SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI
SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI
SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedManufacturedItem | Version: 0.1.0 | |||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: SubmittedManufacturedItem | ||
Details around the actual item, i.e tablet, solution, etc. that is packaged as part of the medicinal product.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ManufacturedItemDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ManufacturedItemDefinition |
ManufacturedItemDefinition | |||
  Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
 marketingStatusDates |
S | 0..1 | Period | Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates |
 status |
1..1 | code | draft | active | retired | unknown Required Pattern: active | |
| manufacturedDoseForm |
S | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: http://evs.nci.nih.gov/valueset/FDA/C54456 (required) |
  Slices for property |
S | 0..* | BackboneElement | General characteristics of this item Slice: Unordered, Open by value:type |
  property:All Slices |
Content/Rules for all slices | |||
  type |
S | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required) |
 value[x] |
S | 1..1 | CodeableConcept, Quantity, date, boolean, Attachment | A value for the characteristic |
| property:Color |
0..* | BackboneElement | General characteristics of this item | |
 type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
 code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCOLOR | |
  value[x] |
0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54453 (required) | |
| property:Imprint |
0..1 | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMPRINT | |
 value[x] |
0..1 | CodeableConcept | Text is only allowed as the imprint is a string. | |
| coding |
0..0 | |||
| text |
1..1 | string | Plain text representation of the concept | |
| property:Score |
0..1 | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSCORE | |
| value[x] |
0..1 | Quantity | A value for the characteristic | |
| property:Shape |
0..1 | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSHAPE | |
| value[x] |
0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54454 (required) | |
| property:Size |
0..1 | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSIZE | |
| value[x] |
0..1 | Quantity | A value for the characteristic | |
| property:Flavor |
0..* | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLFLAVOR | |
| value[x] |
0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C73339 (required) | |
 property:Image |
0..* | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMAGE | |
| value[x] |
0..1 | Attachment | A value for the characteristic | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| ManufacturedItemDefinition.manufacturedDoseForm | required | http://evs.nci.nih.gov/valueset/FDA/C54456http://evs.nci.nih.gov/valueset/FDA/C54456 | |
| ManufacturedItemDefinition.property.type | required | SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypesfrom this IG | |
| ManufacturedItemDefinition.property:Color.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54453http://evs.nci.nih.gov/valueset/FDA/C54453 | |
| ManufacturedItemDefinition.property:Shape.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54454http://evs.nci.nih.gov/valueset/FDA/C54454 | |
| ManufacturedItemDefinition.property:Flavor.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C73339http://evs.nci.nih.gov/valueset/FDA/C73339 |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ManufacturedItemDefinition |
0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| marketingStatusDates |
S | 0..1 | Period | Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. Required Pattern: active |
| manufacturedDoseForm |
SΣ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: http://evs.nci.nih.gov/valueset/FDA/C54456 (required) |
| Slices for property |
SΣ | 0..* | BackboneElement | General characteristics of this item Slice: Unordered, Open by value:type |
| property:All Slices |
Content/Rules for all slices | |||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required) |
 value[x] |
SΣ | 1..1 | A value for the characteristic | |
| valueCodeableConcept |
CodeableConcept | |||
| valueQuantity |
Quantity | |||
| valueDate |
date | |||
| valueBoolean |
boolean | |||
| valueAttachment |
Attachment | |||
| property:Color |
Σ | 0..* | BackboneElement | General characteristics of this item |
 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCOLOR | |
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54453 (required) |
| property:Imprint |
Σ | 0..1 | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMPRINT | |
| value[x] |
Σ | 0..1 | CodeableConcept | Text is only allowed as the imprint is a string. |
| text |
Σ | 1..1 | string | Plain text representation of the concept |
| property:Score |
Σ | 0..1 | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSCORE | |
| value[x] |
Σ | 0..1 | Quantity | A value for the characteristic |
| property:Shape |
Σ | 0..1 | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSHAPE | |
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54454 (required) |
| property:Size |
Σ | 0..1 | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSIZE | |
| value[x] |
Σ | 0..1 | Quantity | A value for the characteristic |
| property:Flavor |
Σ | 0..* | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLFLAVOR | |
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C73339 (required) |
| property:Image |
Σ | 0..* | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMAGE | |
| value[x] |
Σ | 0..1 | Attachment | A value for the characteristic |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| ManufacturedItemDefinition.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|4.3.0from the FHIR Standard | |
| ManufacturedItemDefinition.manufacturedDoseForm | required | http://evs.nci.nih.gov/valueset/FDA/C54456http://evs.nci.nih.gov/valueset/FDA/C54456 | |
| ManufacturedItemDefinition.property.type | required | SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypesfrom this IG | |
| ManufacturedItemDefinition.property:Color.type | example | Pattern: SPLCOLORhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Color.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54453http://evs.nci.nih.gov/valueset/FDA/C54453 | |
| ManufacturedItemDefinition.property:Imprint.type | example | Pattern: SPLIMPRINThttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Score.type | example | Pattern: SPLSCOREhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Shape.type | example | Pattern: SPLSHAPEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Shape.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54454http://evs.nci.nih.gov/valueset/FDA/C54454 | |
| ManufacturedItemDefinition.property:Size.type | example | Pattern: SPLSIZEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Flavor.type | example | Pattern: SPLFLAVORhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Flavor.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C73339http://evs.nci.nih.gov/valueset/FDA/C73339 | |
| ManufacturedItemDefinition.property:Image.type | example | Pattern: SPLIMAGEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ManufacturedItemDefinition | 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 | ||||
|---|---|---|---|---|---|---|---|---|
| ManufacturedItemDefinition |
0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| marketingStatusDates |
S | 0..1 | Period | Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates | ||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Unique identifier | ||||
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. Required Pattern: active | ||||
| manufacturedDoseForm |
SΣ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: http://evs.nci.nih.gov/valueset/FDA/C54456 (required) | ||||
| unitOfPresentation |
Σ | 0..1 | CodeableConcept | The “real world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient. | ||||
 manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues) | ||||
| ingredient |
Σ | 0..* | CodeableConcept | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: substance-codes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| Slices for property |
SΣ | 0..* | BackboneElement | General characteristics of this item Slice: Unordered, Open by value:type | ||||
| property: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 | ||||
| type |
SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required) | ||||
| value[x] |
SΣ | 1..1 | A value for the characteristic | |||||
| valueCodeableConcept |
CodeableConcept | |||||||
| valueQuantity |
Quantity | |||||||
| valueDate |
date | |||||||
| valueBoolean |
boolean | |||||||
| valueAttachment |
Attachment | |||||||
| property:Color |
Σ | 0..* | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCOLOR | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54453 (required) | ||||
| property:Imprint |
Σ | 0..1 | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMPRINT | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | CodeableConcept | Text is only allowed as the imprint is a string. | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| text |
Σ | 1..1 | string | Plain text representation of the concept | ||||
| property:Score |
Σ | 0..1 | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSCORE | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | Quantity | A value for the characteristic | ||||
| property:Shape |
Σ | 0..1 | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSHAPE | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54454 (required) | ||||
| property:Size |
Σ | 0..1 | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSIZE | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | Quantity | A value for the characteristic | ||||
| property:Flavor |
Σ | 0..* | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLFLAVOR | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C73339 (required) | ||||
| property:Image |
Σ | 0..* | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMAGE | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | Attachment | A value for the characteristic | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| ManufacturedItemDefinition.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| ManufacturedItemDefinition.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|4.3.0from the FHIR Standard | ||||
| ManufacturedItemDefinition.manufacturedDoseForm | required | http://evs.nci.nih.gov/valueset/FDA/C54456http://evs.nci.nih.gov/valueset/FDA/C54456 | ||||
| ManufacturedItemDefinition.unitOfPresentation | example | UnitOfPresentationhttp://hl7.org/fhir/ValueSet/unit-of-presentationfrom the FHIR Standard | ||||
| ManufacturedItemDefinition.ingredient | example | http://hl7.org/fhir/ValueSet/substance-codeshttp://hl7.org/fhir/ValueSet/substance-codes | ||||
| ManufacturedItemDefinition.property.type | required | SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypesfrom this IG | ||||
| ManufacturedItemDefinition.property:Color.type | example | Pattern: SPLCOLORhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Color.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54453http://evs.nci.nih.gov/valueset/FDA/C54453 | ||||
| ManufacturedItemDefinition.property:Imprint.type | example | Pattern: SPLIMPRINThttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Score.type | example | Pattern: SPLSCOREhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Shape.type | example | Pattern: SPLSHAPEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Shape.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54454http://evs.nci.nih.gov/valueset/FDA/C54454 | ||||
| ManufacturedItemDefinition.property:Size.type | example | Pattern: SPLSIZEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Flavor.type | example | Pattern: SPLFLAVORhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Flavor.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C73339http://evs.nci.nih.gov/valueset/FDA/C73339 | ||||
| ManufacturedItemDefinition.property:Image.type | example | Pattern: SPLIMAGEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ManufacturedItemDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| dom-r4b | warning | ManufacturedItemDefinition.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ManufacturedItemDefinition
Summary
Mandatory: 0 element(2 nested mandatory elements)
Must-Support: 5 elements
Prohibited: 1 element
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Maturity: 1
Differential View
This structure is derived from ManufacturedItemDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ManufacturedItemDefinition |
ManufacturedItemDefinition | |||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| marketingStatusDates |
S | 0..1 | Period | Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates |
| status |
1..1 | code | draft | active | retired | unknown Required Pattern: active | |
| manufacturedDoseForm |
S | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: http://evs.nci.nih.gov/valueset/FDA/C54456 (required) |
| Slices for property |
S | 0..* | BackboneElement | General characteristics of this item Slice: Unordered, Open by value:type |
| property:All Slices |
Content/Rules for all slices | |||
| type |
S | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required) |
| value[x] |
S | 1..1 | CodeableConcept, Quantity, date, boolean, Attachment | A value for the characteristic |
| property:Color |
0..* | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCOLOR | |
| value[x] |
0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54453 (required) | |
| property:Imprint |
0..1 | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMPRINT | |
| value[x] |
0..1 | CodeableConcept | Text is only allowed as the imprint is a string. | |
| coding |
0..0 | |||
| text |
1..1 | string | Plain text representation of the concept | |
| property:Score |
0..1 | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSCORE | |
| value[x] |
0..1 | Quantity | A value for the characteristic | |
| property:Shape |
0..1 | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSHAPE | |
| value[x] |
0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54454 (required) | |
| property:Size |
0..1 | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSIZE | |
| value[x] |
0..1 | Quantity | A value for the characteristic | |
| property:Flavor |
0..* | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLFLAVOR | |
| value[x] |
0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C73339 (required) | |
| property:Image |
0..* | BackboneElement | General characteristics of this item | |
| type |
1..1 | CodeableConcept | A code expressing the type of characteristic 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMAGE | |
| value[x] |
0..1 | Attachment | A value for the characteristic | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| ManufacturedItemDefinition.manufacturedDoseForm | required | http://evs.nci.nih.gov/valueset/FDA/C54456http://evs.nci.nih.gov/valueset/FDA/C54456 | |
| ManufacturedItemDefinition.property.type | required | SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypesfrom this IG | |
| ManufacturedItemDefinition.property:Color.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54453http://evs.nci.nih.gov/valueset/FDA/C54453 | |
| ManufacturedItemDefinition.property:Shape.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54454http://evs.nci.nih.gov/valueset/FDA/C54454 | |
| ManufacturedItemDefinition.property:Flavor.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C73339http://evs.nci.nih.gov/valueset/FDA/C73339 |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ManufacturedItemDefinition |
0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| marketingStatusDates |
S | 0..1 | Period | Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. Required Pattern: active |
| manufacturedDoseForm |
SΣ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: http://evs.nci.nih.gov/valueset/FDA/C54456 (required) |
| Slices for property |
SΣ | 0..* | BackboneElement | General characteristics of this item Slice: Unordered, Open by value:type |
| property:All Slices |
Content/Rules for all slices | |||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required) |
| value[x] |
SΣ | 1..1 | A value for the characteristic | |
| valueCodeableConcept |
CodeableConcept | |||
| valueQuantity |
Quantity | |||
| valueDate |
date | |||
| valueBoolean |
boolean | |||
| valueAttachment |
Attachment | |||
| property:Color |
Σ | 0..* | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCOLOR | |
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54453 (required) |
| property:Imprint |
Σ | 0..1 | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMPRINT | |
| value[x] |
Σ | 0..1 | CodeableConcept | Text is only allowed as the imprint is a string. |
| text |
Σ | 1..1 | string | Plain text representation of the concept |
| property:Score |
Σ | 0..1 | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSCORE | |
| value[x] |
Σ | 0..1 | Quantity | A value for the characteristic |
| property:Shape |
Σ | 0..1 | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSHAPE | |
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54454 (required) |
| property:Size |
Σ | 0..1 | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSIZE | |
| value[x] |
Σ | 0..1 | Quantity | A value for the characteristic |
| property:Flavor |
Σ | 0..* | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLFLAVOR | |
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C73339 (required) |
| property:Image |
Σ | 0..* | BackboneElement | General characteristics of this item |
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMAGE | |
| value[x] |
Σ | 0..1 | Attachment | A value for the characteristic |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| ManufacturedItemDefinition.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|4.3.0from the FHIR Standard | |
| ManufacturedItemDefinition.manufacturedDoseForm | required | http://evs.nci.nih.gov/valueset/FDA/C54456http://evs.nci.nih.gov/valueset/FDA/C54456 | |
| ManufacturedItemDefinition.property.type | required | SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypesfrom this IG | |
| ManufacturedItemDefinition.property:Color.type | example | Pattern: SPLCOLORhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Color.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54453http://evs.nci.nih.gov/valueset/FDA/C54453 | |
| ManufacturedItemDefinition.property:Imprint.type | example | Pattern: SPLIMPRINThttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Score.type | example | Pattern: SPLSCOREhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Shape.type | example | Pattern: SPLSHAPEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Shape.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54454http://evs.nci.nih.gov/valueset/FDA/C54454 | |
| ManufacturedItemDefinition.property:Size.type | example | Pattern: SPLSIZEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Flavor.type | example | Pattern: SPLFLAVORhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | |
| ManufacturedItemDefinition.property:Flavor.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C73339http://evs.nci.nih.gov/valueset/FDA/C73339 | |
| ManufacturedItemDefinition.property:Image.type | example | Pattern: SPLIMAGEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ManufacturedItemDefinition | 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 | ||||
|---|---|---|---|---|---|---|---|---|
| ManufacturedItemDefinition |
0..* | ManufacturedItemDefinition | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| marketingStatusDates |
S | 0..1 | Period | Manufactured Item Marketing Status Date Range URL: http://hl7.org/fhir/us/spl/StructureDefinition/itemMarketingStatusDates | ||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Unique identifier | ||||
| status |
?!Σ | 1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact. Required Pattern: active | ||||
| manufacturedDoseForm |
SΣ | 1..1 | CodeableConcept | Dose form as manufactured (before any necessary transformation) Binding: http://evs.nci.nih.gov/valueset/FDA/C54456 (required) | ||||
| unitOfPresentation |
Σ | 0..1 | CodeableConcept | The “real world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient. | ||||
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues) | ||||
| ingredient |
Σ | 0..* | CodeableConcept | The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: substance-codes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set. | ||||
| Slices for property |
SΣ | 0..* | BackboneElement | General characteristics of this item Slice: Unordered, Open by value:type | ||||
| property: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 | ||||
| type |
SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: SPL Product Characteristic Types ValueSet (required) | ||||
| value[x] |
SΣ | 1..1 | A value for the characteristic | |||||
| valueCodeableConcept |
CodeableConcept | |||||||
| valueQuantity |
Quantity | |||||||
| valueDate |
date | |||||||
| valueBoolean |
boolean | |||||||
| valueAttachment |
Attachment | |||||||
| property:Color |
Σ | 0..* | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCOLOR | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54453 (required) | ||||
| property:Imprint |
Σ | 0..1 | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMPRINT | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | CodeableConcept | Text is only allowed as the imprint is a string. | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| text |
Σ | 1..1 | string | Plain text representation of the concept | ||||
| property:Score |
Σ | 0..1 | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSCORE | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | Quantity | A value for the characteristic | ||||
| property:Shape |
Σ | 0..1 | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSHAPE | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C54454 (required) | ||||
| property:Size |
Σ | 0..1 | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLSIZE | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | Quantity | A value for the characteristic | ||||
| property:Flavor |
Σ | 0..* | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLFLAVOR | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | CodeableConcept | A value for the characteristic Binding: http://evs.nci.nih.gov/valueset/FDA/C73339 (required) | ||||
| property:Image |
Σ | 0..* | BackboneElement | General characteristics of this item | ||||
| 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: product-characteristic-codes (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. 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: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLIMAGE | |||||
| 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 | |||||
| value[x] |
Σ | 0..1 | Attachment | A value for the characteristic | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| ManufacturedItemDefinition.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| ManufacturedItemDefinition.status | required | Pattern: activehttp://hl7.org/fhir/ValueSet/publication-status|4.3.0from the FHIR Standard | ||||
| ManufacturedItemDefinition.manufacturedDoseForm | required | http://evs.nci.nih.gov/valueset/FDA/C54456http://evs.nci.nih.gov/valueset/FDA/C54456 | ||||
| ManufacturedItemDefinition.unitOfPresentation | example | UnitOfPresentationhttp://hl7.org/fhir/ValueSet/unit-of-presentationfrom the FHIR Standard | ||||
| ManufacturedItemDefinition.ingredient | example | http://hl7.org/fhir/ValueSet/substance-codeshttp://hl7.org/fhir/ValueSet/substance-codes | ||||
| ManufacturedItemDefinition.property.type | required | SubmittedMedicinalProductCharacteristicTypes (a valid code from SPL Product Characteristic Types CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-SubmittedMedicinalProductCharacteristicTypesfrom this IG | ||||
| ManufacturedItemDefinition.property:Color.type | example | Pattern: SPLCOLORhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Color.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54453http://evs.nci.nih.gov/valueset/FDA/C54453 | ||||
| ManufacturedItemDefinition.property:Imprint.type | example | Pattern: SPLIMPRINThttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Score.type | example | Pattern: SPLSCOREhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Shape.type | example | Pattern: SPLSHAPEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Shape.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C54454http://evs.nci.nih.gov/valueset/FDA/C54454 | ||||
| ManufacturedItemDefinition.property:Size.type | example | Pattern: SPLSIZEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Flavor.type | example | Pattern: SPLFLAVORhttp://hl7.org/fhir/ValueSet/product-characteristic-codes | ||||
| ManufacturedItemDefinition.property:Flavor.value[x] | required | http://evs.nci.nih.gov/valueset/FDA/C73339http://evs.nci.nih.gov/valueset/FDA/C73339 | ||||
| ManufacturedItemDefinition.property:Image.type | example | Pattern: SPLIMAGEhttp://hl7.org/fhir/ValueSet/product-characteristic-codes |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | ManufacturedItemDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | ManufacturedItemDefinition | 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 | ManufacturedItemDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | ManufacturedItemDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| dom-r4b | warning | ManufacturedItemDefinition.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from ManufacturedItemDefinition
Summary
Mandatory: 0 element(2 nested mandatory elements)
Must-Support: 5 elements
Prohibited: 1 element
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Maturity: 1
Other representations of profile: CSV, Excel, Schematron
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.1.0 based on FHIR 4.3.0. Generated 2024-05-02
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change