WHO-UMC IDMP Management and Publish API
0.1.0 - CI Build International flag

WHO-UMC IDMP Management and Publish API, published by Uppsala Monitoring Centre. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/Uppsala-Monitoring-Centre/WHO-UMC-IDMP-Service/ and changes regularly. See the Directory of published versions

Resource Profile: MedicinalProductDefinition for publication

Official URL: http://who-umc.org/idmp/StructureDefinition/MedicinalProductDefinition-who-php-pub Version: 0.1.0
Active as of 2024-11-11 Computable Name: MedicinalProductDefinitionWhoPhP

This profile specifies how the MedicinalProductDefinition is published by the WHO-UMC IDMP FHIR Service representing the WHODrug dictionary

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 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id 1..1 id Logical id of this artifact
... contained 0..1 Organization Contained, inline Resources
... identifier 1..* Identifier Business identifier for this product. Could be an MPID
.... system 1..1 uri The namespace for the identifier value
Binding: MPID system (extensible)
.... value 1..1 string The value that is unique
... domain 0..1 CodeableConcept If this medicine applies to human or veterinary uses.
Binding: MedicinalProductDomain (required)
... status 0..1 CodeableConcept The status within the lifecycle of this product record.
... statusDate 0..1 dateTime Not used in this profile
... description 0..1 markdown Not used in this profile
... combinedPharmaceuticalDoseForm 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM Pharmaceutical 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 Not used in this profile
... legalStatusOfSupply 0..1 CodeableConcept Not used in this profile
... additionalMonitoringIndicator 0..1 CodeableConcept Not used in this profile
... specialMeasures 0..* CodeableConcept Not used in this profile
... pediatricUseIndicator 0..1 CodeableConcept Not used in this profile
... classification 0..* CodeableConcept Allows the product to be classified by various systems (e.g. ATC)
Binding: WHO ATC (example)
... marketingStatus 0..* MarketingStatus Not used in this profile
... packagedMedicinalProduct 0..* CodeableConcept Not used in this profile
... contact
.... type 0..1 CodeableConcept Allows the Marketing Authorization Holder to be classified
.... contact 1..1 Reference(Organization | PractitionerRole) A specific Marketing Authorization Holder for this product
... name
.... productName 1..1 string The full product name.
.... 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 1..1 BackboneElement Country and jurisdiction where the name applies
..... country 1..1 CodeableConcept Country where this name applies
...... coding 1..1 Coding Code defined by a terminology system
....... system 0..1 uri Identity of the terminology system
Required Pattern: urn:iso:std:iso:3166
....... code 1..1 code Symbol in syntax defined by the system
..... jurisdiction 0..1 CodeableConcept Jurisdiction where this name applies
...... coding 1..1 Coding Code defined by a terminology system
....... code 1..1 code Symbol in syntax defined by the system
Binding: Jurisdiction Value Set (example)
..... language 1..1 CodeableConcept Language for this name

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.identifier.systemextensibleVsMpIdSystem
http://who-umc.org/idmp/ValueSet/mpid-system
from this IG
MedicinalProductDefinition.domainrequiredMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexamplepharmaceuticalForm
http://who-umc.org/idmp/ValueSet/pharmaceuticalForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://who-umc.org/idmp/ValueSet/routeOfAdministration
from this IG
MedicinalProductDefinition.classificationexampleVsAtcClassification
http://who-umc.org/idmp/ValueSet/atcClassification
from this IG
MedicinalProductDefinition.name.usage.jurisdiction.coding.codeexampleVsJurisdiction
http://who-umc.org/idmp/ValueSet/jurisdiction
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 1..1 id Logical id of this artifact
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..1 Organization Contained, inline Resources
... identifier Σ 1..* Identifier Business identifier for this product. Could be an MPID
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

.... system Σ 1..1 uri The namespace for the identifier value
Binding: MPID system (extensible)
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 (required)
... 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 Not used in this profile
... description Σ 0..1 markdown Not used in this profile
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM Pharmaceutical 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 Not used in this profile
... legalStatusOfSupply Σ 0..1 CodeableConcept Not used in this profile
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

... additionalMonitoringIndicator Σ 0..1 CodeableConcept Not used in this profile
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).

... specialMeasures Σ 0..* CodeableConcept Not used in this profile
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ 0..1 CodeableConcept Not used in this profile
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 Not used in this profile
... packagedMedicinalProduct Σ 0..* CodeableConcept Not used in this profile
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.
.... usage Σ 1..1 BackboneElement Country and jurisdiction where the name applies
..... 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

...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 0..1 uri Identity of the terminology system
Required Pattern: urn:iso:std:iso:3166
....... code ΣC 1..1 code Symbol in syntax defined by the system
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

...... coding Σ 1..1 Coding Code defined by a terminology system
....... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Jurisdiction Value Set (example)
..... language Σ 1..1 CodeableConcept Language for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

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.identifier.systemextensibleVsMpIdSystem
http://who-umc.org/idmp/ValueSet/mpid-system
from this IG
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainrequiredMedicinalProductDomain
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.combinedPharmaceuticalDoseFormexamplepharmaceuticalForm
http://who-umc.org/idmp/ValueSet/pharmaceuticalForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://who-umc.org/idmp/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://who-umc.org/idmp/ValueSet/atcClassification
from this IG
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-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.jurisdiction.coding.codeexampleVsJurisdiction
http://who-umc.org/idmp/ValueSet/jurisdiction
from this IG
MedicinalProductDefinition.name.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
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 1..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..1 Organization 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
Binding: MPID system (extensible)
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 (required)
... 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 Not used in this profile
... description Σ 0..1 markdown Not used in this profile
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM Pharmaceutical 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 Not used in this profile
... legalStatusOfSupply Σ 0..1 CodeableConcept Not used in this profile
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

... additionalMonitoringIndicator Σ 0..1 CodeableConcept Not used in this profile
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).

... specialMeasures Σ 0..* CodeableConcept Not used in this profile
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ 0..1 CodeableConcept Not used in this profile
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 Not used in this profile
... packagedMedicinalProduct Σ 0..* CodeableConcept Not used in this profile
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 Marketing Authorization Holder to be classified
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

.... contact Σ 1..1 Reference(Organization | PractitionerRole) A specific Marketing Authorization Holder 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.
.... 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 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 1..1 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

...... 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 1..1 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: urn:iso:std:iso:3166
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..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
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

...... 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 1..1 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
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Jurisdiction Value Set (example)
....... 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
..... 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.identifier.systemextensibleVsMpIdSystem
http://who-umc.org/idmp/ValueSet/mpid-system
from this IG
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainrequiredMedicinalProductDomain
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.combinedPharmaceuticalDoseFormexamplepharmaceuticalForm
http://who-umc.org/idmp/ValueSet/pharmaceuticalForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://who-umc.org/idmp/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://who-umc.org/idmp/ValueSet/atcClassification
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.jurisdiction.coding.codeexampleVsJurisdiction
http://who-umc.org/idmp/ValueSet/jurisdiction
from this IG
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: 7 elements(2 nested mandatory elements)

Differential View

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id 1..1 id Logical id of this artifact
... contained 0..1 Organization Contained, inline Resources
... identifier 1..* Identifier Business identifier for this product. Could be an MPID
.... system 1..1 uri The namespace for the identifier value
Binding: MPID system (extensible)
.... value 1..1 string The value that is unique
... domain 0..1 CodeableConcept If this medicine applies to human or veterinary uses.
Binding: MedicinalProductDomain (required)
... status 0..1 CodeableConcept The status within the lifecycle of this product record.
... statusDate 0..1 dateTime Not used in this profile
... description 0..1 markdown Not used in this profile
... combinedPharmaceuticalDoseForm 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM Pharmaceutical 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 Not used in this profile
... legalStatusOfSupply 0..1 CodeableConcept Not used in this profile
... additionalMonitoringIndicator 0..1 CodeableConcept Not used in this profile
... specialMeasures 0..* CodeableConcept Not used in this profile
... pediatricUseIndicator 0..1 CodeableConcept Not used in this profile
... classification 0..* CodeableConcept Allows the product to be classified by various systems (e.g. ATC)
Binding: WHO ATC (example)
... marketingStatus 0..* MarketingStatus Not used in this profile
... packagedMedicinalProduct 0..* CodeableConcept Not used in this profile
... contact
.... type 0..1 CodeableConcept Allows the Marketing Authorization Holder to be classified
.... contact 1..1 Reference(Organization | PractitionerRole) A specific Marketing Authorization Holder for this product
... name
.... productName 1..1 string The full product name.
.... 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 1..1 BackboneElement Country and jurisdiction where the name applies
..... country 1..1 CodeableConcept Country where this name applies
...... coding 1..1 Coding Code defined by a terminology system
....... system 0..1 uri Identity of the terminology system
Required Pattern: urn:iso:std:iso:3166
....... code 1..1 code Symbol in syntax defined by the system
..... jurisdiction 0..1 CodeableConcept Jurisdiction where this name applies
...... coding 1..1 Coding Code defined by a terminology system
....... code 1..1 code Symbol in syntax defined by the system
Binding: Jurisdiction Value Set (example)
..... language 1..1 CodeableConcept Language for this name

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.identifier.systemextensibleVsMpIdSystem
http://who-umc.org/idmp/ValueSet/mpid-system
from this IG
MedicinalProductDefinition.domainrequiredMedicinalProductDomain
http://hl7.org/fhir/ValueSet/medicinal-product-domain
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormexamplepharmaceuticalForm
http://who-umc.org/idmp/ValueSet/pharmaceuticalForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://who-umc.org/idmp/ValueSet/routeOfAdministration
from this IG
MedicinalProductDefinition.classificationexampleVsAtcClassification
http://who-umc.org/idmp/ValueSet/atcClassification
from this IG
MedicinalProductDefinition.name.usage.jurisdiction.coding.codeexampleVsJurisdiction
http://who-umc.org/idmp/ValueSet/jurisdiction
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 1..1 id Logical id of this artifact
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..1 Organization Contained, inline Resources
... identifier Σ 1..* Identifier Business identifier for this product. Could be an MPID
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

.... system Σ 1..1 uri The namespace for the identifier value
Binding: MPID system (extensible)
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 (required)
... 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 Not used in this profile
... description Σ 0..1 markdown Not used in this profile
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM Pharmaceutical 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 Not used in this profile
... legalStatusOfSupply Σ 0..1 CodeableConcept Not used in this profile
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

... additionalMonitoringIndicator Σ 0..1 CodeableConcept Not used in this profile
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).

... specialMeasures Σ 0..* CodeableConcept Not used in this profile
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ 0..1 CodeableConcept Not used in this profile
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 Not used in this profile
... packagedMedicinalProduct Σ 0..* CodeableConcept Not used in this profile
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.
.... usage Σ 1..1 BackboneElement Country and jurisdiction where the name applies
..... 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

...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 0..1 uri Identity of the terminology system
Required Pattern: urn:iso:std:iso:3166
....... code ΣC 1..1 code Symbol in syntax defined by the system
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

...... coding Σ 1..1 Coding Code defined by a terminology system
....... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Jurisdiction Value Set (example)
..... language Σ 1..1 CodeableConcept Language for this name
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set

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.identifier.systemextensibleVsMpIdSystem
http://who-umc.org/idmp/ValueSet/mpid-system
from this IG
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainrequiredMedicinalProductDomain
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.combinedPharmaceuticalDoseFormexamplepharmaceuticalForm
http://who-umc.org/idmp/ValueSet/pharmaceuticalForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://who-umc.org/idmp/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://who-umc.org/idmp/ValueSet/atcClassification
from this IG
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-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.jurisdiction.coding.codeexampleVsJurisdiction
http://who-umc.org/idmp/ValueSet/jurisdiction
from this IG
MedicinalProductDefinition.name.usage.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
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 1..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..1 Organization 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
Binding: MPID system (extensible)
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 (required)
... 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 Not used in this profile
... description Σ 0..1 markdown Not used in this profile
... combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: EDQM Pharmaceutical 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 Not used in this profile
... legalStatusOfSupply Σ 0..1 CodeableConcept Not used in this profile
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product

... additionalMonitoringIndicator Σ 0..1 CodeableConcept Not used in this profile
Binding: AdditionalMonitoring (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).

... specialMeasures Σ 0..* CodeableConcept Not used in this profile
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ 0..1 CodeableConcept Not used in this profile
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 Not used in this profile
... packagedMedicinalProduct Σ 0..* CodeableConcept Not used in this profile
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 Marketing Authorization Holder to be classified
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

.... contact Σ 1..1 Reference(Organization | PractitionerRole) A specific Marketing Authorization Holder 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.
.... 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 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 1..1 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

...... 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 1..1 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: urn:iso:std:iso:3166
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..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
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

...... 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 1..1 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
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Jurisdiction Value Set (example)
....... 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
..... 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.identifier.systemextensibleVsMpIdSystem
http://who-umc.org/idmp/ValueSet/mpid-system
from this IG
MedicinalProductDefinition.typeexampleMedicinalProductType
http://hl7.org/fhir/ValueSet/medicinal-product-type
from the FHIR Standard
MedicinalProductDefinition.domainrequiredMedicinalProductDomain
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.combinedPharmaceuticalDoseFormexamplepharmaceuticalForm
http://who-umc.org/idmp/ValueSet/pharmaceuticalForm
from this IG
MedicinalProductDefinition.routeexampleVsRouteOfAdministration
http://who-umc.org/idmp/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://who-umc.org/idmp/ValueSet/atcClassification
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.jurisdiction.coding.codeexampleVsJurisdiction
http://who-umc.org/idmp/ValueSet/jurisdiction
from this IG
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: 7 elements(2 nested mandatory elements)

 

Other representations of profile: CSV, Excel, Schematron