German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide
0.7.0 - ci-build

German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide - Local Development build (v0.7.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: 03 - DEU ePIL Medicinal Product Definition

Official URL: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-MedicinalProductDefinition Version: 0.7.0
Draft as of 2026-05-04 Computable Name: DEU_ePIL_MedicinalProductDefinition

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

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 1..1 id Technical ID of this medicinal product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier SΣ 1..* Identifier Medicinal Product Identifier (MPID)
... 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: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
... route SΣ 0..* CodeableConcept Route of Administration
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... classification SΣ 0..* CodeableConcept Pharmacological Classification
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:atc Σ 0..* Coding ATC Classification Code
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://www.whocc.no/atc
..... coding:spor Σ 0..* Coding EMA/SPOR Therapeutic Classification
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
... ingredient SΣ 0..* 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base example Combined Dose Form 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​route Base example SNOMED CT Route Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.

Constraints

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

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition MedicinalProductDefinition
... id 1..1 id Technical ID of this medicinal product
... identifier S 1..* Identifier Medicinal Product Identifier (MPID)
... combinedPharmaceuticalDoseForm S 0..1 CodeableConcept Dose Form
.... coding
..... system 0..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000000004
... classification S 0..* CodeableConcept Pharmacological Classification
.... Slices for coding 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:atc 0..* Coding ATC Classification Code
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://www.whocc.no/atc
..... coding:spor 0..* Coding EMA/SPOR Therapeutic Classification
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
... ingredient S 0..* CodeableConcept Active Ingredient
... name
.... productName S 1..1 string Product Name

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 1..1 id Technical ID of this medicinal product
... 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 BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier Medicinal Product Identifier (MPID)
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm SΣ 0..1 CodeableConcept Dose Form
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 0..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000000004
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 0..1 code Symbol in syntax defined by the system
..... display ΣC 0..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... route SΣ 0..* CodeableConcept Route of Administration
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... indication Σ 0..1 markdown Description of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.
... classification SΣ 0..* CodeableConcept Pharmacological Classification
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:atc Σ 0..* Coding ATC Classification Code
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://www.whocc.no/atc
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:spor Σ 0..* Coding EMA/SPOR Therapeutic Classification
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs
... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient SΣ 0..* 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 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.
... 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, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
.... part Σ 0..* BackboneElement Coding words or phrases of the name
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... part Σ 1..1 string A fragment of a product name
..... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
.... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
..... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​type Base example Medicinal Product Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​domain Base example Medicinal Product Domain 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base example Combined Dose Form 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​route Base example SNOMED CT Route Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​legalStatusOfSupply Base example Legal Status Of Supply 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​additionalMonitoringIndicator Base example Additional Monitoring 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​specialMeasures Base example Special Measures 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​pediatricUseIndicator Base example Pediatric Use 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​packagedMedicinalProduct Base example Medicinal Product Package Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​impurity Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​contact.type Base example Product Contact Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​code Base example SNOMED CT Medication Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part.type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​crossReference.type Base example Product Cross Reference Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​operation.confidentialityIndicator Base example Product Confidentiality 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​characteristic.type Base example Product Characteristic 📍5.0.0 FHIR Std.

Constraints

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

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 2 elements(2 nested mandatory elements)
Must-Support: 6 elements

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of MedicinalProductDefinition.classification.coding

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 1..1 id Technical ID of this medicinal product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier SΣ 1..* Identifier Medicinal Product Identifier (MPID)
... 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: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
... route SΣ 0..* CodeableConcept Route of Administration
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... classification SΣ 0..* CodeableConcept Pharmacological Classification
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:atc Σ 0..* Coding ATC Classification Code
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://www.whocc.no/atc
..... coding:spor Σ 0..* Coding EMA/SPOR Therapeutic Classification
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
... ingredient SΣ 0..* 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base example Combined Dose Form 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​route Base example SNOMED CT Route Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.

Constraints

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

Differential View

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition MedicinalProductDefinition
... id 1..1 id Technical ID of this medicinal product
... identifier S 1..* Identifier Medicinal Product Identifier (MPID)
... combinedPharmaceuticalDoseForm S 0..1 CodeableConcept Dose Form
.... coding
..... system 0..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000000004
... classification S 0..* CodeableConcept Pharmacological Classification
.... Slices for coding 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:atc 0..* Coding ATC Classification Code
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://www.whocc.no/atc
..... coding:spor 0..* Coding EMA/SPOR Therapeutic Classification
...... system 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
... ingredient S 0..* CodeableConcept Active Ingredient
... name
.... productName S 1..1 string Product Name

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 1..1 id Technical ID of this medicinal product
... 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 BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 1..* Identifier Medicinal Product Identifier (MPID)
... type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: MedicinalProductType (example): Overall defining type of this medicinal product.
... domain Σ 0..1 CodeableConcept If this medicine applies to human or veterinary uses
Binding: MedicinalProductDomain (example): Applicable domain for this product (e.g. human, veterinary).
... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm SΣ 0..1 CodeableConcept Dose Form
Binding: CombinedDoseForm (example): Dose forms for a product as a whole, considering all individual parts, but before any mixing
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 0..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000000004
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 0..1 code Symbol in syntax defined by the system
..... display ΣC 0..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... route SΣ 0..* CodeableConcept Route of Administration
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
... indication Σ 0..1 markdown Description of indication(s) for this product, used when structured indications are not required
... legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
... additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).
... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
... pediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
Binding: PediatricUse (example): Suitability for age groups, in particular children.
... classification SΣ 0..* CodeableConcept Pharmacological Classification
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding Σ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:system
..... coding:atc Σ 0..* Coding ATC Classification Code
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://www.whocc.no/atc
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:spor Σ 0..* Coding EMA/SPOR Therapeutic Classification
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: https://spor.ema.europa.eu/v1/lists/100000093533
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs
... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient SΣ 0..* 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 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.
... 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, BAN, Proprietary, Non-Proprietary
Binding: ProductNameType (example): Type of a name for a Medicinal Product.
.... part Σ 0..* BackboneElement Coding words or phrases of the name
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... part Σ 1..1 string A fragment of a product name
..... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.
.... usage Σ 0..* BackboneElement Country and jurisdiction where the name applies
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... country Σ 1..1 CodeableConcept Country code for where this name applies
Binding: CountryValueSet (example): Jurisdiction codes
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
..... language Σ 1..1 CodeableConcept Language code for this name
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... crossReference Σ 0..* BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
.... type Σ 0..1 CodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: ProductCrossReferenceType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableReference(ActivityDefinition | PlanDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 CodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: ProductConfidentiality (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
... characteristic Σ 0..* BackboneElement Key product features such as "sugar free", "modified release"
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 CodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
MedicinalProductDefinition.​language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​type Base example Medicinal Product Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​domain Base example Medicinal Product Domain 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​combinedPharmaceuticalDoseForm Base example Combined Dose Form 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​route Base example SNOMED CT Route Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​legalStatusOfSupply Base example Legal Status Of Supply 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​additionalMonitoringIndicator Base example Additional Monitoring 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​specialMeasures Base example Special Measures 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​pediatricUseIndicator Base example Pediatric Use 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​classification Base example Product Classification 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​packagedMedicinalProduct Base example Medicinal Product Package Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​ingredient Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​impurity Base example SNOMED CT Substance Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​contact.type Base example Product Contact Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​code Base example SNOMED CT Medication Codes 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.type Base example Product Name Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.part.type Base example Product Name Part Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.country Base example Country ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​name.usage.language Base required All Languages 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​crossReference.type Base example Product Cross Reference Type 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​operation.confidentialityIndicator Base example Product Confidentiality 📍5.0.0 FHIR Std.
MedicinalProductDefinition.​characteristic.type Base example Product Characteristic 📍5.0.0 FHIR Std.

Constraints

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

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 2 elements(2 nested mandatory elements)
Must-Support: 6 elements

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of MedicinalProductDefinition.classification.coding

 

Other representations of profile: CSV, Excel, Schematron