CH EPL (R5)
1.0.0-ci-build - ci-build Switzerland flag

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 MedicinalProductDefinition

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

Copyright/Legal: CC0-1.0

Profile of the MedicinalProductDefinition resource for representing the detailed data of medicinal products.

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
.. MedicinalProductDefinition 0..* MedicinalProductDefinition CH IDMP MedicinalProductDefinition
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:authorizedDoseForm 0..1 CodeableConcept CH - SMC Authorized Dose Form
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
Binding: CH SMC - Authorised Pharmaceutical Dose Form (required)
.... extension:fullLimitationText 0..1 string CH - EPL Full Limitation Text
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM - Combined Pharmaceutical Dose Form (required)
.... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:EDQM Σ 0..1 Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://standardterms.edqm.eu
...... code ΣC 1..1 code Symbol in syntax defined by the system
... indication Σ 0..1 markdown Description of indication(s) for this product
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: CH SMC - Additional Monitoring Indicator (required)
.... Slices for coding Σ 0..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-additional-monitoring-indicator
...... code ΣC 1..1 code Symbol in syntax defined by the system
... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: CH SMC - Pediatric Use Indicator (required)
.... Slices for coding Σ 0..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-pediatric-use-indicator
...... code ΣC 1..1 code Symbol in syntax defined by the system
... Slices for classification Σ 0..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Open by value:coding.system
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... classification:ATC Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... coding Σ 1..* Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://www.whocc.no/atc
...... code ΣC 1..1 code Symbol in syntax defined by the system
.... classification:AuthorisationCategory Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... coding Σ 1..* Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category
...... code ΣC 1..1 code Symbol in syntax defined by the system
.... classification:TherapeuticProductcode Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... coding Σ 1..* Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode
...... code ΣC 1..1 code Symbol in syntax defined by the system
.... classification:ProductType Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... coding Σ 1..* Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type
...... code ΣC 1..1 code Symbol in syntax defined by the system
... attachedDocument Σ 0..* Reference(CH IDMP DocumentReference) Professional information and/or patient information
... Slices for name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
Slice: Unordered, Open by value:usage.language
.... name:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name
.... name:en Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name in English
.... name:de-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name in German (Switzerland)
.... name:fr-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name in French (Switzerland)
.... name:it-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name in Italian (Switzerland)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base required EDQM - Combined Pharmaceutical Dose Form 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​additionalMonitoringIndicator Base required CH SMC - Additional Monitoring Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​pediatricUseIndicator Base required CH SMC - Pediatric Use Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​classification Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:ATC Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:AuthorisationCategory Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:TherapeuticProductcode Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:ProductType Base example Product Classification 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error MedicinalProductDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error MedicinalProductDefinition 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 MedicinalProductDefinition 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 MedicinalProductDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice MedicinalProductDefinition 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 MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition CH IDMP MedicinalProductDefinition
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:authorizedDoseForm 0..1 CodeableConcept CH - SMC Authorized Dose Form
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
Binding: CH SMC - Authorised Pharmaceutical Dose Form (required)
.... extension:fullLimitationText 0..1 string CH - EPL Full Limitation Text
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText
... identifier
.... system 1..1 uri The namespace for the identifier value
Required Pattern: http://fhir.ch/ig/ch-epl/sid/mpid
.... value 1..1 string The value that is unique
... combinedPharmaceuticalDoseForm 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM - Combined Pharmaceutical Dose Form (required)
.... Slices for coding 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:EDQM 0..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://standardterms.edqm.eu
...... code 1..1 code Symbol in syntax defined by the system
... additionalMonitoringIndicator 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: CH SMC - Additional Monitoring Indicator (required)
.... Slices for coding 0..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-additional-monitoring-indicator
...... code 1..1 code Symbol in syntax defined by the system
... pediatricUseIndicator 0..1 CodeableConcept If authorised for use in children
Binding: CH SMC - Pediatric Use Indicator (required)
.... Slices for coding 0..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-pediatric-use-indicator
...... code 1..1 code Symbol in syntax defined by the system
... Slices for classification 0..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Open by value:coding.system
.... classification:ATC 0..1 CodeableConcept Allows the product to be classified by various systems
..... coding 1..* Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://www.whocc.no/atc
...... code 1..1 code Symbol in syntax defined by the system
.... classification:AuthorisationCategory 0..1 CodeableConcept Allows the product to be classified by various systems
..... coding 1..* Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category
...... code 1..1 code Symbol in syntax defined by the system
.... classification:TherapeuticProductcode 0..1 CodeableConcept Allows the product to be classified by various systems
..... coding 1..* Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode
...... code 1..1 code Symbol in syntax defined by the system
.... classification:ProductType 0..1 CodeableConcept Allows the product to be classified by various systems
..... coding 1..* Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type
...... code 1..1 code Symbol in syntax defined by the system
... marketingStatus
.... country 0..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
...... system 1..1 uri Identity of the terminology system
Fixed Value: urn:iso:std:iso:3166
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: CH
.... status
..... Slices for coding 0..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-marketing-status
... attachedDocument 0..* Reference(CH IDMP DocumentReference) Professional information and/or patient information
... Slices for name 1..* BackboneElement The product's name, including full name and possibly coded parts
Slice: Unordered, Open by value:usage.language
.... name:en 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... productName 1..1 string The full product name in English
..... part
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage
...... country 1..1 CodeableConcept Country code for where this name applies
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
...... language 1..1 CodeableConcept Language code for this name
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:ietf:bcp:47
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: en
.... name:de-CH 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... productName 1..1 string The full product name in German (Switzerland)
..... part
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage
...... country 1..1 CodeableConcept Country code for where this name applies
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
...... language 1..1 CodeableConcept Language code for this name
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:ietf:bcp:47
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: de-CH
.... name:fr-CH 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... productName 1..1 string The full product name in French (Switzerland)
..... part
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage
...... country 1..1 CodeableConcept Country code for where this name applies
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
...... language 1..1 CodeableConcept Language code for this name
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:ietf:bcp:47
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: fr-CH
.... name:it-CH 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... productName 1..1 string The full product name in Italian (Switzerland)
..... part
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage
...... country 1..1 CodeableConcept Country code for where this name applies
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
...... language 1..1 CodeableConcept Language code for this name
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:ietf:bcp:47
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: it-CH

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base required EDQM - Combined Pharmaceutical Dose Form 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​additionalMonitoringIndicator Base required CH SMC - Additional Monitoring Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​pediatricUseIndicator Base required CH SMC - Pediatric Use Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​name:en.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition CH IDMP MedicinalProductDefinition
... 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 BindingsPurpose
CommonLanguages Starter
... 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
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:authorizedDoseForm 0..1 CodeableConcept CH - SMC Authorized Dose Form
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
Binding: CH SMC - Authorised Pharmaceutical Dose Form (required)
.... extension:fullLimitationText 0..1 string CH - EPL Full Limitation Text
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business identifier for this product. Could be an MPID
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://fhir.ch/ig/ch-epl/sid/mpid
.... value ΣC 1..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM - Combined Pharmaceutical Dose Form (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..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:EDQM 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://standardterms.edqm.eu
...... 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
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... indication Σ 0..1 markdown Description of indication(s) for this product
... legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: CH SMC - Additional Monitoring Indicator (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: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-additional-monitoring-indicator
...... 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
... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: CH SMC - Pediatric Use Indicator (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: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-pediatric-use-indicator
...... 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
... Slices for classification Σ 0..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Open by value:coding.system
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... classification:ATC Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 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
Fixed Value: http://www.whocc.no/atc
...... 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
.... classification:AuthorisationCategory Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 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
Fixed Value: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category
...... 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
.... classification:TherapeuticProductcode Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 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
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode
...... 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
.... classification:ProductType Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 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
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-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
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... country Σ 0..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
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
.... jurisdiction Σ 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
.... status Σ 1..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
..... 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: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-marketing-status
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..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
.... dateRange Σ 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
.... restoreDate Σ 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs
... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... impurity Σ 0..* CodeableReference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... attachedDocument Σ 0..* Reference(CH IDMP DocumentReference) Professional information and/or patient information
... masterFile Σ 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization
.... 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
.... type Σ 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
.... contact Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
... Slices for name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
Slice: Unordered, Open by value:usage.language
.... name:All Slices Content/Rules for all slices
..... 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
..... productName Σ 1..1 string The full product name
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... 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
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes
...... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
.... name:en Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... 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
..... productName Σ 1..1 string The full product name in English
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... 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
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (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
...... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter

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:ietf:bcp:47
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: en
........ 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
.... name:de-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... 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
..... productName Σ 1..1 string The full product name in German (Switzerland)
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... 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
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (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
...... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter

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:ietf:bcp:47
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: de-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
.... name:fr-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... 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
..... productName Σ 1..1 string The full product name in French (Switzerland)
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... 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
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (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
...... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter

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:ietf:bcp:47
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: fr-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
.... name:it-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... 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
..... productName Σ 1..1 string The full product name in Italian (Switzerland)
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... 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
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (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
...... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter

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:ietf:bcp:47
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: it-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
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... 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
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... 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
.... type Σ 0..1 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... 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
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​identifier.type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​type Base example Medicinal Product Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​domain Base example Medicinal Product Domain 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base required EDQM - Combined Pharmaceutical Dose Form 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​route Base example SNOMED CT Route Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​legalStatusOfSupply Base example Legal Status Of Supply 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​additionalMonitoringIndicator Base required CH SMC - Additional Monitoring Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​specialMeasures Base example Special Measures 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​pediatricUseIndicator Base required CH SMC - Pediatric Use Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​classification Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:ATC Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:AuthorisationCategory Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:TherapeuticProductcode Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:ProductType Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​packagedMedicinalProduct Base example Medicinal Product Package Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​impurity Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​contact.type Base example Product Contact Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​code Base example SNOMED CT Medication Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part.type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:en.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:en.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:en.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:en.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:en.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​crossReference.type Base example Product Cross Reference Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​operation.confidentialityIndicator Base example Product Confidentiality 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​characteristic.type Base example Product Characteristic 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error MedicinalProductDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error MedicinalProductDefinition 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 MedicinalProductDefinition 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 MedicinalProductDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice MedicinalProductDefinition 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 MedicinalProductDefinition

Summary

Mandatory: 0 element(21 nested mandatory elements)
Fixed: 4 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding
  • The element 1 is sliced based on the value of MedicinalProductDefinition.additionalMonitoringIndicator.coding
  • The element 1 is sliced based on the value of MedicinalProductDefinition.pediatricUseIndicator.coding
  • The element 1 is sliced based on the value of MedicinalProductDefinition.classification
  • The element 1 is sliced based on the value of MedicinalProductDefinition.marketingStatus.status.coding
  • The element 1 is sliced based on the value of MedicinalProductDefinition.name

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition CH IDMP MedicinalProductDefinition
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:authorizedDoseForm 0..1 CodeableConcept CH - SMC Authorized Dose Form
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
Binding: CH SMC - Authorised Pharmaceutical Dose Form (required)
.... extension:fullLimitationText 0..1 string CH - EPL Full Limitation Text
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM - Combined Pharmaceutical Dose Form (required)
.... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:EDQM Σ 0..1 Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://standardterms.edqm.eu
...... code ΣC 1..1 code Symbol in syntax defined by the system
... indication Σ 0..1 markdown Description of indication(s) for this product
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: CH SMC - Additional Monitoring Indicator (required)
.... Slices for coding Σ 0..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-additional-monitoring-indicator
...... code ΣC 1..1 code Symbol in syntax defined by the system
... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: CH SMC - Pediatric Use Indicator (required)
.... Slices for coding Σ 0..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-pediatric-use-indicator
...... code ΣC 1..1 code Symbol in syntax defined by the system
... Slices for classification Σ 0..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Open by value:coding.system
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... classification:ATC Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... coding Σ 1..* Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://www.whocc.no/atc
...... code ΣC 1..1 code Symbol in syntax defined by the system
.... classification:AuthorisationCategory Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... coding Σ 1..* Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category
...... code ΣC 1..1 code Symbol in syntax defined by the system
.... classification:TherapeuticProductcode Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... coding Σ 1..* Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode
...... code ΣC 1..1 code Symbol in syntax defined by the system
.... classification:ProductType Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... coding Σ 1..* Coding Code defined by a terminology system
...... system Σ 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type
...... code ΣC 1..1 code Symbol in syntax defined by the system
... attachedDocument Σ 0..* Reference(CH IDMP DocumentReference) Professional information and/or patient information
... Slices for name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
Slice: Unordered, Open by value:usage.language
.... name:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name
.... name:en Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name in English
.... name:de-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name in German (Switzerland)
.... name:fr-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name in French (Switzerland)
.... name:it-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name in Italian (Switzerland)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base required EDQM - Combined Pharmaceutical Dose Form 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​additionalMonitoringIndicator Base required CH SMC - Additional Monitoring Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​pediatricUseIndicator Base required CH SMC - Pediatric Use Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​classification Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:ATC Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:AuthorisationCategory Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:TherapeuticProductcode Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:ProductType Base example Product Classification 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error MedicinalProductDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error MedicinalProductDefinition 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 MedicinalProductDefinition 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 MedicinalProductDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice MedicinalProductDefinition 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 MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition CH IDMP MedicinalProductDefinition
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:authorizedDoseForm 0..1 CodeableConcept CH - SMC Authorized Dose Form
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
Binding: CH SMC - Authorised Pharmaceutical Dose Form (required)
.... extension:fullLimitationText 0..1 string CH - EPL Full Limitation Text
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText
... identifier
.... system 1..1 uri The namespace for the identifier value
Required Pattern: http://fhir.ch/ig/ch-epl/sid/mpid
.... value 1..1 string The value that is unique
... combinedPharmaceuticalDoseForm 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM - Combined Pharmaceutical Dose Form (required)
.... Slices for coding 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:EDQM 0..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://standardterms.edqm.eu
...... code 1..1 code Symbol in syntax defined by the system
... additionalMonitoringIndicator 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: CH SMC - Additional Monitoring Indicator (required)
.... Slices for coding 0..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-additional-monitoring-indicator
...... code 1..1 code Symbol in syntax defined by the system
... pediatricUseIndicator 0..1 CodeableConcept If authorised for use in children
Binding: CH SMC - Pediatric Use Indicator (required)
.... Slices for coding 0..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-pediatric-use-indicator
...... code 1..1 code Symbol in syntax defined by the system
... Slices for classification 0..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Open by value:coding.system
.... classification:ATC 0..1 CodeableConcept Allows the product to be classified by various systems
..... coding 1..* Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://www.whocc.no/atc
...... code 1..1 code Symbol in syntax defined by the system
.... classification:AuthorisationCategory 0..1 CodeableConcept Allows the product to be classified by various systems
..... coding 1..* Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category
...... code 1..1 code Symbol in syntax defined by the system
.... classification:TherapeuticProductcode 0..1 CodeableConcept Allows the product to be classified by various systems
..... coding 1..* Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode
...... code 1..1 code Symbol in syntax defined by the system
.... classification:ProductType 0..1 CodeableConcept Allows the product to be classified by various systems
..... coding 1..* Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type
...... code 1..1 code Symbol in syntax defined by the system
... marketingStatus
.... country 0..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
...... system 1..1 uri Identity of the terminology system
Fixed Value: urn:iso:std:iso:3166
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: CH
.... status
..... Slices for coding 0..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-marketing-status
... attachedDocument 0..* Reference(CH IDMP DocumentReference) Professional information and/or patient information
... Slices for name 1..* BackboneElement The product's name, including full name and possibly coded parts
Slice: Unordered, Open by value:usage.language
.... name:en 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... productName 1..1 string The full product name in English
..... part
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage
...... country 1..1 CodeableConcept Country code for where this name applies
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
...... language 1..1 CodeableConcept Language code for this name
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:ietf:bcp:47
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: en
.... name:de-CH 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... productName 1..1 string The full product name in German (Switzerland)
..... part
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage
...... country 1..1 CodeableConcept Country code for where this name applies
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
...... language 1..1 CodeableConcept Language code for this name
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:ietf:bcp:47
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: de-CH
.... name:fr-CH 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... productName 1..1 string The full product name in French (Switzerland)
..... part
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage
...... country 1..1 CodeableConcept Country code for where this name applies
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
...... language 1..1 CodeableConcept Language code for this name
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:ietf:bcp:47
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: fr-CH
.... name:it-CH 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... productName 1..1 string The full product name in Italian (Switzerland)
..... part
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage
...... country 1..1 CodeableConcept Country code for where this name applies
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
...... language 1..1 CodeableConcept Language code for this name
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:ietf:bcp:47
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: it-CH

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base required EDQM - Combined Pharmaceutical Dose Form 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​additionalMonitoringIndicator Base required CH SMC - Additional Monitoring Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​pediatricUseIndicator Base required CH SMC - Pediatric Use Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​name:en.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition CH IDMP MedicinalProductDefinition
... 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 BindingsPurpose
CommonLanguages Starter
... 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
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:authorizedDoseForm 0..1 CodeableConcept CH - SMC Authorized Dose Form
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm
Binding: CH SMC - Authorised Pharmaceutical Dose Form (required)
.... extension:fullLimitationText 0..1 string CH - EPL Full Limitation Text
URL: http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business identifier for this product. Could be an MPID
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://fhir.ch/ig/ch-epl/sid/mpid
.... value ΣC 1..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM - Combined Pharmaceutical Dose Form (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..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:EDQM 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://standardterms.edqm.eu
...... 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
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... indication Σ 0..1 markdown Description of indication(s) for this product
... legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: CH SMC - Additional Monitoring Indicator (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: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-additional-monitoring-indicator
...... 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
... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: CH SMC - Pediatric Use Indicator (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: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-pediatric-use-indicator
...... 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
... Slices for classification Σ 0..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Open by value:coding.system
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... classification:ATC Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 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
Fixed Value: http://www.whocc.no/atc
...... 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
.... classification:AuthorisationCategory Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 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
Fixed Value: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category
...... 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
.... classification:TherapeuticProductcode Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 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
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode
...... 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
.... classification:ProductType Σ 0..1 CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 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
Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-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
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... country Σ 0..1 CodeableConcept The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
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
.... jurisdiction Σ 0..1 CodeableConcept Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
.... status Σ 1..1 CodeableConcept This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
..... 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: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-marketing-status
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 0..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
.... dateRange Σ 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
.... restoreDate Σ 0..1 dateTime The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs
... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... impurity Σ 0..* CodeableReference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
... attachedDocument Σ 0..* Reference(CH IDMP DocumentReference) Professional information and/or patient information
... masterFile Σ 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization
.... 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
.... type Σ 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
.... contact Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.
... Slices for name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
Slice: Unordered, Open by value:usage.language
.... name:All Slices Content/Rules for all slices
..... 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
..... productName Σ 1..1 string The full product name
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... 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
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes
...... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
.... name:en Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... 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
..... productName Σ 1..1 string The full product name in English
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... 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
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (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
...... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter

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:ietf:bcp:47
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: en
........ 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
.... name:de-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... 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
..... productName Σ 1..1 string The full product name in German (Switzerland)
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... 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
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (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
...... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter

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:ietf:bcp:47
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: de-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
.... name:fr-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... 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
..... productName Σ 1..1 string The full product name in French (Switzerland)
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... 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
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (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
...... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter

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:ietf:bcp:47
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: fr-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
.... name:it-CH Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... 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
..... productName Σ 1..1 string The full product name in Italian (Switzerland)
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... 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
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (required)
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... 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
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (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
...... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter

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:ietf:bcp:47
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: it-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
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... 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
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... 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
.... type Σ 0..1 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... 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
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​identifier.type Base extensible Identifier Type Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​type Base example Medicinal Product Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​domain Base example Medicinal Product Domain 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base required EDQM - Combined Pharmaceutical Dose Form 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​route Base example SNOMED CT Route Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​legalStatusOfSupply Base example Legal Status Of Supply 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​additionalMonitoringIndicator Base required CH SMC - Additional Monitoring Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​specialMeasures Base example Special Measures 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​pediatricUseIndicator Base required CH SMC - Pediatric Use Indicator 📦1.0.0-ci-build This IG
MedicinalProductDefinition.​classification Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:ATC Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:AuthorisationCategory Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:TherapeuticProductcode Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification:ProductType Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​packagedMedicinalProduct Base example Medicinal Product Package Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​impurity Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​contact.type Base example Product Contact Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​code Base example SNOMED CT Medication Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part.type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:en.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:en.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:en.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:en.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:en.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:de-CH.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:fr-CH.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.part.type Base required Product Name Part Type 📦5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name:it-CH.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​crossReference.type Base example Product Cross Reference Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​operation.confidentialityIndicator Base example Product Confidentiality 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​characteristic.type Base example Product Characteristic 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error MedicinalProductDefinition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error MedicinalProductDefinition 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 MedicinalProductDefinition 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 MedicinalProductDefinition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice MedicinalProductDefinition 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 MedicinalProductDefinition

Summary

Mandatory: 0 element(21 nested mandatory elements)
Fixed: 4 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding
  • The element 1 is sliced based on the value of MedicinalProductDefinition.additionalMonitoringIndicator.coding
  • The element 1 is sliced based on the value of MedicinalProductDefinition.pediatricUseIndicator.coding
  • The element 1 is sliced based on the value of MedicinalProductDefinition.classification
  • The element 1 is sliced based on the value of MedicinalProductDefinition.marketingStatus.status.coding
  • The element 1 is sliced based on the value of MedicinalProductDefinition.name

 

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