Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 2.0.0 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

## Resource Profile: Drug Product Description

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | 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.

Usages:

- Use this Profile: CMC eCTD 32P10 Document
- Refer to this Profile: ContainerClosure and eCTD Product Description and Composition

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
MedicinalProductDefinition |  | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product
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 | S Σ | 1..1 | markdown | Drug Product Description
combinedPharmaceuticalDoseForm | S Σ | 1..1 | CodeableConcept | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required)
route | S Σ | 1..* | CodeableConcept | Route of Administration Binding: Drug Route Of Administration Terminology (required)
Slices for name | S Σ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Closed by value:type
name:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
productName | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required)
name:Proprietary | S 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 | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required) 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C71898
display |  | 1..1 | string | Representation defined by the system Fixed Value: Proprietary Name
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
text |  | 0..1 | string | Plain text representation of the concept
part | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required)
name:NonProprietary | S Σ C | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts Constraints: cmc-strength-name-must-reference-scientific
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
productName | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required) 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C96971
display |  | 1..1 | string | Representation defined by the system Fixed Value: Nonproprietary Name
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 | S Σ | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Closed by value:type
part:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required)
part:Scientific | S Σ | 1..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 1..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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
text | S Σ | 1..1 | string | Plain text representation of the concept
part:Container | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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
crossReference | S Σ | 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 | S Σ | 1..1 | LiteralCodeableReference(Drug Product Handle) {b} | Co-Packaged Product
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
MedicinalProductDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | SplPharmaceuticalDosageFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology` From this IG
MedicinalProductDefinition.route | required | SplDrugRouteofAdministrationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology` From this IG
MedicinalProductDefinition.name.type | required | CmcProductNameTypesVS `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:Proprietary.type | required | Pattern Value: C71898("Proprietary Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.type | required | Pattern Value: C96971("Nonproprietary Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Scientific.type | required | Pattern Value: SCI `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Invented.type | required | Pattern Value: INV `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Formulation.type | required | Pattern Value: FORMUL `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Strength.type | required | Pattern Value: STR `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Container.type | required | Pattern Value: CON `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Form.type | required | Pattern Value: FRM `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Device.type | required | Pattern Value: DEV `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG

#### Constraints

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() |

This structure is derived from MedicinalProductDefinition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
MedicinalProductDefinition |  |  | MedicinalProductDefinition |
identifier |  | 0..1 | Identifier | optional user designated identifier
description | S | 1..1 | markdown | Drug Product Description
combinedPharmaceuticalDoseForm | S | 1..1 | CodeableConcept | 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, Closed 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 Binding: Product Name Types Terminology (required)
usage |  |  |  |
jurisdiction |  | 0..0 |  |
name:Proprietary | S | 0..1 | BackboneElement | The product's name, including full name and possibly coded parts
type |  | 1..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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C71898
display |  | 1..1 | string | Representation defined by the system Fixed Value: Proprietary Name
part | S | 0..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Closed 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 | S C | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts Constraints: cmc-strength-name-must-reference-scientific
type |  | 1..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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C96971
display |  | 1..1 | string | Representation defined by the system Fixed Value: Nonproprietary Name
Slices for part | S | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Closed 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 | S | 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 | S | 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 | S | 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 | S | 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 | S | 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 | S | 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 | S | 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 | S | 1..1 | LiteralCodeableReference(Drug Product Handle) {b} | Co-Packaged Product
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | SplPharmaceuticalDosageFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology` From this IG
MedicinalProductDefinition.route | required | SplDrugRouteofAdministrationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology` From this IG
MedicinalProductDefinition.name.type | required | CmcProductNameTypesVS `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG

#### Constraints

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 Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
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 | S Σ | 1..1 | markdown | Drug Product Description
combinedPharmaceuticalDoseForm | S Σ | 1..1 | CodeableConcept | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required)
route | S Σ | 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 | S Σ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Closed 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 | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required)
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
Additional Bindings | Purpose
CommonLanguages | Starter
name:Proprietary | S 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 | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required) 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C71898
display |  | 1..1 | string | Representation defined by the system Fixed Value: Proprietary Name
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
text |  | 0..1 | string | Plain text representation of the concept
part | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 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
Additional Bindings | Purpose
CommonLanguages | Starter
name:NonProprietary | S Σ C | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts Constraints: cmc-strength-name-must-reference-scientific
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 | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required) 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C96971
display |  | 1..1 | string | Representation defined by the system Fixed Value: Nonproprietary Name
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 | S Σ | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Closed 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required)
part:Scientific | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 1..1 | string | Plain text representation of the concept
part:Container | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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
Additional Bindings | Purpose
CommonLanguages | Starter
crossReference | S Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
product | S Σ | 1..1 | LiteralCodeableReference(Drug Product Handle) {b} | 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

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
MedicinalProductDefinition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
MedicinalProductDefinition.type | example | MedicinalProductType `http://hl7.org/fhir/ValueSet/medicinal-product-type` From the FHIR Standard
MedicinalProductDefinition.domain | example | MedicinalProductDomain `http://hl7.org/fhir/ValueSet/medicinal-product-domain` From the FHIR Standard
MedicinalProductDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | SplPharmaceuticalDosageFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology` From this IG
MedicinalProductDefinition.route | required | SplDrugRouteofAdministrationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology` From this IG
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupply `http://hl7.org/fhir/ValueSet/legal-status-of-supply` From the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoring `http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring` From the FHIR Standard
MedicinalProductDefinition.specialMeasures | example | SpecialMeasures `http://hl7.org/fhir/ValueSet/medicinal-product-special-measures` From the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUse `http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use` From the FHIR Standard
MedicinalProductDefinition.classification | example | ProductClassification `http://hl7.org/fhir/ValueSet/medicinal-product-classification` From the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageType `http://hl7.org/fhir/ValueSet/medicinal-product-package-type` From the FHIR Standard
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
MedicinalProductDefinition.contact.type | example | ProductContactType `http://hl7.org/fhir/ValueSet/medicinal-product-contact-type` From the FHIR Standard
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodes `http://hl7.org/fhir/ValueSet/medication-codes` From the FHIR Standard
MedicinalProductDefinition.name.type | required | CmcProductNameTypesVS `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name.part.type | example | ProductNamePartType `http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type` From the FHIR Standard
MedicinalProductDefinition.name.usage.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
MedicinalProductDefinition.name.usage.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
MedicinalProductDefinition.name:Proprietary.type | required | Pattern Value: C71898("Proprietary Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:Proprietary.usage.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
MedicinalProductDefinition.name:Proprietary.usage.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.type | required | Pattern Value: C96971("Nonproprietary Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Scientific.type | required | Pattern Value: SCI `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Invented.type | required | Pattern Value: INV `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Formulation.type | required | Pattern Value: FORMUL `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Strength.type | required | Pattern Value: STR `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Container.type | required | Pattern Value: CON `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Form.type | required | Pattern Value: FRM `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Device.type | required | Pattern Value: DEV `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.usage.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.usage.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceType `http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type` From the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentiality `http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality` From the FHIR Standard
MedicinalProductDefinition.characteristic.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard

#### Constraints

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() |

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 8 elements
Must-Support: 24 elements
Prohibited: 3 elements

Structures

This structure refers to these other structures:

- Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
- Drug Product Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle)

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of MedicinalProductDefinition.name (Closed)
- The element 1 is sliced based on the value of MedicinalProductDefinition.name.part (Closed)

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
MedicinalProductDefinition |  | 0..* | MedicinalProductDefinition | Detailed definition of a medicinal product
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 | S Σ | 1..1 | markdown | Drug Product Description
combinedPharmaceuticalDoseForm | S Σ | 1..1 | CodeableConcept | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required)
route | S Σ | 1..* | CodeableConcept | Route of Administration Binding: Drug Route Of Administration Terminology (required)
Slices for name | S Σ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Closed by value:type
name:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
productName | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required)
name:Proprietary | S 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 | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required) 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C71898
display |  | 1..1 | string | Representation defined by the system Fixed Value: Proprietary Name
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
text |  | 0..1 | string | Plain text representation of the concept
part | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required)
name:NonProprietary | S Σ C | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts Constraints: cmc-strength-name-must-reference-scientific
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
productName | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required) 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C96971
display |  | 1..1 | string | Representation defined by the system Fixed Value: Nonproprietary Name
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 | S Σ | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Closed by value:type
part:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required)
part:Scientific | S Σ | 1..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 1..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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
text | S Σ | 1..1 | string | Plain text representation of the concept
part:Container | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 0..* | BackboneElement | Coding words or phrases of the name
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
part | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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
crossReference | S Σ | 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 | S Σ | 1..1 | LiteralCodeableReference(Drug Product Handle) {b} | Co-Packaged Product
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
MedicinalProductDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | SplPharmaceuticalDosageFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology` From this IG
MedicinalProductDefinition.route | required | SplDrugRouteofAdministrationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology` From this IG
MedicinalProductDefinition.name.type | required | CmcProductNameTypesVS `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:Proprietary.type | required | Pattern Value: C71898("Proprietary Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.type | required | Pattern Value: C96971("Nonproprietary Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Scientific.type | required | Pattern Value: SCI `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Invented.type | required | Pattern Value: INV `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Formulation.type | required | Pattern Value: FORMUL `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Strength.type | required | Pattern Value: STR `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Container.type | required | Pattern Value: CON `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Form.type | required | Pattern Value: FRM `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Device.type | required | Pattern Value: DEV `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG

#### Constraints

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() |

Differential View

This structure is derived from MedicinalProductDefinition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
MedicinalProductDefinition |  |  | MedicinalProductDefinition |
identifier |  | 0..1 | Identifier | optional user designated identifier
description | S | 1..1 | markdown | Drug Product Description
combinedPharmaceuticalDoseForm | S | 1..1 | CodeableConcept | 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, Closed 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 Binding: Product Name Types Terminology (required)
usage |  |  |  |
jurisdiction |  | 0..0 |  |
name:Proprietary | S | 0..1 | BackboneElement | The product's name, including full name and possibly coded parts
type |  | 1..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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C71898
display |  | 1..1 | string | Representation defined by the system Fixed Value: Proprietary Name
part | S | 0..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Closed 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 | S C | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts Constraints: cmc-strength-name-must-reference-scientific
type |  | 1..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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C96971
display |  | 1..1 | string | Representation defined by the system Fixed Value: Nonproprietary Name
Slices for part | S | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Closed 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 | S | 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 | S | 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 | S | 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 | S | 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 | S | 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 | S | 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 | S | 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 | S | 1..1 | LiteralCodeableReference(Drug Product Handle) {b} | Co-Packaged Product
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | SplPharmaceuticalDosageFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology` From this IG
MedicinalProductDefinition.route | required | SplDrugRouteofAdministrationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology` From this IG
MedicinalProductDefinition.name.type | required | CmcProductNameTypesVS `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG

#### Constraints

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 ))) |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
Additional Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained |  | 0..* | Resource | Contained, inline Resources
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 | S Σ | 1..1 | markdown | Drug Product Description
combinedPharmaceuticalDoseForm | S Σ | 1..1 | CodeableConcept | Product Dosage Form Binding: Pharmaceutical Dosage Form Terminology (required)
route | S Σ | 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 | S Σ | 1..2 | BackboneElement | The product's name, including full name and possibly coded parts Slice: Unordered, Closed 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 | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required)
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
Additional Bindings | Purpose
CommonLanguages | Starter
name:Proprietary | S 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 | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required) 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C71898
display |  | 1..1 | string | Representation defined by the system Fixed Value: Proprietary Name
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
text |  | 0..1 | string | Plain text representation of the concept
part | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 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
Additional Bindings | Purpose
CommonLanguages | Starter
name:NonProprietary | S Σ C | 1..1 | BackboneElement | The product's name, including full name and possibly coded parts Constraints: cmc-strength-name-must-reference-scientific
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 | S Σ | 1..1 | string | The full product name
type | S Σ | 1..1 | CodeableConcept | Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: Product Name Types Terminology (required) 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: C96971
display |  | 1..1 | string | Representation defined by the system Fixed Value: Nonproprietary Name
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 | S Σ | 2..* | BackboneElement | Coding words or phrases of the name Slice: Unordered, Closed 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required)
part:Scientific | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S Σ | 1..1 | string | Plain text representation of the concept
part:Container | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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 | S 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 | S Σ | 1..1 | string | A fragment of a product name
type | S Σ | 1..1 | CodeableConcept | Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required) 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
Additional Bindings | Purpose
CommonLanguages | Starter
crossReference | S Σ | 0..* | BackboneElement | Reference to another product, e.g. for linking authorised to investigational product
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
product | S Σ | 1..1 | LiteralCodeableReference(Drug Product Handle) {b} | 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

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
MedicinalProductDefinition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
MedicinalProductDefinition.type | example | MedicinalProductType `http://hl7.org/fhir/ValueSet/medicinal-product-type` From the FHIR Standard
MedicinalProductDefinition.domain | example | MedicinalProductDomain `http://hl7.org/fhir/ValueSet/medicinal-product-domain` From the FHIR Standard
MedicinalProductDefinition.status | preferred | PublicationStatus `http://hl7.org/fhir/ValueSet/publication-status` From the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm | required | SplPharmaceuticalDosageFormTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology` From this IG
MedicinalProductDefinition.route | required | SplDrugRouteofAdministrationTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology` From this IG
MedicinalProductDefinition.legalStatusOfSupply | example | LegalStatusOfSupply `http://hl7.org/fhir/ValueSet/legal-status-of-supply` From the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicator | example | AdditionalMonitoring `http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring` From the FHIR Standard
MedicinalProductDefinition.specialMeasures | example | SpecialMeasures `http://hl7.org/fhir/ValueSet/medicinal-product-special-measures` From the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicator | example | PediatricUse `http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use` From the FHIR Standard
MedicinalProductDefinition.classification | example | ProductClassification `http://hl7.org/fhir/ValueSet/medicinal-product-classification` From the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProduct | example | MedicinalProductPackageType `http://hl7.org/fhir/ValueSet/medicinal-product-package-type` From the FHIR Standard
MedicinalProductDefinition.ingredient | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
MedicinalProductDefinition.impurity | example | SNOMEDCTSubstanceCodes `http://hl7.org/fhir/ValueSet/substance-codes` From the FHIR Standard
MedicinalProductDefinition.contact.type | example | ProductContactType `http://hl7.org/fhir/ValueSet/medicinal-product-contact-type` From the FHIR Standard
MedicinalProductDefinition.code | example | SNOMEDCTMedicationCodes `http://hl7.org/fhir/ValueSet/medication-codes` From the FHIR Standard
MedicinalProductDefinition.name.type | required | CmcProductNameTypesVS `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name.part.type | example | ProductNamePartType `http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type` From the FHIR Standard
MedicinalProductDefinition.name.usage.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
MedicinalProductDefinition.name.usage.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
MedicinalProductDefinition.name:Proprietary.type | required | Pattern Value: C71898("Proprietary Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:Proprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:Proprietary.usage.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
MedicinalProductDefinition.name:Proprietary.usage.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.type | required | Pattern Value: C96971("Nonproprietary Name") `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-product-name-types-vs` From this IG
MedicinalProductDefinition.name:NonProprietary.part.type | required | PqcmcNamePartTerminology `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Scientific.type | required | Pattern Value: SCI `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Invented.type | required | Pattern Value: INV `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Formulation.type | required | Pattern Value: FORMUL `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Strength.type | required | Pattern Value: STR `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Container.type | required | Pattern Value: CON `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Form.type | required | Pattern Value: FRM `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.part:Device.type | required | Pattern Value: DEV `http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology` From this IG
MedicinalProductDefinition.name:NonProprietary.usage.country | example | CountryValueSet `http://hl7.org/fhir/ValueSet/country` From the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.usage.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
MedicinalProductDefinition.crossReference.type | example | ProductCrossReferenceType `http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type` From the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicator | example | ProductConfidentiality `http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality` From the FHIR Standard
MedicinalProductDefinition.characteristic.type | example | ProductCharacteristic `http://hl7.org/fhir/ValueSet/product-characteristic-codes` From the FHIR Standard

#### Constraints

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() |

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 8 elements
Must-Support: 24 elements
Prohibited: 3 elements

Structures

This structure refers to these other structures:

- Literal Coded Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference)
- Drug Product Handle (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle)

Slices

This structure defines the following Slices:

- The element 1 is sliced based on the value of MedicinalProductDefinition.name (Closed)
- The element 1 is sliced based on the value of MedicinalProductDefinition.name.part (Closed)

Maturity: 2

Other representations of profile: CSV, Excel, Schematron