ISO/TS 20451:2017
(Main)Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616. Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017. Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of ISO/TS 20451:2017.
Informatique de santé — Identification des médicaments — Lignes directrices pour l’implémentation des éléments de données et structures ISO 11616 pour l’identification unique et l’échange d’informations réglementées sur les produits pharmaceutiques
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TECHNICAL ISO/TS
SPECIFICATION 20451
First edition
2017-10
Health informatics — Identification
of medicinal products —
Implementation guidelines for ISO
11616 data elements and structures
for the unique identification and
exchange of regulated pharmaceutical
product information
Informatique de santé — Identification des médicaments — Lignes
directrices pour l’implémentation des éléments de données et
structures ISO 11616 pour l’identification unique et l’échange
d’informations réglementées sur les produits pharmaceutiques
Reference number
ISO/TS 20451:2017(E)
©
ISO 2017
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ISO/TS 20451:2017(E)
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ISO/TS 20451:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Conformance . 2
5 Concepts required for the unique identification of pharmaceutical products .2
5.1 General considerations for elements required for the unique identification of
pharmaceutical products . 2
5.2 Principles required for the unique identification of a pharmaceutical product . 2
6 Identifying characteristics for the identification of pharmaceutical products .3
6.1 Pharmaceutical product identification strata and levels . 3
6.2 PhPID specified substance . 4
6.3 Pharmaceutical product specified substance identification (PhPID SpSub) . 5
6.4 Cardinality . 5
6.5 Representation of strength concentration . 6
6.6 Pharmaceutical product identifier (PhPID) . 6
6.7 PhPID algorithm and product code concept. 7
7 Ingredient, substance and strength . 8
7.1 General considerations . 8
7.2 Ingredient . 9
7.2.1 Ingredient role . 9
7.2.2 Substance .10
7.2.3 Specified substance .10
7.2.4 Specified substance group .10
7.2.5 Confidentiality indicator .11
7.2.6 Strength .11
7.2.7 Pharmaceutical product code concept for representing the normalised
strength for liquid preparations .11
7.2.8 Strength (presentation) .12
7.2.9 Strength (concentration) .12
7.2.10 Measurement point .13
7.2.11 Country . .13
7.2.12 Reference strength .13
7.2.13 Reference substance .13
7.2.14 Reference specified substance .13
7.2.15 Reference strength .13
7.2.16 Reference strength measurement point .14
7.2.17 Reference strength country .14
8 Pharmaceutical product: adjuvants and devices .14
8.1 General considerations .14
8.1.1 Detailed description of pharmaceutical product and device information .14
8.1.2 Pharmaceutical product .15
8.1.3 Pharmaceutical product characteristics .17
8.1.4 Device (pharmaceutical product) .18
Annex A (normative) Messaging: Ingredient, substance and strength .19
Annex B (normative) Messaging: Pharmaceutical product and device .33
Annex C (informative) Examples .40
Annex D (informative) Examples of representation of strength .45
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ISO/TS 20451:2017(E)
Bibliography .48
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ISO/TS 20451:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
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ISO/TS 20451:2017(E)
Introduction
This document gives guidelines for implementing ISO 11616, one of the five ISO IDMP standards. The
five ISO Standards and four ISO Technical Specifications, when used together, provide the basis for
exchanging data elements that will support the unique and unambiguous identification of Medicinal
Products. The primary purpose of this document is to provide technical guidance to software
implementers; short descriptions of business rationale are also included, where relevant, to provide
context. Thus, this document focuses on business and technical considerations for implementation
that will construct and parse well-formed, transmittable IDMP messages. Following transmission of
required data elements, unique identifiers are to be produced in conformance with the standards to
support applications where it is necessary to reliably identify and trace regulated biopharmaceutical
products. However, this document does not include extensive information on creation or maintenance
of identifier repositories. Reference is made to regional guidance/implementation guides to support
practical implementation within a given region/jurisdiction. The development of an ISO technical
report for identifying core principles for the maintenance of identifiers and terms for ISO IDMP is
to be developed and referenced for applicable ISO IDMP standards and corresponding technical
specifications.
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TECHNICAL SPECIFICATION ISO/TS 20451:2017(E)
Health informatics — Identification of medicinal products
— Implementation guidelines for ISO 11616 data elements
and structures for the unique identification and exchange
of regulated pharmaceutical product information
1 Scope
This document defines the concepts required to associate pharmaceutical products with an appropriate
set of PhPID(s) in accordance with ISO 11616.
Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a
Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards
can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of this
document.
Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7
Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured
Product Labelling (SPL) can be applied for pharmaceutical product information in the context of this
document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3166-1, Codes for the representation of names of countries and their subdivisions — Part 1: Country codes
ISO 11238, Health informatics — Identification of Medicinal Products — Data elements and structures for
the unique identification and exchange of regulated information on substances
ISO 11239, Health informatics — Identification of Medicinal Products — Data elements and structures for
the unique identification and exchange of regulated information on pharmaceutical dose forms, units of
presentation, routes of administration and packaging
ISO 11240, Health informatics — Identification of Medicinal Products — Data elements and structures for
the unique identification and exchange of units of measurement
ISO 11615, Health informatics — Identification of Medicinal Products — Data elements and structures for
the unique identification and exchange of regulated Medicinal Product information
ISO/TS 19844, Health informatics — Identification of Medicinal Products — Implementation guidelines
for data elements and structures for the unique identification and exchange of regulated information on
substances
ISO/TS 20440, Health informatics — Identification of Medicinal Products — Implementation guide for
ISO 11239 data elements and structures for the unique identification and exchange of regulated information
on pharmaceutical dose forms, units of presentation, routes of administration and packaging
ISO/TS 20443, Health informatics — Identification of Medicinal Products — Implementation guidelines for
ISO 11615 data elements and structures for the unique identification and exchange of regulated Medicinal
Product information
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ISO/TS 20451:2017(E)
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
4 Conformance
— Mandatory: Defining elements necessary for the unique identification of Medicinal Products per the
ISO IDMP standards/technical specifications.
— Conditional: Conditional applies to the “within category” data elements, as applicable, when there
are alternative data sources for a given data element(s) to identify a medicinal/pharmaceutical
product. Regional implementation of the ISO IDMP standards/technical specifications may elevate
the conditional conformance categories to “mandatory” per regional requirements.
— Optional: When listed at the category level (e.g. specified substance), optional corresponds to
ISO categories or data elements that are not absolutely necessary for the unique identification of
medicinal/pharmaceutical products according to the ISO IDMP standards/technical specifications.
Regional implementation of the ISO IDMP standards/technical specifications may elevate the
optional conformance categories to “mandatory” or “conditional” per regional requirements.
5 Concepts required for the unique identification of pharmaceutical products
5.1 General considerations for elements required for the unique identification of
pharmaceutical products
This clause, along with Annex A and Annex B, describes the elements and messaging required to
uniquely identify and characterise a pharmaceutical product. It provides the requirements to support
pharmaceutical product identification. Examples are given in Annex C.
Pharmaceutical product identification (PhPID) shall be based on the following subset of elements that
describe the pharmaceutical product (see Figure 1):
a) active substance(s)/specified substance(s);
NOTE The substance(s) within the ingredient role “active” and “adjuvant” are utilised to define the PhPID.
b) strength(s), strength units (units of measurement and/or unit of presentation);
c) reference strength(s) includes reference substance(s) (i.e. active moiety and its corresponding
strength);
d) administrable dose form;
e) medical device, when it is a component of a Medicinal Product.
5.2 Principles required for the unique identification of a pharmaceutical product
The following principles for the unique identification of a pharmaceutical product shall apply:
a) a Medicinal Product may relate to one or more pharmaceutical products as part of a treatment
regime [e.g. a kit, which might be a combination pack containing vaginal tablets (500 mg) and an
external vaginal cream (10 %)];
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ISO/TS 20451:2017(E)
b) the characterisation of the pharmaceutical product(s) based on the active substance(s)/specified
substance(s), the (reference) strength thereof, the administrable dose form(s), and the medical
device (e.g. a scaffolding for cell-based products) being part of the Medicinal Product (e.g.
drug/device combination);
c) the description of the pharmaceutical product(s) in the pharmaceutical dose form approved for
administration, where applicable, after reconstitution and as authorised in accordance with the
regulated product information;
d) the association of the regulated (investigational) Medicinal Product and the pharmaceutical
product(s) using the PhPID(s).
6 Identifying characteristics for the identification of pharmaceutical products
6.1 Pharmaceutical product identification strata and levels
PhPID sets shall be represented within two strata (active substance stratum and specified substance
stratum), both of which contain four PhPID identification levels, for each pharmaceutical product
contained in a Medicinal Product.
PhPID sets shall be generated using the substance standard (see ISO 11238 and ISO/TS 19844), the
strength and administrable dose form section (see ISO 11239 and ISO/TS 20440) and the unit(s) of
measurement standard (see ISO 11240) as illustrated below.
Reference strength shall be repeated in both PhPID strata. The reference strength shall be derived from
the active moiety/moieties of an active substance(s) depending on the specific product characteristics.
All the PhPID strata can be described at four different levels from 1 to 4 as shown in Table 1.
Table 1 — Four levels of PhPID
PhPID_SUB_L1 → substance(s)
PhPID_SUB_L2 → substance(s) + strength + reference strength
PhPID active
substance PhPID_SUB_L3 → substance(s) + administrable dose form
stratum
PhPID_SUB_L4 → substance(s) + strength + reference strength
+ administrable dose form
PhPID_SpSUB_L1 → specified substance(s)
PhPID_SpSUB_L2 → specified substance(s) + strength + reference strength
PhPID specified
substance PhPID_SpSUB_L3 → specified substance(s) + administrable dose form
stratum
PhPID_SpSUB_L4 → specified substance(s) + strength + reference strength
+ administrable dose form
A pharmaceutical product may refer to a drug that is associated with a medical device. In this instance,
the device term and term ID (i.e. unique device identifier) shall be displayed with the active substance(s)
and specified substance(s) terms for the product at all applicable PhPID levels. This association shall
be made by directly associating the assigned PhPIDs to a Medicinal Product and its corresponding
MPID/PCID as outlined in ISO 11615 and ISO/TS 20443.
Strength is not applicable to a device.
A region may further refine the requirements in relation to specification of the medical device as part
of this document at implementation so that this information is to be specified only if required.
A pharmaceutical product may refer to a drug that is associated with an adjuvant (e.g. vaccine). In this
instance, the adjuvant term and term ID shall be displayed with the active substance(s) and specified
substance(s) terms for the product at all applicable PhPID levels. This association shall be made by
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ISO/TS 20451:2017(E)
directly associating the assigned PhPIDs to a Medicinal Product and its corresponding MPID and PCID
as outlined in ISO 11615 and ISO/TS 20443.
Strength shall indicate quantity, unit of measurement and/or unit of presentation.
Administrable dose form is derived from the pharmaceutical product.
Placebos shall be captured as active substances when utilised as a comparator. Regional implementation
guides will provide more information as some regional regulation defines what is considered a placebo
or active substance.
6.2 PhPID specified substance
As described in ISO 11238, specified substance(s) shall capture detailed characteristics of single
substances or the composition of material that contains multiple substances or multiple physical forms.
The elements necessary to define specified substances shall be divided into four groups to facilitate
implementation.
These groups are described as follows.
a) Specified Substance Group 1. Elements shall be used to describe material that contains multiple
substances, solvents used in the preparation of herbal or allergenic extracts, specific marker or
signature substances present in plant or animal derived materials, the physical form of a substance,
when relevant, and any properties essential to the description of the material.
The element groups used to define a Specified Substance Group 1 shall include constituents,
physical form and property.
NOTE 1 This grouping of elements allows for the definitions of many materials in commerce that are used
in the formulation of Medicinal Products.
b) Specified Substance Group 2. Group 2 elements shall be used to capture the manufacturer of either
a substance or Specified Substance Group 1 along with minimal manufacturing information.
The minimal manufacturing information shall include the overall production method type (i.e.
synthetic, extractive, recombinant), production system type (i.e. cell line, plant or animal tissue)
and production system (specific cell line).
NOTE 2 Group 2 elements would allow the tracking of the substance to the manufacturer. It also allows
the distinguishing of synthetic peptides from recombinant peptides and the capture of the product cell line.
c) Specified Substance Group 3. Group 3 elements shall capture the grade of the material along with
the source that defines the given grade.
Group 3 elements shall be used to distinguish specific pharmacopoeia grades and technical grades
of material.
The grade for each pharmacopoeia shall be a separate substance if a pharmacopoeia monograph
related to a substance is not harmonised.
NOTE 3 For most active pharmaceutical substances, generally recognised pharmacopoeias are USP, Ph.
Eur. or JP. For herbal substances, the grades would be standardised, quantified and unstandardised.
d) Specified Substance Group 4. Group 4 elements shall contain the most detailed information on a
substance. This information shall include critical manufacturing processes, specifications (e.g.
impurities and related substance limits would be captured using constituents), unitage, reference
material and analytical methods used for potency determination.
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NOTE 4 The specific information described for Specified Substance Group 4 is often submitted in
regulatory submissions in an unstructured manner that is difficult to capture and organise. The fields
developed here will attempt to organise and structure the data in a manner that will facilitate its use in both
review and compliance activities. It is anticipated that the suite of ISO IDMP standards will extend into more
granular regulatory content as adoption increases by stakeholders and the standards extend deeper into
additional regulatory and clinical use cases over time.
6.3 Pharmaceutical product specified substance identification (PhPID SpSub)
The PhPIDs for specified substance(s) shall be generated from three of the four groups (Groups 1 to 3)
identified within ISO 11238 and ISO/TS 19844.
Groups 1, 2, and 3 contain necessary data elements for more detailed pharmaceutical product
identification which supports the scope and purpose of this document.
Groups 1 to 3, as assigned to an active substance(s), shall be utilised within this document for
pharmaceutical product identification with corresponding PhPIDs attributed as applicable.
Group 4 is a more comprehensive level of substance identification that is not necessary for the purposes
of pharmaceutical product identification and shall not be utilised for PhPID generation.
Specified substance information shall be represented with the active substance(s) elements within a
pharmaceutical product and within a Specified Substance Group 1, as applicable.
Groups 2 and 3 shall be associated directly with the active substance(s) of a pharmaceutical product
and to a Specified Substance Group 1 as applicable.
ISO/TS 19844 addresses the assignment and association of specified substance groups for defined
product classes. See ISO 11238 and ISO/TS 19844 for detailed information related to substance and
specified substance elements and identification.
A region may further refine the requirements in relation to specification of specified substances as part
of this document at implementation such that this information is to be specified only if required.
6.4 Cardinality
The relationships within the elements of a pharmaceutical product shall respect the following
cardinality:
— a PhPID has one administrable dose form (cardinality relationship: 1.1);
— a PhPID may have zero to one unit of presentation (cardinality relationship: 0.1);
NOTE This is often used specifically at the point of delivery to the patient in cases where a quantitative
unit of measurement is not applicable.
— a PhPID has one or more active substances (cardinality relationship: 1.*);
— a PhPID has one or more active specified substances (cardinality relationship: 1.*);
— a PhPID has one strength (cardinality relationship: 1.1) based on one to many active substances or
specified substances (cardinality relationship: 1.*);
For liquid preparations, the strength (presentation) and strength (concentration) shall both be
represented.
A separate PhPID shall be generated to represent the strength concentration, i.e. per unit volume as
applicable. This shall be known as the product code concept as it represents a calculation of the strength
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ISO/TS 20451:2017(E)
presentation of a liquid preparation (i.e. total volume per container) as authorised by a medicines
regulatory agency.
— a PhPID has one to many reference strengths (i.e. active mo
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