ISO 11615 Regulated Medicinal Product Information Ontology
type: Ontology
abstract: The regulated medicinal product information ontology provides a semantic model representing the definitions for exchanging basic concepts for the unique identification and exchange of regulated medicinal product information. It is derived from the ISO 11615:2017 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information.
license: https://opensource.org/licenses/MIT
imports: ISO11238-Substances
imports: ISO11240-UnitsOfMeasurement
imports: ISO21090-HarmonizedDatatypes
imports: ChangeManagement
imports: ISOConformanceAnnotations
imports: AnnotationVocabulary
imports: Classifiers
imports: CodesAndCodeSets
imports: Collections
imports: ContextualDesignators
imports: ContextualIdentifiers
imports: DatesAndTimes
imports: Designators
imports: Documents
imports: Identifiers
imports: Locations
imports: Organizations
imports: PartiesAndSituations
imports: ProductsAndServices
imports: QuantitiesAndUnits
imports: RegistrationAuthorities
imports: RegulatoryAgencies
imports: RolesAndCompositions
imports: SitesAndFacilities
imports: StatisticalMeasures
imports: TextDatatype
imports: CountryRepresentation
imports: ISO639-1-LanguageCodes
imports: LanguageRepresentation
imports: ISO1087-TerminologyScience
imports: ISO1087-VocabularyForTermsAndDefinitions
imports: MultipleVocabularyFacility
version IRI: ISO11615-MedicinalProducts
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was augmented to add SKOS prefLabels for elements that have multiple labels (IDMP-734), modified to clean up URIs that had an erroneous final slash or do not resolve reliably, and rephrased the definition of 'marketing status reason code' to be grammatically correct.
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was extended to complete the details for marketing authorization (IDMP-747) and marketing status (IDMP-750).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was extended to complete the details for medicinal product name (IDMP-745), integrate revisions to the content from the 1.2 revision of the OMG Commons Ontology Library (IDMP-774), complete the linkage beween a manufacturer, a given business operation (facility), and the manufacturing site(s) at which a particular medicinal product (or component of a medicinal product) is manufactured (IDMP-779), revised the name of concentration to concentration strength for consistency (IDMP-776), and added a link between the packaged medicinal product and marketing status record (IDMP-777).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to (1) integrate content related to modifications from Figure 15 in ISO 11238 (IDMP-540), (2) support isotopes and nuclides as in ISO 11238, Figure 14 (IDMP-539), (3) integrate content related to therapeutic indications in ISO 11615 (IDMP-561), (4) clarify the definition of marketing authorization holder (IDMP-395), (5) refine restrictions between medicinal products and authorized medicinal products (IDMP-550), (6) aligne the ontology with the revised basis of strength pattern (IDMP-582), and (7) loosen a constraint on ingredient with respect to manufactured item (IDMP-602).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to (1) make indication texts as nodes instead of literals (IDMP-591), (2) add the concept of shelf life / storage per Figure 11 in the ISO 11615 specification (IDMP-371), (3) add undesirable effect per Figure 14 in the ISO 11615 specification (IDMP-591), (4) rename 'has medical condition' to use a more aligned label with ISO 11615 (IDMP-591), (5) add the concept of route of administration (IDMP-614), and (6) integrate the refined pattern for controlled vocabularies (IDMP-533).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to add content from ISO 11615 that was incomplete but required for representation of jurisdiction-agnostic medicinal products (IDMP-726).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to add other therapy specifics (IDMP-639), and to (1) reflect the migration of some content in Commons from the Parties and Situations ontology to a new Roles and Compositions ontology at OMG (IDMP-642), to (1) rename cmns-doc;isSpecifiedBy to cmns-doc;isSpecifiedIn, (2) incorporate hasExpirationDate, which was simplified out of the OMG Commons ontology, and (3) rename concepts including Quantity, QuantityValue, and QuantityValueRange to ScalarQuantity, ScalarQuantityValue, and ScalarQuantityValueRange per the Commons 1.1 release (IDMP-655), and to restructure the inheritance hierarchy with respect to Batch and Lot definitions (IDMP-632).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to add package components, devices, and physical characteristics (IDMP-659), to eliminate default codes on Ingredient and InactiveIngredient (IDMP-634), and add characteristics for target populations (IDMP-640).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to correct definitions to be compliant with IDMP-O policies (GitHub-501), fill in gaps with respect to the top-level class definitions and relationships in the complete model figures for authorized and investigational medicinal product in Annex A and Annex B, respectively, in ISO 11615 (IDMP-677), and to update the conformance points to be current (IDMP-322).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to correctly represent the notion of age as a population characteristic (IDMP-682) and simplify the representation of container roles (IDMP-748).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to extend the definition of product role to relate to product specifications in addition to products (IDMP-633).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to fill gaps to support the CMC use case.
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to further simplify the packaging / container model (IDMP-744).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to integrate additional manufacturing and packaging details required for UC-2 (IDMP-465), to make manufactured item and pharmaceutical product disjoint, but both product specifications (IDMP-466), to change the status of this ontology to 'release' (IDMP-525), to add content related to dose forms (IDMP-531, IDMP-538), and to complete the set of ingredient roles specified in the implementation guide for ISO 11615 (IDMP-304).
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to refactor concepts including substance, moiety, and add physical substance in order to distinguish specifications for substances, which is the primary perspective of the IDMP standards from physical substances, and rename product constituency to product composition, which is better understood by the user community, and to move a couple of restrictions from ingredient to substance, including strength and whether or not that substance is potentially allergenic. (IDMP-405)
change note: The https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts.rdf version of this ontology was modified to rename 'ingredient role's to ingredients for clarification and refine the restrictions relating ingredients to pharmaceutical products and manufactured items per discussion at the Pistoia Alliance Conference Workshop on 3 November 2022 (IDMP-298). It was also extended to include concepts such as process, manufacturing process, process identifier, batch, batch identifier, lot, lot number, and others required in support of the regulatory to manufacturing bridge use case.
has maturity level: Release
copyright: Copyright (c) 2022-2024 EDM Council, Inc.
copyright: Copyright (c) 2022-2024 Pistoia Alliance, Inc.

ActiveIngredient
type: Class
subclass of: Restriction
  on property: has reference strength
  on class: reference strength
  min qualified cardinality: 0

ActiveMoietyRole
type: Class
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, clause 3.1.80

Adjuvant
type: Class
subclass of: Restriction
  on property: isSignifiedBy
  has value: ingredient role - ADJV
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, clause 3.1.1

Ingredient
type: Class
subclass of: Restriction
  on property: isManifestedIn
  on class: pharmaceutical product
  max qualified cardinality: 1
subclass of: Restriction
  on property: isManifestedIn
  on class: ManufacturedItem
  min qualified cardinality: 0
subclass of: Restriction
  on property: has strength
  on class: strength
  min qualified cardinality: 0
subclass of: Restriction
  on property: isPlayedBy
  on class: Restriction
    on property: isIncludedIn
    on class: pharmaceutical product
    min qualified cardinality: 0
  min qualified cardinality: 0
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, clauses 3.1.28 and 9.7, Figure 12
note: An ingredient is part of a medicinal product, either alone or in combination with other ingredients. The ingredient is also a component of a pharmaceutical product. Ingredient is equal to a substance with the indication of the specific role it is playing in the product.

ManufacturedItem
type: Class
subclass of: product specification
subclass of: Restriction
  on property: hasUnitOfPresentation
  on class: UnitOfPresentation
  max qualified cardinality: 1
subclass of: Restriction
  on property: has dose form
  on class: manufactured dose form
  max qualified cardinality: 1
subclass of: Restriction
  on property: has physical characteristic
  on class: PhysicalCharacteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: specifies
  on class: PhysicalManufacturedItem
  min qualified cardinality: 0
subclass of: Restriction
  on property: has other characteristic
  on class: other product characteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: isDefinedIn
  on class: product composition
  min qualified cardinality: 0
subclass of: Restriction
  on property: hasQuantityValue
  on class: manufactured item quantity
  qualified cardinality: 1
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, clause 3.1.47
disjoint with: pharmaceutical product
editorial note: Note that because a manufactured item might be some sort of container or other package item, the dose form is optional.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
adapted from: 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 packagings, clause 3.1.16
synonym: manufactured item specification

Manufacturer
type: Class
subclass of: Restriction
  on property: manages
  some values from: manufacturing or business operation
subclass of: Restriction
  on property: produces
  some values from: Class
    union of: Matter
    union of: MaterialSpecification
    union of: container specification
    union of: product specification
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, clause 3.1.47
synonym: manufacturer / establishment (organisation)
synonym: manufacturer / establishment (organization)

Material
type: Class
subclass of: Restriction
  on property: has physical characteristic
  on class: PhysicalCharacteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: isDescribedBy
  on class: image
  min qualified cardinality: 0
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, clause 3.1.47
note: Material is more specifically defined in ISO 11615 to be a 'substance or specified substance of which a certain packaging or device is made. This definition applies to a medicinal product package item (container), package (component) and device.

MaterialClassifier
type: Class
adapted from: 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 3.1.47

MaterialSpecification
type: Class
subclass of: Restriction
  on property: isProducedBy
  on class: Manufacturer
  min qualified cardinality: 0
subclass of: Restriction
  on property: has physical characteristic
  on class: PhysicalCharacteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: isDescribedBy
  on class: image
  min qualified cardinality: 0
subclass of: Restriction
  on property: is defined as potentially allergenic
  min qualified cardinality: 0
  on data range: boolean
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, clause 3.1.47
note: Material is more specifically defined in ISO 11615 to be a 'substance or specified substance of which a certain packaging or device is made. This definition applies to a medicinal product package item (container), package (component) and device.

Matter
type: Class
subclass of: Restriction
  on property: isProducedBy
  on class: Manufacturer
  min qualified cardinality: 0

PhysicalSubstance
type: Class
subclass of: Restriction
  on property: has strength
  on class: strength
  min qualified cardinality: 0
subclass of: Restriction
  on property: is allergenic
  min qualified cardinality: 0
  on data range: boolean

SpecifiedSubstance
type: Class
subclass of: Restriction
  on property: has confidentiality indicator
  on class: confidentiality indicator
  max qualified cardinality: 1
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, clause 3.1.77

Substance
type: Class
subclass of: product specification
subclass of: Restriction
  on property: has defining strength
  on class: strength
  min qualified cardinality: 0
subclass of: Restriction
  on property: is defined as potentially allergenic
  min qualified cardinality: 0
  on data range: boolean

UnitOfPresentation
type: Class
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, clause 3.1.84

active ingredient active moiety basis of strength
type: Class
subclass of: ActiveIngredient
subclass of: ActiveMoietyRole
subclass of: Restriction
  on property: isSignifiedBy
  has value: ingredient role - ACTIM
subclass of: Restriction
  on property: has reference strength
  some values from: Class
    intersection of: reference strength
    intersection of: Restriction
      on property: has reference substance
      some values from: Moiety
subclass of: Restriction
  on property: has strength
  some values from: strength
subclass of: Restriction
  on property: isPlayedBy
  some values from: Moiety
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: role of a substance present in a currently or previously marketed drug product indicating that it is or becomes pharmacologically active once delivered to patients, where the active moiety is basis of strength
example: For example, 287 mg amoxicillin trihydrate equivalent to 250 mg anhydrous amoxicillin.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
explanatory note: Note that in the example case both substances can be use as a basis of strength (BOSS) because there is a stoichiometric relationship between them. In all cases where there is no stoichiometric relationship between the reference substance and salt forms, the base or the acid must be taken as the reference substance (BOSS).

active ingredient entire substance basis of strength
type: Class
subclass of: ActiveIngredient
subclass of: Restriction
  on property: isSignifiedBy
  has value: ingredient role - ACTIB
subclass of: Restriction
  on property: has reference strength
  some values from: Class
    intersection of: reference strength
    intersection of: Restriction
      on property: has reference substance
      some values from: Substance
subclass of: Restriction
  on property: has strength
  some values from: strength
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: role of a substance present in a currently or previously marketed drug product indicating that it is or becomes pharmacologically active once delivered to patients, where the entire substance is the basis of strength
example: For example, propranolol hydrochloride quantified as the propranolol hydrochloride salt.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant

active ingredient reference substance basis of strength
type: Class
subclass of: ActiveIngredient
subclass of: Restriction
  on property: isSignifiedBy
  has value: ingredient role - ACTIR
subclass of: Restriction
  on property: has strength
  on class: strength
  min qualified cardinality: 0
subclass of: Restriction
  on property: has reference strength
  some values from: Class
    intersection of: reference strength
    intersection of: Restriction
      on property: has reference substance
      some values from: Substance
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: role of a substance present in a currently or previously marketed drug product indicating that it is or becomes pharmacologically active once delivered to patients, where another reference substance is the basis of strength
example: For example, metoprolol succinate quantified by amount of metoprolol tartrate with the equal amount of metoprolol active moiety.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant

active ingredient without basis of strength
type: Class
subclass of: ActiveIngredient
subclass of: Restriction
  on property: isSignifiedBy
  has value: ingredient role - ACTI
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: role of a substance present in a currently or previously marketed drug product indicating that it is or becomes pharmacologically active once delivered to patients whose basis of strength cannot be specified
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant

activity-based strength
type: Class
subclass of: strength
definition: quantity or range of quantities of the substance/specified substance (i.e., its potency) based on its biological or pharmacological activity, rather than its mass or concentration
has conformance to ISO level: ConformanceToISOLevel-Extension

administrable dose form
type: Class
subclass of: pharmaceutical dose form
subclass of: Restriction
  on property: isSignifiedBy
  some values from: administrable dose form code
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, clause 3.1.2
definition: pharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured items and their corresponding manufactured dose forms has been carried out
note: Administered dose form and pharmaceutical administrable dose form are synonyms of administrable dose form.
note: The administrable dose form is identical to the manufactured dose form in cases where no transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the pharmaceutical product).
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
synonym: administered dose form
synonym: pharmaceutical administrable dose form

administrable dose form code
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: denotes
  on class: administrable dose form
  qualified cardinality: 1
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 13
definition: code for the pharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured items and their corresponding manufactured dose forms has been carried out
has conformance to ISO level: ConformanceToISOLevel-Extension
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

age classifier
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: denotes
  on class: age population characteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: classifies
  on class: target population
  min qualified cardinality: 0
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, clause 8.2.2.4 and Figure 14
source: ISO/TS 20443:2017(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, Figure F.1, clause F.2.7.1
definition: qualitative classifier for a range of ages, specified in terms of a controlled vocabulary
example: Adults (18 to < 65)
note: The age group of the specific population for an indication, undesirable effect, or a contraindication as authorized for the medicinal product in accordance with the regulated medicinal product information can be specified using an appropriate controlled terminology.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
synonym: age
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

age population characteristic
type: Class
subclass of: population characteristic
subclass of: Restriction
  on property: isSignifiedBy
  on class: age classifier
  min qualified cardinality: 0
subclass of: Restriction
  on property: hasQuantityValueRange
  on class: age range value
  min qualified cardinality: 0
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, clause 8.2.2.4 and Figure 14
source: ISO/TS 20443:2017(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, Figure F.1, clause F.2.7.1
definition: classifier for a statistical population based on the age of its members
note: Age is both a duration and a quantity. Its magnitude value can be expressed as quantity value with a time unit or as an ISO 8601 duration expression, depending on the domain.
note: The age group of the specific population for an indication, undesirable effect, or a contraindication as authorized for the medicinal product in accordance with the regulated medicinal product information can be specified using an appropriate controlled terminology.
has conformance level: ConformanceLevel-Conditional
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
usage note: The age is either expressed as an explicit range of ages or by an age classifier from a controlled vocabulary.

age range value
type: Class
subclass of: TimeQuantityValueRange
subclass of: Restriction
  on property: hasLowerBound
  all values from: age value
subclass of: Restriction
  on property: hasUpperBound
  all values from: age value
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, clause 8.2.2.4 and Figure 14
source: ISO/TS 20443:2017(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, Figure F.1, clause F.2.7.1
definition: time quantity value range expressing the upper and lower bounds amount of time passed since creation of something
has conformance level: ConformanceLevel-Conditional
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
usage note: Age is both a duration and a quantity. Its magnitude value can be expressed as quantity value with a time unit or as an ISO 8601 duration expression, depending on the domain.

age value
type: Class
subclass of: TimeQuantityValue
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, clause 8.2.2.4 and Figure 14
source: ISO/TS 20443:2017(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, Figure F.1, clause F.2.7.1
definition: time quantity value expressing the amount of time passed since creation of something
is encoded as: DatatypeCode-PQ
has conformance to ISO level: ConformanceToISOLevel-Extension
usage note: Age is both a duration and a quantity. Its magnitude value can be expressed as quantity value with a time unit or as an ISO 8601 duration expression, depending on the domain.

attached document
type: Class
subclass of: ReferenceDocument
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, clauses 9.2.2.11, 11.3.2.6 and Figure 6
definition: document officially submitted to a medicines regulatory agency

authorization
type: Class
subclass of: Situation
subclass of: Restriction
  on property: has authorized party
  some values from: authorized party
subclass of: Restriction
  on property: has authorizing party
  some values from: authorizing party
label: authorisation
definition: situation in which a party authorizes someone to act on their behalf or to have other responsibilities or capabilities under certain conditions for some period of time
has conformance to ISO level: ConformanceToISOLevel-Extension

authorization status
type: Class
subclass of: State
subclass of: Restriction
  on property: isSignifiedBy
  on class: authorization status code
  qualified cardinality: 1
subclass of: Restriction
  on property: has authorization status date
  on data range: CombinedDateTime
  qualified cardinality: 1
label: authorisation status
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, clause 9.3.1 and Figure 7
source: ISO/TS 20443:2017(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 B.2.4
definition: status of an authorization as of a particular point in the lifecycle of a medicinal product depending on the regulatory process applicable in a region
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
explanatory note: During the lifetime of a Medicinal Product, its marketing authorization is likely to have had a variety of changes. Therefore, the status of a marketing authorization will change over time, which has to be recorded accordingly.
usage note: Note that the authorization status code and date are modeled as part of the status rather than as independent attributes of the marketing authorization, allowing for a given authorization to have multiple status values with unique dates over the lifecycle of the authorization. This is slightly different from the way it appears in the ISO 11615:2017 standard, but is more in line with the explanatory text. This approach allows potentially multiple status values to be associated with the same marketing authorization if nothing else has changed aside from where it stands in the authorization lifecycle. If the authorization itself has been revised, however, a new individual representing that authorization should be created with the relevant statns value and date, however, and the authorizations linked using properties such as 'precedes' or 'succeeds' from the Commons Dates and Times ontology.

authorization status code
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: denotes
  on class: authorization status
  qualified cardinality: 1
label: authorisation status code
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, clause 9.3.1 and Figure 7
source: ISO/TS 20443:2017(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 B.2.4
definition: sequence of characters denoting the status of an authorization as of a particular point in the lifecycle of a medicinal product depending on the regulatory process applicable in a region
has conformance level: ConformanceLevel-Mandatory
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

authorized medicinal product
type: Class
subclass of: product role
subclass of: Restriction
  on property: is authorized for manufacturing through
  some values from: manufacturing authorization
subclass of: Restriction
  on property: is authorized for marketing through
  some values from: marketing authorization
subclass of: Restriction
  on property: isPlayedBy
  some values from: medicinal product
label: authorised medicinal product
definition: role of a medicinal product that has been authorized for some purpose in some jurisdiction
note: The unique identification of authorized medicinal Products and the description of their main characteristics shall apply the following principles: a) the assignment of a unique medicinal product identifier (MPID) to reliably recognize, monitor and trace the use of medicinal products; b) the assignment of a unique medicinal product package identifier (PCID) to reliably recognize and trace medicinal products as packaged for sale or supply; c) the assignment of a unique medicinal product batch identifier (BAID1) to reliably recognize and trace a manufacturer's batch number, which appears on the outer packaging of the medicinal product, in compliance with the requirements of the marketing authorization; d) the assignment of a unique medicinal product batch identifier (BAID2) to reliably recognize and trace a batch number on the immediate packaging of the medicinal product, where this is not the outer packaging, in compliance with the requirements of the marketing authorization.
adapted from: 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, clauses 6.2, 8, and Figures 5, 6 and Annex A

authorized party
type: Class
subclass of: PartyRole
subclass of: Restriction
  on property: is authorized through
  some values from: authorization
label: authorised party
definition: party that has been given the responsibility to act on behalf of another party or to have other responsibilities or capabilities under some set of guidelines
has conformance to ISO level: ConformanceToISOLevel-Extension

authorizing party
type: Class
subclass of: Actor
subclass of: Restriction
  on property: authorizes through
  some values from: authorization
label: authorising party
definition: party that delegates some role, authority, capability, or control to another party
has conformance to ISO level: ConformanceToISOLevel-Extension

batch
type: Class
subclass of: Constituent
subclass of: Restriction
  on property: has expiration date
  some values from: ExplicitDate
subclass of: Restriction
  on property: is output of
  some values from: batch manufacturing process
subclass of: Restriction
  on property: comprises
  some values from: Matter
subclass of: Restriction
  on property: isConstituentOf
  some values from: Product
subclass of: Restriction
  on property: isSignifiedBy
  some values from: batch number
subclass of: Restriction
  on property: hasReleaseDate
  some values from: ExplicitDate
source: ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6)
definition: material that is being produced or that has been produced by a single execution of a process that leads to the production of finite quantities of material by subjecting quantities of input materials to an ordered set of processing activities over a finite period of time
editorial note: The restriction with respect to matter should be revised or augmented to define a specific amount (or amounts) of matter used to produce the batch. Also note that in order to shorten the definition to use the term 'batch process' in place of most of the definition of a batch process requires loosening the constraint on circular definitions, or creating an exception for a compound term where that term appears in a different label in the ontology.
note: From an ISO 11615 perspective, a batch is a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
has conformance to ISO level: ConformanceToISOLevel-NamingConformant
adapted from: 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 3.1.8

batch manufacturing process
type: Class
subclass of: manufacturing process
source: ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.8)
definition: process that leads to the production of finite quantities of material by subjecting quantities of input materials to an ordered set of processing activities over a finite period of time using one or more pieces of equipment
editorial note: This is a starting point that requires extension to include further axioms including relationships with input and output materials, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL).
note: Batch processes are discontinuous processes, which are neither discrete nor continuous but have characteristics of both.
has conformance to ISO level: ConformanceToISOLevel-Extension
synonym: batch process

batch number
type: Class
subclass of: ContextualDesignation
subclass of: Restriction
  on property: denotes
  some values from: batch
definition: identifier assigned to a specific batch of material that is being produced or that has been produced by a single execution of a batch process
note: From an ISO 11615 perspective, a batch number is an identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing process at a specific point of time
has conformance to ISO level: ConformanceToISOLevel-NamingConformant
adapted from: ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6)
adapted from: 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 3.1.9
synonym: batch identifier

change request organization type
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: characterizes
  all values from: marketing status reason
label: change request organisation type
definition: sequence of characters denoting the nature of the organization that triggered the legal action taken on the marketing or on the marketing authorization
example: marketing authorization revoked by the competent authority, marketing authorization not renewed by the MAH
note: The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Optional
is encoded as: DatatypeCode-CD
adapted from: 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 B.2.19.8
direct 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, clause 9.3.2.9.9 and Figure 7
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

clinical trial
type: Class
subclass of: Situation
subclass of: Restriction
  on property: evaluates
  some values from: investigational medicinal product
subclass of: Restriction
  on property: has sponsor
  some values from: sponsor
subclass of: Restriction
  on property: manages administration of
  some values from: investigational medicinal product
subclass of: Restriction
  on property: isIdentifiedBy
  some values from: clinical trial identifier
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, clause 3.1.11
source: National Cancer Institute Thesaurus, see http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71104
definition: investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational medicinal product(s), and/or to study absorption, distribution, metabolism and excretion of investigational medicinal product(s) with the object of ascertaining its safety and/or efficacy
note: A clinical trial is a research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant

clinical trial authorization
type: Class
subclass of: authorization
subclass of: Restriction
  on property: refersTo
  on class: clinical trial identifier
  qualified cardinality: 1
subclass of: Restriction
  on property: has authorizing party
  some values from: medicines regulatory agency
subclass of: Restriction
  on property: appliesTo
  some values from: clinical trial
subclass of: Restriction
  on property: isApplicableIn
  some values from: GeographicRegion
label: clinical trial authorisation
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, clause 3.1.12
definition: approval given by a medicines regulatory agency to conduct a clinical trial in a region
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant

clinical trial identifier
type: Class
subclass of: CodeElement
subclass of: RegisteredIdentifier
subclass of: Restriction
  on property: identifies
  on class: clinical trial
  qualified cardinality: 1
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, clause 3.1.74
definition: identifier assigned to a clinical trial by a medicines regulatory agency in a region for tracking purposes
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
synonym: registration number

color characteristic
type: Class
subclass of: PhysicalCharacteristic
subclass of: Restriction
  on property: hasTextValue
  min qualified cardinality: 0
  on data range: string
label: colour characteristic
definition: composite chromatic physical characteristic composed of hue, saturation and intensity
is encoded as: DatatypeCode-ST
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.6.2.21.9
synonym: color
synonym: colour

combined pharmaceutical dose form
type: Class
subclass of: pharmaceutical dose form
subclass of: Collection
subclass of: Restriction
  on property: isSignifiedBy
  some values from: combined pharmaceutical dose form classifier
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 clauses 3.1.14 and 9.2.2.2.3
definition: two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product, and that includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product
note: Once the Medicinal Product containing the two manufactured items has been fully specified, a term code for combined dose form shall be specified, representing the dose forms of the manufactured items prior to preparation.
note: The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology.
has conformance level: ConformanceLevel-Conditional
adapted from: 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.2.3

combined pharmaceutical dose form classifier
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: denotes
  on class: combined pharmaceutical dose form
  qualified cardinality: 1
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 13
definition: classifier for a combined dose form for administration to the patient, representing two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product
has conformance level: ConformanceLevel-Conditional
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

comorbidity
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: denotes
  all values from: Class
    union of: contraindication
    union of: therapeutic indication
subclass of: Restriction
  on property: classifies
  all values from: Class
    union of: contraindication
    union of: therapeutic indication
definition: classifier for a cooccurring condition or co-infection that is described as part of the indication
note: If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.2.5, 9.9.2.2.3.5 and Figure 14
adapted from: 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 F.2
explanatory note: For a much more comprehensive treatise on the concept of comorbidity, including distinctions based on (1) the nature of the health condition, (2) the relative importance of the co-occurring conditions, (3) the chronology of presentation of the conditions, and (4) expanded conceptualizations, see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2713155/.
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

Concentration
type: Class
deprecated: true
equivalent class: concentration strength

concentration strength
type: Class
subclass of: strength
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, clause 9.7.2.5.3
definition: quantity or range of quantities of the substance/specified substance present per unitary volume (or mass)
note: For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required.
note: When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
synonym: strength (concentration)

condition
type: Class
subclass of: Situation
subclass of: Restriction
  on property: isExperiencedBy
  some values from: PhysicalOrganism
source: National Cancer Institute Thesaurus, see http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25457
definition: state of being, such as a state of health
has conformance to ISO level: ConformanceToISOLevel-Extension

condition to restore authorization
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: characterizes
  all values from: marketing status reason
definition: sequence of characters denoting the condition under which the marketing authorization or the marketing is restored
note: The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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 B.2.19.6
direct 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, clause 9.3.2.9.7 and Figure 7
synonym: condition to restore
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

confidentiality indicator
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  on class: Class
    union of: SpecifiedSubstance
    union of: Organization
    union of: manufacturing or business operation
  min qualified cardinality: 0
definition: classifier for information about a specified substance, an organization, a manufacturing or business operation, or a contact, describing the level of confidentiality associated with information about it
note: The confidentiality level can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.4.2.2.5, 9.4.2.4.5, 9.5.2.3.5, and 9.7.2.2.4, and Figures 8, 10 and 12
adapted from: 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, clauses D.2.5.3, G.2.4, G.2.6.4, and H.2.1.4
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

container
type: Class
subclass of: Material
definition: object that can be used to hold things
has conformance to ISO level: ConformanceToISOLevel-NamingConformant
adapted from: 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, clause 3.1.16
adapted from: https://ncithesaurus.nci.nih.gov/ncitbrowser/pages/home.jsf
usage note: The ISO 11615 definition for 'container' is too specific to be a generalization of some of its subordinate concepts, such as intermediate container and other packaging related concepts.

ContainerConstituency
type: Class
deprecated: true
equivalent class: medicinal product container

container constituent
type: Class
subclass of: Constituent
subclass of: Restriction
  on property: hasQuantityValue
  on class: ScalarQuantityValue
  min qualified cardinality: 0
subclass of: Restriction
  on property: isCharacterizedBy
  some values from: Class
    union of: Classifier
    union of: Specification
subclass of: Restriction
  on property: isConstituentOf
  some values from: medicinal product container
definition: constituent that specifies the number or quantity of things of the same kind being held in a given container or package
has conformance to ISO level: ConformanceToISOLevel-Extension
usage note: In IDMP packaging, constituents are either package items, if the container is an outer or intermediate packaging of a packaged medicinal product, or manufactured items if the container is the immediate container.

container role
type: Class
subclass of: FunctionalRole
subclass of: Restriction
  on property: isPlayedBy
  on class: medicinal product container
  min qualified cardinality: 0
subclass of: Restriction
  on property: isClassifiedBy
  some values from: container role kind
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, clause 9.6
definition: functional role of a package item with respect to inclusive layering within a medicinal product
has conformance to ISO level: ConformanceToISOLevel-Extension

container role kind
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: container role
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, clause 9.6
definition: classifier for the functional role of a package item with respect to inclusive layering within a medicinal product
has conformance to ISO level: ConformanceToISOLevel-Extension

container specification
type: Class
subclass of: Specification
subclass of: Restriction
  on property: isProducedBy
  on class: Manufacturer
  min qualified cardinality: 0
subclass of: Restriction
  on property: has physical characteristic
  on class: PhysicalCharacteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: isDescribedBy
  on class: image
  min qualified cardinality: 0
subclass of: Restriction
  on property: specifies
  some values from: container
definition: specification for an object that can be used to hold things
has conformance to ISO level: ConformanceToISOLevel-Extension
adapted from: 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, clause 3.1.16
adapted from: https://ncithesaurus.nci.nih.gov/ncitbrowser/pages/home.jsf
usage note: The ISO 11615 definition for 'container' is too specific to be a generalization of some of its subordinate concepts, such as intermediate container and other packaging related concepts.

continuous manufacturing process
type: Class
subclass of: manufacturing process
source: ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 4.2.2)
definition: process in which materials are passed in a continuous flow through processing equipment
editorial note: This is a starting point that requires extension to include further axioms including relationships with input and output materials, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL).
note: Once established in a steady operating state, the nature of the process is not dependent on the length of time of operation. Start-ups, transitions, and shutdowns are usually treated as separate activities and do not necessarily contribute to achieving the desired processing.
has conformance to ISO level: ConformanceToISOLevel-Extension
synonym: continuous process

contraindication
type: Class
subclass of: Specification
subclass of: Restriction
  on property: has contraindication as disease/symptom/procedure
  on class: contraindication as 'disease/symptom/procedure'
  max qualified cardinality: 1
subclass of: Restriction
  on property: has disease status
  on class: disease status
  max qualified cardinality: 1
subclass of: Restriction
  on property: isApplicableIn
  on class: authorized medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: has comorbidity
  on class: comorbidity
  min qualified cardinality: 0
subclass of: Restriction
  on property: isApplicableIn
  on class: investigational medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: is contraindication for
  on class: medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: has other therapy specifics
  on class: other therapy specifics
  min qualified cardinality: 0
subclass of: Restriction
  on property: has target population
  on class: target population
  min qualified cardinality: 0
subclass of: Restriction
  on property: is contraindication for
  on class: therapeutic indication
  min qualified cardinality: 0
subclass of: Restriction
  on property: has contraindication text
  on class: contraindication text
  qualified cardinality: 1
definition: situation where the medicinal product shall not be given for safety reasons
note: This class shall be used to describe the authorised contraindication(s) for the Medicinal Product as described in the regulated product information. A jurisdiction may further refine the requirements in relation to the contraindications information at implementation so that this information is to be specified only if required.
adapted from: 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, clauses 3.1.17 and 9.9.2.3
adapted from: 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 F.3

contraindication as 'disease/symptom/procedure'
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: medical condition
subclass of: Restriction
  on property: denotes
  all values from: medical condition
definition: classifier for diseases, symptoms or procedures from medical terminology that is used for, but not limited to, the registration, documentation and safety monitoring of medicinal products
note: Classifiers for diseases, symptoms or procedures are defined in controlled vocabularies such as SNOMED-CT or MedDRA.
note: The underlying disease, symptom or procedure of the contraindication should be specified as it is referenced in the regulated product information using an appropriate controlled reference terminology. The controlled term and the controlled term identifier should be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 3.1.82, 9.9.2.3.3 and Figure 14
adapted from: 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 F.2
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

contraindication text
type: Class
subclass of: Document
subclass of: Restriction
  on property: hasTextValue
  on data range: string
  qualified cardinality: 1
definition: textual description of the contraindications of a medicinal product
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-ST
adapted from: 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, clauses 3.1.82, 9.9.2.3.3 and Figure 14
adapted from: 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 F.2
synonym: contraindications text

data carrier identifier
type: Class
subclass of: StructuredIdentifier
subclass of: RegisteredIdentifier
subclass of: Restriction
  on property: identifies
  on class: package item
  min qualified cardinality: 0
definition: unique identifier for items that are traded (e.g. pharmaceuticals, medical devices) in the supply chain
example: For example, a GTIN is used to identify any item upon which there is a need to retrieve predefined information and that may be priced, ordered or invoiced at any point in any supply chain. GTINs may be 8, 12, 13 or 14 digits in length. GS1 advocates the use of global standardisation to aid compliance to the regulatory requirements of all countries.
note: A modification to any of the basic elements that characterize a trade item will usually lead to a change in the data carrier identifier. Additional data can be included with the data carrier such as batch number and expiration date.
note: Data carrier identifiers such as barcodes can be presented at each packaging level. Regional regulatory requirements can specify the data carrier(s) to be used.
note: The basic predefined characteristics of a data carrier identifier can be: - product name, product brand and product description; - formulation (active ingredients); - strength; - dosage (or usage); - net quantity (weight, volume, or other dimension impacting trade); - packaging configuration; - form, fit or function; - for groupings, the number of elementary items contained and their subdivision in subpackaging units, the nature of the grouping (carton, blister, blister-cell).
direct 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, clauses 6.6 and 9.6.2.4

data exclusivity period
type: Class
subclass of: ExplicitDatePeriod
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, clause 9.3.1 and Figure 7
source: ISO/TS 20443:2017(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 B.2.4
definition: explicit time period from initial authorization of the reference product granting exclusivity for a given marketing authorization
has conformance level: ConformanceLevel-Conditional

depth characteristic
type: Class
subclass of: PhysicalCharacteristic
subclass of: Restriction
  on property: hasQuantityValue
  on class: ScalarQuantityValue
  max qualified cardinality: 1
definition: 1-D extent physical characteristic inhering in a bearer by virtue of the bearer's downward or backward or inward dimension
is encoded as: DatatypeCode-PQ
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.6.2.21.4
synonym: depth

diameter characteristic
type: Class
subclass of: PhysicalCharacteristic
subclass of: Restriction
  on property: hasQuantityValue
  on class: ScalarQuantityValue
  max qualified cardinality: 1
definition: length physical characteristic which is equal to the length of any straight line segment that passes through the center of a circle and whose endpoints are on the circular boundary.
is encoded as: DatatypeCode-PQ
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.6.2.21.7
synonym: diameter

discrete manufacturing process
type: Class
subclass of: manufacturing process
source: ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 4.2.3)
definition: process in which a specified quantity of parts moves as a unit (group of parts) between workstations and each part maintains its unique identity
editorial note: This is a starting point that requires extension to include further axioms including relationships with input and output materials, specific quantities thereof, production lots, and so forth, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL).
note: Products are classified into production lots that are based on common raw materials, production requirements, and production histories.
has conformance to ISO level: ConformanceToISOLevel-Extension
synonym: discrete process

disease status
type: Class
subclass of: State
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: denotes
  all values from: Class
    union of: contraindication
    union of: therapeutic indication
subclass of: Restriction
  on property: classifies
  all values from: Class
    union of: contraindication
    union of: therapeutic indication
definition: classifier for the status of a disease or symptom
note: The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.2.4 and Figure 14
adapted from: 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 F.2
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

dose
type: Class
subclass of: ScalarQuantityValue
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, clause 3.1.23
definition: specified quantity of a medicine, to be taken at one time or at stated intervals

frequency of occurrence
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
definition: classifier for the number of occurrences of a given symptom, condition or effect within a specified period of time
note: The frequency of occurrence of the 'symptom/condition/effect' can be specified, using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.4.5 and Figure 14
adapted from: 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 F.4.4
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

gender population characteristic
type: Class
subclass of: population characteristic
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
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, clause 9.9.2.5.5
definition: classifier for a statistical population based on the biological sex of an organism or for humans the characteristics of women, men, girls and boys that are socially constructed
note: The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
has conformance to ISO level: ConformanceToISOLevel-ModelConformant
adapted from: WHO Gender and Health https://www.who.int/health-topics/gender
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

geographic area for action taken
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: GeographicRegionIdentifier
subclass of: Restriction
  on property: characterizes
  all values from: marketing status reason
definition: sequence of characters denoting the geographic area where the legal action taken on the marketing or the on marketing authorization is having effect
note: The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Optional
is encoded as: DatatypeCode-CD
adapted from: 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 B.2.19.9
direct 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, clause 9.3.2.9.10 and Figure 7
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

height characteristic
type: Class
subclass of: PhysicalCharacteristic
subclass of: Restriction
  on property: hasQuantityValue
  on class: ScalarQuantityValue
  max qualified cardinality: 1
definition: 1-D extent physical characteristic inhering in a bearer by virtue of the bearer's vertical dimension of extension
is encoded as: DatatypeCode-PQ
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.6.2.21.2
synonym: height

ISO 11615 - ingredient role vocabulary
type: NamedIndividual
type: ControlledVocabulary
type: ClassificationScheme
type: CodeSet
definition: controlled vocabulary denoting an ingredient role, according to the ISO 20443 implementation guide for ISO 11615
adapted from: 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, clauses 9.7.2.2.2 and Figure 12
adapted from: ISO/TS 20443:2017(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, table D.1, clause D.2.1
is constituent of: ISO 20443 code set
has description: controlled vocabulary denoting an ingredient role, according to the ISO 20443 implementation guide for ISO 11615
has language: English
has textual name: ISO 11615 Ingredient Role vocabulary

ISO 20443 code set
type: NamedIndividual
type: CodeSet
definition: set of controlled vocabularies and codes for reporting of medicinal product-related information specified in the ISO/TS 20443 guidelines
has conformance to ISO level: ConformanceToISOLevel-Extension

image
type: Class
subclass of: Document
subclass of: Restriction
  on property: depicts
  min cardinality: 0
definition: visual representation of something
note: The format of the image attachment shall be specified by regional implementations. The format of the image shall follow ISO 12639 and shall be held in an ED data type.
has conformance level: ConformanceLevel-Optional
is encoded as: DatatypeCode-ED
has conformance to ISO level: ConformanceToISOLevel-NamingConformant
adapted from: 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, clauses 9.6.2.9.5, 9.6.2.17, 9.6.2.20.5, 9.6.2.21.1 and 9.6.2.21.11
adapted from: ISO/TS 20443:2017(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.3.14.9
usage note: In ISO 11615, an image is modeled as a physical characteristic. This is not correct from an ontological perspective.

immediate container
type: NamedIndividual
type: container role kind
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, clause 3.1.27
definition: packaging in which a manufactured item or pharmaceutical product is contained and with which it is in direct contact
note: An immediate container can be fitted with or have integrated into it an administration device and/or closure. A pharmaceutical dose form can fulfil the role of an immediate container, e.g. a capsule containing a powder for inhalation; the capsule in this case is not a container. An alternative, compatible definition of immediate container ('immediate packaging') is given in Directive 92/27/EEC.

imprint
type: Class
subclass of: PhysicalCharacteristic
subclass of: Restriction
  on property: hasTextValue
  min qualified cardinality: 0
  on data range: string
definition: stamp or impress on a surface
is encoded as: DatatypeCode-ST
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.6.2.21.10
adapted from: ISO/TS 20443:2017(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.3.14.10

indication as 'disease/symptom/procedure'
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: medical condition
subclass of: Restriction
  on property: denotes
  all values from: medical condition
definition: classifier for diseases, symptoms or procedures from medical terminology that is used for, but not limited to, the registration, documentation and safety monitoring of medicinal products
note: Classifiers for diseases, symptoms or procedures are defined in controlled vocabularies such as SNOMED-CT or MedDRA.
note: The underlying disease, symptom or procedure that is the indication for treatment or contraindication should be specified as it is referenced in the regulated product information using an appropriate controlled reference terminology. The controlled term and the controlled term identifier should be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
adapted from: 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, clauses 3.1.82, 9.9.2.2.3 and Figure 14
adapted from: 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 F.2
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

ingredient role - ACTI
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an active ingredient whose basis of strength cannot be specified
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: ACTI

ingredient role - ACTIB
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an active ingredient where the entire substance is the basis of strength
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: ACTIB

ingredient role - ACTIM
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an active ingredient where the active moiety is basis of strength
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: ACTIM

ingredient role - ACTIR
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an active ingredient where another reference substance is the basis of strength
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: ACTIR

ingredient role - ADJV
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an adjuvant, an ingredient(s) which augments or promotes the pharmacological effect of the active ingredient(s) without itself being considered active (typically used with vaccines)
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: ADJV

ingredient role - ADTV
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an ingredient that is any additive added
note: Use only when there is no described pharmacological action and classification as merely 'inactive' ingredient is not appropriate
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: ADTV

ingredient role - BASE
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an ingredient that is the base of a preparation
example: water, vaseline, ethanol
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: BASE

ingredient role - CNTM
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for a contaminant, an ingredient whose presence is not intended but may not be reasonably avoided given the circumstances of the mixture's nature or origin
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: CNTM

ingredient role - COLR
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an ingredient added to alter the color appearance
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: COLR

ingredient role - FLVR
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an ingredient added to alter the taste of the product
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: FLVR

ingredient role - IACT
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an inactive ingredient, i.e. ingredients added for a purpose other than the intended pharmacological action
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: IACT

ingredient role - INGR
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for an ingredient not otherwise specified, used in cases of devices or foods where further classification is not common
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: INGR

ingredient role - MECH
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for a mechanical ingredient, an ingredient which, as a whole, lends a spatial structure to the product, which structure is meaningful to the delivery of the pharmacologically active ingredients near the target site
example: For example, a collagen matrix used as a base for transplanting skin cells.
note: Such ingredient has a function other than merely delivering the pharmacologically active substances into a systemic compartment (such as, for example, an ordinary capsule would have.)
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: MECH

ingredient role - PRSV
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for a preservative, an ingredient added to delay the risk of the product's spoiling
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: PRSV

ingredient role - STBL
type: NamedIndividual
type: ingredient role code
source: ISO/TS 20443:2017(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, table D.1, clause D.2.1
definition: code for a stabilizer, an ingredient added to keep the mixture homogenic (e.g. prevent the phases of an emulsion to separate)
is member of: ISO 11615 - ingredient role vocabulary
is defined in: ISO 11615 - ingredient role vocabulary
has text value: STBL

ingredient role code
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: Ingredient
subclass of: Restriction
  on property: denotes
  all values from: Ingredient
equivalent class: Class
  one of: ingredient role - ACTI
  one of: ingredient role - ACTIB
  one of: ingredient role - ACTIM
  one of: ingredient role - ACTIR
  one of: ingredient role - ADJV
  one of: ingredient role - ADTV
  one of: ingredient role - BASE
  one of: ingredient role - CNTM
  one of: ingredient role - COLR
  one of: ingredient role - FLVR
  one of: ingredient role - IACT
  one of: ingredient role - INGR
  one of: ingredient role - MECH
  one of: ingredient role - PRSV
  one of: ingredient role - STBL
definition: sequence of characters denoting an ingredient role, according to the ISO 20443 implementation guide for ISO 11615
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.7.2.2.2 and Figure 12
adapted from: ISO/TS 20443:2017(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, table D.1, clause D.2.1

intended effect
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: Class
    union of: contraindication
    union of: therapeutic indication
subclass of: Restriction
  on property: denotes
  all values from: Class
    union of: contraindication
    union of: therapeutic indication
definition: classifier for the type of outcome or result intended for the target condition
note: The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population.
note: The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.2.6 and Figure 14
adapted from: 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 F.2
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

interaction
type: Class
subclass of: Specification
subclass of: Restriction
  on property: isClassifiedBy
  on class: interaction classifier
  max qualified cardinality: 1
subclass of: Restriction
  on property: isSignifiedBy
  on class: interaction classifier
  max qualified cardinality: 1
subclass of: Restriction
  on property: has interaction text
  on class: interaction text
  qualified cardinality: 1
definition: specification of a change in the effect of a medicinal product when it is taken with another substance, such as another medicinal product, food, alcohol, or herbal product
note: The change can be an increase or decrease in the effectiveness or side effects of the medicinal product. Medicinal product interactions can have different mechanisms, such as affecting the absorption, distribution, metabolism, or excretion of the medicinal product, or interfering with its target site. Medicinal product interactions can be beneficial or harmful, depending on the situation and the desired outcome of the treatment. They may be with respect to other medicinal products or other forms of interactions as described in the regulated product information.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
has conformance to ISO level: ConformanceToISOLevel-ModelConformant
adapted from: 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 9.9.2.7
adapted from: 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 F.5
usage note: This class can be used to describe the interactions of the Medicinal Product (with other Medicinal Products) and other forms of interactions as described in the regulated product information.

interaction classifier
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: interaction
subclass of: Restriction
  on property: denotes
  all values from: interaction
definition: classifier for the type of interaction with the regulated product
note: The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.2.6 and Figure 14
adapted from: 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 F.2
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

interaction text
type: Class
subclass of: Document
subclass of: Restriction
  on property: hasTextValue
  on data range: string
  qualified cardinality: 1
definition: textual description of a change in the effect of a medicinal product when it is taken with another substance, such as another medicinal product, food, alcohol, or herbal product
note: The text of the interaction in accordance with the regulated product information shall be provided.
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-ST
adapted from: 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 9.9.2.7
adapted from: 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 F.5
synonym: interactions text

intermediate packaging
type: NamedIndividual
type: container role kind
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, clauses 3.1.29 and 9.6
definition: container between the outer packaging and the immediate container

investigational medicinal product
type: Class
subclass of: product role
definition: role of a pharmaceutical product or combination of pharmaceutical products or placebo(s) being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (packaged) in a way different from the authorized form, used for an unauthorized indication, or used to gain further information about the authorized form
abbreviation: IMP
direct 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, clause 3.1.31

investigational medicinal product identifier
type: Class
subclass of: CodeElement
subclass of: RegisteredIdentifier
subclass of: Restriction
  on property: identifies
  on class: investigational medicinal product
  qualified cardinality: 1
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, clause 3.1.32
definition: unique identifier allocated to an investigational medicinal product supplementary to any existing identifier as ascribed by a medicines regulatory agency in a region/jurisdiction or a sponsor of a clinical trial
note: This is an alphanumeric text field.
note: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products worldwide.
abbreviation: IMPID

jurisdictional marketing authorization
type: Class
subclass of: marketing authorization
subclass of: Restriction
  on property: extends
  on class: marketing authorization
  max qualified cardinality: 1
subclass of: Restriction
  on property: isIdentifiedBy
  on class: marketing authorization number
  max qualified cardinality: 1
subclass of: Restriction
  on property: hasJurisdiction
  on class: Jurisdiction
  max qualified cardinality: 1
subclass of: Restriction
  on property: isApplicableIn
  on class: GeographicRegion
  qualified cardinality: 1
label: jurisdictional marketing authorisation
definition: marketing authorization that provides additional information about how the authorization applies in a given country and jurisdiction(s) within that country when a marketing activity is undertaken in multiple subdivisions within a country
adapted from: 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 B.1
direct 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, clause 9.3.2 and Figure 7

legal grounds
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: characterizes
  all values from: marketing status reason
definition: sequence of characters denoting the legal basis for the action taken on the marketing or on the marketing authorization
note: The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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 B.2.19.3
direct 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, clause 9.3.2.9.4 and Figure 7
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

legal status of supply
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: marketing authorization
definition: sequence of characters denoting the regional/jurisdictional rule as to whether a medicinal product is subject to a medical prescription before it may be supplied to a patient or consumer
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 3.1.35 and 9.3.2.2.4, and Figure 7
adapted from: 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 B.2.3
explanatory note: The legal status of supply of the Medicinal Product as classified by the regulatory medicines agency should be specified (e.g. subject to medical prescription). Note that the primary controlled terms in EMA RMS are related to whether or not a prescription is required, and under what circumstances, such as dosage, and/or whether or not the substance is controlled under certain regulations, such as for narcotics.
synonym: legal status for the supply
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

lot
type: Class
subclass of: Constituent
subclass of: Restriction
  on property: comprises
  some values from: Matter
subclass of: Restriction
  on property: isSignifiedBy
  some values from: lot number
source: ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.32)
definition: unique amount of material having a set of common traits
editorial note: This is preliminary and needs extension to specify common characteristics of a given lot.
note: As defined in ANSI/ISA-95 and IEC 62264-1 as material lot: uniquely identifiable amount of a material.
note: Some examples of common traits are material source, the master recipe used to produce the material, and distinct physical properties.
has conformance to ISO level: ConformanceToISOLevel-Extension

lot number
type: Class
subclass of: ContextualDesignation
subclass of: Restriction
  on property: denotes
  some values from: lot
definition: identifier assigned to a unique amount of material having a set of common traits
has conformance to ISO level: ConformanceToISOLevel-Extension
adapted from: ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.32)
synonym: lot ID
synonym: lot identifier

manufactured dose form
type: Class
subclass of: pharmaceutical dose form
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, clause 3.1.36
definition: pharmaceutical dose form of a manufactured item as manufactured and, where applicable, before transformation into the pharmaceutical product
note: The manufactured dose form is identical to the administrable dose form in cases where no transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the pharmaceutical product).

manufactured item quantity
type: Class
subclass of: ScalarQuantityValue
subclass of: Restriction
  on property: hasMeasurementUnit
  some values from: MeasurementUnit
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, clause 9.6.2.20.4
definition: quantity (or count number) of the manufactured item
note: It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be 'unit' and the 'unit of presentation' shall be the item that is counted.
is encoded as: DatatypeCode-PQ
adapted from: 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.3.13.3

manufacturing authorization
type: Class
subclass of: authorization
subclass of: Restriction
  on property: isSignifiedBy
  on class: manufacturing authorization reference number
  min qualified cardinality: 0
subclass of: Restriction
  on property: hasEffectiveDate
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: authorizes manufacturing at
  some values from: manufacturing or business operation
subclass of: Restriction
  on property: authorizes manufacturing of
  some values from: Class
    union of: medicinal product
    union of: ManufacturedItem
subclass of: Restriction
  on property: has authorized party
  some values from: Manufacturer
subclass of: Restriction
  on property: has authorizing party
  some values from: medicines regulatory agency
subclass of: Restriction
  on property: isApplicableIn
  some values from: GeographicRegion
subclass of: Restriction
  on property: holdsDuring
  some values from: validity period
label: manufacturing authorisation
definition: authorization provided by a medicines regulatory agency to manufacture medicinal products within a region
note: Such authorization may be required for both total and partial manufacture and for the various processes of dividing up, packaging or presentation. However, such authorization may not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorized in a region to carry out such processes.
adapted from: 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 F.2
direct 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, clause 3.1.39

manufacturing authorization reference number
type: Class
subclass of: CodeElement
subclass of: Restriction
  on property: denotes
  all values from: manufacturing authorization
label: manufacturing authorisation reference number
definition: reference number of the authorization for manufacturing or equivalent
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ST
adapted from: 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 H.2.1.2
direct 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, clause 9.5.2.3.3

manufacturing operation type
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: manufacturing or business operation
definition: sequence of characters denoting the nature of the manufacturing operation and classifying it accordingly
note: The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-CD
adapted from: 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, clause 9.5.2.3.2
adapted from: 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 B.1
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

manufacturing or business operation
type: Class
subclass of: Facility
subclass of: Restriction
  on property: has confidentiality indicator
  on class: confidentiality indicator
  max qualified cardinality: 1
subclass of: Restriction
  on property: isRegulatedBy
  on class: medicines regulatory agency
  min qualified cardinality: 0
subclass of: Restriction
  on property: isManagedBy
  on class: Manufacturer
  qualified cardinality: 1
subclass of: Restriction
  on property: isClassifiedBy
  some values from: manufacturing operation type
subclass of: Restriction
  on property: isSituatedAt
  some values from: manufacturing site
definition: facility (operation) managed by a given manufacturer that provides some operational capability
note: The manufacturing/business operation being undertaken by the particular manufacturer/establishment (organisation) shall be specified.
adapted from: 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, clause 9.5.2.3
adapted from: 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 B.1
synonym: manufacturing / business operation

manufacturing process
type: Class
subclass of: process
source: ISO 18629-11:2005(en) Industrial automation systems and integration — Process specification language — Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.15
definition: structured set of activities or operations performed upon material to convert it from the raw material or a semifinished state to a state of further completion
editorial note: This is a starting point that requires extension to include further axioms including relationships with input and output materials, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL).
note: Manufacturing processes may be arranged in process layout, product layout, cellular layout or fixed position layout. Manufacturing processes may be planned to support make-to-stock, make-to-order, assemble-to-order, etc., based on strategic use and placements of inventories. [SOURCE:ISO 15531-1]
has conformance to ISO level: ConformanceToISOLevel-Extension

manufacturing site
type: Class
subclass of: Site
subclass of: Restriction
  on property: isIdentifiedBy
  on class: manufacturing site identifier
  min qualified cardinality: 0
subclass of: Restriction
  on property: hasName
  on class: manufacturing site name
  min qualified cardinality: 0
definition: place, setting, or context in which a manufacturing or business operation is situated
note: A given manufacturing site may be associated with one or more manufacturing or business operations (facilities). A given facility (manufacturing or business operation) may span multiple manufacturing sites.
has conformance to ISO level: ConformanceToISOLevel-Extension

manufacturing site identifier
type: Class
subclass of: CodeElement
subclass of: RegisteredIdentifier
subclass of: Restriction
  on property: identifies
  all values from: manufacturing site
definition: unique identifier (code) for a place, setting, or context in which a manufacturing or business operation is situated
has conformance to ISO level: ConformanceToISOLevel-Extension

manufacturing site name
type: Class
subclass of: ContextualName
subclass of: Restriction
  on property: hasTextualName
  on data range: string
  qualified cardinality: 1
subclass of: Restriction
  on property: isNameOf
  some values from: manufacturing site
definition: designation for a place, setting, or context in which a manufacturing or business operation is situated
has conformance to ISO level: ConformanceToISOLevel-Extension

marketing authorization
type: Class
subclass of: authorization
subclass of: Restriction
  on property: has data exclusivity period
  on class: data exclusivity period
  max qualified cardinality: 1
subclass of: Restriction
  on property: has date of first authorization
  on class: ExplicitDate
  max qualified cardinality: 1
subclass of: Restriction
  on property: hasExtension
  on class: jurisdictional marketing authorization
  min qualified cardinality: 0
subclass of: Restriction
  on property: refersTo
  on class: marketing status reason
  min qualified cardinality: 0
subclass of: Restriction
  on property: appliesTo
  on class: packaged medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: isClassifiedBy
  on class: legal status of supply
  qualified cardinality: 1
subclass of: Restriction
  on property: has international birth date
  on class: ExplicitDate
  qualified cardinality: 1
subclass of: Restriction
  on property: has authorization procedure
  some values from: marketing authorization procedure
subclass of: Restriction
  on property: has authorization status
  some values from: authorization status
subclass of: Restriction
  on property: has authorized party
  some values from: marketing authorization holder
subclass of: Restriction
  on property: has authorizing party
  some values from: medicines regulatory agency
subclass of: Restriction
  on property: is applicable in country
  some values from: Alpha2RegionCode
subclass of: Restriction
  on property: appliesTo
  some values from: medicinal product
subclass of: Restriction
  on property: isApplicableIn
  some values from: GeographicRegion
subclass of: Restriction
  on property: isIdentifiedBy
  some values from: marketing authorization number
subclass of: Restriction
  on property: holdsDuring
  some values from: validity period
subclass of: Restriction
  on property: isRecognizedIn
  some values from: Jurisdiction
label: marketing authorisation
definition: authorization issued from a medicines regulatory agency that allows a medicinal product to be placed on the market
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
adapted from: 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 B.1 and Figure B.1
direct 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, clauses 3.1.40 and 9.3.2, Figure 7
explanatory note: Note that certain cardinality constraints have been relaxed to allow for tracking status changes, amendments, and other process-related revisions to the same marketing authorization per SME discussions.
explanatory note: Note that marketing status in the ISO 11615:2017 standard is not linked directly to marketing authorization, only to medicinal product. We have augmented that pattern in the ontology, to link the status directly to the authorization along with status reasons that are specific to a given status. In discussion with SMEs, there was agreement that this was an oversight in the ISO standard that may be addressed in a subsequent version.
explanatory note: Note that rather than mapping directly to a single country code, a marketing authorization may be applicable in a region, in order to include the EU (which is not a valid ISO 3166 country code). At a high level, a marketing authorization may be applicable in one or more regions and may be recognized officially in others. For example, an EU-wide authorization may be recognized in the EU, and potentially in at least one country, but perhaps not in others.
explanatory note: Note that the marketing authorization is applicable in a region rather than country, given that the European Union is a region. The addition of the jurisdiction in which the authorization is recognized, which may include some but not all EU countries in the case of a general authorization issued in the EU is important for similar reasons and has been added as a required element.

marketing authorization application
type: Class
subclass of: ReferenceDocument
subclass of: Restriction
  on property: isAbout
  on class: marketing authorization
  min qualified cardinality: 0
subclass of: Restriction
  on property: isIdentifiedBy
  on class: marketing authorization application identifier
  qualified cardinality: 1
subclass of: Restriction
  on property: isReferredToBy
  on class: marketing authorization procedure
  qualified cardinality: 1
subclass of: Restriction
  on property: hasExplicitDate
  on class: ExplicitDate
  qualified cardinality: 1
label: marketing authorisation application
definition: formal written request for the authorization to market a medicinal product
note: A marketing authorization shall be supported by an application(s), which may comprise of a number of submissions (regulatory activities): initial marketing application and subsequent applications for changes to an existing marketing authorization (e.g. to renew, vary or withdraw).
has conformance level: ConformanceLevel-Conditional
adapted from: 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 B.2.16
direct 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, clause 9.3.2.7, Figure 7

marketing authorisation application classifier
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: marketing authorization application
label: marketing authorization application classifier
definition: sequence of characters characterizing the kind of marketing procedure that is followed to grant or update a marketing authorization
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-CD
adapted from: 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, clause 9.3.2.6
adapted from: 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 B.2.15
synonym: application type
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

marketing authorization application identifier
type: Class
subclass of: CodeElement
subclass of: RegisteredIdentifier
subclass of: Restriction
  on property: identifies
  all values from: marketing authorization application
label: marketing authorisation application identifier
definition: unique identifier for a marketing authorization application for a medicinal product
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-II
adapted from: 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 B.2.16
direct 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, clause 9.3.2.7, Figure 7
explanatory note: A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a medicines regulatory agency.
synonym: application identifier/number

marketing authorization holder
type: Class
subclass of: authorized party
subclass of: Restriction
  on property: isPlayedBy
  on class: LegalEntity
  min qualified cardinality: 0
label: marketing authorisation holder
definition: authorized party role of a legal entity (organization) that holds the authorization for marketing a medicinal product in a region
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
adapted from: 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, clause 3.1.41
adapted from: 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 B.1

marketing authorization holder identifier
type: Class
subclass of: CodeElement
subclass of: RegisteredIdentifier
subclass of: Restriction
  on property: identifies
  on class: marketing authorization holder
  qualified cardinality: 1
label: marketing authorisation holder identifier
definition: unique identifier for the marketing authorization holder (organization) for the medicinal product
adapted from: 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, clause 8.2.2.3
adapted from: 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 B.1
explanatory note: An international coding system for unique marketing authorisation holders (organisations) identifiers can be applied, if available.

marketing authorization number
type: Class
subclass of: CodeElement
subclass of: RegisteredIdentifier
subclass of: Restriction
  on property: identifies
  on class: marketing authorization
  qualified cardinality: 1
subclass of: Restriction
  on property: isRegisteredBy
  on class: medicines regulatory agency
  qualified cardinality: 1
label: marketing authorisation number
definition: identifier assigned by a medicines regulatory agency to a medicinal product
adapted from: 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 B.1
direct 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, clause 3.1.42

marketing authorization procedure
type: Class
subclass of: process specification
subclass of: Restriction
  on property: isIdentifiedBy
  on class: marketing authorization procedure identifier
  max qualified cardinality: 1
subclass of: Restriction
  on property: hasEndDate
  on class: Date
  max qualified cardinality: 1
subclass of: Restriction
  on property: hasStartDate
  on class: Date
  max qualified cardinality: 1
subclass of: Restriction
  on property: appliesTo
  on class: marketing authorization
  min qualified cardinality: 0
subclass of: Restriction
  on property: refersTo
  on class: marketing authorization application
  min qualified cardinality: 0
subclass of: Restriction
  on property: isClassifiedBy
  on class: marketing procedure classifier
  qualified cardinality: 1
label: marketing authorisation procedure
definition: regulatory procedure applied to grant or amend a marketing authorisation for a medicinal product
note: A region may further refine the requirements in relation to the marketing authorization procedure (and the associated marketing authorization application) at implementation such that this information is to be specified only if required.
has conformance level: ConformanceLevel-Mandatory
adapted from: 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, clause 9.3.2.6
adapted from: 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 B.2.15

marketing authorization procedure identifier
type: Class
subclass of: CodeElement
subclass of: RegisteredIdentifier
subclass of: Restriction
  on property: identifies
  all values from: marketing authorization procedure
label: marketing authorisation procedure identifier
definition: unique identifier for the specific instance of a procedure undertaken
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-II
adapted from: 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, clause 9.3.2.6
adapted from: 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 B.2.15
synonym: procedure identifier/number

marketing procedure classifier
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: marketing authorization procedure
definition: sequence of characters characterizing the kind of marketing procedure that is followed to grant or update a marketing authorization
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-CD
adapted from: 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, clause 9.3.2.6
adapted from: 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 B.2.15
synonym: procedure type
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

marketing status code
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: marketing status record
subclass of: Restriction
  on property: denotes
  all values from: marketing status record
definition: sequence of characters denoting the marketing status of a medicinal product
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-CD
adapted from: 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 B.1
direct 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, clause 9.3.2 and Figure 7
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

marketing status reason
type: Class
subclass of: Record
subclass of: Restriction
  on property: isCharacterizedBy
  on class: change request organization type
  max qualified cardinality: 1
subclass of: Restriction
  on property: isCharacterizedBy
  on class: condition to restore authorization
  max qualified cardinality: 1
subclass of: Restriction
  on property: isCharacterizedBy
  on class: geographic area for action taken
  max qualified cardinality: 1
subclass of: Restriction
  on property: isCharacterizedBy
  on class: legal grounds
  max qualified cardinality: 1
subclass of: Restriction
  on property: isClassifiedBy
  on class: marketing status reason code
  max qualified cardinality: 1
subclass of: Restriction
  on property: isSignifiedBy
  on class: marketing status reason code
  max qualified cardinality: 1
subclass of: Restriction
  on property: has restore date
  on class: ExplicitDate
  max qualified cardinality: 1
subclass of: Restriction
  on property: has condition to restore comment
  max qualified cardinality: 1
  on data range: string
subclass of: Restriction
  on property: has legal grounds comment
  max qualified cardinality: 1
  on data range: string
subclass of: Restriction
  on property: has status reason comment
  max qualified cardinality: 1
  on data range: string
subclass of: Restriction
  on property: isReferredToBy
  on class: Class
    union of: marketing status record
    union of: marketing authorization
  min qualified cardinality: 0
definition: record indicating the reason for a legal action taken on the marketing or on the marketing authorization and in reference to the status of these elements
example: the marketing status is permanently ceased as the medicine is harmful
adapted from: 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 B.2.19
direct 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, clause 9.3.2.9 and Figure 7
synonym: status reason
synonym: status reasons

marketing status reason code
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: marketing status reason
subclass of: Restriction
  on property: denotes
  all values from: marketing status reason
definition: sequence of characters denoting the reason for a legal action taken on the marketing or on the marketing authorization, which can be specified using an appropriate controlled vocabulary
note: The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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 B.2.19.1
direct 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, clause 9.3.2.9.2 and Figure 7
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

marketing status record
type: Class
subclass of: Record
subclass of: Restriction
  on property: isAbout
  all values from: medicinal product
subclass of: Restriction
  on property: isApplicableInJurisdiction
  all values from: GeographicRegionIdentifier
subclass of: Restriction
  on property: refersTo
  on class: marketing status reason
  max qualified cardinality: 1
subclass of: Restriction
  on property: has marketing stop date
  on class: ExplicitDate
  max qualified cardinality: 1
subclass of: Restriction
  on property: has risk of supply shortage
  max qualified cardinality: 1
  on data range: boolean
subclass of: Restriction
  on property: has risk of supply shortage comment
  max qualified cardinality: 1
  on data range: string
subclass of: Restriction
  on property: has marketing start date
  on class: ExplicitDate
  qualified cardinality: 1
definition: record indicating when a medicinal product (or, optionally, a packaged medicinal product) is actually put on the market or is no longer available in a country or jurisdiction
note: Description of the status of the marketing of the medicinal product shall be provided (e.g. temporary cease, permanently cease, withdrawn from the market, marketed).
note: There may be circumstances where additional information on marketing status is specific to local provisions within a jurisdiction (e.g. states, provinces or territories). Marketing status allows indicating these circumstances as well, where this is specifically applicable.
has conformance level: ConformanceLevel-Mandatory
has conformance to ISO level: ConformanceToISOLevel-ModelConformant
adapted from: 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 B.1
direct 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, clauses 3.1.46 and 9.3.2 and Figure 7
synonym: marketing status

mass-based strength
type: Class
subclass of: strength
definition: quantity or range of quantities of the substance/specified substance present per unitary volume (or mass)
has conformance to ISO level: ConformanceToISOLevel-Extension
adapted from: 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 9.7.2.5.3

medical condition
type: Class
subclass of: condition
definition: condition that impairs the body's normal functioning or its parts and is characterized by specific symptoms and/or signs
note: A medical condition can be kind of illness or circumstance which requires medical monitoring.
has conformance to ISO level: ConformanceToISOLevel-Extension
adapted from: National Cancer Institute Thesaurus, see http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C156809

medical device
type: Class
subclass of: MaterialSpecification
subclass of: Restriction
  on property: isSignifiedBy
  on class: medical device batch identifier
  min qualified cardinality: 0
subclass of: Restriction
  on property: comprises
  on class: medical device material
  min qualified cardinality: 0
subclass of: Restriction
  on property: refersTo
  on class: medical device nomenclature
  min qualified cardinality: 0
subclass of: Restriction
  on property: has other characteristic
  on class: other product characteristic
  min qualified cardinality: 0
definition: specification of an instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease; — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; — investigation, replacement or modification of the anatomy or of a physiological process; — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means
example: Some examples of devices in the context of pharmaceutical products are drug delivery systems, drug-eluting stents, insulin pumps, glucose meters, and diagnostic test kits.
note: Devices may be of several types such as separate administration devices, an integral administration device or a part of a medicinal product. Where a medicinal product is combined with a medical device and where the pharmacological, immunological or metabolic action should be considered as the principal mode of action, the medical device is presented as part of the pharmaceutical product.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
adopted from: 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, clauses 3.1.49 and 9.6.2.12
explanatory note: The FDA further clarifies this definition to say that such a device does not achieve its primary intended purposes through chemical action within or on the body of a man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
synonym: device

medical device batch identifier
type: Class
subclass of: batch number
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, clause 9.6.2.15
definition: unique identifier allocated to a specific batch of a medical device
note: At implementation, any batch number and expiry date for a device in a packaged medicinal product will be related to a particular batch or batches of that packaged medicinal product (as described using the BAID1), but for simplification at a conceptual level, the 'many-to-many' relationship that this would give has been omitted.
note: This class can be used to describe the batch number and/or expiry date of a device in a packaged medicinal product.
synonym: device batch identifier

medical device material
type: Class
subclass of: MaterialSpecification
subclass of: Restriction
  on property: isIncludedIn
  on class: medical device
  min qualified cardinality: 0
definition: specification of the material(s) of which a given device is made
note: This class is used to list the substances that are used to create the material(s) of which the device is made and also for indicating if the substance is representing an alternate material and if the substance is a known allergen.
adopted from: 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, clause 9.6.2.13
synonym: device material

medical device nomenclature
type: Class
subclass of: Nomenclature
subclass of: Restriction
  on property: isReferredToBy
  on class: medical device
  min qualified cardinality: 0
definition: terminology structured systematically according to pre-established naming rules for medical devices
note: There are a variety of nomenclature systems available to identify devices. This structure supports the description of the device in these nomenclature systems.
adopted from: 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, clause 9.6.2.14
synonym: device nomenclature

medication
type: Class
subclass of: FunctionalRole
subclass of: Class
  union of: product role
  union of: SubstanceRole
subclass of: Restriction
  on property: isManifestedIn
  some values from: medication therapy
definition: role of a substance or product that is used in the treatment of a disease or symptom
note: Reference to a specific medication, which can be expressed as an active substance, medicinal product or class of medicinal products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary [see medication classifier].
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
adopted from: 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, clause 9.9.2.6.3

medication classifier
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: medication
subclass of: Restriction
  on property: denotes
  all values from: medication
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, clause 9.9.2.6.3, Figure 14
definition: classifier for a medication by active substance or medicinal product(s)
note: Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

medication therapy
type: Class
subclass of: therapy
subclass of: Restriction
  on property: manifests
  some values from: medication
definition: therapy in which a medication is administered to the patient
has conformance to ISO level: ConformanceToISOLevel-Extension
synonym: therapy with medication

medicinal product
type: Class
subclass of: product specification
subclass of: Restriction
  on property: has dose form
  on class: combined pharmaceutical dose form
  max qualified cardinality: 1
subclass of: Restriction
  on property: isClassifiedBy
  on class: medicinal product monitoring indicator
  max qualified cardinality: 1
subclass of: Restriction
  on property: isClassifiedBy
  on class: orphan designation
  max qualified cardinality: 1
subclass of: Restriction
  on property: isClassifiedBy
  on class: pediatric use indicator
  max qualified cardinality: 1
subclass of: Restriction
  on property: has contraindication
  on class: contraindication
  min qualified cardinality: 0
subclass of: Restriction
  on property: has interaction
  on class: interaction
  min qualified cardinality: 0
subclass of: Restriction
  on property: is authorized for manufacturing through
  on class: manufacturing authorization
  min qualified cardinality: 0
subclass of: Restriction
  on property: isDescribedBy
  on class: marketing status record
  min qualified cardinality: 0
subclass of: Restriction
  on property: refersTo
  on class: medicinal product cross-reference
  min qualified cardinality: 0
subclass of: Restriction
  on property: isDescribedBy
  on class: medicinal product master file
  min qualified cardinality: 0
subclass of: Restriction
  on property: specifies
  on class: physical medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: isClassifiedBy
  on class: product classifier
  min qualified cardinality: 0
subclass of: Restriction
  on property: playsRole
  on class: product role
  min qualified cardinality: 0
subclass of: Restriction
  on property: has shelf life
  on class: shelf life
  min qualified cardinality: 0
subclass of: Restriction
  on property: has undesirable effect
  on class: undesirable effect
  min qualified cardinality: 0
subclass of: Restriction
  on property: has special measures
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: isDescribedBy
  on class: medicinal product header record
  qualified cardinality: 1
subclass of: Restriction
  on property: has attached document
  some values from: attached document
subclass of: Restriction
  on property: has therapeutic indication
  some values from: therapeutic indication
subclass of: Restriction
  on property: comprises
  some values from: Class
    union of: ManufacturedItem
    union of: pharmaceutical product
subclass of: Restriction
  on property: defines
  some values from: packaged medicinal product
subclass of: Restriction
  on property: hasName
  some values from: medicinal product name
subclass of: Restriction
  on property: isIdentifiedBy
  some values from: medicinal product identifier
definition: specification for a pharmaceutical product or combination of pharmaceutical products that may be administered to human beings (or animals) for treating or preventing disease, with the aim/purpose of making a medical diagnosis or to restore, correct or modify physiological functions
note: The provisions in this document [ontology] apply to proprietary medicinal products for human use intended to be placed on the market and to industrially manufactured medicinal products, the marketing of which has been authorized by a medicines regulatory agency. However, the provisions do not apply to: i) medicinal products prepared according to prescription (e.g. prepared in a pharmacy from a prescription intended for a specific patient), ii) medicinal products prepared in accordance with an official formula (e.g. prepared in a pharmacy in accordance with the instructions in a pharmacopoeia and intended to be given direct to the patient by the pharmacy), iii) medicinal products intended for research and development trials, and to iv) intermediate products intended for subsequent processing by an authorized manufacturer.
adapted from: ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.42
adapted from: 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, clause 3.1.50
usage note: Note that while the constraints defined above enable optional inclusion of either a pharmaceutical product or manufactured item, in most cases at least one pharmaceutical product should be included and likely both. This definition allows for the option of a medicinal product that is limited to a manufactured item, such as a medical device, as well as the option of some sort of pharmaceutical product that is not considered a manufactured item within a given context.

medicinal product batch identifier for immediate packaging
type: Class
subclass of: batch number
subclass of: StructuredIdentifier
subclass of: Restriction
  on property: comprises
  some values from: pharmaceutical product batch number
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, clause 3.1.52
definition: unique identifier allocated to a specific batch of a medicinal product, which appears on the immediate packaging, where this is not the outer packaging
editorial note: For more explicit modeling of the semantics we should consider creating a property chain that links the BAID1 through the pharmaceutical product batch identifier, through the pharmaceutical product batch to its expiration date (future update).
note: It is constructed by using the batch number assigned by the manufacturer and the expiration date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of a medicinal product based at the level of the immediate container.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
abbreviation: BAID2
synonym: medicinal product batch identifier 2

medicinal product batch identifier for outer packaging
type: Class
subclass of: batch number
subclass of: StructuredIdentifier
subclass of: Restriction
  on property: comprises
  some values from: pharmaceutical product batch number
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, clause 3.1.51
definition: unique identifier allocated to a specific batch of a medicinal product, which appears on the outer packaging of the medicinal product
editorial note: For more explicit modeling of the semantics we should consider creating a property chain that links the BAID1 through the pharmaceutical product batch identifier, through the pharmaceutical product batch to its expiration date (future update).
note: It is constructed by using the batch number assigned by the manufacturer and the expiration date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of a medicinal product at the package level.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
abbreviation: BAID1
synonym: medicinal product batch identifier 1

medicinal product code segment
type: Class
subclass of: CodeElement
subclass of: Restriction
  on property: isIncludedIn
  on class: medicinal product identifier
  qualified cardinality: 1
definition: code assigned to each package presentation of a medicinal product
note: It utilises defining attributes to determine a single medicinal product to which a code is assigned. A different medicinal product code segment shall be assigned, leading to a unique MPID, whenever any of the following items of information for a medicinal product are modified, as applicable, per a medicines regulatory agency process(es): a) marketing authorisation indicated in a region; NOTE The change of a marketing authorization (MA), depending on regional requirements, might not lead to a change of MPID. b) legal status of supply as a value/attribute (e.g. prescription only or 'over the counter' sale); Legal status of supply may be considered a defining element for medicinal product identification per regional requirements as this supports regulatory compliance and pharmacovigilance activities. c) medicinal product name; d) pharmaceutical dose form; e) active ingredient(s)/active moieties and their corresponding strength; f) device(s) where a medicinal product is combined with a medical device and where the pharmacological, immunological or metabolic action should be considered as the principal mode of action; the medical device is presented as part of the medicinal product; g) therapeutic indication(s) as authorized for the medicinal product.
direct 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, clause 8.3.2

medicinal product container
type: Class
subclass of: container specification
subclass of: product specification
subclass of: Restriction
  on property: playsRole
  on class: container role
  min qualified cardinality: 0
subclass of: Restriction
  on property: specifies
  on class: physical medicinal product container
  min qualified cardinality: 0
subclass of: Restriction
  on property: contains
  some values from: Class
    union of: ManufacturedItem
    union of: medical device
    union of: package item
subclass of: Restriction
  on property: hasConstituent
  some values from: container constituent
subclass of: Restriction
  on property: isPartOf
  some values from: Class
    union of: medicinal product
    union of: packaged medicinal product
definition: specification for a container that is part of a medicinal product and is used for storage, identification and/or transport of the components of the medicinal product or packaged medicinal product
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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, clause 3.1.16
usage note: In the ISO 11615 standard, the term container was used more generally and in some cases more specifically. This concept, medicinal product container, was added with the original definition for container in the IDMP standard in order to differentiate the two concepts and enable proper representation of some of the more specific kinds of containers included in the standard.

medicinal product cross-reference
type: Class
subclass of: Reference
subclass of: Restriction
  on property: isReferredToBy
  some values from: medicinal product
definition: reference to another medicinal product that bears some relationship with the medicinal product in question
note: There can be a cross-reference between the MPIDs/PCIDs of the authorized Medicinal Product(s) and the related IMPIDs/IPCIDs of an Investigational Medicinal Product(s) assigned during the development phase and clinical investigation of that Medicinal Product. In addition, there may be references between authorized Medicinal Products and their corresponding identifiers. The related Medicinal Products and Investigational Medicinal Products can be specified with their corresponding identifiers.
adapted from: 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 6
synonym: product cross-reference

medicinal product header identifier
type: Class
subclass of: Identifier
subclass of: Restriction
  on property: identifies
  all values from: medicinal product header record
definition: unique identifier allocated to a specific version of a header [record], i.e., a record specifying the versioning of the core identifiers related to a medicinal product in a region, as well as the characteristics associated with the medicinal product and the documentation that supports the versioning
is encoded as: DatatypeCode-II
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
has conformance to ISO level: ConformanceToISOLevel-ModelConformant
adapted from: 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 9.3. Figure 6
synonym: identifier

medicinal product header record
type: Class
subclass of: Record
subclass of: Restriction
  on property: isIdentifiedBy
  on class: medicinal product header identifier
  qualified cardinality: 1
subclass of: Restriction
  on property: hasEffectiveDate
  on data range: string
  qualified cardinality: 1
subclass of: Restriction
  on property: describes
  some values from: medicinal product
definition: record that specifies the versioning of the core identifiers related to a medicinal product in a region [jurisdiction], as well as the characteristics associated with the medicinal product and the documentation that supports the versioning
note: Regional guidance might contain additional criteria which may warrant a new version of a regulated document as it relates to the characteristics of a medicinal product, including potentially language-specific versions.
note: The characteristics of an authorized medicinal product as defined herein shall be versioned within a regulated document, as applicable. For a given version, some characteristics of the medicinal product have changed but are not different to a sufficient extent to warrant the assignment of a new primary identifier. However, the difference(s) are required to be recorded and tracked against the MPID/PCID.
note: This is also a record to track against previous versions of a regulated document, including but not limited to language-specific variations, regardless of whether the revisions warrant a new primary identifier (primary identifier reference shall be listed as an example of a change within a regulated document).
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
has conformance to ISO level: ConformanceToISOLevel-ModelConformant
adapted from: 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 6
synonym: header
usage note: A given medicinal product will have exactly 1 'header', although a given 'header' may apply to multiple medicinal products.

medicinal product identifier
type: Class
subclass of: CodeElement
subclass of: StructuredIdentifier
subclass of: RegisteredIdentifier
subclass of: Restriction
  on property: comprises
  some values from: marketing authorization holder identifier
subclass of: Restriction
  on property: comprises
  some values from: medicinal product code segment
subclass of: Restriction
  on property: comprises
  some values from: Alpha2RegionCode
subclass of: Restriction
  on property: identifies
  some values from: medicinal product
definition: unique identifier allocated to a medicinal product supplementary to any existing authorization number as ascribed by a medicines regulatory agency in a region
note: This is an alphanumeric text field.
note: This is for indexing purposes and to contribute to improved patient safety by allowing for the unique identification of medicinal products worldwide.
abbreviation: MPID
direct 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, clause 3.1.53

medicinal product manufacturing process
type: Class
subclass of: manufacturing process
source: ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.40
definition: process of production for a substance or medicinal product from the acquisition of all materials through all processing stages
editorial note: This is a starting point that requires extension to include additional relationships as described in the note.
note: The critical process, critical process steps, starting and processing materials and critical production parameters are included.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
synonym: manufacturing

medicinal product master file
type: Class
subclass of: Registry
subclass of: Restriction
  on property: isManagedBy
  on class: medicinal product master file holder
  max qualified cardinality: 1
subclass of: Restriction
  on property: describes
  some values from: medicinal product
definition: collection of records submitted to a medicines regulatory agency that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs
example: Pharmacovigilance System Master File
note: This may be either an invented name not liable to be confused with the common name, or a common or a scientific name accompanied by a trade mark or any other applicable descriptor.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 6
adapted from: https://www.fda.gov/drugs/guidances-drugs/drug-master-files-guidelines
synonym: master file

medicinal product master file holder
type: Class
subclass of: authorized party
subclass of: Restriction
  on property: isPlayedBy
  on class: LegalEntity
  min qualified cardinality: 0
subclass of: Restriction
  on property: manages
  some values from: medicinal product master file
definition: authorized role of a legal entity (organization) that holds a master file for a given medicinal product
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 6
synonym: master file holder
synonym: master file holder (organisation)
synonym: master file holder (organization)

medicinal product monitoring indicator
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  some values from: medicinal product
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
definition: classifier for medicinal products, specifying whether a given product is subject to additional monitoring
note: If the medicinal product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
has conformance to ISO level: ConformanceToISOLevel-ModelConformant
adapted from: 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
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

medicinal product name
type: Class
subclass of: ContextualName
subclass of: Restriction
  on property: has company name part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has container part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has delimiter part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has device part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has flavor part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has formulation part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has intended use part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has invented name part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has pharmaceutical dose form part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has scientific name part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has strength name part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has target population part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has time period part
  min qualified cardinality: 0
  on data range: string
subclass of: Restriction
  on property: has full medicinal product name
  on data range: string
  qualified cardinality: 1
subclass of: Restriction
  on property: isApplicableIn
  some values from: medicinal product name locale
subclass of: Restriction
  on property: isNameOf
  some values from: medicinal product
definition: name as authorized by a medicines regulatory agency
note: The medicinal product name is one of the defining characteristics of a medicinal product and its MPID. There may be more than one medicinal product name for a medicinal product instance. A medicinal product may have more than one proprietary/non-proprietary name across jurisdictions. Multiple languages may also be applicable per jurisdictional requirements. The convention applied for naming a medicinal product can differ between medicines regulatory agencies within regions. As a general principle, a marketing authorization is granted to a single marketing authorization holder who is responsible for placing the medicinal product on the market. The marketing authorization contains the name of the medicinal product, which can refer to, for example, a single invented name or a scientific name [when available, the international non-proprietary name (INN) of the active substance(s)] accompanied by a trademark or other characteristics).
note: This may be either an invented name not liable to be confused with the common name, or a common or a scientific name accompanied by a trade mark or any other applicable descriptor.
direct 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, clauses 3.1.54 and 9.2.2.8, Figure 6

medicinal product name locale
type: Class
subclass of: Context
subclass of: Restriction
  on property: hasJurisdiction
  on class: Jurisdiction
  max qualified cardinality: 1
subclass of: Restriction
  on property: hasReach
  on class: GeographicRegion
  qualified cardinality: 1
subclass of: Restriction
  on property: hasLanguage
  on class: Language
  qualified cardinality: 1
definition: context in which a given medicinal product name applies
note: The country and optionally the region where the medicinal product name of a medicinal product is authorized shall be specified in the official language as applicable.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
has conformance to ISO level: ConformanceToISOLevel-ModelConformant
adapted from: 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 6
synonym: Country / Language

medicines regulatory agency
type: Class
subclass of: authorizing party
subclass of: RegistrationAuthority
subclass of: RegulatoryAgency
subclass of: Restriction
  on property: authorizes through
  on class: manufacturing authorization
  min qualified cardinality: 0
subclass of: Restriction
  on property: authorizes through
  on class: marketing authorization
  min qualified cardinality: 0
subclass of: Restriction
  on property: regulates
  on class: medicinal product
  min qualified cardinality: 0
definition: institutional body that, according to the legal system under which it has been established, is responsible for the granting of marketing authorizations, clinical trial authorizations and manufacturing authorizations for medicinal products
note: In certain regions, the role of the institutional body, which according to the legal system grants the marketing authorization of medicinal products, may be complemented by an additional institutional body responsible for the evaluation and supervision of medicinal products. For example, in the EU, the European Commission is the institutional body that grants the marketing authorization of medicinal products and the European Medicines Agency is the body responsible for the evaluation and supervision of medicinal products.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
direct 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, clause 3.1.56
synonym: medicines regulatory agency (organisation)
synonym: medicines regulatory agency (organization)

orphan designation
type: Class
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  some values from: medicinal product
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
definition: classifier for medicinal products, including drugs and biologics, that have orphan status, especially with respect to rare diseases and or populations that meet certain criteria
note: This class includes several attributes required to have all the information related to a product with an orphan designation status.
explanatory note: In some cases, a rare disease indication may provide marketing exclusivity for a period of time, which may or may not be approved once a product is authorized. For certain new drugs that are not covered by patent exclusivity, there may also be a period of time when market exclusivity is granted. This may be complicated by jurisdiction specific designations, for example, in the US and EU. There may be multiple orphan designations for the same product, not only by jurisdiction, but by intended use, such as for pediatric patients.
usage note: 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.

other product characteristic
type: Class
subclass of: NonEssentialCharacteristic
subclass of: Restriction
  on property: describes
  all values from: Class
    union of: ManufacturedItem
    union of: package item
    union of: medical device
subclass of: Restriction
  on property: isSignifiedBy
  on class: other product characteristic code
  qualified cardinality: 1
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
disjoint with: PhysicalCharacteristic
definition: aspect of a manufactured item, package item, or medical device that describes that product
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.
has conformance level: ConformanceLevel-Optional
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
has conformance to ISO level: ConformanceToISOLevel-ModelConformant
adapted from: 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
synonym: other characteristic

other product characteristic code
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: denotes
  all values from: other product characteristic
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
definition: value for an aspect of a manufactured item, package item, or medical device that describes that product, derived from a controlled vocabulary
is encoded as: DatatypeCode-CD
adapted from: 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
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

other therapy specifics
type: Class
subclass of: Specification
subclass of: Restriction
  on property: has medication
  some values from: medication classifier
subclass of: Restriction
  on property: has therapy relationship type
  some values from: therapy relationship type
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, clause 9.9.2.6.1
definition: specification of the relationship between the indication or contraindication of a medicinal product with another therapy
note: If there is information about the use of the Medicinal Product in relation to other therapies described as part of the indication or contraindication in accordance with the regulated product information, this can be specified using this class.
synonym: other therapy relationship

outer packaging
type: NamedIndividual
type: container role kind
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, clause 3.1.57
definition: external container in which a medicinal product is supplied
explanatory note: The manufactured item or pharmaceutical product is not in direct contact with the outer packaging except where the outer packaging also serves as the immediate container. An alternative, compatible definition of outer packaging is given in Directive 92/27/EEC.

package component
type: Class
subclass of: MaterialComponentSpecification
subclass of: Restriction
  on property: has physical characteristic
  on class: PhysicalCharacteristic
  min qualified cardinality: 0
definition: specification of a part of a package item
example: specification of a closure
adopted from: 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, clause 9.6.2.9

package description code segment
type: Class
subclass of: CodeElement
subclass of: Restriction
  on property: isIncludedIn
  on class: package identifier
  qualified cardinality: 1
definition: code assigned to each package presentation of a medicinal product
direct 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, clause 8.3.2

package identifier
type: Class
subclass of: CodeElement
subclass of: StructuredIdentifier
subclass of: RegisteredIdentifier
subclass of: Restriction
  on property: comprises
  some values from: medicinal product identifier
subclass of: Restriction
  on property: comprises
  some values from: package description code segment
subclass of: Restriction
  on property: identifies
  some values from: packaged medicinal product
definition: unique identifier allocated in addition to any existing authorisation/approval number at package level as ascribed by a Medicines Regulatory Agency in a region
note: The PCID shall use a common segment pattern related to a package of a Medicinal Product, which when each segment is valued, shall define a specific PCID concept. The pattern is: a) MPID for the Medicinal Product; b) package description code segment, which refers to a unique identifier for each package.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
has conformance to ISO level: ConformanceToISOLevel-ModelConformant
abbreviation: PCID
direct 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, clause 8.3, 9.6.2.2.1
synonym: packaged medicinal product identifier

package item
type: Class
subclass of: MaterialSpecification
subclass of: medicinal product container
subclass of: Restriction
  on property: has physical characteristic
  on class: PhysicalCharacteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: isIdentifiedBy
  on class: data carrier identifier
  min qualified cardinality: 0
subclass of: Restriction
  on property: has other characteristic
  on class: other product characteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: hasMember
  on class: package component
  min qualified cardinality: 0
subclass of: Restriction
  on property: has shelf life
  on class: shelf life
  min qualified cardinality: 0
subclass of: Restriction
  on property: hasQuantityValue
  on class: package item quantity
  qualified cardinality: 1
subclass of: Restriction
  on property: has package item type
  on class: package item type
  qualified cardinality: 1
subclass of: Restriction
  on property: hasMaterial
  some values from: Class
    union of: MaterialSpecification
    union of: MaterialClassifier
    union of: Substance
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 and clauses 3.1.58, 9.6.2.3
definition: specification for an individual, distinct item contained in a packaged medicinal product that acts as a container for one or more manufactured item(s)
note: The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO/TS 20440 and its resulting terminology. The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of '1'. The material(s) of the package item shall be described in accordance with ISO 11238 and ISO/TS 19844 and its resulting terminology as applicable.
note: The package item class has a recursive relationship with itself; this complexity is necessary to describe situations where there are packages within packages, for example, cartridges within a blister sleeve within a box. A package item can be identified by one or more data carrier identifiers. The package item can have component parts such as closures; this is facilitated by the package (component) class. The lowest level package item (container), when any recursion has been unrolled, is that which is in contact with the physical medicinal product represented in the manufactured item.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
adapted from: 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.1
explanatory note: The manufactured item or pharmaceutical product is not in direct contact with the outer packaging except where the outer packaging also serves as the immediate container. An alternative, compatible definition of outer packaging is given in Directive 92/27/EEC.

package item quantity
type: Class
subclass of: ScalarQuantityValue
subclass of: Restriction
  on property: hasMeasurementUnit
  some values from: MeasurementUnit
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 and clauses 3.1.58, 9.6.2.3
definition: quantity (or count number) of the package item
note: The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of '1'.
is encoded as: DatatypeCode-PQ
adapted from: 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.1
synonym: package item container quantity
synonym: packaged quantity

package item type
type: Class
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  some values from: package item
definition: classifier for package items (containers)
direct 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, clause 9.6.2.3.2
synonym: container type
synonym: package item (container) type

packaged medicinal product
type: Class
subclass of: product specification
subclass of: Restriction
  on property: isDescribedBy
  on class: marketing status record
  max qualified cardinality: 1
subclass of: Restriction
  on property: isIdentifiedBy
  on class: batch number
  min qualified cardinality: 0
subclass of: Restriction
  on property: isDefinedIn
  on class: medicinal product
  qualified cardinality: 1
subclass of: Restriction
  on property: isIdentifiedBy
  on class: package identifier
  qualified cardinality: 1
subclass of: Restriction
  on property: hasDescription
  on data range: string
  qualified cardinality: 1
subclass of: Restriction
  on property: comprises
  some values from: package item
definition: medicinal product in a container being part of a package, representing the entirety that has been packaged for sale or supply
note: Packaged medicinal product specifies information about the packaging and container(s) of a medicinal product and any associated device(s) which is an integral part or provided in combination with a medicinal product, as supplied by the manufacturer for sale and distribution. It also specifies the ingredient information for the manufactured item(s).
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
adapted from: 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 and clauses 3.1.57, 9.1.7, and 9.6
adapted from: 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

pediatric use indicator
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  some values from: medicinal product
label: paediatric use indicator
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
definition: classifier for medicinal products, specifying whether a given product is authorized for use in children
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

pharmaceutical dose form
type: Class
subclass of: Specification
subclass of: Restriction
  on property: hasQuantityValue
  on class: ScalarQuantityValue
  qualified cardinality: 1
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, clause 3.1.24
definition: specification for the physical manifestation of a medicinal product that contains the active ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient
note: 'Pharmaceutical dose form' can refer to the administrable dose form or the manufactured dose form.
synonym: dosage form
synonym: dose form

pharmaceutical product
type: Class
subclass of: product specification
subclass of: Restriction
  on property: hasUnitOfPresentation
  on class: UnitOfPresentation
  max qualified cardinality: 1
subclass of: Restriction
  on property: isDescribedBy
  on class: pharmaceutical product characteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: specifies
  on class: physical pharmaceutical product
  min qualified cardinality: 0
subclass of: Restriction
  on property: has dose form
  on class: administrable dose form
  qualified cardinality: 1
subclass of: Restriction
  on property: has route of administration
  some values from: route of administration
subclass of: Restriction
  on property: isCharacterizedBy
  some values from: pharmaceutical product identifier set
subclass of: Restriction
  on property: comprises
  some values from: Substance
subclass of: Restriction
  on property: isDefinedIn
  some values from: product composition
definition: specification for the qualitative and quantitative composition of a medicinal product in the dose form approved for administration in line with the regulated product information
note: In many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item shall undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
adapted from: ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.58
adapted from: 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 and clauses 3.1.60, 9.8.2.2
adapted from: 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 I.2.20
explanatory note: Note that the ingredients that a pharmaceutical product contains are linked via its composition rather than directly. There is also a direct 'comprises' relationship to the individual substances that are part of the product for the sake of convenience, though understanding the role(s) of a given substance requires linking through the product composition.

pharmaceutical product batch
type: Class
subclass of: batch
subclass of: Restriction
  on property: has expiration date
  some values from: ExplicitDate
subclass of: Restriction
  on property: isConstituentOf
  some values from: physical pharmaceutical product
subclass of: Restriction
  on property: hasQuantityValue
  some values from: ScalarQuantityValue
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, clause 3.1.8
definition: specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture
editorial note: This definition of batch entails axioms relating the batch to a manufacturing order and identifying the manufacturing cycle, which need to be added.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant

pharmaceutical product batch number
type: Class
subclass of: batch number
subclass of: Restriction
  on property: denotes
  some values from: pharmaceutical product batch
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, clause 3.1.9
definition: identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing process at a specific point of time
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant

pharmaceutical product characteristic
type: Class
subclass of: EssentialCharacteristic
subclass of: Restriction
  on property: describes
  all values from: pharmaceutical product
subclass of: Restriction
  on property: isClassifiedBy
  on class: pharmaceutical product characteristic status
  min qualified cardinality: 0
subclass of: Restriction
  on property: isSignifiedBy
  on class: pharmaceutical product characteristic code
  qualified cardinality: 1
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 9.8.2.4
definition: aspect of a pharmaceutical product that describes that product, such as its onset of action
has conformance level: ConformanceLevel-Conditional
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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, clauses I.2.21, E.2.5

pharmaceutical product characteristic code
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: denotes
  all values from: pharmaceutical product characteristic
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 9.8.2.4
definition: value for a specific pharmaceutical product characteristic value, derived from a controlled vocabulary
note: The value from the pharmaceutical product characteristics system can be specified.
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-CD
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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, clauses I.2.21, E.2.5
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

pharmaceutical product characteristic status
type: Class
subclass of: State
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: classifies
  all values from: pharmaceutical product characteristic
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
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
example: assigned, not assigned or pending
has conformance level: ConformanceLevel-Optional
is encoded as: DatatypeCode-CD
adapted from: 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 I.2.21, Annex E
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

pharmaceutical product identifier
type: Class
subclass of: Identifier
subclass of: Restriction
  on property: identifies
  some values from: Class
    union of: pharmaceutical product
    union of: physical pharmaceutical product
definition: unique identifier for a pharmaceutical product
abbreviation: PhPID
direct 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, clause 3.1.61

pharmaceutical product identifier set
type: Class
subclass of: Collection
subclass of: Restriction
  on property: comprises
  some values from: Identifier
definition: collection of identifiers associated with a given pharmaceutical product
note: This class shall be assigned the relevant identifiers as defined by ISO 11616 and ISO/TS 20451. This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device.
abbreviation: PhPID set
adapted from: 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 E.2.3
direct 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 and clause 9.8.2.6

physical medicinal product
type: Class
subclass of: Material
subclass of: CommercialProduct
subclass of: Restriction
  on property: is produced by manufacturing operation
  all values from: manufacturing or business operation
subclass of: Restriction
  on property: is produced at manufacturing site
  all values from: manufacturing site
subclass of: Restriction
  on property: comprises
  on class: PhysicalManufacturedItem
  min qualified cardinality: 0
subclass of: Restriction
  on property: isDefinedIn
  on class: medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: has shelf life
  on class: shelf life
  min qualified cardinality: 0
subclass of: Restriction
  on property: hasSpecifiedIdentifier
  some values from: medicinal product identifier
subclass of: Restriction
  on property: isProducedBy
  some values from: Manufacturer
definition: pharmaceutical product or combination of pharmaceutical products that may be administered to human beings (or animals) for treating or preventing disease, with the aim/purpose of making a medical diagnosis or to restore, correct or modify physiological functions
note: A medicinal product may contain in the packaging one or more manufactured items and one or more pharmaceutical products. In certain regions, a medicinal product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis.
note: The provisions in this document [ontology] apply to proprietary medicinal products for human use intended to be placed on the market and to industrially manufactured medicinal products, the marketing of which has been authorized by a medicines regulatory agency. However, the provisions do not apply to: i) medicinal products prepared according to prescription (e.g. prepared in a pharmacy from a prescription intended for a specific patient), ii) medicinal products prepared in accordance with an official formula (e.g. prepared in a pharmacy in accordance with the instructions in a pharmacopoeia and intended to be given direct to the patient by the pharmacy), iii) medicinal products intended for research and development trials, and to iv) intermediate products intended for subsequent processing by an authorized manufacturer.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
direct source: ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.42
direct 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, clause 3.1.50

physical medicinal product container
type: Class
subclass of: PhysicalManufacturedItem
subclass of: container
subclass of: Restriction
  on property: isPartOf
  some values from: physical medicinal product
definition: container that is part of a medicinal product and is used for storage, identification and/or transport of the components of the medicinal product
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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, clause 3.1.16
usage note: In the ISO 11615 standard, the term container was used more generally and in some cases more specifically. This concept, medicinal product container, was added with the original definition for container in the IDMP standard in order to differentiate the two concepts and enable proper representation of some of the more specific kinds of containers included in the standard.

physical pharmaceutical product
type: Class
subclass of: Material
subclass of: Product
definition: qualitative and quantitative composition of a medicinal product in the dose form approved for administration in line with the regulated product information
note: In many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item shall undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
direct source: ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.58
direct 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, clause 3.1.60

physiological condition
type: Class
subclass of: condition
source: National Cancer Institute Thesaurus, see http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C176718
definition: condition or state of the external or internal milieu for an organism
example: Being in good health and being pregnant are physiological conditions but not necessarily medical conditions. Pregnancy can have complications that would be classified as medical conditions, however.
note: With respect to a person, physiological condition is defined as the functional state of the body or body systems.
has conformance to ISO level: ConformanceToISOLevel-Extension

physiological condition population characteristic
type: Class
subclass of: population characteristic
subclass of: Restriction
  on property: specifies
  some values from: physiological condition
definition: classifier for a statistical population based on the physiological condition of its members
note: Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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, clause Figure 14, and clause 9.9.2.5.7
adapted from: 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 F.2.7.5
synonym: Physiological Condition: CD

placebo
type: Class
subclass of: product role
source: National Cancer Institute Thesaurus, see http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C753
definition: inactive substance, treatment or procedure that is intended to provide baseline measurements for the experimental protocol of a clinical trial
has conformance to ISO level: ConformanceToISOLevel-Extension
explanatory note: A placebo is essentially a medicinal product, with the same packaging, etc. from a patient perspective as the actual investigational or authorized product used in a clinical trial, but without the active ingredient studied in the trial.

population characteristic
type: Class
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  some values from: StatisticalPopulation
definition: classifier of a target population intended as the target of a therapeutic indication or contraindication
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.9.2.5

presentation strength
type: Class
subclass of: strength
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, clause 9.7.2.5.3
definition: quantity or range of quantities of the substance/specified substance present per unitary volume (or mass) expressed in units of presentation
has conformance to ISO level: ConformanceToISOLevel-Extension
synonym: strength (presentation)

process
type: Class
source: ISO 18629-11:2005(en) Industrial automation systems and integration - Process specification language - Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.21
definition: structured set of activities involving various enterprise entities designed and organized for a given purpose
editorial note: This is a starting point that requires extension to include the activities that comprise the process, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL).
note: The definition provided here is very close to that given in ISO 10303-49. Nevertheless ISO 15531 needs the notion of structured set of activities, without any predefined reference to the time or steps. In addition, from the point of view of flow management, some empty processes may be needed for a synchronisation purpose although they are not actually doing anything (ghost task). [SOURCE:ISO 15531-1]
has conformance to ISO level: ConformanceToISOLevel-Extension

process identifier
type: Class
subclass of: ContextualDesignation
subclass of: Restriction
  on property: denotes
  some values from: process
definition: identifier assigned to a structured set of activities involving various enterprise entities, that is designed and organized for a given purpose
has conformance to ISO level: ConformanceToISOLevel-Extension
adapted from: ISO 18629-11:2005(en) Industrial automation systems and integration — Process specification language — Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.21

process specification
type: Class
subclass of: Specification
definition: specification for a structured set of activities involving various enterprise entities designed and organized for a given purpose
has conformance to ISO level: ConformanceToISOLevel-Extension
adapted from: ISO 18629-11:2005(en) Industrial automation systems and integration - Process specification language - Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.21

process step
type: Class
subclass of: Constituent
subclass of: Restriction
  on property: isPartOf
  some values from: process
source: ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6)
definition: part of a process that usually operates independently from other process stages and that usually results in a planned sequence of chemical or physical changes in the material being processed
editorial note: Note that this is an early representation of the concept only, and will likely require extension in future releases.
has conformance to ISO level: ConformanceToISOLevel-Extension

process step identifier
type: Class
subclass of: ContextualDesignation
subclass of: Restriction
  on property: denotes
  some values from: process step
definition: identifier assigned to a part of a process
has conformance to ISO level: ConformanceToISOLevel-Extension
adapted from: ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6)

product classifier
type: Class
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  some values from: medicinal product
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
definition: classifier for a product using a categorization or grouping of medicinal products based on specific properties
note: The Medicinal Product can be classified according to various classification systems, which may be regional or international.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
synonym: product classification

product composition
type: Class
subclass of: Composition
subclass of: Restriction
  on property: has reference strength
  on class: reference strength
  min qualified cardinality: 0
subclass of: Restriction
  on property: hasIngredient
  some values from: Ingredient
subclass of: Restriction
  on property: defines
  some values from: Class
    union of: ManufacturedItem
    union of: medicinal product
    union of: pharmaceutical product
definition: constituency that defines some product based on its relationship(s) to some other substance(s) (ingredient(s)), potentially with a given strength, in some context
has conformance to ISO level: ConformanceToISOLevel-Extension
usage note: From an implementation (mapping) perspective, this product constituency class provides the basis for a (blank) node in the relationship 'product realizes ingredient role played by some substance', where the ingredient role may be that of an active ingredient which, in turn, may have some basis of strength in some context. The same product constituency could be used to link inactive ingredients to a product in which they are realized. A given product may include multiple active ingredients, each of which may have a different basis of strength.

product role
type: Class
subclass of: FunctionalRole
subclass of: Restriction
  on property: isPlayedBy
  some values from: Class
    union of: Product
    union of: product specification
definition: functional role played by a product or specification for a product that is part of or used in the preparation of some manufactured item, or pharmaceutical product, medication, or drug, or in some investigation
has conformance to ISO level: ConformanceToISOLevel-Extension

product specification
type: Class
subclass of: Specification
subclass of: Restriction
  on property: isProducedBy
  on class: Manufacturer
  min qualified cardinality: 0
subclass of: Restriction
  on property: has physical characteristic
  on class: PhysicalCharacteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: isDescribedBy
  on class: image
  min qualified cardinality: 0
subclass of: Restriction
  on property: specifies
  on class: Product
  min qualified cardinality: 0
definition: specification for something that is produced by, results from, or obtained as a consequence of some process or transformation
has conformance to ISO level: ConformanceToISOLevel-Extension

qualitative composition
type: Class
subclass of: product composition
subclass of: Restriction
  on property: defines
  some values from: medicinal product
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, clause 3.1.70
definition: composition of all the constituents of the investigational or authorized medicinal product), if applicable, before or after reconstitution and functioning of the constituents of: - the substance (and specified substance description; - the excipients, whatever their nature or the quantity used, including colouring matter, preservatives, adjuvants, stabilizers, thickeners, emulsifiers, flavouring and aromatic substances, etc.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant

quantitative composition
type: Class
subclass of: product composition
subclass of: Restriction
  on property: defines
  some values from: medicinal product
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, clause 3.1.71
definition: amount of substance and specified substance constituents of the investigational or authorized medicinal product expressed in a ratio scale
note: It is necessary for the quantitative composition of the substance(s) or the specified substance descriptions of the finished investigational or authorized Medicinal Products (depending on the pharmaceutical form concerned) to specify the mass, or the number of units of biological activity, either per dosage unit or per unit of mass or volume, of each substance or specified substance. Substance or specified substance descriptions present in the form of compounds or derivatives are always designated quantitatively by their total mass and, if necessary or relevant, by the mass of active entity, or entities, of the molecule. The term strength is a synonym of quantitative composition.
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant
usage note: Note that quantitative composition is modeled as a kind of product composition in the ontology rather than as a quantity value, which is how the strength of a given ingredient is modeled.

race or ethnicity
type: Class
subclass of: Aspect
subclass of: Restriction
  on property: characterizes
  some values from: PhysicalOrganism
definition: subdivision of human population based on common culture or descent or a subspecies of animals
has conformance to ISO level: ConformanceToISOLevel-Extension

race or ethnicity population characteristic
type: Class
subclass of: population characteristic
subclass of: Restriction
  on property: specifies
  some values from: race or ethnicity
definition: classifier for a statistical population based on the race or ethnicity of its members
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.9.2.5
usage note: HL7 uses PHIN-VADS Race & Ethnicity - CDC as vocabulary for this

reference strength
type: Class
subclass of: strength
subclass of: Restriction
  on property: has reference ingredient role
  on class: SubstanceRole
  min qualified cardinality: 0
subclass of: Restriction
  on property: has reference substance
  on class: Class
    union of: Moiety
    union of: Substance
    union of: PhysicalSubstance
  min qualified cardinality: 0
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, clause 3.1.72
definition: strength of an active substance(s) and/or specified substance(s) used as a reference from which the strength of an investigational or authorized medicinal product is described
note: The strength of the active substance(s) and/or specified substance(s) shall be described as a quantity of the substance present in a given unit of the pharmaceutical product or manufactured item.
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant

registration number
type: Class
subclass of: clinical trial identifier
subclass of: Restriction
  on property: isRegisteredBy
  some values from: medicines regulatory agency
subclass of: Restriction
  on property: isApplicableInJurisdiction
  some values from: GeographicRegionIdentifier
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, clause 11.4.2.2
definition: identifier assigned to a clinical trial by a medicines regulatory agency in a region for tracking purposes

route of administration
type: Class
subclass of: Specification
subclass of: Restriction
  on property: isSignifiedBy
  on class: route of administration code
  qualified cardinality: 1
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 13, clauses 3.1.76 and 9.8.2.3
definition: specification for the path by which the pharmaceutical product is taken into or makes contact with the body
note: The Route of Administration shall be specified using terms and a term identifiers as defined in ISO 11239, ISO/TS 20440, and its resulting terminology.
has conformance level: ConformanceLevel-Mandatory
adapted from: 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, clauses 10.7 and E.2.4

route of administration code
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Restriction
  on property: denotes
  all values from: route of administration
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, clause 9.9.2.6.3, Figure 14
definition: code for the path by which the pharmaceutical product is taken into or makes contact with the body
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 10.7 and E.2.4
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

scoring
type: Class
subclass of: PhysicalCharacteristic
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  on class: Class
    union of: ManufacturedItem
    union of: package item
    union of: medical device
  min qualified cardinality: 0
definition: classifier for a debossed line that runs across the planar surface of a tablet
note: Scoring is the process of creating a groove or mark on a tablet to facilitate splitting it into equal parts. Scoring can help patients adjust their dosage, reduce costs, or improve swallowing of the tablet. However, scoring also requires careful evaluation and labeling to ensure the safety and efficacy of the drug product.
is encoded as: DatatypeCode-CD
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.6.2.21.12
adapted from: Nomenclature, Labeling, and Data for Evaluation, FDA Guidance for Industry, March 2013.
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

shape
type: Class
subclass of: PhysicalCharacteristic
subclass of: Restriction
  on property: hasTextValue
  min qualified cardinality: 0
  on data range: string
definition: morphological physical characteristic inhering in a bearer by virtue of the bearer's ratios of distances between its features (points, edges, surfaces and also holes etc).
is encoded as: DatatypeCode-ST
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.6.2.21.8

shelf life
type: Class
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  on class: medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: classifies
  on class: package item
  min qualified cardinality: 0
subclass of: Restriction
  on property: has special precautions for storage
  on class: special precautions for storage
  min qualified cardinality: 0
subclass of: Restriction
  on property: has shelf life time period
  some values from: Duration
subclass of: Restriction
  on property: has shelf life type
  some values from: shelf life type
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 11 and clause 9.6.2.11
definition: medicinal product classifier describing the period during which a medicinal product retains its properties and stated performance within specified limits if stored under defined conditions
has conformance level: ConformanceLevel-Conditional
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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.3.7
adapted from: NCI Thesaurus, see https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&version=23.06d&ns=ncit&code=C70855
explanatory note: The stability period is determined from the date the product was manufactured. After the end of the product shelf life it is not to be used. The chemical, physical and microbiological aspects of stability are to be considered for a medical product according to 21 CFR Part 211 GMP
synonym: medical product shelf life
synonym: shelf life / storage
usage note: Note that while the IDMP standard indicates a single value for shelf life type and time period, because shelf life can apply at the individual package item level as well as at the medicinal product level, there may be cases where more than one value is present. Limiting the number of values to one could cause a logical inconsistency in such cases. There may also be multiple sources for codes related to shelf life for a given product that need to be captured, depending on the jurisdiction.

shelf life type
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: shelf life
subclass of: Restriction
  on property: denotes
  all values from: shelf life
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 11 and clause 9.6.2.11
definition: classifier for the period during which a medical product retains its properties and stated performance within specified limits if stored under defined conditions, taking into account various scenarios such as shelf life of the packaged medicinal product itself, shelf life after transformation where necessary, shelf life after first opening of a bottle, etc.
has conformance level: ConformanceLevel-Mandatory
adapted from: 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.3.7
adapted from: NCI Thesaurus, see https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&version=23.06d&ns=ncit&code=C70855
explanatory note: The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

small to medium enterprise
type: Class
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  on class: LegalEntity
  min qualified cardinality: 0
definition: classifier indicating that an entity has been certified based on its size in order to receive authorization for something under special rules
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
abbreviation: SME
adapted from: 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 9.3.2.4

special precautions for storage
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: shelf life
subclass of: Restriction
  on property: denotes
  all values from: shelf life
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 11 and clause 9.6.2.11
definition: classifier describing additional storage conditions for a medicinal product or package item, if any
has conformance level: ConformanceLevel-Optional
adapted from: 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.3.7
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

sponsor
type: Class
subclass of: Actor
subclass of: Restriction
  on property: sponsors
  some values from: clinical trial
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, clause 3.1.78
definition: individual, company, institution or organization (party), which takes responsibility for the initiation, management and/or financing of a clinical trial

strength
type: Class
subclass of: Expression
subclass of: Restriction
  on property: hasDenominator
  on class: Class
    union of: ScalarQuantityValue
    union of: ScalarQuantityValueRange
  qualified cardinality: 1
subclass of: Restriction
  on property: hasNumerator
  on class: Class
    union of: ScalarQuantityValue
    union of: ScalarQuantityValueRange
  qualified cardinality: 1
subclass of: Restriction
  on property: refersTo
  some values from: Substance
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, clause 9.7.2.5.3
definition: quantity or range of quantities of the substance/specified substance present per unitary volume (or mass)
note: For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required.
is encoded as: DatatypeCode-PQ
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
explanatory note: When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified.

symptom/condition/effect classification
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
definition: classifier for the symptom, condition or effect that is undesirable effect
note: The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.4.3 and Figure 14
adapted from: 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 F.2
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

target population
type: Class
subclass of: StatisticalPopulation
subclass of: Restriction
  on property: hasMember
  all values from: PhysicalOrganism
subclass of: Restriction
  on property: has population characteristic
  on class: age population characteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: has population characteristic
  on class: gender population characteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: has population characteristic
  on class: physiological condition population characteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: has population characteristic
  on class: race or ethnicity population characteristic
  min qualified cardinality: 0
subclass of: Restriction
  on property: hasDescription
  min qualified cardinality: 0
  on data range: string
definition: collection of patients or consumers for which the indication of a medicinal product is authorized or is under investigation
has conformance to ISO level: ConformanceToISOLevel-ModelConformant
adapted from: 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, clause 3.1.81
synonym: population specifics

therapeutic indication
type: Class
subclass of: Specification
subclass of: Restriction
  on property: has disease status
  on class: disease status
  max qualified cardinality: 1
subclass of: Restriction
  on property: has indication as disease/symptom/procedure
  on class: indication as 'disease/symptom/procedure'
  max qualified cardinality: 1
subclass of: Restriction
  on property: has intended effect
  on class: intended effect
  max qualified cardinality: 1
subclass of: Restriction
  on property: has timing/duration
  on class: Duration
  max qualified cardinality: 1
subclass of: Restriction
  on property: isApplicableIn
  on class: authorized medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: has comorbidity
  on class: comorbidity
  min qualified cardinality: 0
subclass of: Restriction
  on property: isApplicableIn
  on class: investigational medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: has other therapy specifics
  on class: other therapy specifics
  min qualified cardinality: 0
subclass of: Restriction
  on property: has therapeutic indication text
  on class: therapeutic indication text
  qualified cardinality: 1
subclass of: Restriction
  on property: has target population
  some values from: target population
subclass of: Restriction
  on property: is therapeutic indication for
  some values from: medicinal product
source: indication
definition: specification that defines the target disease or condition for which the medicinal product is authorized or under investigation
adapted from: 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, clauses 3.1.82, 9.9.2.2 and Figure 14
adapted from: 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 F.2
explanatory note: A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease. (EMA)
synonym: indication
usage note: This class shall be used to describe the authorized indication(s) for the medicinal product in accordance with the regulated product information. A region may further refine the requirements in relation to the therapeutic indication(s) information at implementation so that this information is to be specified only if required.

therapeutic indication text
type: Class
subclass of: Document
subclass of: Restriction
  on property: hasTextValue
  on data range: string
  qualified cardinality: 1
definition: textual description of the therapeutic indications of a medicinal product
is encoded as: DatatypeCode-ST
has conformance to ISO level: ConformanceToISOLevel-NameAndAnnotationConformant

therapy
type: Class
subclass of: process
definition: action or administration of therapeutic agents to produce an effect that is intended to alter the course of a pathologic process
has conformance to ISO level: ConformanceToISOLevel-Extension
adapted from: NCI Thesaurus, see the entry for treatment, C15368
synonym: treatment

therapy relationship
type: Class
subclass of: Context
subclass of: Restriction
  on property: isClassifiedBy
  all values from: therapy relationship type
subclass of: Restriction
  on property: appliesTo
  on class: therapy
  min qualified cardinality: 0
definition: relationship that applies to a therapy or therapy specification
adapted from: 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 9.9.2.6.2

therapy relationship type
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  on class: therapy relationship
  min qualified cardinality: 0
definition: classifier for a the relationship to a therapy or therapy specification
note: The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
adapted from: 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 9.9.2.6.2
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

undesirable effect
type: Class
subclass of: Specification
subclass of: Restriction
  on property: has frequency of occurrence
  on class: frequency of occurrence
  max qualified cardinality: 1
subclass of: Restriction
  on property: isApplicableIn
  on class: authorized medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: isApplicableIn
  on class: investigational medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: is undesirable effect of
  on class: medicinal product
  min qualified cardinality: 0
subclass of: Restriction
  on property: has symptom/condition/effect classification
  on class: symptom/condition/effect classification
  min qualified cardinality: 0
subclass of: Restriction
  on property: is undesirable effect of
  on class: therapeutic indication
  min qualified cardinality: 0
subclass of: Restriction
  on property: has undesirable effect as symptom/condition/effect
  on class: undesirable effect as 'symptom/condition/effect'
  min qualified cardinality: 0
subclass of: Restriction
  on property: has undesirable effect text
  on class: undesirable effect text
  qualified cardinality: 1
subclass of: Restriction
  on property: has target population
  some values from: target population
definition: specification of any potential undesirable side effect, adverse reaction or event, complication, or other similar potential consequence associated with the medicinal product as authorized or under investigation
adapted from: 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, clauses 3.1.82, 9.9.2.2 and Figure 14
adapted from: 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 F.2

undesirable effect as 'symptom/condition/effect'
type: Class
subclass of: ISO21090-ConceptDescriptor
subclass of: Classifier
subclass of: Restriction
  on property: classifies
  all values from: medical condition
subclass of: Restriction
  on property: denotes
  all values from: medical condition
definition: classifier for symptoms, conditions or effects from medical terminology that is used for, but not limited to, the registration, documentation and safety monitoring of medicinal products
note: Classifiers for medical conditions are defined in controlled vocabularies such as SNOMED-CT or MedDRA.
note: The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 3.1.82, 9.9.2.4.3 and Figure 14
adapted from: 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 F.2
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

undesirable effect text
type: Class
subclass of: Document
subclass of: Restriction
  on property: hasTextValue
  on data range: string
  qualified cardinality: 1
definition: textual description of an undesirable effect of a medicinal product

validity period
type: Class
subclass of: ExplicitDatePeriod
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, clause 9.3.1 and Figure 7
source: ISO/TS 20443:2017(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 B.2.4
definition: explicit time period of the marketing authorization for the relevant status
has conformance level: ConformanceLevel-Mandatory

volume characteristic
type: Class
subclass of: PhysicalCharacteristic
subclass of: Restriction
  on property: hasQuantityValue
  on class: ScalarQuantityValue
  max qualified cardinality: 1
definition: 3-D extent physical characteristic inhering in a bearer by virtue of the bearer's amount of 3-dimensional space it occupies
is encoded as: DatatypeCode-PQ
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.6.2.21.6
synonym: volume

weight characteristic
type: Class
subclass of: PhysicalCharacteristic
subclass of: Restriction
  on property: hasQuantityValue
  on class: ScalarQuantityValue
  max qualified cardinality: 1
definition: physical characteristic inhering in a bearer that has mass near a gravitational body
is encoded as: DatatypeCode-PQ
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.6.2.21.5
synonym: weight

width characteristic
type: Class
subclass of: PhysicalCharacteristic
subclass of: Restriction
  on property: hasQuantityValue
  on class: ScalarQuantityValue
  max qualified cardinality: 1
definition: 1-D extent physical characteristic which is equal to the distance from one side of an object to another side which is opposite
is encoded as: DatatypeCode-PQ
has conformance to ISO level: ConformanceToISOLevel-DefinitionallyConformant
adapted from: 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 9.6.2.21.3
synonym: width

administers
type: ObjectProperty
sub property of: provides
range: medicinal product
inverse of: is administered by
definition: indicates a medicinal product that is administered by some party, such as a clinician

authorizes
type: ObjectProperty
sub property of: actsOn
domain: authorizing party
range: authorized party
inverse of: is authorized by
definition: endorses, enables, empowers, or gives permission to

authorizes manufacturing at
type: ObjectProperty
sub property of: appliesTo
domain: manufacturing authorization
range: manufacturing or business operation
definition: gives permission to manufacture at

authorizes manufacturing of
type: ObjectProperty
sub property of: appliesTo
domain: manufacturing authorization
range: medicinal product
definition: gives permission to manufacture

authorizes marketing of
type: ObjectProperty
sub property of: appliesTo
domain: marketing authorization
range: medicinal product
definition: gives permission to manufacture

authorizes through
type: ObjectProperty
sub property of: actsIn
domain: authorizing party
range: authorization
inverse of: has authorizing party
definition: indicates the situation that facilitates designation of an authorized party by the authorizing party for some purpose

contains
type: ObjectProperty
type: TransitiveProperty
sub property of: hasPart
domain: container specification
inverse of: is contained in
definition: is specified to hold within its volume or area

evaluates
type: ObjectProperty
sub property of: appliesTo
inverse of: is evaluated by
definition: assesses the nature, quality, or ability of someone or something

has active ingredient
type: ObjectProperty
sub property of: hasIngredient
range: ActiveIngredient
definition: relates something representing the constituents of a pharmaceutical or medicinal product to something in the role of an active ingredient

has attached document
type: ObjectProperty
sub property of: refersTo
range: attached document
definition: indicates a reference document that is specifically associated with a pharmaceutical or medicinal product

has authorization
type: ObjectProperty
sub property of: isApplicableIn
range: authorization
definition: relates a medicinal product to a specific authorization (manufacturing or marketing) in some jurisdiction

has authorization procedure
type: ObjectProperty
sub property of: refersTo
label: has authorisation procedure
domain: marketing authorization
range: marketing authorization procedure
definition: indicates the regulatory procedure applied to grant or amend a marketing authorization for a medicinal product
note: A region may further refine the requirements in relation to the marketing authorization procedure (and the associated marketing authorization application) at implementation such that this information is to be specified only if required.
has conformance level: ConformanceLevel-Mandatory
adapted from: 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, clause 9.3.2.6
adapted from: 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 B.2.15

has authorization status
type: ObjectProperty
sub property of: isClassifiedBy
label: has authorisation status
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, clause 9.3.1 and Figure 7
source: ISO/TS 20443:2017(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 B.2.4
domain: marketing authorization
range: authorization status
definition: indicates the status of a marketing authorization as of a particular point in the lifecycle of a medicinal product depending on the regulatory process applicable in a region

has authorization status date
type: DatatypeProperty
sub property of: hasObservedDateTime
label: has authorisation status date
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, clause 9.3.1 and Figure 7
source: ISO/TS 20443:2017(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, clauses B.2.4 and B.2.5
range: CombinedDateTime
definition: indicates the date at which the given status has become applicable
has conformance level: ConformanceLevel-Mandatory
explanatory note: The date shall be specified using the ISO 8601 date format. ISO 8601 can accommodate year and month should day of the month not be known. (i.e., YYYY-MM).

has authorized party
type: ObjectProperty
sub property of: hasUndergoer
domain: authorization
range: authorized party
inverse of: is authorized through
definition: indicates the party that is endorsed, enabled, empowered, or otherwise permitted to do something in the situation

has authorizing party
type: ObjectProperty
sub property of: hasActor
domain: authorization
range: authorizing party
definition: indicates the party that endorses, enables, empowers, or gives permission in the situation

has basis of strength
type: ObjectProperty
sub property of: isRelatedTo
range: Substance
definition: relates a pharmaceutical or medicinal product to a substance that is its basis of strength

has basis of strength as manufactured
type: ObjectProperty
sub property of: has active ingredient
definition: indicates the role of an active ingredient as the basis of strength of any substance or pharmaceutical product as manufactured

has color
type: ObjectProperty
sub property of: has physical characteristic
range: color characteristic
definition: specifies the color of some material
adapted from: 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 9.6.2.21.8

has comorbidity
type: ObjectProperty
sub property of: isClassifiedBy
domain: Class
  union of: contraindication
  union of: therapeutic indication
range: comorbidity
definition: any comorbidity (concurrent condition) or co-infection described as part of the indication or contraindication as it is referenced in the regulated product information
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.2.5, 9.9.2.2.3.5 and Figure 14
adapted from: 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 F.2

has company name part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.12
source: 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.2.13.11
domain: medicinal product name
definition: provides information regarding any trademark or company name component if included in the medicinal product name
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP
synonym: trademark or company name part

has condition to restore comment
type: DatatypeProperty
sub property of: hasComment
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 7 and clause 9.3.2.9.8
source: 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 B.2.19.7
domain: marketing status reason
definition: provides any additional comments on the condition to restore the marketing or the marketing authorization of the product
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ST

has confidentiality indicator
type: ObjectProperty
sub property of: isClassifiedBy
definition: relates information about a specified substance, an organization, a manufacturing or business operation, or a contact to a classifier describing the level of confidentiality associated with information about it
note: The confidentiality level can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.4.2.2.5, 9.4.2.4.5, 9.5.2.3.5, and 9.7.2.2.4, and Figures 8, 10 and 12
adapted from: 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, clauses D.2.5.3, G.2.4, G.2.6.4, and H.2.1.4

has container part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.10
source: 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.2.13.9
domain: medicinal product name
definition: provides information regarding the container or pack component if included in the medicinal product name
example: Vial (glass) – 4 ml – 1 Vial, Titration Pack, Multidose Vial
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP
synonym: container or pack part

has contraindication
type: ObjectProperty
sub property of: isSpecifiedIn
range: contraindication
inverse of: is contraindication for
definition: relates a product to a situation wherein the medicinal product shall not be given for safety reasons
adapted from: 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, clauses 3.1.17, 9.9.2.3.3

has contraindication as disease/symptom/procedure
type: ObjectProperty
sub property of: isClassifiedBy
domain: contraindication
definition: relates the contraindication to a classifier / code for medical terminology that is used for, but not limited to, the registration, documentation and safety monitoring of medicinal products
note: Classifiers for medical conditions are defined in controlled vocabularies such as SNOMED-CT or MedDRA.
note: The underlying disease, symptom or procedure of the contraindication should be specified as it is referenced in the regulated product information using an appropriate controlled reference terminology. The controlled term and the controlled term identifier should be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 3.1.82, 9.9.2.3.3 and Figure 14
adapted from: 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 F.2
synonym: contraindication as 'disease/symptom/procedure'

has contraindication text
type: ObjectProperty
sub property of: isDescribedBy
domain: contraindication
range: contraindication text
definition: description of the contraindication(s) in line with the regulated product information as text
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-ST
adapted from: 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 9.9.2.3.2 and Figure 14
adapted from: 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 F.3.1

has data exclusivity period
type: ObjectProperty
sub property of: hasDatePeriod
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, clause 9.3.1 and Figure 7
source: ISO/TS 20443:2017(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 B.2.4
domain: marketing authorization
range: data exclusivity period
definition: indicates an explicit time period from initial authorization of the reference product granting exclusivity for a given marketing authorization
has conformance level: ConformanceLevel-Conditional

has date of first authorization
type: ObjectProperty
sub property of: hasExplicitDate
label: has date of first authorisation
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, clause 9.3.1 and Figure 7
source: ISO/TS 20443:2017(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 B.2.10
range: ExplicitDate
definition: indicates the date when the first authorization was granted by the authorizing body
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-TS
explanatory note: The date shall be specified using the ISO 8601 date format. ISO 8601 can accommodate year and month should day of the month not be known. (i.e., YYYY-MM).

has defining strength
type: ObjectProperty
sub property of: hasExpression
range: strength
definition: specifies the strength of any element in a substance or pharmaceutical product

has delimiter part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.15
source: 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.2.13.14
domain: medicinal product name
definition: provides a delimiter that separates one composite in a segment from another, or separates one sub-composite from another
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP

has depth
type: ObjectProperty
sub property of: has physical characteristic
range: depth characteristic
definition: specifies the depth of some material
adapted from: 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 9.6.2.21.4

has device part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.11
source: 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.2.13.10
domain: medicinal product name
definition: provides information regarding any device component of the product, if included in the medicinal product name
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP

has disease status
type: ObjectProperty
sub property of: isClassifiedBy
domain: Class
  union of: contraindication
  union of: therapeutic indication
definition: status of the disease or symptom of the indication or contraindication
note: The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier should be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.2.4, 9.9.2.3.4 and Figure 14
adapted from: 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 F.2

has dose form
type: ObjectProperty
sub property of: specifies
range: pharmaceutical dose form
definition: specifies the physical manifestation of a manufactured item or pharmaceutical product containing the active ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient
adapted from: 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 3.1.24

has expiration date
type: ObjectProperty
sub property of: hasEndDate
sub property of: hasExplicitDate
range: ExplicitDate
definition: links something, such as an agreement, contract, report, other document, or perishable item, with a date beyond which it is no longer valid

has external diameter
type: ObjectProperty
sub property of: has physical characteristic
range: diameter characteristic
definition: specifies the diameter of some material measured from the outside
adapted from: 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 9.6.2.21.7

has flavor part
type: DatatypeProperty
sub property of: hasTextualName
label: has flavour part
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 9.2.2.8.14
source: 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.2.13.13
domain: medicinal product name
definition: provides the flavor component, if reflected in the medicinal product name
example: Orange Flavour
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP

has formulation part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.7
source: 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.2.13.6
domain: medicinal product name
definition: provides information regarding the formulation of the product, if included in the medicinal product name
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP

has frequency of occurrence
type: ObjectProperty
sub property of: isClassifiedBy
domain: undesirable effect
range: frequency of occurrence
definition: relates the undesirable effect to a classifier / code for medical terminology that is used for, but not limited to, the registration, documentation and safety monitoring of medicinal products, that indicates how often the undesirable effect occurs
note: The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.4.5 and Figure 14
adapted from: 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 F.4.4

has full medicinal product name
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.2
source: 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.2.13.1
domain: medicinal product name
definition: provides the full and complete medicinal product name as approved by the medicines regulatory agency in a region, as text
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-ST
explanatory note: The main brand name, or generic name is provided without name part tags. Additional name parts may be added as prefixes or suffixes to the main name.
synonym: has full name

has height
type: ObjectProperty
sub property of: has physical characteristic
range: height characteristic
definition: specifies the height of some material
adapted from: 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 9.6.2.21.2

has image
type: ObjectProperty
sub property of: isDescribedBy
range: image
definition: refers to an image of some material
adapted from: 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 9.6.2.21.8

has imprint
type: ObjectProperty
sub property of: has physical characteristic
range: imprint
definition: specifies an imprint on the surface of some material
adapted from: 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 9.6.2.21.8

has indication as disease/symptom/procedure
type: ObjectProperty
sub property of: isClassifiedBy
domain: therapeutic indication
definition: relates the therapeutic indication to a classifier / code for medical terminology that is used for, but not limited to, the registration, documentation and safety monitoring of medicinal products
example: MedDRA term 10002383 for "stable angina pectoris"
example: SNOMED CT term 233819005 for "stable angina"
note: Classifiers for medical conditions are defined in controlled vocabularies such as SNOMED-CT or MedDRA.
note: The underlying disease, symptom or procedure that is the indication for treatment should be specified as it is referenced in the regulated product information using an appropriate controlled reference terminology. The controlled term and the controlled term identifier should be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 3.1.82, 9.9.2.2.3 and Figure 14
adapted from: 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 F.2
synonym: indication as 'disease/symptom/procedure'

has intended effect
type: ObjectProperty
sub property of: isClassifiedBy
domain: therapeutic indication
range: intended effect
definition: specifies a classifier for the type of outcome or result intended for the target condition
note: The intended effect can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier should be specified. The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population.
note: The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.2.6 and Figure 14
adapted from: 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 F.2

has intended use part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.8
source: 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.2.13.7
domain: medicinal product name
definition: provides information regarding the intended use of the product, if included in the medicinal product name
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP

has interaction
type: ObjectProperty
sub property of: isSpecifiedIn
range: interaction
inverse of: is interaction for
definition: relates a product to a change in the effect of a medicinal product when it is taken with another substance, such as another medicinal product, food, alcohol, or herbal product
adapted from: 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 9.9.2.7
adapted from: 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 F.5

has interaction text
type: ObjectProperty
sub property of: isDescribedBy
domain: interaction
range: interaction text
definition: provides a description of the interaction in accordance with the regulated product information
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-ST
adapted from: 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 9.9.2.7
adapted from: 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 F.5

has international birth date
type: ObjectProperty
sub property of: hasExplicitDate
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, clause 9.3.1 and Figure 7
source: ISO/TS 20443:2017(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 B.2.11
range: ExplicitDate
definition: indicates the date of the first marketing authorization for any product containing the active substance granted to any company in any country in the world
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-TS

has invented name part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.3
source: 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.2.13.2
domain: medicinal product name
definition: provides the invented name of the medicinal product without the trademark or any other similar designations reflected in the full medicinal product name
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP
synonym: has invented name
synonym: has trade name

has legal grounds comment
type: DatatypeProperty
sub property of: hasComment
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 7 and clause 9.3.2.9.5
source: 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 B.2.19.4
domain: marketing status reason
definition: provides any additional description of the action taken on the marketing or on the marketing authorization
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ST

has manufactured item quantity
type: ObjectProperty
sub property of: hasQuantityValue
source: 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, clauses C.3.13.3
definition: indicates the number/quantity of manufactured items in the immediate container of a packaged medicinal product
note: It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240/TS 20440 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be 'unit' and the 'unit of presentation' shall be the item that is counted within the immediate container.
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-PQ
adapted from: 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 and clause 9.6.2.11

has marketing start date
type: ObjectProperty
sub property of: hasExplicitDate
sub property of: hasStartDate
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, clauses 3.1.44 and 9.3.2.8.5, and Figure 7
source: ISO/TS 20443:2017(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 B.2.18.4
range: ExplicitDate
definition: indicates the date when the authorized medicinal product is marketed in a region
note: 'Placed on the market' refers to the release of the medicinal product into the distribution chain.
note: Marketing date(s) refers to each instance of a packaged medicinal product (PCID level).
note: The date of actual marketing of a medicinal product is always after a marketing authorization has been granted by a medicines regulatory agency.
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-TS
explanatory note: The date when the medicinal product is placed on the market by the marketing authorization holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

has marketing stop date
type: ObjectProperty
sub property of: hasEndDate
sub property of: hasExplicitDate
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, clauses 3.1.45 and 9.3.2.8.5, and Figure 7
source: ISO/TS 20443:2017(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 B.2.18.4
range: ExplicitDate
definition: indicates when the marketing of the authorized medicinal product is stopped in a region
note: 'No longer available on the market' can refer to the fact that the marketing authorization holder has taken a decision to no longer market the medicinal product or that the marketing authorization is no longer valid.
note: Marketing date(s) refers to each instance of a packaged medicinal product (PCID level).
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-TS
explanatory note: The date when the medicinal product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

has medication
type: ObjectProperty
sub property of: isSpecifiedIn
range: Class
  union of: medication classifier
  union of: medication
definition: relates to a medication or class of medications
adapted from: 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 9.9.2.6.3

has nominal volume
type: ObjectProperty
sub property of: has physical characteristic
range: volume characteristic
definition: specifies the nominal volume of some material
adapted from: 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 9.6.2.21.6

has other characteristic
type: ObjectProperty
sub property of: isCharacterizedBy
domain: Class
  union of: MaterialSpecification
  union of: ManufacturedItem
range: other product characteristic
definition: specifies a characteristic of some specification for a manufactured item, package item, or device that is not explicitly a defined physical characteristic
note: This can be anything per subject matter expert discussions.
has conformance to ISO level: ConformanceToISOLevel-NonConformant
adapted from: 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 9.6.2.22

has other therapy specifics
type: ObjectProperty
sub property of: isSpecifiedIn
range: other therapy specifics
inverse of: is other therapy specifics of
definition: relates a therapeutic indication or contraindication to the specifics of another related therapy
adapted from: 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 9.9.2.6

has package component
type: ObjectProperty
sub property of: hasPart
domain: package item
range: package component
definition: relates a package item to a one of its components
adapted from: 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 11

has package item quantity
type: ObjectProperty
sub property of: hasQuantityValue
definition: indicates the number/quantity of items of the same type in a container
adapted from: 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, Annex A, Full Model

has package item type
type: ObjectProperty
sub property of: isClassifiedBy
range: package item type
definition: relates a package item to its type of container

has pharmaceutical dose form part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.6
source: 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.2.13.5
domain: medicinal product name
definition: provides dose form information, which may or may not be the same as is specified for the administrable and manufactured dose forms for the product
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP
explanatory note: The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO/TS 20443.

has physical characteristic
type: ObjectProperty
sub property of: isCharacterizedBy
domain: Class
  union of: container specification
  union of: MaterialSpecification
  union of: product specification
  union of: Material
range: PhysicalCharacteristic
definition: specifies a physical characteristic of some specification for a container, product or material, or of actual physical material
has conformance to ISO level: ConformanceToISOLevel-NonConformant
adapted from: 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 9.6.2.20

has population characteristic
type: ObjectProperty
sub property of: isClassifiedBy
range: population characteristic
definition: relates a target population to classifiers that narrow down the population to a specific subset

hasPopulationClassifiedBy
type: ObjectProperty
deprecated: true
equivalent property: isClassifiedBy

has reference ingredient role
type: ObjectProperty
sub property of: hasRole
range: SubstanceRole
definition: indicates a role that the reference substance of an active ingredient in a pharmaceutical or medicinal product plays under certain circumstances

has reference strength
type: ObjectProperty
sub property of: has strength
range: reference strength
definition: indicates the reference strength for the reference substance of an active ingredient in a pharmaceutical or medicinal product

has reference substance
type: ObjectProperty
sub property of: has basis of strength
range: Class
  union of: Moiety
  union of: Substance
  union of: PhysicalSubstance
definition: relates a substance in the role of an active ingredient in a pharmaceutical or medicinal product to a reference substance that is its underlying basis of strength

has restore date
type: ObjectProperty
sub property of: hasExplicitDate
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 7 and clause 9.3.2.9.6
source: 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 B.2.19.5
domain: marketing status reason
range: ExplicitDate
definition: indicates the date when the marketing or the marketing authorization of the product is anticipated to be restored
example: the date of the lift of the marketing authorization suspension
note: A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.
has conformance level: ConformanceLevel-Optional
is encoded as: DatatypeCode-TS

has risk of supply shortage
type: DatatypeProperty
type: FunctionalProperty
sub property of: hasBooleanValue
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, clause 9.3.2.8.7 and Figure 7
source: 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 B.2.18.5
domain: marketing status record
range: boolean
definition: indicates whether there is a risk of a product shortage in a region
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-BL

has risk of supply shortage comment
type: DatatypeProperty
sub property of: hasComment
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 7 and clause 9.3.2.8.8
source: 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 B.2.18.6
domain: marketing status record
definition: provides any additional comments on drug supply shortage
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ST

has route of administration
type: ObjectProperty
sub property of: specifies
range: route of administration
definition: specifies the path by which the pharmaceutical product is taken into or makes contact with the body
adapted from: 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 3.1.76

has scientific name part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.4
source: 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.2.13.3
domain: medicinal product name
definition: provides the scientific or common (i.e. generic) name of the medicinal product without any other descriptors
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP
synonym: has generic name
synonym: has scientific name

has scoring
type: ObjectProperty
sub property of: has physical characteristic
range: scoring
definition: refers to a scoring of some material
adapted from: 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 9.6.2.21.8

has shape
type: ObjectProperty
sub property of: has physical characteristic
range: shape
definition: specifies the shape of some material
adapted from: 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 9.6.2.21.8

has shelf life
type: ObjectProperty
sub property of: isClassifiedBy
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 11 and clause 9.6.2.11
range: shelf life
definition: indicates the period during which a medicinal product or package item retains its properties and stated performance within specified limits if stored under defined conditions
has conformance level: ConformanceLevel-Conditional
adapted from: 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.3.7
adapted from: NCI Thesaurus, see https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&version=23.06d&ns=ncit&code=C70855

has shelf life time period
type: ObjectProperty
sub property of: hasDuration
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 11 and clause 9.6.2.11
domain: shelf life
range: Duration
definition: period during which a medicinal product retains its properties and stated performance within specified limits if stored under defined conditions
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-PQ
adapted from: 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.3.7
adapted from: NCI Thesaurus, see https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&version=23.06d&ns=ncit&code=C70855

has shelf life type
type: ObjectProperty
sub property of: isClassifiedBy
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 11 and clause 9.6.2.11
range: shelf life type
definition: classifies the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc.
has conformance level: ConformanceLevel-Conditional
adapted from: 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

has special measures
type: DatatypeProperty
sub property of: hasTextValue
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
domain: medicinal product
definition: indicates whether a medicinal product is subject to specific special measures
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ST
adapted from: 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
usage note: No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.

has special precautions for storage
type: ObjectProperty
sub property of: isClassifiedBy
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 11 and clause 9.6.2.11
domain: shelf life
definition: indicates additional storage conditions for a the shelf life, if any
has conformance level: ConformanceLevel-Optional
adapted from: 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.3.7

has sponsor
type: ObjectProperty
sub property of: hasActor
domain: clinical trial
range: sponsor
inverse of: sponsors
definition: indicates the party that initiates, manages, and/or finances the clinical trial
adapted from: 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 3.1.78

has status reason comment
type: DatatypeProperty
sub property of: hasComment
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 7 and clause 9.3.2.9.3
source: 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 B.2.19.2
domain: marketing status reason
definition: provides any additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorization
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ST
synonym: has reason comment

has strength
type: ObjectProperty
sub property of: hasExpression
range: strength
definition: indicates the actual strength of any element in a substance or pharmaceutical product

has strength name part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.5
source: 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.2.13.4
domain: medicinal product name
definition: provides the strength, if reflected in the medicinal product name
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP
explanatory note: This strength name part can differ from the concept of 'Strength'.

has symptom/condition/effect classification
type: ObjectProperty
sub property of: isClassifiedBy
domain: undesirable effect
definition: relates the undesirable effect to a classifier / code for medical terminology that is used for, but not limited to, the registration, documentation and safety monitoring of medicinal products
note: The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.4.4 and Figure 14
adapted from: 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 F.2
synonym: undesirable effect as 'symptom/condition/effect'

has target population
type: ObjectProperty
sub property of: specifies
domain: Class
  union of: contraindication
  union of: therapeutic indication
  union of: undesirable effect
range: target population
definition: relates a therapeutic indication or contraindication to its the target population
adapted from: 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 9.9.2.5

has target population part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.9
source: 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.2.13.8
domain: medicinal product name
definition: provides information regarding the target population for the product, if included in the medicinal product name
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP

has therapeutic indication
type: ObjectProperty
sub property of: isSpecifiedIn
range: therapeutic indication
inverse of: is therapeutic indication for
definition: relates a pharmaceutical product to a therapeutic indication that type of medical conditions where the treatment with the medicinal product is adviced
note: indication as "Disease / Symptom / Procedure"

has therapeutic indication text
type: ObjectProperty
sub property of: isDescribedBy
domain: therapeutic indication
range: therapeutic indication text
definition: relates a therapeutic indication to its the textual description
has conformance level: ConformanceLevel-Mandatory
adapted from: 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 9.9.2.2.2 and Figure 14
adapted from: 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 F.2.1
synonym: indication text

has therapy relationship type
type: ObjectProperty
sub property of: isSpecifiedIn
range: therapy relationship type
definition: relates to a classifier of a therapy relationship
adapted from: 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 9.9.2.6.2

has time period part
type: DatatypeProperty
sub property of: hasTextualName
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 9.2.2.8.13
source: 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.2.13.12
domain: medicinal product name
definition: provides the time/period component of the medicinal product name
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-ENXP

has timing/duration
type: ObjectProperty
sub property of: hasDuration
domain: therapeutic indication
range: Duration
definition: timing or duration information described as part of the indication
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-PQ
adapted from: 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 9.9.2.2.7 and Figure 14
adapted from: 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 F.2.6

has undesirable effect
type: ObjectProperty
sub property of: isSpecifiedIn
range: undesirable effect
inverse of: is undesirable effect of
definition: relates a medicinal product to undesirable effects that the the medicinal product has on a target population or therapeutic indication
adapted from: 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, clauses 3.1.17, 9.9.2.4.1

has undesirable effect as symptom/condition/effect
type: ObjectProperty
sub property of: isClassifiedBy
domain: undesirable effect
definition: relates the undesirable effect to a classifier / code for medical terminology that is used for, but not limited to, the registration, documentation and safety monitoring of medicinal products
note: Classifiers for medical conditions are defined in controlled vocabularies such as SNOMED-CT or MedDRA.
note: The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-CD
adapted from: 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, clauses 9.9.2.4.3 and Figure 14
adapted from: 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 F.2
synonym: undesirable effect as 'symptom/condition/effect'

has undesirable effect text
type: ObjectProperty
sub property of: isDescribedBy
domain: undesirable effect
range: undesirable effect text
definition: description of an undesirable effect in line with the regulated product information as text
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-ST
adapted from: 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 9.9.2.4.2 and Figure 14
adapted from: 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 F.3.1

has weight
type: ObjectProperty
sub property of: has physical characteristic
range: weight characteristic
definition: specifies the weight of some material
adapted from: 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 9.6.2.21.5

has width
type: ObjectProperty
sub property of: has physical characteristic
range: width characteristic
definition: specifies the width of some material
adapted from: 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 9.6.2.21.3

immediately contains
type: ObjectProperty
sub property of: contains
sub property of: hasDirectPart
domain: container specification
inverse of: is immediately contained in
definition: is specified to hold within its volume or area and to be in direct contact with
adapted from: 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, clause 3.1.27

is administered by
type: ObjectProperty
sub property of: isProvidedBy
domain: medicinal product
definition: indicates a party, such as a clinician, that administers some medicinal product

is administered in
type: ObjectProperty
sub property of: isObjectRoleIn
domain: investigational medicinal product
range: clinical trial
inverse of: manages administration of
definition: indicates a clinical trial in which a given investigational medicinal product is administered

is allergenic
type: DatatypeProperty
type: FunctionalProperty
sub property of: hasBooleanValue
source: 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, clauses C.3.16.3 and D.2.2
range: boolean
definition: is a device that contains allergens and/or materials of concern or ingredient that is a known or suspected allergen
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-BL
adapted from: 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 9.7.2.2.3

is applicable in country
type: ObjectProperty
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, clause 9.3.2.8.2 and Figure 7
source: ISO/TS 20443:2017(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 B.2.10
property chain axiom: hasCountry
property chain axiom: isIdentifiedBy
definition: relates something, such as a marketing authorization or related status, country in which authorization has been granted or in which the status applies
note: The country in which the marketing activity is undertaken shall be specified. It should be specified using the ISO 3166-1 alpha-2 codes.
has conformance level: ConformanceLevel-Mandatory
is encoded as: DatatypeCode-CD
usage note: Note that the valid values for this property are limited to countries and do not include country subdivisions (or other jurisdictions specified using another controlled vocabulary) or multinational regions such as the European Union. While in some cases the standard calls for use of the code 'EU' for the European Union, it mistakenly says that 'EU' is allocated as a code in ISO 3166 when in fact it is not.

is authorized by
type: ObjectProperty
sub property of: isAffectedBy
domain: authorized party
range: authorizing party
definition: is endorsed, enabled, empowered, or otherwise permitted by

is authorized for manufacturing through
type: ObjectProperty
sub property of: has authorization
domain: medicinal product
range: manufacturing authorization
inverse of: authorizes manufacturing of
definition: relates a medicinal product to its manufacturing authorization(s)

is authorized for marketing through
type: ObjectProperty
sub property of: has authorization
domain: medicinal product
range: marketing authorization
inverse of: authorizes marketing of
definition: relates a medicinal product to its marketing authorization(s)

is authorized through
type: ObjectProperty
sub property of: undergoes
domain: authorized party
range: authorization
definition: indicates the situation that facilitates endorsement of the authorized party for some purpose

is authorized to manufacture
type: ObjectProperty
sub property of: isApplicableIn
domain: manufacturing or business operation
range: medicinal product
definition: has permission to manufacture

is characterized by manufactured item
type: ObjectProperty
sub property of: isCharacterizedBy
domain: container constituent
range: ManufacturedItem
definition: relates the container constituent to its manufactured item
example: A blister contains 20 tablets. One container constituent of the blister has the quantity of 10 tablets (units) chracterized by the tablet manufactured item.

is characterized by package item
type: ObjectProperty
sub property of: isCharacterizedBy
domain: container constituent
range: package item
definition: relates the container constituent to its package item
example: A box contains 5 blisters. One container constituent of the box has the quantity of 5 blisters (units) characterized by a blister package item.

is contained in
type: ObjectProperty
type: TransitiveProperty
sub property of: isPartOf
range: container specification
definition: is held within

is contraindication for
type: ObjectProperty
sub property of: specifies
domain: contraindication
definition: inverse of has contraindication

is defined as potentially allergenic
type: DatatypeProperty
type: FunctionalProperty
sub property of: hasBooleanValue
source: 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, clauses C.3.16.3 and D.2.2
range: boolean
definition: is a specification for a device that may contain allergens and/or materials of concern or ingredient that may include a known or suspected allergen
has conformance level: ConformanceLevel-Conditional
is encoded as: DatatypeCode-BL
adapted from: 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 9.7.2.2.3

is evaluated by
type: ObjectProperty
sub property of: isApplicableIn
definition: is ascertained or determined by

is immediately contained in
type: ObjectProperty
sub property of: is contained in
sub property of: isDirectPartOf
range: container specification
definition: is specified to hold within its volume or area and be in direct contact with

is input to
type: ObjectProperty
sub property of: isRelatedTo
definition: is put in, taken in, or operated on by

is interaction for
type: ObjectProperty
sub property of: specifies
domain: interaction
definition: inverse of has interaction

is other therapy specifics of
type: ObjectProperty
sub property of: specifies
domain: other therapy specifics
definition: relates the specifics of another therapy to a therapeutic indication or contraindication
adapted from: 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 9.9.2.6

is output of
type: ObjectProperty
sub property of: isRelatedTo
definition: is produced by or results from some process, process step, action, activity, or other effort

is package component of
type: ObjectProperty
sub property of: isPartOf
inverse of: has package component
definition: relates a package component to the package item that it is part of
adapted from: 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 11

is produced at manufacturing site
type: ObjectProperty
property chain axiom: isProducedBy
property chain axiom: manages
property chain axiom: isSituatedAt
definition: relates a substance, manufactured item, medicinal product, or pharmaceutical product to a manufacturing site where it is produced

is produced by manufacturing operation
type: ObjectProperty
property chain axiom: isProducedBy
property chain axiom: manages
definition: relates a substance, manufactured item, medicinal product, or pharmaceutical product to a manufacturing operation that produces it

is therapeutic indication for
type: ObjectProperty
sub property of: specifies
domain: therapeutic indication
definition: inverse of has therapeutic indication

is undesirable effect of
type: ObjectProperty
sub property of: specifies
domain: undesirable effect
definition: inverse of has undesirable effect

manages administration of
type: ObjectProperty
sub property of: hasObjectRole
domain: clinical trial
range: investigational medicinal product
definition: indicates an investigational medicinal product that is administered in the context of a clinical trial

manufactures at site
type: ObjectProperty
property chain axiom: manages
property chain axiom: isSituatedAt
definition: relates a manufacturer to a site at which it, or a delegated third party, conducts manufacturing

manufactures in region
type: ObjectProperty
property chain axiom: is authorized through
property chain axiom: isApplicableIn
definition: relates a manufacturer to a region in which it is authorized to manufacture something

sponsors
type: ObjectProperty
sub property of: actsIn
domain: sponsor
range: clinical trial
definition: indicates the clinical trial that an individual, company, institution or organization (party), initiates, manages and/or finances
adapted from: 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 3.1.78

LegalEntity
type: Class
subclass of: Restriction
  on property: has confidentiality indicator
  on class: confidentiality indicator
  max qualified cardinality: 1
subclass of: Restriction
  on property: isClassifiedBy
  on class: small to medium enterprise
  max qualified cardinality: 1
note: The confidentiality level of the organization information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified.
adapted from: 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 9.4.2.2.5

Axiom
annotated property: subClassOf
annotated source: batch number
annotated target: Restriction
  on property: denotes
  some values from: batch
has data support: false

Axiom
annotated property: subClassOf
annotated source: lot number
annotated target: Restriction
  on property: denotes
  some values from: lot
has data support: false

Axiom
annotated property: subClassOf
annotated source: process identifier
annotated target: Restriction
  on property: denotes
  some values from: process
has data support: false

Axiom
annotated property: subClassOf
annotated source: process step identifier
annotated target: Restriction
  on property: denotes
  some values from: process step
has data support: false