Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description | Version: 0.1.20 | |||
| Draft as of 2024-03-04 | Computable Name: DrugProductDescription | |||
Includes the properties of the drug product and components. Profile of Drug Product profile.
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 | MedicinalProductDefinition | |||
  meta | ||||
  profile | S | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
 identifier | 0..1 | Identifier | optional user designated identifier | |
| description | S | 0..1 | markdown | Drug Product Description |
| combinedPharmaceuticalDoseForm | S | 1..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product |
 coding | ||||
 code | S | 1..1 | code | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required) |
| route | S | 0..1 | CodeableConcept | Route of Administration |
| coding | ||||
| code | S | 1..1 | code | Symbol in syntax defined by the system Binding: Drug Route Of Administration Terminology (required) |
 Slices for name | S | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type |
 name:All Slices | Content/Rules for all slices | |||
  productName | S | 1..1 | string | The full product name |
 type | S | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary |
 name:Proprietary | 0..1 | BackboneElement | The product's name, including full name and possibly coded parts | |
 type | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PROP | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Proprietary | |
 part | S | 0..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type |
 part:All Slices | Content/Rules for all slices | |||
| part | S | 1..1 | string | A fragment of a product name |
| type | S | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (required) |
| name:NonProprietary | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts | |
| type | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: NON | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Non-Proprietary | |
| Slices for part | S | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type |
| part:All Slices | Content/Rules for all slices | |||
| part | S | 1..1 | string | A fragment of a product name |
| type | S | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (required) |
| part:Scientific | 1..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SCI | |
| part:Invented | 0..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: INV | |
| part:Formulation | 0..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FORMUL | |
| part:Strength | 1..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: STR | |
| part:Container | 0..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CON | |
| part:Form | 0..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FRM | |
| part:Device | 0..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DEV | |
| crossReference | S | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product |
 product | 1..1 | CodeableReference(Drug Product Description) | Co-Packaged Product | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding.code | required | SplPharmaceuticalDosageFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminologyfrom this IG | |
| MedicinalProductDefinition.route.coding.code | required | SplDrugRouteofAdministrationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminologyfrom this IG | |
| MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG | |
| MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |
 meta | Σ | 0..1 | Meta | Metadata about the resource |
 profile | SΣ | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained | 0..* | Resource | Contained, inline Resources | |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 0..1 | Identifier | optional user designated identifier |
| status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| description | SΣ | 0..1 | markdown | Drug Product Description |
| combinedPharmaceuticalDoseForm | SΣ | 1..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing |
| coding | Σ | 0..* | Coding | Code defined by a terminology system |
| code | SΣC | 1..1 | code | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required) |
| route | SΣ | 0..1 | CodeableConcept | Route of Administration Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body. |
| coding | Σ | 0..* | Coding | Code defined by a terminology system |
| code | SΣC | 1..1 | code | Symbol in syntax defined by the system Binding: Drug Route Of Administration Terminology (required) |
| Slices for name | SΣ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type |
| name:All Slices | Content/Rules for all slices | |||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| productName | SΣ | 1..1 | string | The full product name |
| type | SΣ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. |
| name:Proprietary | 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 |
| 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. 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PROP | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Proprietary | |
| part | SΣ | 0..* | BackboneElement | Coding words or phrases of the name |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | SΣ | 1..1 | string | A fragment of a product name |
| type | SΣ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (required) |
| name:NonProprietary | Σ | 1..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 |
| 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. 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: NON | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Non-Proprietary | |
| Slices for part | SΣ | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type |
| part:All Slices | Content/Rules for all slices | |||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | SΣ | 1..1 | string | A fragment of a product name |
| type | SΣ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (required) |
| part:Scientific | Σ | 1..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SCI | |
| part:Invented | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: INV | |
| part:Formulation | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FORMUL | |
| part:Strength | Σ | 1..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: STR | |
| part:Container | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CON | |
| part:Form | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FRM | |
| part:Device | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DEV | |
| crossReference | SΣ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| product | Σ | 1..1 | CodeableReference(Drug Product Description) | Co-Packaged Product |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | CombinedDoseFormhttp://hl7.org/fhir/ValueSet/combined-dose-formfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding.code | required | SplPharmaceuticalDosageFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminologyfrom this IG | |
| MedicinalProductDefinition.route | example | SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.route.coding.code | required | SplDrugRouteofAdministrationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminologyfrom this IG | |
| MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.type | example | Pattern: PROP("Proprietary")http://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG | |
| MedicinalProductDefinition.name:NonProprietary.type | example | Pattern: NON("Non-Proprietary")http://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG | |
| MedicinalProductDefinition.name:NonProprietary.part:Scientific.type | example | Pattern: SCIhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Invented.type | example | Pattern: INVhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Formulation.type | example | Pattern: FORMULhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Strength.type | example | Pattern: STRhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Container.type | example | Pattern: CONhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Form.type | example | Pattern: FRMhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Device.type | example | Pattern: DEVhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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 | Detailed definition of a medicinal product | |||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
 extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| versionId | Σ | 0..1 | id | Version specific identifier | ||||
| lastUpdated | Σ | 0..1 | instant | When the resource version last changed | ||||
| source | Σ | 0..1 | uri | Identifies where the resource comes from | ||||
| profile | SΣ | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
| security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
| tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
| 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 | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..1 | Identifier | optional user designated identifier | ||||
| type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: MedicinalProductType (example): Overall defining type of this medicinal product. | ||||
| domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary). | ||||
| version | Σ | 0..1 | string | A business identifier relating to a specific version of the product | ||||
| status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable | ||||
| description | SΣ | 0..1 | markdown | Drug Product Description | ||||
| combinedPharmaceuticalDoseForm | SΣ | 1..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing | ||||
| 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 | 0..* | 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 | 0..1 | uri | Identity of the terminology system | ||||
| version | Σ | 0..1 | string | Version of the system - if relevant | ||||
| code | SΣC | 1..1 | code | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required) | ||||
| 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 | SΣ | 0..1 | CodeableConcept | Route of Administration Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body. | ||||
| 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 | 0..* | 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 | 0..1 | uri | Identity of the terminology system | ||||
| version | Σ | 0..1 | string | Version of the system - if relevant | ||||
| code | SΣC | 1..1 | code | Symbol in syntax defined by the system Binding: Drug Route Of Administration Terminology (required) | ||||
| 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 | ||||
| indication | Σ | 0..1 | markdown | Description of indication(s) for this product, used when structured indications are not required | ||||
| 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: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | ||||
| 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: PediatricUse (example): Suitability for age groups, in particular children. | ||||
| classification | Σ | 0..* | 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. | ||||
| marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization | ||||
| 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(DocumentReference) | Additional documentation about the medicinal product | ||||
| 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 | SΣ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type | ||||
| 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 | SΣ | 1..1 | string | The full product name | ||||
| type | SΣ | 1..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:Proprietary | 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 | ||||
| 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. 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PROP | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: Proprietary | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| part | SΣ | 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 | SΣ | 1..1 | string | A fragment of a product name | ||||
| type | SΣ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (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 | ||||
| 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:NonProprietary | Σ | 1..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 | ||||
| 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. 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: NON | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: Non-Proprietary | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| Slices for part | SΣ | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type | ||||
| part: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 | ||||
| part | SΣ | 1..1 | string | A fragment of a product name | ||||
| type | SΣ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (required) | ||||
| part:Scientific | Σ | 1..* | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SCI | |||||
| 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 | |||||
| part:Invented | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: INV | |||||
| 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 | |||||
| part:Formulation | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FORMUL | |||||
| 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 | |||||
| part:Strength | Σ | 1..* | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: STR | |||||
| 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 | |||||
| part:Container | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CON | |||||
| 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 | |||||
| part:Form | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FRM | |||||
| 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 | |||||
| part:Device | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DEV | |||||
| 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 | |||||
| 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
| ||||
| crossReference | SΣ | 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(Drug Product Description) | Co-Packaged 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.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labelsfrom the FHIR Standard | |
| MedicinalProductDefinition.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tagsfrom the FHIR Standard | |
| MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-typefrom the FHIR Standard | |
| MedicinalProductDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | CombinedDoseFormhttp://hl7.org/fhir/ValueSet/combined-dose-formfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding.code | required | SplPharmaceuticalDosageFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminologyfrom this IG | |
| MedicinalProductDefinition.route | example | SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.route.coding.code | required | SplDrugRouteofAdministrationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminologyfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supplyfrom the FHIR Standard | |
| MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoringhttp://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoringfrom the FHIR Standard | |
| MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measuresfrom the FHIR Standard | |
| MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUsehttp://hl7.org/fhir/ValueSet/medicinal-product-pediatric-usefrom the FHIR Standard | |
| MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-typefrom the FHIR Standard | |
| MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.type | example | Pattern: PROP("Proprietary")http://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG | |
| MedicinalProductDefinition.name:Proprietary.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.type | example | Pattern: NON("Non-Proprietary")http://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG | |
| MedicinalProductDefinition.name:NonProprietary.part:Scientific.type | example | Pattern: SCIhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Invented.type | example | Pattern: INVhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Formulation.type | example | Pattern: FORMULhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Strength.type | example | Pattern: STRhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Container.type | example | Pattern: CONhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Form.type | example | Pattern: FRMhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Device.type | example | Pattern: DEVhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceTypehttp://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-typefrom the FHIR Standard | |
| MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentialityhttp://hl7.org/fhir/ValueSet/medicinal-product-confidentialityfrom the FHIR Standard | |
| MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom 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: 5 elements (3 nested mandatory elements)
Must-Support: 16 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from MedicinalProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProductDefinition | MedicinalProductDefinition | |||
| meta | ||||
| profile | S | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| identifier | 0..1 | Identifier | optional user designated identifier | |
| description | S | 0..1 | markdown | Drug Product Description |
| combinedPharmaceuticalDoseForm | S | 1..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product |
| coding | ||||
| code | S | 1..1 | code | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required) |
| route | S | 0..1 | CodeableConcept | Route of Administration |
| coding | ||||
| code | S | 1..1 | code | Symbol in syntax defined by the system Binding: Drug Route Of Administration Terminology (required) |
| Slices for name | S | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type |
| name:All Slices | Content/Rules for all slices | |||
| productName | S | 1..1 | string | The full product name |
| type | S | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary |
| name:Proprietary | 0..1 | BackboneElement | The product's name, including full name and possibly coded parts | |
| type | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PROP | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Proprietary | |
| part | S | 0..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type |
| part:All Slices | Content/Rules for all slices | |||
| part | S | 1..1 | string | A fragment of a product name |
| type | S | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (required) |
| name:NonProprietary | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts | |
| type | 0..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: NON | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Non-Proprietary | |
| Slices for part | S | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type |
| part:All Slices | Content/Rules for all slices | |||
| part | S | 1..1 | string | A fragment of a product name |
| type | S | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (required) |
| part:Scientific | 1..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SCI | |
| part:Invented | 0..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: INV | |
| part:Formulation | 0..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FORMUL | |
| part:Strength | 1..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: STR | |
| part:Container | 0..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CON | |
| part:Form | 0..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FRM | |
| part:Device | 0..* | BackboneElement | Coding words or phrases of the name | |
| type | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DEV | |
| crossReference | S | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product |
| product | 1..1 | CodeableReference(Drug Product Description) | Co-Packaged Product | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding.code | required | SplPharmaceuticalDosageFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminologyfrom this IG | |
| MedicinalProductDefinition.route.coding.code | required | SplDrugRouteofAdministrationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminologyfrom this IG | |
| MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG | |
| MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| MedicinalProductDefinition | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product | |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| profile | SΣ | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained | 0..* | Resource | Contained, inline Resources | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 0..1 | Identifier | optional user designated identifier |
| status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| description | SΣ | 0..1 | markdown | Drug Product Description |
| combinedPharmaceuticalDoseForm | SΣ | 1..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing |
| coding | Σ | 0..* | Coding | Code defined by a terminology system |
| code | SΣC | 1..1 | code | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required) |
| route | SΣ | 0..1 | CodeableConcept | Route of Administration Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body. |
| coding | Σ | 0..* | Coding | Code defined by a terminology system |
| code | SΣC | 1..1 | code | Symbol in syntax defined by the system Binding: Drug Route Of Administration Terminology (required) |
| Slices for name | SΣ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type |
| name:All Slices | Content/Rules for all slices | |||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| productName | SΣ | 1..1 | string | The full product name |
| type | SΣ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. |
| name:Proprietary | 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 |
| 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. 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PROP | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Proprietary | |
| part | SΣ | 0..* | BackboneElement | Coding words or phrases of the name |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | SΣ | 1..1 | string | A fragment of a product name |
| type | SΣ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (required) |
| name:NonProprietary | Σ | 1..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 |
| 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. 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: NON | |
| display | 1..1 | string | Representation defined by the system Fixed Value: Non-Proprietary | |
| Slices for part | SΣ | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type |
| part:All Slices | Content/Rules for all slices | |||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| part | SΣ | 1..1 | string | A fragment of a product name |
| type | SΣ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (required) |
| part:Scientific | Σ | 1..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SCI | |
| part:Invented | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: INV | |
| part:Formulation | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FORMUL | |
| part:Strength | Σ | 1..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: STR | |
| part:Container | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CON | |
| part:Form | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FRM | |
| part:Device | Σ | 0..* | BackboneElement | Coding words or phrases of the name |
| 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DEV | |
| crossReference | SΣ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| product | Σ | 1..1 | CodeableReference(Drug Product Description) | Co-Packaged Product |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | CombinedDoseFormhttp://hl7.org/fhir/ValueSet/combined-dose-formfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding.code | required | SplPharmaceuticalDosageFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminologyfrom this IG | |
| MedicinalProductDefinition.route | example | SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.route.coding.code | required | SplDrugRouteofAdministrationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminologyfrom this IG | |
| MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.type | example | Pattern: PROP("Proprietary")http://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG | |
| MedicinalProductDefinition.name:NonProprietary.type | example | Pattern: NON("Non-Proprietary")http://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG | |
| MedicinalProductDefinition.name:NonProprietary.part:Scientific.type | example | Pattern: SCIhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Invented.type | example | Pattern: INVhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Formulation.type | example | Pattern: FORMULhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Strength.type | example | Pattern: STRhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Container.type | example | Pattern: CONhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Form.type | example | Pattern: FRMhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Device.type | example | Pattern: DEVhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom 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 | Detailed definition of a medicinal product | |||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| id | 0..1 | id | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| versionId | Σ | 0..1 | id | Version specific identifier | ||||
| lastUpdated | Σ | 0..1 | instant | When the resource version last changed | ||||
| source | Σ | 0..1 | uri | Identifies where the resource comes from | ||||
| profile | SΣ | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to | ||||
| security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System. | ||||
| tag | Σ | 0..* | Coding | Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
| 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 | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..1 | Identifier | optional user designated identifier | ||||
| type | Σ | 0..1 | CodeableConcept | Regulatory type, e.g. Investigational or Authorized Binding: MedicinalProductType (example): Overall defining type of this medicinal product. | ||||
| domain | Σ | 0..1 | CodeableConcept | If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary). | ||||
| version | Σ | 0..1 | string | A business identifier relating to a specific version of the product | ||||
| status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable | ||||
| description | SΣ | 0..1 | markdown | Drug Product Description | ||||
| combinedPharmaceuticalDoseForm | SΣ | 1..1 | CodeableConcept | The dose form for a single part product, or combined form of a multiple part product Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing | ||||
| 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 | 0..* | 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 | 0..1 | uri | Identity of the terminology system | ||||
| version | Σ | 0..1 | string | Version of the system - if relevant | ||||
| code | SΣC | 1..1 | code | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required) | ||||
| 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 | SΣ | 0..1 | CodeableConcept | Route of Administration Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body. | ||||
| 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 | 0..* | 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 | 0..1 | uri | Identity of the terminology system | ||||
| version | Σ | 0..1 | string | Version of the system - if relevant | ||||
| code | SΣC | 1..1 | code | Symbol in syntax defined by the system Binding: Drug Route Of Administration Terminology (required) | ||||
| 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 | ||||
| indication | Σ | 0..1 | markdown | Description of indication(s) for this product, used when structured indications are not required | ||||
| 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: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring). | ||||
| 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: PediatricUse (example): Suitability for age groups, in particular children. | ||||
| classification | Σ | 0..* | 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. | ||||
| marketingStatus | Σ | 0..* | MarketingStatus | Marketing status of the medicinal product, in contrast to marketing authorization | ||||
| 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(DocumentReference) | Additional documentation about the medicinal product | ||||
| 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 | SΣ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type | ||||
| 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 | SΣ | 1..1 | string | The full product name | ||||
| type | SΣ | 1..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:Proprietary | 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 | ||||
| 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. 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: PROP | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: Proprietary | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| part | SΣ | 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 | SΣ | 1..1 | string | A fragment of a product name | ||||
| type | SΣ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (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 | ||||
| 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:NonProprietary | Σ | 1..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 | ||||
| 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. 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/pq-cmc-fda/CodeSystem/cmc-product-name-types | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: NON | |||||
| display | 1..1 | string | Representation defined by the system Fixed Value: Non-Proprietary | |||||
| userSelected | 0..1 | boolean | If this coding was chosen directly by the user | |||||
| text | 0..1 | string | Plain text representation of the concept | |||||
| Slices for part | SΣ | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Open by value:type | ||||
| part: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 | ||||
| part | SΣ | 1..1 | string | A fragment of a product name | ||||
| type | SΣ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: Name Part Terminology (required) | ||||
| part:Scientific | Σ | 1..* | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: SCI | |||||
| 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 | |||||
| part:Invented | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: INV | |||||
| 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 | |||||
| part:Formulation | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FORMUL | |||||
| 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 | |||||
| part:Strength | Σ | 1..* | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: STR | |||||
| 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 | |||||
| part:Container | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: CON | |||||
| 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 | |||||
| part:Form | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: FRM | |||||
| 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 | |||||
| part:Device | 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. 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://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 | |||||
| version | 0..1 | string | Version of the system - if relevant | |||||
| code | 1..1 | code | Symbol in syntax defined by the system Fixed Value: DEV | |||||
| 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 | |||||
| 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
| ||||
| crossReference | SΣ | 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(Drug Product Description) | Co-Packaged 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.meta.security | extensible | AllSecurityLabelshttp://hl7.org/fhir/ValueSet/security-labelsfrom the FHIR Standard | |
| MedicinalProductDefinition.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tagsfrom the FHIR Standard | |
| MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-typefrom the FHIR Standard | |
| MedicinalProductDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domainfrom the FHIR Standard | |
| MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | CombinedDoseFormhttp://hl7.org/fhir/ValueSet/combined-dose-formfrom the FHIR Standard | |
| MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding.code | required | SplPharmaceuticalDosageFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminologyfrom this IG | |
| MedicinalProductDefinition.route | example | SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.route.coding.code | required | SplDrugRouteofAdministrationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminologyfrom this IG | |
| MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supplyfrom the FHIR Standard | |
| MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoringhttp://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoringfrom the FHIR Standard | |
| MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measuresfrom the FHIR Standard | |
| MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUsehttp://hl7.org/fhir/ValueSet/medicinal-product-pediatric-usefrom the FHIR Standard | |
| MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classificationfrom the FHIR Standard | |
| MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-typefrom the FHIR Standard | |
| MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-typefrom the FHIR Standard | |
| MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codesfrom the FHIR Standard | |
| MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.part.type | example | ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.type | example | Pattern: PROP("Proprietary")http://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG | |
| MedicinalProductDefinition.name:Proprietary.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name:Proprietary.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.type | example | Pattern: NON("Non-Proprietary")http://hl7.org/fhir/ValueSet/medicinal-product-name-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminologyfrom this IG | |
| MedicinalProductDefinition.name:NonProprietary.part:Scientific.type | example | Pattern: SCIhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Invented.type | example | Pattern: INVhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Formulation.type | example | Pattern: FORMULhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Strength.type | example | Pattern: STRhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Container.type | example | Pattern: CONhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Form.type | example | Pattern: FRMhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.part:Device.type | example | Pattern: DEVhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-typefrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.usage.country | example | CountryValueSethttp://hl7.org/fhir/ValueSet/countryfrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.usage.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| MedicinalProductDefinition.name:NonProprietary.usage.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceTypehttp://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-typefrom the FHIR Standard | |
| MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentialityhttp://hl7.org/fhir/ValueSet/medicinal-product-confidentialityfrom the FHIR Standard | |
| MedicinalProductDefinition.characteristic.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom 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: 5 elements (3 nested mandatory elements)
Must-Support: 16 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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