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-ballot 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

• Content
• Detailed Descriptions
• XML
• JSON

Resource Profile: Drug Product Description

Includes the properties of the drug product and components. Profile of Drug Product profile.

Usage:

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

Formal Views of Profile Content

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

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

This structure is derived from MedicinalProductDefinition

Name	Flags	Card.	Type	Description & Constraints
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		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://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	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://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		1..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SCI
part:Invented		0..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: INV
part:Formulation		0..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: FORMUL
part:Strength		1..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: STR
text	S	1..1	string	Plain text representation of the concept
part:Container		0..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CON
part:Form		0..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: FRM
part:Device		0..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: DEV
usage
jurisdiction		0..0
crossReference	S	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
product	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
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	SΣ	1..1	markdown	Drug Product Description
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, 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	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: Product Name Types Terminology (required)
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://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	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://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	SΣ	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	SΣ	1..1	string	A fragment of a product name
type	SΣ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required)
part:Scientific	Σ	1..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SCI
part:Invented	Σ	0..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: INV
part:Formulation	Σ	0..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: FORMUL
part:Strength	Σ	1..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: STR
text	SΣ	1..1	string	Plain text representation of the concept
part:Container	Σ	0..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CON
part:Form	Σ	0..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: FRM
part:Device	Σ	0..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: DEV
crossReference	SΣ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
product	S	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	example	Pattern: C71898("Proprietary Name") http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
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	example	Pattern: C96971("Nonproprietary Name") http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
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	example	Pattern: SCI http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Invented.type	example	Pattern: INV http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Formulation.type	example	Pattern: FORMUL http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Strength.type	example	Pattern: STR http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Container.type	example	Pattern: CON http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Form.type	example	Pattern: FRM http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Device.type	example	Pattern: DEV http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type 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()

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
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 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	Σ	0..1	Identifier	optional user designated identifier
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
description	SΣ	1..1	markdown	Drug Product Description
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, 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	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: 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 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://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	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 Bindings Purpose 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://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	SΣ	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	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 Bindings Purpose CommonLanguages Starter Set
crossReference	SΣ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
product	S	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	example	Pattern: C71898("Proprietary Name") http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
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	example	Pattern: C96971("Nonproprietary Name") http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
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	example	Pattern: SCI http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Invented.type	example	Pattern: INV http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Formulation.type	example	Pattern: FORMUL http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Strength.type	example	Pattern: STR http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Container.type	example	Pattern: CON http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Form.type	example	Pattern: FRM http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Device.type	example	Pattern: DEV http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
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: 15 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)

Differential View

This structure is derived from MedicinalProductDefinition

Name	Flags	Card.	Type	Description & Constraints
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		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://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	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://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		1..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SCI
part:Invented		0..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: INV
part:Formulation		0..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: FORMUL
part:Strength		1..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: STR
text	S	1..1	string	Plain text representation of the concept
part:Container		0..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CON
part:Form		0..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: FRM
part:Device		0..*	BackboneElement	Coding words or phrases of the name
type		1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: DEV
usage
jurisdiction		0..0
crossReference	S	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
product	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 )))

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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	SΣ	1..1	markdown	Drug Product Description
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, 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	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: Product Name Types Terminology (required)
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://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	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://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	SΣ	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	SΣ	1..1	string	A fragment of a product name
type	SΣ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: PQCMC Name Part Terminology (required)
part:Scientific	Σ	1..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: SCI
part:Invented	Σ	0..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: INV
part:Formulation	Σ	0..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: FORMUL
part:Strength	Σ	1..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: STR
text	SΣ	1..1	string	Plain text representation of the concept
part:Container	Σ	0..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CON
part:Form	Σ	0..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: FRM
part:Device	Σ	0..*	BackboneElement	Coding words or phrases of the name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2
code		1..1	code	Symbol in syntax defined by the system Fixed Value: DEV
crossReference	SΣ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
product	S	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	example	Pattern: C71898("Proprietary Name") http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
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	example	Pattern: C96971("Nonproprietary Name") http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
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	example	Pattern: SCI http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Invented.type	example	Pattern: INV http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Formulation.type	example	Pattern: FORMUL http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Strength.type	example	Pattern: STR http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Container.type	example	Pattern: CON http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Form.type	example	Pattern: FRM http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Device.type	example	Pattern: DEV http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type 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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
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 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	Σ	0..1	Identifier	optional user designated identifier
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
description	SΣ	1..1	markdown	Drug Product Description
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, 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	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: 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 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://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	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 Bindings Purpose 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://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	SΣ	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	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 Bindings Purpose CommonLanguages Starter Set
crossReference	SΣ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
product	S	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	example	Pattern: C71898("Proprietary Name") http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
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	example	Pattern: C96971("Nonproprietary Name") http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
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	example	Pattern: SCI http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Invented.type	example	Pattern: INV http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Formulation.type	example	Pattern: FORMUL http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Strength.type	example	Pattern: STR http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Container.type	example	Pattern: CON http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Form.type	example	Pattern: FRM http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.part:Device.type	example	Pattern: DEV http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
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: 15 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)