# baseURI: https://spec.pistoiaalliance.org/idmp/ontology/master/v1.4.0/ISO/ISO11239-PharmaceuticalDoseForms/
# imports: https://spec.pistoiaalliance.org/idmp/ontology/master/v1.4.0/ISO/ISO11238-Substances/
# imports: https://spec.pistoiaalliance.org/idmp/ontology/master/v1.4.0/ISO/ISO11615-MedicinalProducts/
# imports: https://spec.pistoiaalliance.org/idmp/ontology/master/v1.4.0/ISO/ISO11616-PharmaceuticalProducts/
# imports: https://spec.pistoiaalliance.org/idmp/ontology/master/v1.4.0/META/ChangeManagement/
# imports: https://www.omg.org/spec/Commons/AnnotationVocabulary/
# imports: https://www.omg.org/spec/Commons/Classifiers/
# imports: https://www.omg.org/spec/Commons/CodesAndCodeSets/
# imports: https://www.omg.org/spec/Commons/Collections/
# imports: https://www.omg.org/spec/Commons/ContextualDesignators/
# imports: https://www.omg.org/spec/Commons/DatesAndTimes/
# imports: https://www.omg.org/spec/Commons/Documents/
# imports: https://www.omg.org/spec/Commons/Identifiers/
# imports: https://www.omg.org/spec/Commons/PartiesAndSituations/
# imports: https://www.omg.org/spec/Commons/RegistrationAuthorities/
# imports: https://www.omg.org/spec/Commons/RegulatoryAgencies/
# imports: https://www.omg.org/spec/Commons/SitesAndFacilities/
@base .
@prefix cmns-av: .
@prefix cmns-cds: .
@prefix cmns-cls: .
@prefix cmns-col: .
@prefix cmns-cxtdsg: .
@prefix cmns-doc: .
@prefix cmns-dt: .
@prefix cmns-id: .
@prefix cmns-pts: .
@prefix cmns-ra: .
@prefix cmns-rga: .
@prefix cmns-sfc: .
@prefix dcterms: .
@prefix idmp-chg: .
@prefix idmp-mprd: .
@prefix idmp-phdf: .
@prefix idmp-sub: .
@prefix owl: .
@prefix rdf: .
@prefix rdfs: .
@prefix skos: .
@prefix xsd: .
a owl:Ontology ;
rdfs:label "ISO 11239 Regulated Pharmaceutical Dose Forms Ontology" ;
dcterms:abstract "The regulated pharmaceutical dose forms ontology provides a semantic model representing the definitions for exchanging basic concepts for the unique identification and exchange of regulated pharmaceutical dose forms information. It is derived from the ISO 11239:2012 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging." ;
dcterms:license "https://opensource.org/licenses/MIT"^^xsd:anyURI ;
owl:imports
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;
owl:versionIRI ;
idmp-chg:hasMaturityLevel idmp-chg:Provisional ;
cmns-av:copyright
"Copyright (c) 2022-2024 EDM Council, Inc." ,
"Copyright (c) 2022-2024 Pistoia Alliance, Inc."
;
.
idmp-sub:ManufacturedItem
a owl:Class ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.16" ;
skos:note
"In many instances, the manufactured item is equal to the pharmaceutical product. However, there are instances where the manufactured item(s) must undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal." ,
"The manufactured item is not in direct contact with the outer packaging except where the outer packaging also serves as the immediate container."
;
.
idmp-phdf:AdministrationMethod
a owl:Class ;
rdfs:subClassOf idmp-mprd:ProcessSpecification ;
rdfs:label "administration method" ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.3" ;
rdfs:isDefinedBy ;
skos:definition "general method by which a pharmaceutical product is intended to be administered to the patient" ;
skos:example "application, inhalation, injection" ;
skos:note "The administration method is a general term that is used to group related pharmaceutical dose form concepts, and is not intended to describe a precise method or route of administration." ;
.
idmp-phdf:BasicDoseForm
a owl:Class ;
rdfs:subClassOf idmp-mprd:PharmaceuticalDoseForm ;
rdfs:label "basic dose form" ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.4" ;
rdfs:isDefinedBy ;
skos:definition "generalized version of the pharmaceutical dose form, used to group together related pharmaceutical dose forms" ;
skos:example "capsule, tablet, powder, solution" ;
.
idmp-phdf:IntendedSite
a owl:Class ;
rdfs:subClassOf cmns-sfc:Site ;
rdfs:label "intended site" ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.13" ;
rdfs:isDefinedBy ;
skos:definition "general body site at which a pharmaceutical product is intended to be administered" ;
skos:example "auricular, ocular, oral" ;
skos:note "The intended site is a general term that is used to group related pharmaceutical dose form concepts, and is not intended to describe a precise site or route of administration." ;
.
idmp-phdf:ReleaseCharacteristic
a owl:Class ;
rdfs:subClassOf cmns-cls:Aspect ;
rdfs:label "release characteristic" ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.23" ;
rdfs:isDefinedBy ;
skos:definition "description of the modified timing by which an active ingredient is made available in the body after administration of the pharmaceutical product, in comparison with a conventional, direct release of the active ingredient" ;
skos:example "delayed, extended, none" ;
.
idmp-phdf:Transformation
a owl:Class ;
rdfs:subClassOf
idmp-mprd:ProcessSpecification ,
[
a owl:Restriction ;
owl:onProperty cmns-doc:refersTo ;
owl:onClass idmp-mprd:PharmaceuticalDoseForm ;
owl:minQualifiedCardinality "0"^^xsd:nonNegativeInteger ;
]
;
rdfs:label "transformation" ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clauses 3.1.26, 5.3.2.6" ;
rdfs:isDefinedBy ;
skos:definition "procedure that is carried out in order to convert a manufactured item that requires such a procedure into a pharmaceutical product, i.e. from its manufactured dose form to its administrable dose form" ;
skos:example "dilution, dissolution, suspension" ;
skos:note
"No transformation is needed if the dose forms of the manufactured item and the pharmaceutical product are equal." ,
"Where there is no transformation, the class has an appropriate null value. A transformation is associated with zero to many pharmaceutical dose forms."
;
cmns-av:explanatoryNote "See also Annex A (Table A.3) for controlled vocabulary examples, and Annex B for medicinal product examples." ;
.
idmp-phdf:hasAdministrationMethod
a owl:ObjectProperty ;
rdfs:subPropertyOf cmns-doc:specifies ;
rdfs:label "has administration method" ;
rdfs:isDefinedBy ;
rdfs:range idmp-phdf:AdministrationMethod ;
skos:definition "specifies a general method by which a pharmaceutical product is intended to be administered to the patient" ;
cmns-av:adaptedFrom "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.3" ;
.
idmp-phdf:hasBasicDoseForm
a owl:ObjectProperty ;
rdfs:subPropertyOf idmp-mprd:hasDoseForm ;
rdfs:label "has basic dose form" ;
rdfs:domain idmp-mprd:PharmaceuticalDoseForm ;
rdfs:isDefinedBy ;
rdfs:range idmp-phdf:BasicDoseForm ;
skos:definition "specifies the generalized dose form associated with the pharmaceutical dose form" ;
cmns-av:adaptedFrom "ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 3.1.4" ;
.
idmp-phdf:hasIntendedSite
a owl:ObjectProperty ;
rdfs:subPropertyOf
cmns-doc:specifies ,
cmns-sfc:isSituatedAt
;
rdfs:label "has intended site" ;
rdfs:isDefinedBy ;
rdfs:range idmp-phdf:IntendedSite ;
skos:definition "specifies a general body site at which a pharmaceutical product is intended to be administered" ;
cmns-av:adaptedFrom "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.13" ;
.
idmp-phdf:hasReleaseCharacteristic
a owl:ObjectProperty ;
rdfs:subPropertyOf cmns-cls:isCharacterizedBy ;
rdfs:label "has release characteristic" ;
rdfs:isDefinedBy ;
rdfs:range idmp-phdf:ReleaseCharacteristic ;
skos:definition "specifies the description of the modified timing by which an active ingredient is made available in the body after administration of the pharmaceutical product" ;
cmns-av:adaptedFrom "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.23" ;
.
idmp-phdf:hasTransformationProcedure
a owl:ObjectProperty ;
rdfs:subPropertyOf cmns-doc:specifies ;
rdfs:label "has transformation procedure" ;
rdfs:isDefinedBy ;
rdfs:range idmp-phdf:Transformation ;
skos:definition "specifies a procedure that is carried out in order to convert a manufactured item that requires such a procedure into a pharmaceutical product, i.e. from its manufactured dose form to its administrable dose form" ;
cmns-av:adaptedFrom "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.26" ;
.
idmp-mprd:AdministrableDoseForm
a owl:Class ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.1" ;
skos:example "solution for injection, tablet for oral use, hard-capsule powder for inhalation" ;
.
idmp-mprd:CombinedPharmaceuticalDoseForm
a owl:Class ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.8" ;
skos:example "powder and solvent for solution for injection: the medicinal product contains two manufactured items (a powder for solution for injection and a solvent for solution for injection); the pharmaceutical product that is prepared from the two manufactured items is a solution for injection. The combined pharmaceutical dose form for the medicinal product is 'powder and solvent for solution for injection'" ;
.
idmp-mprd:Container
a owl:Class ;
skos:example "ampoule, bottle, box" ;
skos:note "'Container' is a general concept that groups together the concepts of immediate container, intermediate packaging and outer packaging." ;
cmns-av:adaptedFrom "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.9" ;
.
idmp-mprd:ImmediateContainer
a owl:NamedIndividual ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.12" ;
skos:example "ampoule, vial, prefilled syringe, bottle, blister" ;
skos:note "Adapted from ENV 12610:1997." ;
.
idmp-mprd:IntermediatePackaging
a owl:NamedIndividual ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.14" ;
skos:example "box" ;
.
idmp-mprd:ManufacturedDoseForm
a owl:Class ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.15" ;
skos:example "powder for solution for injection" ;
.
idmp-mprd:MedicinalProduct
a owl:Class ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.17" ;
skos:note
"A medicinal product may consist of one or more manufactured items and one or more pharmaceutical products." ,
"In certain jurisdictions, a medicinal product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis."
;
.
idmp-mprd:MedicinalProductIdentifier
a owl:Class ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.18" ;
.
idmp-mprd:OuterPackaging
a owl:NamedIndividual ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.19" ;
skos:example "box" ;
.
idmp-mprd:PharmaceuticalDoseForm
a owl:Class ;
rdfs:subClassOf
[
a owl:Restriction ;
owl:onProperty idmp-phdf:hasTransformationProcedure ;
owl:onClass idmp-phdf:Transformation ;
owl:minQualifiedCardinality "0"^^xsd:nonNegativeInteger ;
] ,
[
a owl:Restriction ;
owl:onProperty idmp-phdf:hasBasicDoseForm ;
owl:onClass idmp-phdf:BasicDoseForm ;
owl:qualifiedCardinality "1"^^xsd:nonNegativeInteger ;
] ,
[
a owl:Restriction ;
owl:onProperty idmp-phdf:hasReleaseCharacteristic ;
owl:onClass idmp-phdf:ReleaseCharacteristic ;
owl:qualifiedCardinality "1"^^xsd:nonNegativeInteger ;
] ,
[
a owl:Restriction ;
owl:onProperty idmp-phdf:hasAdministrationMethod ;
owl:someValuesFrom idmp-phdf:AdministrationMethod ;
] ,
[
a owl:Restriction ;
owl:onProperty idmp-phdf:hasIntendedSite ;
owl:someValuesFrom idmp-phdf:IntendedSite ;
]
;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.20" ;
.
idmp-mprd:PharmaceuticalProduct
a owl:Class ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.21" ;
skos:note "A medicinal product may contain one or more pharmaceutical products." ;
.
idmp-mprd:PharmaceuticalProductIdentifier
a owl:Class ;
dcterms:source "ISO 11239:2012 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging, clause 3.1.22" ;
.