CH EPL (R5)
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CH EPL (R5), published by Federal Office of Public Health FOPH. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ci-build built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/bag-epl/bag-epl-fhir/ and changes regularly. See the Directory of published versions

Resource Profile: IDMP RegulatedAuthorization

Official URL: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization Version: 1.0.0-ci-build
Active as of 2025-11-11 Computable Name: CHIDMPRegulatedAuthorization

Copyright/Legal: CC0-1.0

Profile of the RegulatedAuthorization resource for representing the market authorization of a (packaged) medicinal product.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization 0..* RegulatedAuthorization IDMP RegulatedAuthorization
... 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
... type Σ 0..1 CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: CH - Authorisation Type (required)
.... 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
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
...... code ΣC 1..1 code Symbol in syntax defined by the system
... 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)
.... 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
...... system Σ 1..1 uri Identity of the terminology system
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
..... coding:FOPH Σ 0..1 Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
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
... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
RegulatedAuthorization.​type Base required CH - Authorisation Type 📦1.0.0-ci-build This IG
RegulatedAuthorization.​region Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
RegulatedAuthorization.​status Base required CH SMC - Authorisation Status 📦1.0.0-ci-build This IG

Constraints

Id Grade Path(s) Description Expression
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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
.... 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

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
RegulatedAuthorization.​type Base required CH - Authorisation Type 📦1.0.0-ci-build This IG
RegulatedAuthorization.​status Base required CH SMC - Authorisation Status 📦1.0.0-ci-build This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
RegulatedAuthorization.​language Base required All Languages 📍5.0.0 FHIR Std.
RegulatedAuthorization.​type Base required CH - Authorisation Type 📦1.0.0-ci-build This IG
RegulatedAuthorization.​region Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
RegulatedAuthorization.​status Base required CH SMC - Authorisation Status 📦1.0.0-ci-build This IG
RegulatedAuthorization.​intendedUse Base preferred Product Intended Use 📍5.0.0 FHIR Std.
RegulatedAuthorization.​basis Base example Regulated Authorization Basis 📍5.0.0 FHIR Std.
RegulatedAuthorization.​case.type Base example Regulated Authorization Case Type 📍5.0.0 FHIR Std.
RegulatedAuthorization.​case.status Base preferred PublicationStatus 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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: 0 element(7 nested mandatory elements)

Structures

This structure refers to these other structures:

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

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. RegulatedAuthorization 0..* RegulatedAuthorization IDMP RegulatedAuthorization
... 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
... type Σ 0..1 CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation
Binding: CH - Authorisation Type (required)
.... 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
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type
...... code ΣC 1..1 code Symbol in syntax defined by the system
... 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)
.... 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
...... system Σ 1..1 uri Identity of the terminology system
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
..... coding:FOPH Σ 0..1 Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
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
... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
RegulatedAuthorization.​type Base required CH - Authorisation Type 📦1.0.0-ci-build This IG
RegulatedAuthorization.​region Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
RegulatedAuthorization.​status Base required CH SMC - Authorisation Status 📦1.0.0-ci-build This IG

Constraints

Id Grade Path(s) Description Expression
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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
.... 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

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
RegulatedAuthorization.​type Base required CH - Authorisation Type 📦1.0.0-ci-build This IG
RegulatedAuthorization.​status Base required CH SMC - Authorisation Status 📦1.0.0-ci-build This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
RegulatedAuthorization.​language Base required All Languages 📍5.0.0 FHIR Std.
RegulatedAuthorization.​type Base required CH - Authorisation Type 📦1.0.0-ci-build This IG
RegulatedAuthorization.​region Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
RegulatedAuthorization.​status Base required CH SMC - Authorisation Status 📦1.0.0-ci-build This IG
RegulatedAuthorization.​intendedUse Base preferred Product Intended Use 📍5.0.0 FHIR Std.
RegulatedAuthorization.​basis Base example Regulated Authorization Basis 📍5.0.0 FHIR Std.
RegulatedAuthorization.​case.type Base example Regulated Authorization Case Type 📍5.0.0 FHIR Std.
RegulatedAuthorization.​case.status Base preferred PublicationStatus 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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: 0 element(7 nested mandatory elements)

Structures

This structure refers to these other structures:

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

 

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