SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI United States of America flag

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 0.2.1 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

Resource Profile: SubmittedMedicinalProductMarketing

Official URL: http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalProductMarketing Version: 0.2.1
Standards status: Trial-use Maturity Level: 1 Computable Name: SubmittedMedicinalProductMarketing

Details around the marketing of a submitted medicinal product.

Usage:

Formal Views of Profile Content

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

This structure is derived from RegulatedAuthorization

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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)
.... 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

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
RegulatedAuthorization.typerequiredSPLMarketingCategories
http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... 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)
... 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
.... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
RegulatedAuthorization.typerequiredSPLMarketingCategories
http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories
from this IG
RegulatedAuthorization.regionexamplePattern: USA
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf 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-4errorRegulatedAuthorizationIf 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-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
RegulatedAuthorization.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
RegulatedAuthorization.typerequiredSPLMarketingCategories
http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories
from this IG
RegulatedAuthorization.regionexamplePattern: USA
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
RegulatedAuthorization.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
RegulatedAuthorization.intendedUsepreferredProductIntendedUse
http://hl7.org/fhir/ValueSet/product-intended-use
from the FHIR Standard
RegulatedAuthorization.basisexampleRegulatedAuthorizationBasis
http://hl7.org/fhir/ValueSet/regulated-authorization-basis
from the FHIR Standard
RegulatedAuthorization.case.typeexampleRegulatedAuthorizationCaseType
http://hl7.org/fhir/ValueSet/regulated-authorization-case-type
from the FHIR Standard
RegulatedAuthorization.case.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf 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-4errorRegulatedAuthorizationIf 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-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust 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:

Maturity: 1

Differential View

This structure is derived from RegulatedAuthorization

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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)
.... 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

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
RegulatedAuthorization.typerequiredSPLMarketingCategories
http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... 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)
... 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
.... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
RegulatedAuthorization.typerequiredSPLMarketingCategories
http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories
from this IG
RegulatedAuthorization.regionexamplePattern: USA
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf 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-4errorRegulatedAuthorizationIf 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-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
RegulatedAuthorization.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
RegulatedAuthorization.typerequiredSPLMarketingCategories
http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingCategories
from this IG
RegulatedAuthorization.regionexamplePattern: USA
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
RegulatedAuthorization.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
RegulatedAuthorization.intendedUsepreferredProductIntendedUse
http://hl7.org/fhir/ValueSet/product-intended-use
from the FHIR Standard
RegulatedAuthorization.basisexampleRegulatedAuthorizationBasis
http://hl7.org/fhir/ValueSet/regulated-authorization-basis
from the FHIR Standard
RegulatedAuthorization.case.typeexampleRegulatedAuthorizationCaseType
http://hl7.org/fhir/ValueSet/regulated-authorization-case-type
from the FHIR Standard
RegulatedAuthorization.case.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorRegulatedAuthorizationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorRegulatedAuthorizationIf 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-4errorRegulatedAuthorizationIf 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-5errorRegulatedAuthorizationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceRegulatedAuthorizationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust 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:

Maturity: 1

 

Other representations of profile: CSV, Excel, Schematron