German (DEU) Electronic Product Information (ePI) Product Leaflet (PL) Implementation Guide - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: 03 DEU ePIL Medicinal Product Definition

Defines the MedicinalProductDefinition resource, including the product name, active ingredients, classification, and dose form, based on the specified SPOR coding system.

Usages:

• Use this Profile: 01 DEU ePIL Bundle
• Refer to this Profile: 05 DEU ePIL Composition and 04 DEU ePIL Packaged Product Definition

Formal Views of Profile Content

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

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition		0..*	MedicinalProductDefinitionUvEpi	Detailed definition of a medicinal product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	1..*	Identifier	Medicinal Product Identifier (MPID)
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	1..1	string	The value that is unique Example General: 123456
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record. Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
combinedPharmaceuticalDoseForm	SΣ	0..1	CodeableConcept	Dose Form Binding: Dose Form (example)
route	SΣ	0..*	CodeableConcept	Route of Administration Binding: Route Of Administration (example)
classification	SΣ	1..1	CodeableConcept	Pharmacological Classification (ATC) Binding: WHO ATC (example)
ingredient	SΣ	1..*	CodeableConcept	Active Ingredient Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
name	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	SΣ	1..1	string	Product Name
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	example	VsDoseForm http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm
MedicinalProductDefinition.route	example	VsRouteOfAdministration http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration
MedicinalProductDefinition.classification	example	VsAtcClassification http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification
MedicinalProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard

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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from MedicinalProductDefinitionUvEpi

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition			MedicinalProductDefinitionUvEpi
identifier	S	1..*	Identifier	Medicinal Product Identifier (MPID)
combinedPharmaceuticalDoseForm	S	0..1	CodeableConcept	Dose Form
route	S	0..*	CodeableConcept	Route of Administration
classification	S	1..1	CodeableConcept	Pharmacological Classification (ATC)
ingredient	S	1..*	CodeableConcept	Active Ingredient
name
productName	S	1..1	string	Product Name
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition		0..*	MedicinalProductDefinitionUvEpi	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	1..*	Identifier	Medicinal Product Identifier (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): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	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)
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)
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 this status became applicable.
description	Σ	0..1	markdown	General description of the medicinal product referred by the ePI
combinedPharmaceuticalDoseForm	SΣ	0..1	CodeableConcept	Dose Form Binding: Dose Form (example)
route	SΣ	0..*	CodeableConcept	Route of Administration Binding: Route Of Administration (example)
indication	Σ	0..1	markdown	Narrative text of the authorized indication(s) for this product.
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator. Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons. Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
pediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for pediatric use Binding: PediatricUse (example): Suitability for age groups, in particular children.
classification	SΣ	1..1	CodeableConcept	Pharmacological Classification (ATC) Binding: WHO ATC (example)
marketingStatus	Σ	0..*	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 authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: ISO Country two letter code (preferred)
jurisdiction	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorization 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	Σ	1..1	CodeableConcept	Status of the marketing of the medicinal product.
dateRange	Σ	0..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder
restoreDate	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorization 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
comprisedOf	Σ	0..*	Reference(ManufacturedItemDefinition | DeviceDefinition)	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ingredient	SΣ	1..*	CodeableConcept	Active Ingredient Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
impurity	Σ	0..*	CodeableReference(SubstanceDefinition)	Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
contact	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information. Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
contact	Σ	1..1	Reference(Organization | PractitionerRole)	A specific contact, person (in a role), or an organization for this product
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.
name	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	SΣ	1..1	string	Product Name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product.
part	Σ	0..*	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name.
type	Σ	1..1	CodeableConcept	Type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	1..1	CodeableConcept	Country where this name applies Binding: CountryValueSet (example): Jurisdiction codes
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language for this name Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
crossReference	Σ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
product	Σ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product
type	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
operation	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	CodeableReference(ActivityDefinition | PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging
effectiveDate	Σ	0..1	Period	Date range of applicability
organization	Σ	0..*	Reference(Organization)	The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueMarkdown			markdown
valueQuantity			Quantity
valueInteger			integer
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
MedicinalProductDefinition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard
MedicinalProductDefinition.identifier.type	extensible	IdentifierTypeCodes 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 From the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	example	VsDoseForm http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm
MedicinalProductDefinition.route	example	VsRouteOfAdministration http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration
MedicinalProductDefinition.legalStatusOfSupply	example	LegalStatusOfSupply http://hl7.org/fhir/ValueSet/legal-status-of-supply From the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicator	example	AdditionalMonitoring http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring From the FHIR Standard
MedicinalProductDefinition.specialMeasures	example	SpecialMeasures http://hl7.org/fhir/ValueSet/medicinal-product-special-measures From the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use From the FHIR Standard
MedicinalProductDefinition.classification	example	VsAtcClassification http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification
MedicinalProductDefinition.marketingStatus.country	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType http://hl7.org/fhir/ValueSet/medicinal-product-package-type From the FHIR Standard
MedicinalProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard
MedicinalProductDefinition.impurity	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard
MedicinalProductDefinition.contact.type	example	ProductContactType http://hl7.org/fhir/ValueSet/medicinal-product-contact-type From the FHIR Standard
MedicinalProductDefinition.code	example	SNOMEDCTMedicationCodes http://hl7.org/fhir/ValueSet/medication-codes From the FHIR Standard
MedicinalProductDefinition.name.type	example	ProductNameType http://hl7.org/fhir/ValueSet/medicinal-product-name-type From the FHIR Standard
MedicinalProductDefinition.name.part.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type From the FHIR Standard
MedicinalProductDefinition.name.usage.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country From the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction From the FHIR Standard
MedicinalProductDefinition.name.usage.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
MedicinalProductDefinition.crossReference.type	example	ProductCrossReferenceType http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type From the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality From the FHIR Standard
MedicinalProductDefinition.characteristic.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from MedicinalProductDefinitionUvEpi

Summary

Mandatory: 2 elements
Must-Support: 6 elements

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition		0..*	MedicinalProductDefinitionUvEpi	Detailed definition of a medicinal product
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	1..*	Identifier	Medicinal Product Identifier (MPID)
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	1..1	string	The value that is unique Example General: 123456
status	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record. Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
combinedPharmaceuticalDoseForm	SΣ	0..1	CodeableConcept	Dose Form Binding: Dose Form (example)
route	SΣ	0..*	CodeableConcept	Route of Administration Binding: Route Of Administration (example)
classification	SΣ	1..1	CodeableConcept	Pharmacological Classification (ATC) Binding: WHO ATC (example)
ingredient	SΣ	1..*	CodeableConcept	Active Ingredient Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
name	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	SΣ	1..1	string	Product Name
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard
MedicinalProductDefinition.status	preferred	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	example	VsDoseForm http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm
MedicinalProductDefinition.route	example	VsRouteOfAdministration http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration
MedicinalProductDefinition.classification	example	VsAtcClassification http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification
MedicinalProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard

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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Differential View

This structure is derived from MedicinalProductDefinitionUvEpi

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition			MedicinalProductDefinitionUvEpi
identifier	S	1..*	Identifier	Medicinal Product Identifier (MPID)
combinedPharmaceuticalDoseForm	S	0..1	CodeableConcept	Dose Form
route	S	0..*	CodeableConcept	Route of Administration
classification	S	1..1	CodeableConcept	Pharmacological Classification (ATC)
ingredient	S	1..*	CodeableConcept	Active Ingredient
name
productName	S	1..1	string	Product Name
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
MedicinalProductDefinition		0..*	MedicinalProductDefinitionUvEpi	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	1..*	Identifier	Medicinal Product Identifier (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): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	ΣC	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)
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)
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 this status became applicable.
description	Σ	0..1	markdown	General description of the medicinal product referred by the ePI
combinedPharmaceuticalDoseForm	SΣ	0..1	CodeableConcept	Dose Form Binding: Dose Form (example)
route	SΣ	0..*	CodeableConcept	Route of Administration Binding: Route Of Administration (example)
indication	Σ	0..1	markdown	Narrative text of the authorized indication(s) for this product.
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator. Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons. Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
pediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for pediatric use Binding: PediatricUse (example): Suitability for age groups, in particular children.
classification	SΣ	1..1	CodeableConcept	Pharmacological Classification (ATC) Binding: WHO ATC (example)
marketingStatus	Σ	0..*	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 authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: ISO Country two letter code (preferred)
jurisdiction	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorization 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	Σ	1..1	CodeableConcept	Status of the marketing of the medicinal product.
dateRange	Σ	0..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder
restoreDate	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorization 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
comprisedOf	Σ	0..*	Reference(ManufacturedItemDefinition | DeviceDefinition)	Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
ingredient	SΣ	1..*	CodeableConcept	Active Ingredient Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
impurity	Σ	0..*	CodeableReference(SubstanceDefinition)	Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
contact	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information. Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
contact	Σ	1..1	Reference(Organization | PractitionerRole)	A specific contact, person (in a role), or an organization for this product
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.
name	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	SΣ	1..1	string	Product Name
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, Proprietary, Non-Proprietary Binding: ProductNameType (example): Type of a name for a Medicinal Product.
part	Σ	0..*	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
part	Σ	1..1	string	A fragment of a product name.
type	Σ	1..1	CodeableConcept	Type for this part of the name (e.g. strength part) Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
country	Σ	1..1	CodeableConcept	Country where this name applies Binding: CountryValueSet (example): Jurisdiction codes
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction where this name applies Binding: JurisdictionValueSet (example): Jurisdiction codes
language	Σ	1..1	CodeableConcept	Language for this name Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
crossReference	Σ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
product	Σ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product
type	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
operation	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	0..1	CodeableReference(ActivityDefinition | PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging
effectiveDate	Σ	0..1	Period	Date range of applicability
organization	Σ	0..*	Reference(Organization)	The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueMarkdown			markdown
valueQuantity			Quantity
valueInteger			integer
valueDate			date
valueBoolean			boolean
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
MedicinalProductDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
MedicinalProductDefinition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard
MedicinalProductDefinition.identifier.type	extensible	IdentifierTypeCodes 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 From the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseForm	example	VsDoseForm http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm
MedicinalProductDefinition.route	example	VsRouteOfAdministration http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration
MedicinalProductDefinition.legalStatusOfSupply	example	LegalStatusOfSupply http://hl7.org/fhir/ValueSet/legal-status-of-supply From the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicator	example	AdditionalMonitoring http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring From the FHIR Standard
MedicinalProductDefinition.specialMeasures	example	SpecialMeasures http://hl7.org/fhir/ValueSet/medicinal-product-special-measures From the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicator	example	PediatricUse http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use From the FHIR Standard
MedicinalProductDefinition.classification	example	VsAtcClassification http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification
MedicinalProductDefinition.marketingStatus.country	preferred	VsCountry http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country
MedicinalProductDefinition.packagedMedicinalProduct	example	MedicinalProductPackageType http://hl7.org/fhir/ValueSet/medicinal-product-package-type From the FHIR Standard
MedicinalProductDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard
MedicinalProductDefinition.impurity	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes From the FHIR Standard
MedicinalProductDefinition.contact.type	example	ProductContactType http://hl7.org/fhir/ValueSet/medicinal-product-contact-type From the FHIR Standard
MedicinalProductDefinition.code	example	SNOMEDCTMedicationCodes http://hl7.org/fhir/ValueSet/medication-codes From the FHIR Standard
MedicinalProductDefinition.name.type	example	ProductNameType http://hl7.org/fhir/ValueSet/medicinal-product-name-type From the FHIR Standard
MedicinalProductDefinition.name.part.type	example	ProductNamePartType http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type From the FHIR Standard
MedicinalProductDefinition.name.usage.country	example	CountryValueSet http://hl7.org/fhir/ValueSet/country From the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdiction	example	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction From the FHIR Standard
MedicinalProductDefinition.name.usage.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
MedicinalProductDefinition.crossReference.type	example	ProductCrossReferenceType http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type From the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicator	example	ProductConfidentiality http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality From the FHIR Standard
MedicinalProductDefinition.characteristic.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	MedicinalProductDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	MedicinalProductDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	MedicinalProductDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from MedicinalProductDefinitionUvEpi

Summary

Mandatory: 2 elements
Must-Support: 6 elements

Other representations of profile: CSV, Excel, Schematron