Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 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-fda/ 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: 1.1.6 | |||
Active as of 2024-09-22 | Computable Name: DrugProductDescription | |||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.24 |
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 | 0..* | 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 | S | 1..1 | Coding | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required) |
route | S | 1..* | CodeableConcept | Route of Administration 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 |
usage | ||||
jurisdiction | 0..0 | |||
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: PQCMC Name Part Terminology (required) |
usage | ||||
jurisdiction | 0..0 | |||
name:NonProprietary | C | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once |
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: PQCMC 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 | |
text | S | 1..1 | string | Plain text representation of the concept |
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 | |
usage | ||||
jurisdiction | 0..0 | |||
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 | |
type | ||||
text | 0..1 | string | Plain text representation of the concept Required Pattern: co-packaged | |
Documentation for this format |
Path | Conformance | ValueSet | URI |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding | required | SplPharmaceuticalDosageFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology from this IG | |
MedicinalProductDefinition.route | required | SplDrugRouteofAdministrationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology from this IG | |
MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology from this IG | |
MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology from this IG |
Id | Grade | Path(s) | Details | Requirements |
cmc-strength-name-must-reference-scientific | error | MedicinalProductDefinition.name:NonProprietary | strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once : defineVariable('system','http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2').select( defineVariable('strengthReferences',part.type.where(coding.exists(code = 'STR' and system = %system)).text).select( defineVariable('scientificNames',part.where(type.coding.exists(code = 'SCI' and system = %system)).part).select( %strengthReferences = %scientificNames and %scientificNames.distinct() = %scientificNames ))) |
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 | 0..* | 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 | SΣ | 1..1 | Coding | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required) |
route | SΣ | 1..* | CodeableConcept | Route of Administration 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: PQCMC Name Part Terminology (required) |
name:NonProprietary | ΣC | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once |
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: PQCMC 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 | |
text | SΣ | 1..1 | string | Plain text representation of the concept |
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-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | CombinedDoseFormhttp://hl7.org/fhir/ValueSet/combined-dose-form from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding | required | SplPharmaceuticalDosageFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology from this IG | |
MedicinalProductDefinition.route | required | SplDrugRouteofAdministrationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology from this IG | |
MedicinalProductDefinition.name.type | example | ProductNameTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:Proprietary.type | example | Pattern: PROP("Proprietary")http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology from this IG | |
MedicinalProductDefinition.name:NonProprietary.type | example | Pattern: NON("Non-Proprietary")http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard | |
MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology from this IG | |
MedicinalProductDefinition.name:NonProprietary.part:Scientific.type | example | Pattern: SCIhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:NonProprietary.part:Invented.type | example | Pattern: INVhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:NonProprietary.part:Formulation.type | example | Pattern: FORMULhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:NonProprietary.part:Strength.type | example | Pattern: STRhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:NonProprietary.part:Container.type | example | Pattern: CONhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:NonProprietary.part:Form.type | example | Pattern: FRMhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard | |
MedicinalProductDefinition.name:NonProprietary.part:Device.type | example | Pattern: DEVhttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
cmc-strength-name-must-reference-scientific | error | MedicinalProductDefinition.name:NonProprietary | strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once : defineVariable('system','http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2').select( defineVariable('strengthReferences',part.type.where(coding.exists(code = 'STR' and system = %system)).text).select( defineVariable('scientificNames',part.where(type.coding.exists(code = 'SCI' and system = %system)).part).select( %strengthReferences = %scientificNames and %scientificNames.distinct() = %scientificNames ))) | |
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 | 0..* | 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 | SΣ | 1..1 | Coding | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required) | ||||
text | Σ | 0..1 | string | Plain text representation of the concept | ||||
route | SΣ | 1..* | CodeableConcept | Route of Administration Binding: Drug Route Of Administration Terminology (required) | ||||
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 | ||||
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: PQCMC 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 | ||||
language | Σ | 1..1 | CodeableConcept | Language code for this name Binding: AllLanguages (required): IETF language tag for a human language
| ||||
name:NonProprietary | ΣC | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once | ||||
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: PQCMC 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 | |||||
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 | ||||
text | SΣ | 1..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 | ||||
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. | ||||
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 | ||||
text | Σ | 0..1 | string | Plain text representation of the concept Required Pattern: co-packaged | ||||
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-labels from the FHIR Standard | |
MedicinalProductDefinition.meta.tag | example | CommonTagshttp://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard | |
MedicinalProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
MedicinalProductDefinition.type | example | MedicinalProductTypehttp://hl7.org/fhir/ValueSet/medicinal-product-type from the FHIR Standard | |
MedicinalProductDefinition.domain | example | MedicinalProductDomainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain from the FHIR Standard | |
MedicinalProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | example | CombinedDoseFormhttp://hl7.org/fhir/ValueSet/combined-dose-form from the FHIR Standard | |
MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding | required | SplPharmaceuticalDosageFormTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology from this IG | |
MedicinalProductDefinition.route | required | SplDrugRouteofAdministrationTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology from this IG | |
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply from the FHIR Standard | |
MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoringhttp://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring from the FHIR Standard | |
MedicinalProductDefinition.specialMeasures | example | SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measures from the FHIR Standard | |
MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUsehttp://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use from the FHIR Standard | |
MedicinalProductDefinition.classification | example | ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification from the FHIR Standard | |
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard | |
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard | |
MedicinalProductDefinition.contact.type | example | ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type from the FHIR Standard | |
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codes from the FHIR Standard | |
MedicinalProductDefinition.name.type | example | ProductNa |