SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 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

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• Detailed Descriptions
• Mappings
• Examples
• XML
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• 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.

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

This structure is derived from RegulatedAuthorization

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization			RegulatedAuthorization
identifier	S	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	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation
region	S	0..*	CodeableConcept	The territory in which the authorization has been granted
statusDate	S	0..1	dateTime	The date at which the current status was assigned
Documentation for this format

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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	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	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization.
region	SΣ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: Jurisdiction ValueSet (example): Jurisdiction codes
statusDate	SΣ	0..1	dateTime	The date at which the current status was assigned
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
RegulatedAuthorization.type	example	RegulatedAuthorizationType http://hl7.org/fhir/ValueSet/regulated-authorization-type from the FHIR Standard
RegulatedAuthorization.region	example	Jurisdiction ValueSet 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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	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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	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	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization.
description	Σ	0..1	markdown	General textual supporting information
region	SΣ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: Jurisdiction ValueSet (example): Jurisdiction codes
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..1	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
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	URI
RegulatedAuthorization.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
RegulatedAuthorization.type	example	RegulatedAuthorizationType http://hl7.org/fhir/ValueSet/regulated-authorization-type from the FHIR Standard
RegulatedAuthorization.region	example	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status
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

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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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()
dom-r4b	warning	RegulatedAuthorization.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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: 2 elements
Must-Support: 5 elements

Structures

This structure refers to these other structures:

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

Maturity: 1

Differential View

This structure is derived from RegulatedAuthorization

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization			RegulatedAuthorization
identifier	S	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	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation
region	S	0..*	CodeableConcept	The territory in which the authorization has been granted
statusDate	S	0..1	dateTime	The date at which the current status was assigned
Documentation for this format

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
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	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	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization.
region	SΣ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: Jurisdiction ValueSet (example): Jurisdiction codes
statusDate	SΣ	0..1	dateTime	The date at which the current status was assigned
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
RegulatedAuthorization.type	example	RegulatedAuthorizationType http://hl7.org/fhir/ValueSet/regulated-authorization-type from the FHIR Standard
RegulatedAuthorization.region	example	Jurisdiction ValueSet 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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()

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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	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	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: RegulatedAuthorizationType (example): Overall type of this authorization.
description	Σ	0..1	markdown	General textual supporting information
region	SΣ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: Jurisdiction ValueSet (example): Jurisdiction codes
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..1	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
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	URI
RegulatedAuthorization.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
RegulatedAuthorization.type	example	RegulatedAuthorizationType http://hl7.org/fhir/ValueSet/regulated-authorization-type from the FHIR Standard
RegulatedAuthorization.region	example	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
RegulatedAuthorization.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status
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

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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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()
dom-r4b	warning	RegulatedAuthorization.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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: 2 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