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IDMP-726 - added missing attributes of medicinal product, such as ped…
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…iatric use indicator, added other characteristic and code needed for package item, manufactured item and device; added remaining restrictions on package item

Signed-off-by: Elisa Kendall <[email protected]>
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@ElisaKendall
ElisaKendall committed Apr 3, 2024
1 parent 7a24270 commit 18376e4
Showing 1 changed file with 160 additions and 14 deletions.
174 changes: 160 additions & 14 deletions ISO/ISO11615-MedicinalProducts.rdf
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Original file line number Diff line number Diff line change
Expand Up @@ -2774,13 +2774,34 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli
<owl:maxQualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">1</owl:maxQualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-cls;isClassifiedBy"/>
<owl:onClass rdf:resource="&idmp-mprd;MedicinalProductMonitoringIndicator"/>
<owl:maxQualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">1</owl:maxQualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-cls;isClassifiedBy"/>
<owl:onClass rdf:resource="&idmp-mprd;OrphanDesignation"/>
<owl:maxQualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">1</owl:maxQualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-cls;isClassifiedBy"/>
<owl:onClass rdf:resource="&idmp-mprd;PediatricUseIndicator"/>
<owl:maxQualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">1</owl:maxQualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-prd;isProducedBy"/>
<owl:onClass rdf:resource="&idmp-sub;Manufacturer"/>
<owl:minQualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">0</owl:minQualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&idmp-mprd;hasContraindication"/>
Expand Down Expand Up @@ -2853,15 +2874,15 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-dsg;isDescribedBy"/>
<owl:onClass rdf:resource="&idmp-mprd;MedicinalProductHeaderRecord"/>
<owl:qualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">1</owl:qualifiedCardinality>
<owl:onProperty rdf:resource="&idmp-mprd;hasSpecialMeasures"/>
<owl:minQualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">0</owl:minQualifiedCardinality>
<owl:onDataRange rdf:resource="&xsd;string"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-id;isIdentifiedBy"/>
<owl:onClass rdf:resource="&idmp-mprd;MedicinalProductIdentifier"/>
<owl:onProperty rdf:resource="&cmns-dsg;isDescribedBy"/>
<owl:onClass rdf:resource="&idmp-mprd;MedicinalProductHeaderRecord"/>
<owl:qualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">1</owl:qualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
Expand Down Expand Up @@ -2906,8 +2927,8 @@ d) the assignment of a unique medicinal product batch identifier (BAID2) to reli
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-prd;isProducedBy"/>
<owl:someValuesFrom rdf:resource="&idmp-sub;Manufacturer"/>
<owl:onProperty rdf:resource="&cmns-id;isIdentifiedBy"/>
<owl:someValuesFrom rdf:resource="&idmp-mprd;MedicinalProductIdentifier"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:label>medicinal product</rdfs:label>
Expand Down Expand Up @@ -3189,6 +3210,28 @@ g) therapeutic indication(s) as authorized for the medicinal product.</skos:note
<cmns-av:synonym xml:lang="en-US">master file holder (organization)</cmns-av:synonym>
</owl:Class>

<owl:Class rdf:about="&idmp-mprd;MedicinalProductMonitoringIndicator">
<rdfs:subClassOf rdf:resource="&idmp-dtp;ISO21090-ConceptDescriptor"/>
<rdfs:subClassOf rdf:resource="&cmns-cls;Classifier"/>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-cls;classifies"/>
<owl:someValuesFrom rdf:resource="&idmp-mprd;MedicinalProduct"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:label>additional monitoring indicator</rdfs:label>
<rdfs:label>medicinal product monitoring indicator</rdfs:label>
<dct:source>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, Figure 6 and clause 9.2.2.2.4</dct:source>
<skos:definition>classifier for medicinal products, specifying whether a given product is subject to additional monitoring</skos:definition>
<skos:note>If the medicinal product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary.</skos:note>
<idmp-sub:hasConformanceLevel rdf:resource="&idmp-sub;ConformanceLevel-Conditional"/>
<idmp-dtp:isEncodedAs rdf:resource="&idmp-dtp;DatatypeCode-CD"/>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-DefinitionallyConformant"/>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-ModelConformant"/>
<cmns-av:adaptedFrom>ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause A.2.4</cmns-av:adaptedFrom>
<cmns-av:usageNote>No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.</cmns-av:usageNote>
</owl:Class>

<owl:Class rdf:about="&idmp-mprd;MedicinalProductName">
<rdfs:subClassOf rdf:resource="&cmns-cxtdsg;ContextualName"/>
<rdfs:subClassOf>
Expand Down Expand Up @@ -3291,6 +3334,60 @@ g) therapeutic indication(s) as authorized for the medicinal product.</skos:note
<cmns-av:usageNote>If the value for orphan designation status on the medicinal product is non-empty (i.e., the product has such a status), then from a business rule perspective, at least one instance of this classifier should be present.</cmns-av:usageNote>
</owl:Class>

<owl:Class rdf:about="&idmp-mprd;OtherProductCharacteristic">
<rdfs:subClassOf rdf:resource="&mvf-trm;NonEssentialCharacteristic"/>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-dsg;describes"/>
<owl:allValuesFrom>
<owl:Class>
<owl:unionOf rdf:parseType="Collection">
<rdf:Description rdf:about="&idmp-sub;ManufacturedItem">
</rdf:Description>
<rdf:Description rdf:about="&idmp-mprd;PackageItem">
</rdf:Description>
<rdf:Description rdf:about="&idmp-mprd;MedicalDevice">
</rdf:Description>
</owl:unionOf>
</owl:Class>
</owl:allValuesFrom>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-dsg;isSignifiedBy"/>
<owl:onClass rdf:resource="&idmp-mprd;OtherProductCharacteristicCode"/>
<owl:qualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">1</owl:qualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:label>other product characteristic</rdfs:label>
<dct:source>ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, Figure 11, clause 9.6.2.22</dct:source>
<owl:disjointWith rdf:resource="&idmp-sub;PhysicalCharacteristic"/>
<skos:definition>aspect of a manufactured item, package item, or medical device that describes that product</skos:definition>
<skos:note>Where applicable for a package item, a manufactured item or a device, other characteristics can be specified. This facility is useful for capturing unusual details not explicitly catered for in the other attributes.</skos:note>
<idmp-sub:hasConformanceLevel rdf:resource="&idmp-sub;ConformanceLevel-Optional"/>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-DefinitionallyConformant"/>
<idmp-cmpl:hasConformanceToISOLevel rdf:resource="&idmp-cmpl;ConformanceToISOLevel-ModelConformant"/>
<cmns-av:adaptedFrom>ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause C.3.15</cmns-av:adaptedFrom>
<cmns-av:synonym>other characteristic</cmns-av:synonym>
</owl:Class>

<owl:Class rdf:about="&idmp-mprd;OtherProductCharacteristicCode">
<rdfs:subClassOf rdf:resource="&idmp-dtp;ISO21090-ConceptDescriptor"/>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-dsg;denotes"/>
<owl:allValuesFrom rdf:resource="&idmp-mprd;OtherProductCharacteristic"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:label>other product characteristic code</rdfs:label>
<dct:source>ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, Figure 11, clause 9.6.2.22</dct:source>
<skos:definition>value for an aspect of a manufactured item, package item, or medical device that describes that product, derived from a controlled vocabulary</skos:definition>
<idmp-dtp:isEncodedAs rdf:resource="&idmp-dtp;DatatypeCode-CD"/>
<cmns-av:adaptedFrom>ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause C.3.15</cmns-av:adaptedFrom>
<cmns-av:usageNote>No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.</cmns-av:usageNote>
</owl:Class>

<owl:Class rdf:about="&idmp-mprd;OtherTherapySpecifics">
<rdfs:subClassOf rdf:resource="&cmns-doc;Specification"/>
<rdfs:subClassOf>
Expand Down Expand Up @@ -3456,6 +3553,13 @@ g) therapeutic indication(s) as authorized for the medicinal product.</skos:note
<owl:minQualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">0</owl:minQualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&idmp-mprd;hasOtherCharacteristic"/>
<owl:onClass rdf:resource="&cmns-cls;Aspect"/>
<owl:minQualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">0</owl:minQualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-qtu;hasQuantityValue"/>
Expand All @@ -3470,6 +3574,23 @@ g) therapeutic indication(s) as authorized for the medicinal product.</skos:note
<owl:qualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">1</owl:qualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&idmp-sub;hasMaterial"/>
<owl:someValuesFrom>
<owl:Class>
<owl:unionOf rdf:parseType="Collection">
<rdf:Description rdf:about="&idmp-sub;MaterialSpecification">
</rdf:Description>
<rdf:Description rdf:about="&idmp-sub;MaterialClassifier">
</rdf:Description>
<rdf:Description rdf:about="&idmp-sub;Substance">
</rdf:Description>
</owl:unionOf>
</owl:Class>
</owl:someValuesFrom>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-col;isPartOf"/>
Expand Down Expand Up @@ -3563,6 +3684,25 @@ g) therapeutic indication(s) as authorized for the medicinal product.</skos:note
<cmns-av:adaptedFrom>ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.7</cmns-av:adaptedFrom>
</owl:Class>

<owl:Class rdf:about="&idmp-mprd;PediatricUseIndicator">
<rdfs:subClassOf rdf:resource="&idmp-dtp;ISO21090-ConceptDescriptor"/>
<rdfs:subClassOf rdf:resource="&cmns-cls;Classifier"/>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-cls;classifies"/>
<owl:someValuesFrom rdf:resource="&idmp-mprd;MedicinalProduct"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:label xml:lang="en-GB">paediatric use indicator</rdfs:label>
<rdfs:label xml:lang="en-US">pediatric use indicator</rdfs:label>
<dct:source>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, Figure 6 and clause 9.2.2.2.6</dct:source>
<skos:definition>classifier for medicinal products, specifying whether a given product is authorized for use in children</skos:definition>
<idmp-sub:hasConformanceLevel rdf:resource="&idmp-sub;ConformanceLevel-Conditional"/>
<idmp-dtp:isEncodedAs rdf:resource="&idmp-dtp;DatatypeCode-CD"/>
<cmns-av:adaptedFrom>ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause A.2.6</cmns-av:adaptedFrom>
<cmns-av:usageNote>No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.</cmns-av:usageNote>
</owl:Class>

<owl:Class rdf:about="&idmp-mprd;PharmaceuticalDoseForm">
<rdfs:subClassOf rdf:resource="&cmns-doc;Specification"/>
<rdfs:subClassOf>
Expand Down Expand Up @@ -3686,7 +3826,7 @@ g) therapeutic indication(s) as authorized for the medicinal product.</skos:note
</owl:Class>

<owl:Class rdf:about="&idmp-mprd;PharmaceuticalProductCharacteristic">
<rdfs:subClassOf rdf:resource="&cmns-cls;Aspect"/>
<rdfs:subClassOf rdf:resource="&mvf-trm;EssentialCharacteristic"/>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-dsg;describes"/>
Expand Down Expand Up @@ -3743,12 +3883,6 @@ g) therapeutic indication(s) as authorized for the medicinal product.</skos:note
<owl:allValuesFrom rdf:resource="&idmp-mprd;PharmaceuticalProductCharacteristic"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-dsg;denotes"/>
<owl:allValuesFrom rdf:resource="&idmp-mprd;PharmaceuticalProductCharacteristic"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:label>pharmaceutical product characteristic status</rdfs:label>
<dct:source>ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, Figure 13, clause 9.8.4.4</dct:source>
<skos:definition>classifier for an aspect of a pharmaceutical product that describes that product, such as its onset of action, indicating the state of the characteristic in question</skos:definition>
Expand Down Expand Up @@ -5356,6 +5490,18 @@ g) therapeutic indication(s) as authorized for the medicinal product.</skos:note
<cmns-av:adaptedFrom>ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause 9.6.2.11.2</cmns-av:adaptedFrom>
</owl:ObjectProperty>

<owl:DatatypeProperty rdf:about="&idmp-mprd;hasSpecialMeasures">
<rdfs:subPropertyOf rdf:resource="&cmns-txt;hasTextValue"/>
<rdfs:label>has special measures</rdfs:label>
<dct:source>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, Figure 6 and clause 9.2.2.2.5</dct:source>
<rdfs:domain rdf:resource="&idmp-mprd;MedicinalProduct"/>
<skos:definition>indicates whether a medicinal product is subject to specific special measures</skos:definition>
<idmp-sub:hasConformanceLevel rdf:resource="&idmp-sub;ConformanceLevel-Conditional"/>
<idmp-dtp:isEncodedAs rdf:resource="&idmp-dtp;DatatypeCode-ST"/>
<cmns-av:adaptedFrom>ISO/TS 20443:2018(E) Health informatics - Identification of medicinal products (IDMP) - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information, clause A.2.5</cmns-av:adaptedFrom>
<cmns-av:usageNote>No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.</cmns-av:usageNote>
</owl:DatatypeProperty>

<owl:ObjectProperty rdf:about="&idmp-mprd;hasSpecialPrecautionsForStorage">
<rdfs:subPropertyOf rdf:resource="&cmns-cls;isClassifiedBy"/>
<rdfs:label>has special precautions for storage</rdfs:label>
Expand Down

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