Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Resource Profile: Drug Product Handle

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle Version: 1.1.6
Active as of 2024-09-22 Computable Name: DrugProductHandle
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.51

Includes the essential identifying information of the drug product required to link to other profiles about the product in the eCTD structure.

Usage:

Formal Views of Profile Content

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

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition MedicinalProductDefinition
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier S 0..1 Identifier Optional user designated identifier
... combinedPharmaceuticalDoseForm S 1..1 CodeableConcept Product Dosage Form
Binding: Pharmaceutical Dosage Form Terminology (required)
... Slices for name S 1..2 BackboneElement The product's name, including full name and possibly coded parts
Slice: Unordered, Open by value:type
.... name:All Slices Content/Rules for all slices
..... productName S 1..1 string The full product name
..... type S 1..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
..... usage
...... jurisdiction 0..0
.... name:Proprietary 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... type 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: PROP
....... display 1..1 string Representation defined by the system
Fixed Value: Proprietary
..... part S 0..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
...... part:All Slices Content/Rules for all slices
....... part S 1..1 string A fragment of a product name
....... type S 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: PQCMC Name Part Terminology (required)
..... usage
...... jurisdiction 0..0
.... name:NonProprietary C 1..1 BackboneElement The product's name, including full name and possibly coded parts
cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once
..... type 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: NON
....... display 1..1 string Representation defined by the system
Fixed Value: Non-Proprietary
..... Slices for part S 2..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
...... part:All Slices Content/Rules for all slices
....... part S 1..1 string A fragment of a product name
....... type S 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: PQCMC Name Part Terminology (required)
...... part:Scientific 1..* BackboneElement Coding words or phrases of the name
....... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SCI
...... part:Invented 0..* BackboneElement Coding words or phrases of the name
....... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: INV
...... part:Formulation 0..* BackboneElement Coding words or phrases of the name
....... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: FORMUL
...... part:Strength 1..* BackboneElement Coding words or phrases of the name
....... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: STR
........ text S 1..1 string Plain text representation of the concept
...... part:Container 0..* BackboneElement Coding words or phrases of the name
....... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: CON
...... part:Form 0..* BackboneElement Coding words or phrases of the name
....... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: FRM
...... part:Device 0..* BackboneElement Coding words or phrases of the name
....... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: DEV
..... usage
...... jurisdiction 0..0

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.combinedPharmaceuticalDoseFormrequiredSplPharmaceuticalDosageFormTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology
from this IG
MedicinalProductDefinition.routerequiredSplDrugRouteofAdministrationTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology
from this IG
MedicinalProductDefinition.name:Proprietary.part.typerequiredPqcmcNamePartTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology
from this IG
MedicinalProductDefinition.name:NonProprietary.part.typerequiredPqcmcNamePartTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
cmc-strength-name-must-reference-scientificerrorMedicinalProductDefinition.name:NonProprietarystrength 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 )))
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier SΣ 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.

... combinedPharmaceuticalDoseForm SΣ 1..1 CodeableConcept Product Dosage Form
Binding: Pharmaceutical Dosage Form Terminology (required)
... route SΣ 1..* CodeableConcept Route of Administration
Binding: Drug Route Of Administration Terminology (required)
... Slices for name SΣ 1..2 BackboneElement The product's name, including full name and possibly coded parts
Slice: Unordered, Open by value:type
.... name:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName SΣ 1..1 string The full product name
..... type SΣ 1..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.

.... name:Proprietary Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.


Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: PROP
....... display 1..1 string Representation defined by the system
Fixed Value: Proprietary
..... part SΣ 0..* BackboneElement Coding words or phrases of the name
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part SΣ 1..1 string A fragment of a product name
...... type SΣ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: PQCMC Name Part Terminology (required)
.... name:NonProprietary ΣC 1..1 BackboneElement The product's name, including full name and possibly coded parts
cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.


Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: NON
....... display 1..1 string Representation defined by the system
Fixed Value: Non-Proprietary
..... Slices for part SΣ 2..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
...... part:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part SΣ 1..1 string A fragment of a product name
....... type SΣ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: PQCMC Name Part Terminology (required)
...... part:Scientific Σ 1..* BackboneElement Coding words or phrases of the name
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SCI
...... part:Invented Σ 0..* BackboneElement Coding words or phrases of the name
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: INV
...... part:Formulation Σ 0..* BackboneElement Coding words or phrases of the name
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: FORMUL
...... part:Strength Σ 1..* BackboneElement Coding words or phrases of the name
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: STR
........ text SΣ 1..1 string Plain text representation of the concept
...... part:Container Σ 0..* BackboneElement Coding words or phrases of the name
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: CON
...... part:Form Σ 0..* BackboneElement Coding words or phrases of the name
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: FRM
...... part:Device Σ 0..* BackboneElement Coding words or phrases of the name
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: DEV

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormrequiredSplPharmaceuticalDosageFormTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology
from this IG
MedicinalProductDefinition.routerequiredSplDrugRouteofAdministrationTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology
from this IG
MedicinalProductDefinition.name.typeexampleProductNameType
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.typeexamplePattern: PROP("Proprietary")
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.part.typerequiredPqcmcNamePartTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology
from this IG
MedicinalProductDefinition.name:NonProprietary.typeexamplePattern: NON("Non-Proprietary")
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part.typerequiredPqcmcNamePartTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology
from this IG
MedicinalProductDefinition.name:NonProprietary.part:Scientific.typeexamplePattern: SCI
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Invented.typeexamplePattern: INV
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Formulation.typeexamplePattern: FORMUL
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Strength.typeexamplePattern: STR
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Container.typeexamplePattern: CON
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Form.typeexamplePattern: FRM
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Device.typeexamplePattern: DEV
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-strength-name-must-reference-scientificerrorMedicinalProductDefinition.name:NonProprietarystrength 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-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf 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-4errorMedicinalProductDefinitionIf 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-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 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 Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm SΣ 1..1 CodeableConcept Product Dosage Form
Binding: Pharmaceutical Dosage Form Terminology (required)
... route SΣ 1..* CodeableConcept Route of Administration
Binding: Drug Route Of Administration Terminology (required)
... indication Σ 0..1 markdown Description of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).

... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.

... classification Σ 0..* CodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... impurity Σ 0..* CodeableReference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... attachedDocument Σ 0..* Reference(DocumentReference) Additional documentation about the medicinal product
... masterFile Σ 0..* Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..* BackboneElement A product specific contact, person (in a role), or an organization
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

.... contact Σ 1..1 Reference(Organization | PractitionerRole) A product specific contact, person (in a role), or an organization
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.


... Slices for name SΣ 1..2 BackboneElement The product's name, including full name and possibly coded parts
Slice: Unordered, Open by value:type
.... name:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName SΣ 1..1 string The full product name
..... type SΣ 1..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.

..... part Σ 0..* BackboneElement Coding words or phrases of the name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.

..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes

...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
.... name:Proprietary Σ 0..1 BackboneElement The product's name, including full name and possibly coded parts
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: PROP
....... display 1..1 string Representation defined by the system
Fixed Value: Proprietary
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... part SΣ 0..* BackboneElement Coding words or phrases of the name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part SΣ 1..1 string A fragment of a product name
...... type SΣ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: PQCMC Name Part Terminology (required)
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes

...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
.... name:NonProprietary ΣC 1..1 BackboneElement The product's name, including full name and possibly coded parts
cmc-strength-name-must-reference-scientific: strength parts must modify a scientific part, scientific parts must be modified by a strength part. The same scientific part cannot appear more than once
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... productName Σ 1..1 string The full product name
..... type Σ 0..1 CodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: NON
....... display 1..1 string Representation defined by the system
Fixed Value: Non-Proprietary
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... Slices for part SΣ 2..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
...... part:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part SΣ 1..1 string A fragment of a product name
....... type SΣ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: PQCMC Name Part Terminology (required)
...... part:Scientific Σ 1..* BackboneElement Coding words or phrases of the name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SCI
......... display 0..1 string Representation defined by the system
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ text 0..1 string Plain text representation of the concept
...... part:Invented Σ 0..* BackboneElement Coding words or phrases of the name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: INV
......... display 0..1 string Representation defined by the system
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ text 0..1 string Plain text representation of the concept
...... part:Formulation Σ 0..* BackboneElement Coding words or phrases of the name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: FORMUL
......... display 0..1 string Representation defined by the system
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ text 0..1 string Plain text representation of the concept
...... part:Strength Σ 1..* BackboneElement Coding words or phrases of the name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: STR
......... display 0..1 string Representation defined by the system
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ text 0..1 string Plain text representation of the concept
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding Σ 0..* Coding Code defined by a terminology system
........ text SΣ 1..1 string Plain text representation of the concept
...... part:Container Σ 0..* BackboneElement Coding words or phrases of the name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: CON
......... display 0..1 string Representation defined by the system
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ text 0..1 string Plain text representation of the concept
...... part:Form Σ 0..* BackboneElement Coding words or phrases of the name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: FRM
......... display 0..1 string Representation defined by the system
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ text 0..1 string Plain text representation of the concept
...... part:Device Σ 0..* BackboneElement Coding words or phrases of the name
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... part Σ 1..1 string A fragment of a product name
....... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: DEV
......... display 0..1 string Representation defined by the system
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ text 0..1 string Plain text representation of the concept
..... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes

...... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.

... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
MedicinalProductDefinition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
MedicinalProductDefinition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
MedicinalProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormrequiredSplPharmaceuticalDosageFormTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-pharmaceutical-dosage-form-terminology
from this IG
MedicinalProductDefinition.routerequiredSplDrugRouteofAdministrationTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/spl-drug-route-of-administration-terminology
from this IG
MedicinalProductDefinition.legalStatusOfSupplyexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicatorexampleAdditionalMonitoring
http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
from the FHIR Standard
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorexamplePediatricUse
http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
from the FHIR Standard
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.impurityexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.codeexampleSNOMEDCTMedicationCodes
http://hl7.org/fhir/ValueSet/medication-codes
from the FHIR Standard
MedicinalProductDefinition.name.typeexampleProductNameType
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.usage.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
MedicinalProductDefinition.name.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.typeexamplePattern: PROP("Proprietary")
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.part.typerequiredPqcmcNamePartTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology
from this IG
MedicinalProductDefinition.name:Proprietary.usage.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.typeexamplePattern: NON("Non-Proprietary")
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part.typerequiredPqcmcNamePartTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-name-part-terminology
from this IG
MedicinalProductDefinition.name:NonProprietary.part:Scientific.typeexamplePattern: SCI
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Invented.typeexamplePattern: INV
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Formulation.typeexamplePattern: FORMUL
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Strength.typeexamplePattern: STR
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Container.typeexamplePattern: CON
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Form.typeexamplePattern: FRM
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Device.typeexamplePattern: DEV
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.usage.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.crossReference.typeexampleProductCrossReferenceType
http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type
from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicatorexampleProductConfidentiality
http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality
from the FHIR Standard
MedicinalProductDefinition.characteristic.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmc-strength-name-must-reference-scientificerrorMedicinalProductDefinition.name:NonProprietarystrength 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-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf 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-4errorMedicinalProductDefinitionIf 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-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()