SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
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• TTL

Resource Profile: SubmittedMedicinalProduct

A profile that allows for the submission of Medicinal Product information to the FDA.

Usage:

• Use this Resource Profile: ProductSubmissionBundle
• Refer to this Resource Profile: ProductSubmissionDocument, SubmittedMedicinalPackaging and SubmittedMedicinalProductMarketing
• Examples for this Resource Profile: MedicinalProductDefinition/AllopurinolUSPDefinition, MedicinalProductDefinition/Enbrel010Definition, MedicinalProductDefinition/Enbrel021Definition, MedicinalProductDefinition/Enbrel032Definition... Show 12 more, MedicinalProductDefinition/Enbrel044Definition, MedicinalProductDefinition/Enbrel055Definition, MedicinalProductDefinition/Enbrel425Definition, MedicinalProductDefinition/Enbrel425Part1Definition, MedicinalProductDefinition/Enbrel425Part2Definition, MedicinalProductDefinition/Enbrel435Definition, MedicinalProductDefinition/Enbrel445Definition, MedicinalProductDefinition/Enbrel446Definition, MedicinalProductDefinition/Enbrel455Definition, MedicinalProductDefinition/Enbrel456Definition, MedicinalProductDefinition/LantusSyringeDefinition and MedicinalProductDefinition/LantusVialDefinition

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
Slices for identifier	S	1..*	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
system	S	1..1	uri	The namespace for the identifier value
value	S	1..1	string	The value that is unique
identifier:NDCCode	S	1..1	Identifier	Business identifier for this product. Could be an MPID
system		0..1	uri	The namespace for the identifier value Required Pattern: http://hl7.org/fhir/sid/ndc
route	S	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: http://evs.nci.nih.gov/valueset/FDA/C54455 (required)
specialMeasures	S	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: http://evs.nci.nih.gov/valueset/FDA/C54459 (required)
marketingStatus	S	0..1	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
status	S	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required)
dateRange	S	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
Slices for name	S	2..*	BackboneElement	The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type
name:All Slices				Content/Rules for all slices
productName	S	1..1	string	The full product name
type	S	1..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
name:Proprietary		1..1	BackboneElement	The product's name, including full name and possibly coded parts
type		0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PROPRIETARY
Slices for namePart	S	0..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
namePart: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)
namePart:Suffix		0..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: SFX
name:NonProprietary		1..*	BackboneElement	The product's name, including full name and possibly coded parts
type		0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: NONPROPRIETARY
crossReference	S	0..1	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
product	S	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product Binding: All NDC Products (required)
concept	S	1..1	CodeableConcept	Reference to a concept (by class)
reference		0..0
type	S	1..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual 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: C64637
operation	S	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
type		0..1	CodeableReference(ActivityDefinition | PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging Binding: http://evs.nci.nih.gov/valueset/FDA/C73600 (required)
concept	S	1..1	CodeableConcept	Reference to a concept (by class)
organization	S	1..1	Reference(IdentifiedEstablishment)	The organization responsible for the particular process, e.g. the manufacturer or importer
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.route	required	http://evs.nci.nih.gov/valueset/FDA/C54455 http://evs.nci.nih.gov/valueset/FDA/C54455
MedicinalProductDefinition.specialMeasures	required	http://evs.nci.nih.gov/valueset/FDA/C54459 http://evs.nci.nih.gov/valueset/FDA/C54459
MedicinalProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
MedicinalProductDefinition.crossReference.product	required	AllNDCProducts http://hl7.org/fhir/us/spl/ValueSet/valueset-AllNDCProducts from this IG
MedicinalProductDefinition.operation.type	required	http://evs.nci.nih.gov/valueset/FDA/C73600 http://evs.nci.nih.gov/valueset/FDA/C73600

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
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	1..*	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:NDCCode	SΣ	1..1	Identifier	Business identifier for this product. Could be an MPID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: http://hl7.org/fhir/sid/ndc
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
route	SΣ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: http://evs.nci.nih.gov/valueset/FDA/C54455 (required)
specialMeasures	SΣ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: http://evs.nci.nih.gov/valueset/FDA/C54459 (required)
marketingStatus	SΣ	0..1	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	SΣ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required)
dateRange	SΣ	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
Slices for name	SΣ	2..*	BackboneElement	The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type
name:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	SΣ	1..1	string	The full product name
type	SΣ	1..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product.
name:Proprietary	Σ	1..1	BackboneElement	The product's name, including full name and possibly coded parts
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PROPRIETARY
Slices for namePart	SΣ	0..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
namePart: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: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
namePart:Suffix	Σ	0..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: SFX
name:NonProprietary	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: NONPROPRIETARY
crossReference	SΣ	0..1	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	SΣ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product Binding: All NDC Products (required)
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class)
type	SΣ	1..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. 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: C64637
operation	SΣ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
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 Binding: http://evs.nci.nih.gov/valueset/FDA/C73600 (required)
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class)
organization	SΣ	1..1	Reference(IdentifiedEstablishment)	The organization responsible for the particular process, e.g. the manufacturer or importer
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
MedicinalProductDefinition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.3.0 from the FHIR Standard
MedicinalProductDefinition.identifier:NDCCode.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.3.0 from the FHIR Standard
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status
MedicinalProductDefinition.route	required	http://evs.nci.nih.gov/valueset/FDA/C54455 http://evs.nci.nih.gov/valueset/FDA/C54455
MedicinalProductDefinition.specialMeasures	required	http://evs.nci.nih.gov/valueset/FDA/C54459 http://evs.nci.nih.gov/valueset/FDA/C54459
MedicinalProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
MedicinalProductDefinition.name.type	example	ProductNameType http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.type	example	Pattern: PROPRIETARY http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.namePart.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.namePart:Suffix.type	example	Pattern: SFX http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.type	example	Pattern: NONPROPRIETARY http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.crossReference.product	required	AllNDCProducts http://hl7.org/fhir/us/spl/ValueSet/valueset-AllNDCProducts from this IG
MedicinalProductDefinition.crossReference.type	example	Pattern: C64637 http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard
MedicinalProductDefinition.operation.type	required	http://evs.nci.nih.gov/valueset/FDA/C73600 http://evs.nci.nih.gov/valueset/FDA/C73600

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	1..*	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible)
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:NDCCode	SΣ	1..1	Identifier	Business identifier for this product. Could be an MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible)
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: http://hl7.org/fhir/sid/ndc
value	Σ	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
description	Σ	0..1	markdown	General description of this product
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
route	SΣ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: http://evs.nci.nih.gov/valueset/FDA/C54455 (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	SΣ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: http://evs.nci.nih.gov/valueset/FDA/C54459 (required)
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: product-classification-codes (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
marketingStatus	SΣ	0..1	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	0..1	CodeableConcept	The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
jurisdiction	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
status	SΣ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required)
dateRange	SΣ	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
restoreDate	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
packagedMedicinalProduct	Σ	0..*	CodeableConcept	Package type for the product Binding: MedicinalProductPackageType (example): Types of medicinal product packs
ingredient	Σ	0..*	CodeableConcept	​The ingredients of this medicinal product - when not detailed in other resources Binding: substance-codes (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: substance-codes (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	2..*	BackboneElement	The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type
name:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	SΣ	1..1	string	The full product name
type	SΣ	1..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product.
namePart	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.
countryLanguage	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: Country ValueSet (example): Jurisdiction codes
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Binding: Jurisdiction ValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language code for this name Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
name:Proprietary	Σ	1..1	BackboneElement	The product's name, including full name and possibly coded parts
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PROPRIETARY
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
Slices for namePart	SΣ	0..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
namePart: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: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
namePart:Suffix	Σ	0..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: SFX
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
countryLanguage	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: Country ValueSet (example): Jurisdiction codes
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Binding: Jurisdiction ValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language code for this name Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
name:NonProprietary	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: NONPROPRIETARY
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
namePart	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.
countryLanguage	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: Country ValueSet (example): Jurisdiction codes
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Binding: Jurisdiction ValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language code for this name Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
crossReference	SΣ	0..1	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	SΣ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product Binding: All NDC Products (required)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class)
type	SΣ	1..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. 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: C64637
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
operation	SΣ	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 Binding: http://evs.nci.nih.gov/valueset/FDA/C73600 (required)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class)
reference	Σ	0..1	Reference()	Reference to a resource (by instance)
effectiveDate	Σ	0..1	Period	Date range of applicability
organization	SΣ	1..1	Reference(IdentifiedEstablishment)	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: product-characteristic-codes (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
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
MedicinalProductDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
MedicinalProductDefinition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.3.0 from the FHIR Standard
MedicinalProductDefinition.identifier.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
MedicinalProductDefinition.identifier:NDCCode.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.3.0 from the FHIR Standard
MedicinalProductDefinition.identifier:NDCCode.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type 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
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	example	CombinedDoseForm http://hl7.org/fhir/ValueSet/combined-dose-form from the FHIR Standard
MedicinalProductDefinition.route	required	http://evs.nci.nih.gov/valueset/FDA/C54455 http://evs.nci.nih.gov/valueset/FDA/C54455
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	required	http://evs.nci.nih.gov/valueset/FDA/C54459 http://evs.nci.nih.gov/valueset/FDA/C54459
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use from the FHIR Standard
MedicinalProductDefinition.classification	example	http://hl7.org/fhir/ValueSet/product-classification-codes http://hl7.org/fhir/ValueSet/product-classification-codes
MedicinalProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType http://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard
MedicinalProductDefinition.ingredient	example	http://hl7.org/fhir/ValueSet/substance-codes http://hl7.org/fhir/ValueSet/substance-codes
MedicinalProductDefinition.impurity	example	http://hl7.org/fhir/ValueSet/substance-codes http://hl7.org/fhir/ValueSet/substance-codes
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	example	ProductNameType http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name.namePart.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.countryLanguage.country	example	Country ValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name.countryLanguage.jurisdiction	example	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
MedicinalProductDefinition.name.countryLanguage.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.type	example	Pattern: PROPRIETARY http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.namePart.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.namePart:Suffix.type	example	Pattern: SFX http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.countryLanguage.country	example	Country ValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.countryLanguage.jurisdiction	example	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.countryLanguage.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.type	example	Pattern: NONPROPRIETARY http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.namePart.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.countryLanguage.country	example	Country ValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.countryLanguage.jurisdiction	example	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.countryLanguage.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
MedicinalProductDefinition.crossReference.product	required	AllNDCProducts http://hl7.org/fhir/us/spl/ValueSet/valueset-AllNDCProducts from this IG
MedicinalProductDefinition.crossReference.type	example	Pattern: C64637 http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard
MedicinalProductDefinition.operation.type	required	http://evs.nci.nih.gov/valueset/FDA/C73600 http://evs.nci.nih.gov/valueset/FDA/C73600
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality from the FHIR Standard
MedicinalProductDefinition.characteristic.type	example	http://hl7.org/fhir/ValueSet/product-characteristic-codes http://hl7.org/fhir/ValueSet/product-characteristic-codes

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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()
dom-r4b	warning	MedicinalProductDefinition.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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: 7 elements(5 nested mandatory elements)
Must-Support: 22 elements
Prohibited: 1 element

Structures

This structure refers to these other structures:

• IdentifiedEstablishment (http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of MedicinalProductDefinition.identifier
• The element 1 is sliced based on the value of MedicinalProductDefinition.name
• The element 1 is sliced based on the value of MedicinalProductDefinition.name.namePart

Maturity: 1

Differential View

This structure is derived from MedicinalProductDefinition

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductDefinition			MedicinalProductDefinition
Slices for identifier	S	1..*	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
system	S	1..1	uri	The namespace for the identifier value
value	S	1..1	string	The value that is unique
identifier:NDCCode	S	1..1	Identifier	Business identifier for this product. Could be an MPID
system		0..1	uri	The namespace for the identifier value Required Pattern: http://hl7.org/fhir/sid/ndc
route	S	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: http://evs.nci.nih.gov/valueset/FDA/C54455 (required)
specialMeasures	S	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: http://evs.nci.nih.gov/valueset/FDA/C54459 (required)
marketingStatus	S	0..1	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
status	S	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required)
dateRange	S	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
Slices for name	S	2..*	BackboneElement	The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type
name:All Slices				Content/Rules for all slices
productName	S	1..1	string	The full product name
type	S	1..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
name:Proprietary		1..1	BackboneElement	The product's name, including full name and possibly coded parts
type		0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PROPRIETARY
Slices for namePart	S	0..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
namePart: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)
namePart:Suffix		0..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: SFX
name:NonProprietary		1..*	BackboneElement	The product's name, including full name and possibly coded parts
type		0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: NONPROPRIETARY
crossReference	S	0..1	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
product	S	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product Binding: All NDC Products (required)
concept	S	1..1	CodeableConcept	Reference to a concept (by class)
reference		0..0
type	S	1..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual 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: C64637
operation	S	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
type		0..1	CodeableReference(ActivityDefinition | PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging Binding: http://evs.nci.nih.gov/valueset/FDA/C73600 (required)
concept	S	1..1	CodeableConcept	Reference to a concept (by class)
organization	S	1..1	Reference(IdentifiedEstablishment)	The organization responsible for the particular process, e.g. the manufacturer or importer
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.route	required	http://evs.nci.nih.gov/valueset/FDA/C54455 http://evs.nci.nih.gov/valueset/FDA/C54455
MedicinalProductDefinition.specialMeasures	required	http://evs.nci.nih.gov/valueset/FDA/C54459 http://evs.nci.nih.gov/valueset/FDA/C54459
MedicinalProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
MedicinalProductDefinition.crossReference.product	required	AllNDCProducts http://hl7.org/fhir/us/spl/ValueSet/valueset-AllNDCProducts from this IG
MedicinalProductDefinition.operation.type	required	http://evs.nci.nih.gov/valueset/FDA/C73600 http://evs.nci.nih.gov/valueset/FDA/C73600

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
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	1..*	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:NDCCode	SΣ	1..1	Identifier	Business identifier for this product. Could be an MPID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: http://hl7.org/fhir/sid/ndc
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
route	SΣ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: http://evs.nci.nih.gov/valueset/FDA/C54455 (required)
specialMeasures	SΣ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: http://evs.nci.nih.gov/valueset/FDA/C54459 (required)
marketingStatus	SΣ	0..1	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
status	SΣ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required)
dateRange	SΣ	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
Slices for name	SΣ	2..*	BackboneElement	The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type
name:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	SΣ	1..1	string	The full product name
type	SΣ	1..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product.
name:Proprietary	Σ	1..1	BackboneElement	The product's name, including full name and possibly coded parts
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PROPRIETARY
Slices for namePart	SΣ	0..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
namePart: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: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
namePart:Suffix	Σ	0..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: SFX
name:NonProprietary	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
code		1..1	code	Symbol in syntax defined by the system Fixed Value: NONPROPRIETARY
crossReference	SΣ	0..1	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	SΣ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product Binding: All NDC Products (required)
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class)
type	SΣ	1..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. 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: C64637
operation	SΣ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
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 Binding: http://evs.nci.nih.gov/valueset/FDA/C73600 (required)
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class)
organization	SΣ	1..1	Reference(IdentifiedEstablishment)	The organization responsible for the particular process, e.g. the manufacturer or importer
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
MedicinalProductDefinition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.3.0 from the FHIR Standard
MedicinalProductDefinition.identifier:NDCCode.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.3.0 from the FHIR Standard
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status
MedicinalProductDefinition.route	required	http://evs.nci.nih.gov/valueset/FDA/C54455 http://evs.nci.nih.gov/valueset/FDA/C54455
MedicinalProductDefinition.specialMeasures	required	http://evs.nci.nih.gov/valueset/FDA/C54459 http://evs.nci.nih.gov/valueset/FDA/C54459
MedicinalProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
MedicinalProductDefinition.name.type	example	ProductNameType http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.type	example	Pattern: PROPRIETARY http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.namePart.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.namePart:Suffix.type	example	Pattern: SFX http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.type	example	Pattern: NONPROPRIETARY http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.crossReference.product	required	AllNDCProducts http://hl7.org/fhir/us/spl/ValueSet/valueset-AllNDCProducts from this IG
MedicinalProductDefinition.crossReference.type	example	Pattern: C64637 http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard
MedicinalProductDefinition.operation.type	required	http://evs.nci.nih.gov/valueset/FDA/C73600 http://evs.nci.nih.gov/valueset/FDA/C73600

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	1..*	Identifier	Business identifier for this product. Could be an MPID Slice: Unordered, Open by value:system
identifier:All Slices				Content/Rules for all slices
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible)
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
identifier:NDCCode	SΣ	1..1	Identifier	Business identifier for this product. Could be an MPID
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible)
system	Σ	0..1	uri	The namespace for the identifier value Required Pattern: http://hl7.org/fhir/sid/ndc
value	Σ	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
version	Σ	0..1	string	A business identifier relating to a specific version of the product
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
statusDate	Σ	0..1	dateTime	The date at which the given status became applicable
description	Σ	0..1	markdown	General description of this product
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
route	SΣ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: http://evs.nci.nih.gov/valueset/FDA/C54455 (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	SΣ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: http://evs.nci.nih.gov/valueset/FDA/C54459 (required)
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: product-classification-codes (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
marketingStatus	SΣ	0..1	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	0..1	CodeableConcept	The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
jurisdiction	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
status	SΣ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required)
dateRange	SΣ	1..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
restoreDate	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
packagedMedicinalProduct	Σ	0..*	CodeableConcept	Package type for the product Binding: MedicinalProductPackageType (example): Types of medicinal product packs
ingredient	Σ	0..*	CodeableConcept	​The ingredients of this medicinal product - when not detailed in other resources Binding: substance-codes (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: substance-codes (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	2..*	BackboneElement	The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:type
name:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	SΣ	1..1	string	The full product name
type	SΣ	1..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product.
namePart	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.
countryLanguage	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: Country ValueSet (example): Jurisdiction codes
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Binding: Jurisdiction ValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language code for this name Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
name:Proprietary	Σ	1..1	BackboneElement	The product's name, including full name and possibly coded parts
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PROPRIETARY
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
Slices for namePart	SΣ	0..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by value:type
namePart: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: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
namePart:Suffix	Σ	0..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: SFX
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
countryLanguage	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: Country ValueSet (example): Jurisdiction codes
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Binding: Jurisdiction ValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language code for this name Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
name:NonProprietary	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
productName	Σ	1..1	string	The full product name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-submittedMedicinalProductNameTypes
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: NONPROPRIETARY
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
namePart	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.
countryLanguage	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: Country ValueSet (example): Jurisdiction codes
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Binding: Jurisdiction ValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language code for this name Binding: CommonLanguages (preferred): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
crossReference	SΣ	0..1	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	SΣ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product Binding: All NDC Products (required)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class)
type	SΣ	1..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. 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: C64637
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
operation	SΣ	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 Binding: http://evs.nci.nih.gov/valueset/FDA/C73600 (required)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
concept	SΣ	1..1	CodeableConcept	Reference to a concept (by class)
reference	Σ	0..1	Reference()	Reference to a resource (by instance)
effectiveDate	Σ	0..1	Period	Date range of applicability
organization	SΣ	1..1	Reference(IdentifiedEstablishment)	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: product-characteristic-codes (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
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
MedicinalProductDefinition.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
MedicinalProductDefinition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.3.0 from the FHIR Standard
MedicinalProductDefinition.identifier.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
MedicinalProductDefinition.identifier:NDCCode.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.3.0 from the FHIR Standard
MedicinalProductDefinition.identifier:NDCCode.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type 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
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	example	CombinedDoseForm http://hl7.org/fhir/ValueSet/combined-dose-form from the FHIR Standard
MedicinalProductDefinition.route	required	http://evs.nci.nih.gov/valueset/FDA/C54455 http://evs.nci.nih.gov/valueset/FDA/C54455
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	required	http://evs.nci.nih.gov/valueset/FDA/C54459 http://evs.nci.nih.gov/valueset/FDA/C54459
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use from the FHIR Standard
MedicinalProductDefinition.classification	example	http://hl7.org/fhir/ValueSet/product-classification-codes http://hl7.org/fhir/ValueSet/product-classification-codes
MedicinalProductDefinition.marketingStatus.status	required	SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem) http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatuses from this IG
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType http://hl7.org/fhir/ValueSet/medicinal-product-package-type from the FHIR Standard
MedicinalProductDefinition.ingredient	example	http://hl7.org/fhir/ValueSet/substance-codes http://hl7.org/fhir/ValueSet/substance-codes
MedicinalProductDefinition.impurity	example	http://hl7.org/fhir/ValueSet/substance-codes http://hl7.org/fhir/ValueSet/substance-codes
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	example	ProductNameType http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name.namePart.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name.countryLanguage.country	example	Country ValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name.countryLanguage.jurisdiction	example	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
MedicinalProductDefinition.name.countryLanguage.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.type	example	Pattern: PROPRIETARY http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.namePart.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.namePart:Suffix.type	example	Pattern: SFX http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.countryLanguage.country	example	Country ValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.countryLanguage.jurisdiction	example	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
MedicinalProductDefinition.name:Proprietary.countryLanguage.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.type	example	Pattern: NONPROPRIETARY http://hl7.org/fhir/ValueSet/medicinal-product-name-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.namePart.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.countryLanguage.country	example	Country ValueSet http://hl7.org/fhir/ValueSet/country from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.countryLanguage.jurisdiction	example	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
MedicinalProductDefinition.name:NonProprietary.countryLanguage.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
MedicinalProductDefinition.crossReference.product	required	AllNDCProducts http://hl7.org/fhir/us/spl/ValueSet/valueset-AllNDCProducts from this IG
MedicinalProductDefinition.crossReference.type	example	Pattern: C64637 http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type from the FHIR Standard
MedicinalProductDefinition.operation.type	required	http://evs.nci.nih.gov/valueset/FDA/C73600 http://evs.nci.nih.gov/valueset/FDA/C73600
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality from the FHIR Standard
MedicinalProductDefinition.characteristic.type	example	http://hl7.org/fhir/ValueSet/product-characteristic-codes http://hl7.org/fhir/ValueSet/product-characteristic-codes

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').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()
dom-r4b	warning	MedicinalProductDefinition.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
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: 7 elements(5 nested mandatory elements)
Must-Support: 22 elements
Prohibited: 1 element

Structures

This structure refers to these other structures:

• IdentifiedEstablishment (http://hl7.org/fhir/us/spl/StructureDefinition/IdentifiedEstablishment)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of MedicinalProductDefinition.identifier
• The element 1 is sliced based on the value of MedicinalProductDefinition.name
• The element 1 is sliced based on the value of MedicinalProductDefinition.name.namePart

Maturity: 1