Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use International flag

Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Resource Profile: MedicinalProductDefinition (ePI)

Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi Version: 1.0.0
Standards status: Trial-use Maturity Level: 2 Computable Name: MedicinalProductDefinitionUvEpi

Description of the packaged authorized medicinal product(s) associated to this ePI document.

Usage:

Formal Views of Profile Content

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

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition MedicinalProductDefinition
... identifier 1..* Identifier Business identifier for this product. Could be an MPID
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... type 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized.
... domain 0..1 CodeableConcept If this medicine applies to human or veterinary uses.
Binding: MedicinalProductDomain (example)
... status 0..1 CodeableConcept The status within the lifecycle of this product record.
... statusDate 0..1 dateTime The date at which this status became applicable.
... description 0..1 markdown General description of the medicinal product referred by the ePI
... combinedPharmaceuticalDoseForm 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Dose Form (example)
... route 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
Binding: Route Of Administration (example)
... indication 0..1 markdown Narrative text of the authorized indication(s) for this product.
... legalStatusOfSupply 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator.
... additionalMonitoringIndicator 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.
... specialMeasures 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons.
... pediatricUseIndicator 0..1 CodeableConcept If authorised for pediatric use
... classification 0..* CodeableConcept Allows the product to be classified by various systems (e.g. ATC)
Binding: WHO ATC (example)
... marketingStatus
.... country 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)
.... status 1..1 CodeableConcept Status of the marketing of the medicinal product.
.... dateRange 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder
... packagedMedicinalProduct 0..* CodeableConcept Package type for the product.
... contact
.... type 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.
.... contact 1..1 Reference(Organization | PractitionerRole) A specific contact, person (in a role), or an organization for this product
... name
.... productName 1..1 string The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... type 0..1 CodeableConcept Type of product name, such as rINN, Proprietary, Non-Proprietary
.... part
..... part 1..1 string A fragment of a product name.
..... type 1..1 CodeableConcept Type for this part of the name (e.g. strength part)
.... usage
..... country 1..1 CodeableConcept Country where this name applies
..... jurisdiction 0..1 CodeableConcept Jurisdiction where this name applies
..... language 1..1 CodeableConcept Language for this name

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleVsDoseForm
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration
from this IG
MedicinalProductDefinition.classificationexampleVsAtcClassification
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification
from this IG
MedicinalProductDefinition.marketingStatus.countrypreferredVsCountry
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... 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
... 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 Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Dose Form (example)
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
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 Σ 0..* CodeableConcept Allows the product to be classified by various systems (e.g. ATC)
Binding: WHO ATC (example)
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product.
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... 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 Σ 1..1 string The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... 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.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
MedicinalProductDefinition.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleVsDoseForm
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration
from this IG
MedicinalProductDefinition.legalStatusOfSupplyexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicatorexampleAdditionalMonitoring
http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
from the FHIR Standard
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorexamplePediatricUse
http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
from the FHIR Standard
MedicinalProductDefinition.classificationexampleVsAtcClassification
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification
from this IG
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.name.typeexampleProductNameType
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorMedicinalProductDefinitionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorMedicinalProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceMedicinalProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 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): 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 Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Dose Form (example)
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
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 Σ 0..* CodeableConcept Allows the product to be classified by various systems (e.g. 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 Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


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


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

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

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

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

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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
MedicinalProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleVsDoseForm
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration
from this IG
MedicinalProductDefinition.legalStatusOfSupplyexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicatorexampleAdditionalMonitoring
http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
from the FHIR Standard
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorexamplePediatricUse
http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
from the FHIR Standard
MedicinalProductDefinition.classificationexampleVsAtcClassification
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification
from this IG
MedicinalProductDefinition.marketingStatus.countrypreferredVsCountry
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country
from this IG
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.impurityexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.codeexampleSNOMEDCTMedicationCodes
http://hl7.org/fhir/ValueSet/medication-codes
from the FHIR Standard
MedicinalProductDefinition.name.typeexampleProductNameType
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.usage.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
MedicinalProductDefinition.name.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.crossReference.typeexampleProductCrossReferenceType
http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type
from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicatorexampleProductConfidentiality
http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality
from the FHIR Standard
MedicinalProductDefinition.characteristic.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

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

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 3 elements

Maturity: 2

Differential View

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition MedicinalProductDefinition
... identifier 1..* Identifier Business identifier for this product. Could be an MPID
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... type 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized.
... domain 0..1 CodeableConcept If this medicine applies to human or veterinary uses.
Binding: MedicinalProductDomain (example)
... status 0..1 CodeableConcept The status within the lifecycle of this product record.
... statusDate 0..1 dateTime The date at which this status became applicable.
... description 0..1 markdown General description of the medicinal product referred by the ePI
... combinedPharmaceuticalDoseForm 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Dose Form (example)
... route 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
Binding: Route Of Administration (example)
... indication 0..1 markdown Narrative text of the authorized indication(s) for this product.
... legalStatusOfSupply 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator.
... additionalMonitoringIndicator 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.
... specialMeasures 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons.
... pediatricUseIndicator 0..1 CodeableConcept If authorised for pediatric use
... classification 0..* CodeableConcept Allows the product to be classified by various systems (e.g. ATC)
Binding: WHO ATC (example)
... marketingStatus
.... country 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)
.... status 1..1 CodeableConcept Status of the marketing of the medicinal product.
.... dateRange 0..1 Period The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder
... packagedMedicinalProduct 0..* CodeableConcept Package type for the product.
... contact
.... type 0..1 CodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.
.... contact 1..1 Reference(Organization | PractitionerRole) A specific contact, person (in a role), or an organization for this product
... name
.... productName 1..1 string The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... type 0..1 CodeableConcept Type of product name, such as rINN, Proprietary, Non-Proprietary
.... part
..... part 1..1 string A fragment of a product name.
..... type 1..1 CodeableConcept Type for this part of the name (e.g. strength part)
.... usage
..... country 1..1 CodeableConcept Country where this name applies
..... jurisdiction 0..1 CodeableConcept Jurisdiction where this name applies
..... language 1..1 CodeableConcept Language for this name

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleVsDoseForm
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration
from this IG
MedicinalProductDefinition.classificationexampleVsAtcClassification
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification
from this IG
MedicinalProductDefinition.marketingStatus.countrypreferredVsCountry
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... 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
... 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 Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Dose Form (example)
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
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 Σ 0..* CodeableConcept Allows the product to be classified by various systems (e.g. ATC)
Binding: WHO ATC (example)
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product.
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... 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 Σ 1..1 string The full product name expressed as Proprietary Name (Non-Proprietary Name) strength dose form
.... 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.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
MedicinalProductDefinition.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleVsDoseForm
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration
from this IG
MedicinalProductDefinition.legalStatusOfSupplyexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicatorexampleAdditionalMonitoring
http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
from the FHIR Standard
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorexamplePediatricUse
http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
from the FHIR Standard
MedicinalProductDefinition.classificationexampleVsAtcClassification
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification
from this IG
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.name.typeexampleProductNameType
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard

Constraints

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

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 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): 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 Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Dose Form (example)
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
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 Σ 0..* CodeableConcept Allows the product to be classified by various systems (e.g. 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 Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


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


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

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

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

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

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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
MedicinalProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainexampleMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexampleVsDoseForm
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/doseForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/routeOfAdministration
from this IG
MedicinalProductDefinition.legalStatusOfSupplyexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
from the FHIR Standard
MedicinalProductDefinition.additionalMonitoringIndicatorexampleAdditionalMonitoring
http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
from the FHIR Standard
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorexamplePediatricUse
http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
from the FHIR Standard
MedicinalProductDefinition.classificationexampleVsAtcClassification
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/atcClassification
from this IG
MedicinalProductDefinition.marketingStatus.countrypreferredVsCountry
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country
from this IG
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.impurityexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.codeexampleSNOMEDCTMedicationCodes
http://hl7.org/fhir/ValueSet/medication-codes
from the FHIR Standard
MedicinalProductDefinition.name.typeexampleProductNameType
http://hl7.org/fhir/ValueSet/medicinal-product-name-type
from the FHIR Standard
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.usage.countryexampleCountryValueSet
http://hl7.org/fhir/ValueSet/country
from the FHIR Standard
MedicinalProductDefinition.name.usage.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
MedicinalProductDefinition.name.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.crossReference.typeexampleProductCrossReferenceType
http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type
from the FHIR Standard
MedicinalProductDefinition.operation.confidentialityIndicatorexampleProductConfidentiality
http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality
from the FHIR Standard
MedicinalProductDefinition.characteristic.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Constraints

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

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 3 elements

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron