ISO 11615 Regulated Medicinal Product Information Ontology
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.
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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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).
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).
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)
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.
Copyright (c) 2022-2024 EDM Council, Inc.
Copyright (c) 2022-2024 Pistoia Alliance, Inc.
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
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
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
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.
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 that because a manufactured item might be some sort of container or other package item, the dose form is optional.
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
manufacturer / establishment (organisation)
manufacturer / establishment (organization)
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.
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
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
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
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
For example, 287 mg amoxicillin trihydrate equivalent to 250 mg anhydrous amoxicillin.
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
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
For example, propranolol hydrochloride quantified as the propranolol hydrochloride salt.
active ingredient reference substance basis of strength
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
For example, metoprolol succinate quantified by amount of metoprolol tartrate with the equal amount of metoprolol active moiety.
active ingredient without basis of strength
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
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
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
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
Administered dose form and pharmaceutical administrable dose form are synonyms of administrable dose form.
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).
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
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
No controlled vocabulary is defined in either ISO 11615 or the ISO/TS 20443 implementation guide.
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
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
qualitative classifier for a range of ages, specified in terms of a controlled vocabulary
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.
classifier for a statistical population based on the age of its members
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.
The age is either expressed as an explicit range of ages or by an age classifier from a controlled vocabulary.
time quantity value range expressing the upper and lower bounds amount of time passed since creation of something
time quantity value expressing the amount of time passed since creation of something
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
document officially submitted to a medicines regulatory agency
authorisation
authorization
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
authorisation status
authorization status
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
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
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
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.
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.
authorisation status code
authorization status code
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
authorised medicinal product
authorized medicinal product
role of a medicinal product that has been authorized for some purpose in some jurisdiction
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.
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
authorised party
authorized party
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
authorising party
authorizing party
party that delegates some role, authority, capability, or control to another party
ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6)
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
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.
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.
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
ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.8)
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
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).
Batch processes are discontinuous processes, which are neither discrete nor continuous but have characteristics of both.
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
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
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
change request organisation type
change request organization type
sequence of characters denoting the nature of the organization that triggered the legal action taken on the marketing or on the marketing authorization
marketing authorization revoked by the competent authority, marketing authorization not renewed by the MAH
The controlled term and the controlled term identifier shall be specified.
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
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
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
National Cancer Institute Thesaurus, see http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C71104
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
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.
clinical trial authorisation
clinical trial authorization
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
approval given by a medicines regulatory agency to conduct a clinical trial in a region
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
identifier assigned to a clinical trial by a medicines regulatory agency in a region for tracking purposes
color characteristic
colour characteristic
composite chromatic physical characteristic composed of hue, saturation and intensity
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
color
colour
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
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
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.
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.
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
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
classifier for a cooccurring condition or co-infection that is described as part of the indication
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.
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
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
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/.
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
quantity or range of quantities of the substance/specified substance present per unitary volume (or mass)
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.
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.
National Cancer Institute Thesaurus, see http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25457
state of being, such as a state of health
sequence of characters denoting the condition under which the marketing authorization or the marketing is restored
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
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
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
The confidentiality level can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified.
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
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
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
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.
constituent that specifies the number or quantity of things of the same kind being held in a given container or package
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.
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
functional role of a package item with respect to inclusive layering within a medicinal product
classifier for the functional role of a package item with respect to inclusive layering within a medicinal product
specification for an object that can be used to hold things
ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 4.2.2)
process in which materials are passed in a continuous flow through processing equipment
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.
situation where the medicinal product shall not be given for safety reasons
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.
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
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'
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
Classifiers for diseases, symptoms or procedures are defined in controlled vocabularies such as SNOMED-CT or MedDRA.
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.
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
textual description of the contraindications of a medicinal product
unique identifier for items that are traded (e.g. pharmaceuticals, medical devices) in the supply chain
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.
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.
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.
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).
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
explicit time period from initial authorization of the reference product granting exclusivity for a given marketing authorization
1-D extent physical characteristic inhering in a bearer by virtue of the bearer's downward or backward or inward dimension
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
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.
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
ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 4.2.3)
process in which a specified quantity of parts moves as a unit (group of parts) between workstations and each part maintains its unique identity
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).
Products are classified into production lots that are based on common raw materials, production requirements, and production histories.
classifier for the status of a disease or symptom
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.
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
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
specified quantity of a medicine, to be taken at one time or at stated intervals
classifier for the number of occurrences of a given symptom, condition or effect within a specified period of time
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.
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
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
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
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
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.
WHO Gender and Health https://www.who.int/health-topics/gender
sequence of characters denoting the geographic area where the legal action taken on the marketing or the on marketing authorization is having effect
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
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
1-D extent physical characteristic inhering in a bearer by virtue of the bearer's vertical dimension of extension
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
controlled vocabulary denoting an ingredient role, according to the ISO 20443 implementation guide for ISO 11615
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
set of controlled vocabularies and codes for reporting of medicinal product-related information specified in the ISO/TS 20443 guidelines
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.
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
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
In ISO 11615, an image is modeled as a physical characteristic. This is not correct from an ontological perspective.
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
packaging in which a manufactured item or pharmaceutical product is contained and with which it is in direct contact
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.
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
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'
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.
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
code for an active ingredient whose basis of strength cannot be specified
code for an active ingredient where the entire substance is the basis of strength
code for an active ingredient where the active moiety is basis of strength
code for an active ingredient where another reference substance is the basis of strength
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)
code for an ingredient that is any additive added
Use only when there is no described pharmacological action and classification as merely 'inactive' ingredient is not appropriate
code for an ingredient that is the base of a preparation
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
code for an ingredient added to alter the color appearance
code for an ingredient added to alter the taste of the product
code for an inactive ingredient, i.e. ingredients added for a purpose other than the intended pharmacological action
code for an ingredient not otherwise specified, used in cases of devices or foods where further classification is not common
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
For example, a collagen matrix used as a base for transplanting skin cells.
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.)
code for a preservative, an ingredient added to delay the risk of the product's spoiling
code for a stabilizer, an ingredient added to keep the mixture homogenic (e.g. prevent the phases of an emulsion to separate)
sequence of characters denoting an ingredient role, according to the ISO 20443 implementation guide for ISO 11615
classifier for the type of outcome or result intended for the target condition
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.
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.
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
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
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.
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
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
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.
classifier for the type of interaction with the regulated product
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.
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
The text of the interaction in accordance with the regulated product information shall be provided.
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
container between the outer packaging and the immediate container
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
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
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
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
This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products worldwide.
jurisdictional marketing authorisation
jurisdictional marketing authorization
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
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
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
sequence of characters denoting the legal basis for the action taken on the marketing or on the marketing authorization
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
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
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
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
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
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.
ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.32)
unique amount of material having a set of common traits
This is preliminary and needs extension to specify common characteristics of a given lot.
As defined in ANSI/ISA-95 and IEC 62264-1 as material lot: uniquely identifiable amount of a material.
Some examples of common traits are material source, the master recipe used to produce the material, and distinct physical properties.
identifier assigned to a unique amount of material having a set of common traits
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
pharmaceutical dose form of a manufactured item as manufactured and, where applicable, before transformation into the pharmaceutical product
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).
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
quantity (or count number) of the manufactured item
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.
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 authorisation
manufacturing authorization
authorization provided by a medicines regulatory agency to manufacture medicinal products within a region
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.
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 authorisation reference number
manufacturing authorization reference number
reference number of the authorization for manufacturing or equivalent
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
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
sequence of characters denoting the nature of the manufacturing operation and classifying it accordingly
The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
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
manufacturing or business operation
facility (operation) managed by a given manufacturer that provides some operational capability
The manufacturing/business operation being undertaken by the particular manufacturer/establishment (organisation) shall be specified.
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
manufacturing / business operation
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
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
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]
place, setting, or context in which a manufacturing or business operation is situated
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.
unique identifier (code) for a place, setting, or context in which a manufacturing or business operation is situated
designation for a place, setting, or context in which a manufacturing or business operation is situated
marketing authorisation
marketing authorization
authorization issued from a medicines regulatory agency that allows a medicinal product to be placed on the market
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
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
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.
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.
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.
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 authorisation application
marketing authorization application
formal written request for the authorization to market a medicinal product
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).
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
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
marketing authorization application classifier
sequence of characters characterizing the kind of marketing procedure that is followed to grant or update a marketing authorization
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
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 authorisation application identifier
marketing authorization application identifier
unique identifier for a marketing authorization application for a medicinal product
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.
marketing authorisation holder
marketing authorization holder
authorized party role of a legal entity (organization) that holds the authorization for marketing a medicinal product in a region
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
marketing authorisation holder identifier
marketing authorization holder identifier
unique identifier for the marketing authorization holder (organization) for the medicinal product
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
An international coding system for unique marketing authorisation holders (organisations) identifiers can be applied, if available.
marketing authorisation number
marketing authorization number
identifier assigned by a medicines regulatory agency to a medicinal product
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 authorisation procedure
marketing authorization procedure
regulatory procedure applied to grant or amend a marketing authorisation for a medicinal product
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.
marketing authorisation procedure identifier
marketing authorization procedure identifier
unique identifier for the specific instance of a procedure undertaken
sequence of characters denoting the marketing status of a medicinal product
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
the marketing status is permanently ceased as the medicine is harmful
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
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
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
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
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
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
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).
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.
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
condition that impairs the body's normal functioning or its parts and is characterized by specific symptoms and/or signs
A medical condition can be kind of illness or circumstance which requires medical monitoring.
National Cancer Institute Thesaurus, see http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C156809
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
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.
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.
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
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.
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
unique identifier allocated to a specific batch of a medical device
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.
This class can be used to describe the batch number and/or expiry date of a device in a packaged medicinal product.
specification of the material(s) of which a given device is made
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.
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
terminology structured systematically according to pre-established naming rules for medical devices
There are a variety of nomenclature systems available to identify devices. This structure supports the description of the device in these nomenclature systems.
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
role of a substance or product that is used in the treatment of a disease or symptom
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].
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
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
classifier for a medication by active substance or medicinal product(s)
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.
therapy in which a medication is administered to the patient
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
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.
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
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
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
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
unique identifier allocated to a specific batch of a medicinal product, which appears on the immediate packaging, where this is not the outer packaging
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).
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.
medicinal product batch identifier for outer packaging
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
unique identifier allocated to a specific batch of a medicinal product, which appears on the outer packaging of the medicinal product
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.
code assigned to each package presentation of a medicinal product
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.
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
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
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.
reference to another medicinal product that bears some relationship with the medicinal product in question
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.
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
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
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
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
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.
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.
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).
A given medicinal product will have exactly 1 'header', although a given 'header' may apply to multiple medicinal products.
unique identifier allocated to a medicinal product supplementary to any existing authorization number as ascribed by a medicines regulatory agency in a region
This is for indexing purposes and to contribute to improved patient safety by allowing for the unique identification of medicinal products worldwide.
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
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
process of production for a substance or medicinal product from the acquisition of all materials through all processing stages
This is a starting point that requires extension to include additional relationships as described in the note.
The critical process, critical process steps, starting and processing materials and critical production parameters are included.
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
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.
authorized role of a legal entity (organization) that holds a master file for a given medicinal product
master file holder
master file holder (organisation)
master file holder (organization)
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
classifier for medicinal products, specifying whether a given product is subject to additional monitoring
If the medicinal product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary.
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
name as authorized by a medicines regulatory agency
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).
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
context in which a given medicinal product name applies
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.
Country / Language
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
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.
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
medicines regulatory agency (organisation)
medicines regulatory agency (organization)
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
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
This class includes several attributes required to have all the information related to a product with an orphan designation status.
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.
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.
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
aspect of a manufactured item, package item, or medical device that describes that product
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.
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
value for an aspect of a manufactured item, package item, or medical device that describes that product, derived from a controlled vocabulary
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
specification of the relationship between the indication or contraindication of a medicinal product with another therapy
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.
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
external container in which a medicinal product is supplied
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.
specification of a part of a package item
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
unique identifier allocated in addition to any existing authorisation/approval number at package level as ascribed by a Medicines Regulatory Agency in a region
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.
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
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
specification for an individual, distinct item contained in a packaged medicinal product that acts as a container for one or more manufactured item(s)
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.
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.
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
quantity (or count number) of the package item
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'.
classifier for package items (containers)
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
medicinal product in a container being part of a package, representing the entirety that has been packaged for sale or supply
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).
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
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
paediatric use indicator
pediatric use indicator
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
classifier for medicinal products, specifying whether a given product is authorized for use in children
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
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
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
'Pharmaceutical dose form' can refer to the administrable dose form or the manufactured dose form.
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
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.
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
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
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
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.
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
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
This definition of batch entails axioms relating the batch to a manufacturing order and identifying the manufacturing cycle, which need to be added.
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
identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing process at a specific point of time
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
aspect of a pharmaceutical product that describes that product, such as its onset of action
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
value for a specific pharmaceutical product characteristic value, derived from a controlled vocabulary
The value from the pharmaceutical product characteristics system can be specified.
pharmaceutical product characteristic status
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
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
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
unique identifier for a pharmaceutical product
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
collection of identifiers associated with a given pharmaceutical product
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.
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
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
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
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.
container that is part of a medicinal product and is used for storage, identification and/or transport of the components of the medicinal product
qualitative and quantitative composition of a medicinal product in the dose form approved for administration in line with the regulated product information
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
National Cancer Institute Thesaurus, see http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C176718
condition or state of the external or internal milieu for an organism
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.
With respect to a person, physiological condition is defined as the functional state of the body or body systems.
physiological condition population characteristic
classifier for a statistical population based on the physiological condition of its members
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.
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
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
National Cancer Institute Thesaurus, see http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C753
inactive substance, treatment or procedure that is intended to provide baseline measurements for the experimental protocol of a clinical trial
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.
classifier of a target population intended as the target of a therapeutic indication or contraindication
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
quantity or range of quantities of the substance/specified substance present per unitary volume (or mass) expressed in units of presentation
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
structured set of activities involving various enterprise entities designed and organized for a given purpose
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).
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]
identifier assigned to a structured set of activities involving various enterprise entities, that is designed and organized for a given purpose
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
specification for a structured set of activities involving various enterprise entities designed and organized for a given purpose
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
Note that this is an early representation of the concept only, and will likely require extension in future releases.
identifier assigned to a part of a process
classifier for a product using a categorization or grouping of medicinal products based on specific properties
The Medicinal Product can be classified according to various classification systems, which may be regional or international.
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
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.
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
specification for something that is produced by, results from, or obtained as a consequence of some process or transformation
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
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.
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
amount of substance and specified substance constituents of the investigational or authorized medicinal product expressed in a ratio scale
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.
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.
subdivision of human population based on common culture or descent or a subspecies of animals
race or ethnicity population characteristic
classifier for a statistical population based on the race or ethnicity of its members
HL7 uses PHIN-VADS Race & Ethnicity - CDC as vocabulary for this
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
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
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.
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
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
specification for the path by which the pharmaceutical product is taken into or makes contact with the body
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.
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
code for the path by which the pharmaceutical product is taken into or makes contact with the body
classifier for a debossed line that runs across the planar surface of a tablet
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.
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
Nomenclature, Labeling, and Data for Evaluation, FDA Guidance for Industry, March 2013.
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).
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
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
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
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
NCI Thesaurus, see https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&version=23.06d&ns=ncit&code=C70855
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
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.
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.
The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.
classifier indicating that an entity has been certified based on its size in order to receive authorization for something under special rules
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
classifier describing additional storage conditions for a medicinal product or package item, if any
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
individual, company, institution or organization (party), which takes responsibility for the initiation, management and/or financing of a clinical trial
classifier for the symptom, condition or effect that is undesirable effect
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.
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
collection of patients or consumers for which the indication of a medicinal product is authorized or is under investigation
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
specification that defines the target disease or condition for which the medicinal product is authorized or under investigation
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
A medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease. (EMA)
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.
textual description of the therapeutic indications of a medicinal product
action or administration of therapeutic agents to produce an effect that is intended to alter the course of a pathologic process
NCI Thesaurus, see the entry for treatment, C15368
relationship that applies to a therapy or therapy specification
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
classifier for a the relationship to a therapy or therapy specification
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.
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
undesirable effect as 'symptom/condition/effect'
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
Classifiers for medical conditions are defined in controlled vocabularies such as SNOMED-CT or MedDRA.
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
textual description of an undesirable effect of a medicinal product
explicit time period of the marketing authorization for the relevant status
3-D extent physical characteristic inhering in a bearer by virtue of the bearer's amount of 3-dimensional space it occupies
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
physical characteristic inhering in a bearer that has mass near a gravitational body
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
1-D extent physical characteristic which is equal to the distance from one side of an object to another side which is opposite
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
indicates a medicinal product that is administered by some party, such as a clinician
endorses, enables, empowers, or gives permission to
indicates the situation that facilitates designation of an authorized party by the authorizing party for some purpose
is specified to hold within its volume or area
assesses the nature, quality, or ability of someone or something
relates something representing the constituents of a pharmaceutical or medicinal product to something in the role of an active ingredient
indicates a reference document that is specifically associated with a pharmaceutical or medicinal product
relates a medicinal product to a specific authorization (manufacturing or marketing) in some jurisdiction
has authorisation procedure
has authorization procedure
indicates the regulatory procedure applied to grant or amend a marketing authorization for a medicinal product
has authorisation status
has authorization status
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 authorisation status date
has authorization status date
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
indicates the date at which the given status has become applicable
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).
indicates the party that is endorsed, enabled, empowered, or otherwise permitted to do something in the situation
indicates the party that endorses, enables, empowers, or gives permission in the situation
relates a pharmaceutical or medicinal product to a substance that is its basis of strength
indicates the role of an active ingredient as the basis of strength of any substance or pharmaceutical product as manufactured
any comorbidity (concurrent condition) or co-infection described as part of the indication or contraindication as it is referenced in the regulated product information
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
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
provides information regarding any trademark or company name component if included in the medicinal product name
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
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
provides any additional comments on the condition to restore the marketing or the marketing authorization of the product
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
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
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
provides information regarding the container or pack component if included in the medicinal product name
Vial (glass) – 4 ml – 1 Vial, Titration Pack, Multidose Vial
relates a product to a situation wherein the medicinal product shall not be given for safety reasons
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
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
description of the contraindication(s) in line with the regulated product information as text
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
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
indicates an explicit time period from initial authorization of the reference product granting exclusivity for a given marketing authorization
has date of first authorisation
has date of first authorization
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
indicates the date when the first authorization was granted by the authorizing body
specifies the strength of any element in a substance or pharmaceutical product
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
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
provides a delimiter that separates one composite in a segment from another, or separates one sub-composite from another
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
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
provides information regarding any device component of the product, if included in the medicinal product name
status of the disease or symptom of the indication or contraindication
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.
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
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
links something, such as an agreement, contract, report, other document, or perishable item, with a date beyond which it is no longer valid
specifies the diameter of some material measured from the outside
has flavor part
has flavour part
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
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
provides the flavor component, if reflected in the medicinal product name
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
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
provides information regarding the formulation of the product, if included in the medicinal product name
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
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.
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
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
provides the full and complete medicinal product name as approved by the medicines regulatory agency in a region, as text
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.
specifies an imprint on the surface of some material
has indication as disease/symptom/procedure
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
MedDRA term 10002383 for "stable angina pectoris"
SNOMED CT term 233819005 for "stable angina"
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.
specifies a classifier for the type of outcome or result intended for the target condition
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.
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
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
provides information regarding the intended use of the product, if included in the medicinal product name
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
provides a description of the interaction in accordance with the regulated product information
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
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
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
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
provides the invented name of the medicinal product without the trademark or any other similar designations reflected in the full medicinal product name
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
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
provides any additional description of the action taken on the marketing or on the marketing authorization
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
indicates the number/quantity of manufactured items in the immediate container of a packaged medicinal product
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.
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
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
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
indicates the date when the authorized medicinal product is marketed in a region
'Placed on the market' refers to the release of the medicinal product into the distribution chain.
Marketing date(s) refers to each instance of a packaged medicinal product (PCID level).
The date of actual marketing of a medicinal product is always after a marketing authorization has been granted by a medicines regulatory agency.
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.
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
indicates when the marketing of the authorized medicinal product is stopped in a region
'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.
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.
relates to a medication or class of medications
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
specifies the nominal volume of some material
specifies a characteristic of some specification for a manufactured item, package item, or device that is not explicitly a defined physical characteristic
This can be anything per subject matter expert discussions.
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
relates a therapeutic indication or contraindication to the specifics of another related therapy
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
relates a package item to a one of its components
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
indicates the number/quantity of items of the same type in a container
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
relates a package item to its type of container
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
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
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
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.
specifies a physical characteristic of some specification for a container, product or material, or of actual physical material
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
relates a target population to classifiers that narrow down the population to a specific subset
indicates a role that the reference substance of an active ingredient in a pharmaceutical or medicinal product plays under certain circumstances
indicates the reference strength for the reference substance of an active ingredient in a pharmaceutical or medicinal product
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
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
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
indicates the date when the marketing or the marketing authorization of the product is anticipated to be restored
the date of the lift of the marketing authorization suspension
A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.
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
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
indicates whether there is a risk of a product shortage in a region
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
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
provides any additional comments on drug supply shortage
specifies the path by which the pharmaceutical product is taken into or makes contact with the body
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
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
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
provides the scientific or common (i.e. generic) name of the medicinal product without any other descriptors
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
period during which a medicinal product retains its properties and stated performance within specified limits if stored under defined conditions
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.
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
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
indicates whether a medicinal product is subject to specific special measures
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
indicates additional storage conditions for a the shelf life, if any
indicates the party that initiates, manages, and/or finances the clinical trial
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
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
provides any additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorization
indicates the actual strength of any element in a substance or pharmaceutical product
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
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
provides the strength, if reflected in the medicinal product name
This strength name part can differ from the concept of 'Strength'.
has symptom/condition/effect classification
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
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.
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
relates a therapeutic indication or contraindication to its the target population
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
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
provides information regarding the target population for the product, if included in the medicinal product name
relates a pharmaceutical product to a therapeutic indication that type of medical conditions where the treatment with the medicinal product is adviced
indication as "Disease / Symptom / Procedure"
relates a therapeutic indication to its the textual description
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
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
relates to a classifier of a therapy relationship
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
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
provides the time/period component of the medicinal product name
timing or duration information described as part of the indication
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
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
relates a medicinal product to undesirable effects that the the medicinal product has on a target population or therapeutic indication
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
description of an undesirable effect in line with the regulated product information as text
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
is specified to hold within its volume or area and to be in direct contact with
indicates a party, such as a clinician, that administers some medicinal product
indicates a clinical trial in which a given investigational medicinal product is administered
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
is a device that contains allergens and/or materials of concern or ingredient that is a known or suspected allergen
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
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
relates something, such as a marketing authorization or related status, country in which authorization has been granted or in which the status applies
The country in which the marketing activity is undertaken shall be specified. It should be specified using the ISO 3166-1 alpha-2 codes.
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 endorsed, enabled, empowered, or otherwise permitted by
relates a medicinal product to its manufacturing authorization(s)
relates a medicinal product to its marketing authorization(s)
indicates the situation that facilitates endorsement of the authorized party for some purpose
relates the container constituent to its manufactured item
A blister contains 20 tablets. One container constituent of the blister has the quantity of 10 tablets (units) chracterized by the tablet manufactured item.
relates the container constituent to its package item
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 a specification for a device that may contain allergens and/or materials of concern or ingredient that may include a known or suspected allergen
is specified to hold within its volume or area and be in direct contact with
relates the specifics of another therapy to a therapeutic indication or contraindication
is produced by or results from some process, process step, action, activity, or other effort
relates a package component to the package item that it is part of
relates a substance, manufactured item, medicinal product, or pharmaceutical product to a manufacturing site where it is produced
relates a substance, manufactured item, medicinal product, or pharmaceutical product to a manufacturing operation that produces it
indicates an investigational medicinal product that is administered in the context of a clinical trial
relates a manufacturer to a site at which it, or a delegated third party, conducts manufacturing
relates a manufacturer to a region in which it is authorized to manufacture something
indicates the clinical trial that an individual, company, institution or organization (party), initiates, manages and/or finances
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.
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