketingCategories http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories from this IG
RegulatedAuthorization.region	example	Pattern: USA http://hl7.org/fhir/ValueSet/jurisdiction 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()

This structure is derived from RegulatedAuthorization

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization			RegulatedAuthorization
identifier	S	0..1	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
subject	S	1..1	Reference(SubmittedMedicinalProduct)	The product type, treatment, facility or activity that is being authorized
type	S	1..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: SPL Marketing Categories (required)
region	S	1..1	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: USA
statusDate	S	0..1	dateTime	The date at which the current status was assigned
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
RegulatedAuthorization.type	required	SPLMarketingCategories http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories from this IG

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
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	SΣ	0..1	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
subject	SΣ	1..1	Reference(SubmittedMedicinalProduct)	The product type, treatment, facility or activity that is being authorized
type	SΣ	1..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: SPL Marketing Categories (required)
description	Σ	0..1	markdown	General textual supporting information
region	SΣ	1..1	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: USA
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: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	SΣ	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)	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization)	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	SPLMarketingCategories http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories from this IG
RegulatedAuthorization.region	example	Pattern: USA http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
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()

This structure is derived from RegulatedAuthorization

Summary

Mandatory: 3 elements
Must-Support: 5 elements

Structures

This structure refers to these other structures:

• SubmittedMedicinalProduct (http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct)

Maturity: 1

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
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
identifier	SΣ	0..1	Identifier	Business identifier for the authorization, typically assigned by the authorizing body ele-1: All FHIR elements must have a @value or children
subject	SΣ	1..1	Reference(SubmittedMedicinalProduct)	The product type, treatment, facility or activity that is being authorized ele-1: All FHIR elements must have a @value or children
type	SΣ	1..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: SPL Marketing Categories (required) ele-1: All FHIR elements must have a @value or children
region	SΣ	1..1	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: USA
statusDate	SΣ	0..1	dateTime	The date at which the current status was assigned 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	SPLMarketingCategories http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories from this IG
RegulatedAuthorization.region	example	Pattern: USA http://hl7.org/fhir/ValueSet/jurisdiction 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()

Differential View

This structure is derived from RegulatedAuthorization

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization			RegulatedAuthorization
identifier	S	0..1	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
subject	S	1..1	Reference(SubmittedMedicinalProduct)	The product type, treatment, facility or activity that is being authorized
type	S	1..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: SPL Marketing Categories (required)
region	S	1..1	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: USA
statusDate	S	0..1	dateTime	The date at which the current status was assigned
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
RegulatedAuthorization.type	required	SPLMarketingCategories http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories from this IG

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
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	SΣ	0..1	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
subject	SΣ	1..1	Reference(SubmittedMedicinalProduct)	The product type, treatment, facility or activity that is being authorized
type	SΣ	1..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: SPL Marketing Categories (required)
description	Σ	0..1	markdown	General textual supporting information
region	SΣ	1..1	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: USA
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: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	SΣ	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)	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization)	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	SPLMarketingCategories http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories from this IG
RegulatedAuthorization.region	example	Pattern: USA http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard
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()

This structure is derived from RegulatedAuthorization

Summary

Mandatory: 3 elements
Must-Support: 5 elements

Structures

This structure refers to these other structures:

• SubmittedMedicinalProduct (http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProduct)

Maturity: 1

Other representations of profile: CSV, Excel, Schematron