CH EPL (R5)
0.1.0 - ci-build
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 0.1.0 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
Official URL: http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition | Version: 0.1.0 | |||
Active as of 2024-11-06 | Computable Name: CHIDMPMedicinalProductDefinition | |||
Copyright/Legal: CC0-1.0 |
Profile of the MedicinalProductDefinition resource for representing the detailed data of medicinal products.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from MedicinalProductDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
MedicinalProductDefinition | 0..* | MedicinalProductDefinition | CH IDMP MedicinalProductDefinition | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
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) | |
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://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID | |
value | 1..1 | string | The value that is unique | |
domain | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: EMA - Domain (required) | |
Slices for coding | 1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:system | |
coding:EMA | 0..1 | Coding | Code defined by a terminology system | |
system | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000004 | |
code | 1..1 | code | Symbol in syntax defined by the system | |
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 | |
indication | 0..1 | markdown | Description of indication(s) for this product | |
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 | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.domain | required | EMADomainVS (a valid code from EMA - Domain)http://fhir.ch/ig/ch-epl/ValueSet/ema-domain from this IG | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | EdqmCombinedPharmaceuticalDoseFormVShttp://fhir.ch/ig/ch-epl/ValueSet/edqm-combined-pharmaceutical-dose-form from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | ChSMCAdditionalMonitoringIndicatorVS (a valid code from CH SMC - Additional Monitoring Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-additional-monitoring-indicator from this IG | |
MedicinalProductDefinition.pediatricUseIndicator | required | ChSMCPediatricUseIndicatorVS (a valid code from CH SMC - Pediatric Use Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-pediatric-use-indicator from this IG | |
MedicinalProductDefinition.name:en.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 | |
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) | |
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 |
domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: EMA - Domain (required) |
Slices for coding | Σ | 1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:system |
coding:EMA | Σ | 0..1 | Coding | Code defined by a terminology system |
system | Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000004 |
code | ΣC | 1..1 | code | Symbol in syntax defined by the system |
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) |
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.domain | required | EMADomainVS (a valid code from EMA - Domain)http://fhir.ch/ig/ch-epl/ValueSet/ema-domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | EdqmCombinedPharmaceuticalDoseFormVShttp://fhir.ch/ig/ch-epl/ValueSet/edqm-combined-pharmaceutical-dose-form from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | ChSMCAdditionalMonitoringIndicatorVS (a valid code from CH SMC - Additional Monitoring Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-additional-monitoring-indicator from this IG | |
MedicinalProductDefinition.pediatricUseIndicator | required | ChSMCPediatricUseIndicatorVS (a valid code from CH SMC - Pediatric Use Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-pediatric-use-indicator from this IG | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:ATC | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:AuthorisationCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:TherapeuticProductcode | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:ProductType | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
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) | |||||
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://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-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: EMA - Domain (required) | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
Slices for coding | Σ | 1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:system | ||||
coding:EMA | 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://spor.ema.europa.eu/v1/lists/100000000004 | ||||
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 | ||||
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
| ||||
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
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
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
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
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 | |||||||
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard | |
MedicinalProductDefinition.domain | required | EMADomainVS (a valid code from EMA - Domain)http://fhir.ch/ig/ch-epl/ValueSet/ema-domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | EdqmCombinedPharmaceuticalDoseFormVShttp://fhir.ch/ig/ch-epl/ValueSet/edqm-combined-pharmaceutical-dose-form from this IG | |
MedicinalProductDefinition.route | example | SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard | |
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | ChSMCAdditionalMonitoringIndicatorVS (a valid code from CH SMC - Additional Monitoring Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-additional-monitoring-indicator from this IG | |
MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard | |
MedicinalProductDefinition.pediatricUseIndicator | required | ChSMCPediatricUseIndicatorVS (a valid code from CH SMC - Pediatric Use Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-pediatric-use-indicator from this IG | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:ATC | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:AuthorisationCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:TherapeuticProductcode | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:ProductType | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard | |
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard | |
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard | |
MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.name:en.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:en.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:en.usage.country | example | Pattern: CHhttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name:en.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name:en.usage.language | required | Pattern: enhttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.usage.country | example | Pattern: CHhttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.usage.language | required | Pattern: de-CHhttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.usage.country | example | Pattern: CHhttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.usage.language | required | Pattern: fr-CHhttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.usage.country | example | Pattern: CHhttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.usage.language | required | Pattern: it-CHhttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceTypehttp://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard | |
MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentialityhttp://hl7.org/fhir/ValueSet/medicinal-product-confidentiality from the FHIR Standard | |
MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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(24 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:
Differential View
This structure is derived from MedicinalProductDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
MedicinalProductDefinition | 0..* | MedicinalProductDefinition | CH IDMP MedicinalProductDefinition | |
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
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) | |
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://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID | |
value | 1..1 | string | The value that is unique | |
domain | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: EMA - Domain (required) | |
Slices for coding | 1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:system | |
coding:EMA | 0..1 | Coding | Code defined by a terminology system | |
system | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000004 | |
code | 1..1 | code | Symbol in syntax defined by the system | |
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 | |
indication | 0..1 | markdown | Description of indication(s) for this product | |
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 | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.domain | required | EMADomainVS (a valid code from EMA - Domain)http://fhir.ch/ig/ch-epl/ValueSet/ema-domain from this IG | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | EdqmCombinedPharmaceuticalDoseFormVShttp://fhir.ch/ig/ch-epl/ValueSet/edqm-combined-pharmaceutical-dose-form from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | ChSMCAdditionalMonitoringIndicatorVS (a valid code from CH SMC - Additional Monitoring Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-additional-monitoring-indicator from this IG | |
MedicinalProductDefinition.pediatricUseIndicator | required | ChSMCPediatricUseIndicatorVS (a valid code from CH SMC - Pediatric Use Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-pediatric-use-indicator from this IG | |
MedicinalProductDefinition.name:en.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 | |
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) | |
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 |
domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: EMA - Domain (required) |
Slices for coding | Σ | 1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:system |
coding:EMA | Σ | 0..1 | Coding | Code defined by a terminology system |
system | Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://spor.ema.europa.eu/v1/lists/100000000004 |
code | ΣC | 1..1 | code | Symbol in syntax defined by the system |
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) |
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.domain | required | EMADomainVS (a valid code from EMA - Domain)http://fhir.ch/ig/ch-epl/ValueSet/ema-domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | EdqmCombinedPharmaceuticalDoseFormVShttp://fhir.ch/ig/ch-epl/ValueSet/edqm-combined-pharmaceutical-dose-form from this IG | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | ChSMCAdditionalMonitoringIndicatorVS (a valid code from CH SMC - Additional Monitoring Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-additional-monitoring-indicator from this IG | |
MedicinalProductDefinition.pediatricUseIndicator | required | ChSMCPediatricUseIndicatorVS (a valid code from CH SMC - Pediatric Use Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-pediatric-use-indicator from this IG | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:ATC | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:AuthorisationCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:TherapeuticProductcode | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:ProductType | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
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) | |||||
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://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-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: EMA - Domain (required) | ||||
id | 0..1 | id | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
Slices for coding | Σ | 1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:system | ||||
coding:EMA | 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://spor.ema.europa.eu/v1/lists/100000000004 | ||||
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 | ||||
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
| ||||
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
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
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
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
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 | |||||||
Documentation for this format |
Path | Conformance | ValueSet / Code | URI |
MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard | |
MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard | |
MedicinalProductDefinition.domain | required | EMADomainVS (a valid code from EMA - Domain)http://fhir.ch/ig/ch-epl/ValueSet/ema-domain from this IG | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | EdqmCombinedPharmaceuticalDoseFormVShttp://fhir.ch/ig/ch-epl/ValueSet/edqm-combined-pharmaceutical-dose-form from this IG | |
MedicinalProductDefinition.route | example | SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codes from the FHIR Standard | |
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard | |
MedicinalProductDefinition.additionalMonitoringIndicator | required | ChSMCAdditionalMonitoringIndicatorVS (a valid code from CH SMC - Additional Monitoring Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-additional-monitoring-indicator from this IG | |
MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard | |
MedicinalProductDefinition.pediatricUseIndicator | required | ChSMCPediatricUseIndicatorVS (a valid code from CH SMC - Pediatric Use Indicator)http://fhir.ch/ig/ch-epl/ValueSet/ch-SMC-pediatric-use-indicator from this IG | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:ATC | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:AuthorisationCategory | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:TherapeuticProductcode | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.classification:ProductType | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard | |
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard | |
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard | |
MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.name:en.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:en.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:en.usage.country | example | Pattern: CHhttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name:en.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name:en.usage.language | required | Pattern: enhttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.usage.country | example | Pattern: CHhttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name:de-CH.usage.language | required | Pattern: de-CHhttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.usage.country | example | Pattern: CHhttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name:fr-CH.usage.language | required | Pattern: fr-CHhttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.part.type | required | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.usage.country | example | Pattern: CHhttp://hl7.org/fhir/ValueSet/country from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | |
MedicinalProductDefinition.name:it-CH.usage.language | required | Pattern: it-CHhttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceTypehttp://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard | |
MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentialityhttp://hl7.org/fhir/ValueSet/medicinal-product-confidentiality from the FHIR Standard | |
MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
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(24 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:
Other representations of profile: CSV, Excel, Schematron