ISO/TS 20451:2017

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

General Information

• Status: Published
• Publication Date: 18-Oct-2017
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 6 - Pharmacy and medicines business
• Current Stage: 9092 - International Standard to be revised
• Start Date: 19-Jan-2023
• Completion Date: 13-Dec-2025

Relations

• Consolidates: ISO 17940:2015 - Ships and marine technology - Hinged watertight doors
• Effective Date: 06-Jun-2022
• Revised: ISO/DTS 20451 - Health informatics - Identification of medicinal products - Implementation for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
• Effective Date: 28-Jan-2023

Overview

ISO/TS 20451:2017 - "Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616…" is a technical specification that provides implementation guidance for creating and exchanging unique identifiers for pharmaceutical products in line with ISO 11616. Intended primarily for software implementers, the document explains the concepts and message structures required to associate pharmaceutical products with one or more PhPID(s) (Pharmaceutical Product Identifiers). It focuses on building and parsing well-formed IDMP (Identification of Medicinal Products) messages for regulated product information, not on long‑term identifier repository maintenance. The specification can be applied to regulated product representations (and is usable for off‑label contexts, though off‑label use is outside its current scope).

Key topics and technical requirements

• PhPID fundamentals: Concepts required to generate and associate PhPID(s) with pharmaceutical products per ISO 11616.
• Core identifying elements used to define a PhPID:
  • Active substance(s)/specified substance(s)
  • Strength(s) and strength units (concentration and presentation)
  • Reference strength(s) and reference substance(s) (active moiety)
  • Administrable dose form
  • Medical devices when part of a medicinal product
• Conformance categories: Mandatory, Conditional, Optional - with regional implementations able to tighten requirements.
• Messaging and data structures: Normative guidance for message payloads and element cardinality (see Annex A and B for ingredient/substance/strength and pharmaceutical product/device messaging).
• Representation rules: Guidance on strength normalization, measurement points, confidentiality indicators, and product code/PhPID algorithm concepts (clause references).
• Implementation focus: Practical guidance for constructing/parsing IDMP messages; includes informative examples (Annex C, D).

Practical applications

• Regulatory data exchange and product submission workflows
• Pharmacovigilance and adverse event reporting that require unambiguous product identification
• Interoperability between national/regional regulatory authorities and industry
• EHR, clinical decision support, and medication safety systems needing standardized product identifiers
• Supply chain tracking and serialization where clear product definition is required

Who should use this standard

• Health informatics and interoperability architects
• Regulatory authorities and medicines agencies
• Pharmaceutical companies and submission teams
• EHR and clinical software vendors
• HL7 implementers and integration specialists working with IDMP messaging

Related standards

• ISO 11616 (core PhPID data elements)
• ISO 11238, ISO 11239, ISO 11240, ISO 11615 (IDMP suite)
• ISO/TS 19844, ISO/TS 20440, ISO/TS 20443 (implementation guidance)
• HL7 standards: RIM, V3 Common Product Model (CPM), V3 Structured Product Labelling (SPL)

Keywords: ISO/TS 20451:2017, ISO 11616, PhPID, IDMP, identification of medicinal products, pharmaceutical product identification, health informatics, HL7, regulated pharmaceutical product information.

Standards Content (Sample)

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 2017
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
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Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

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
Bibliography .48
iv © ISO 2017 – All rights reserved

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.
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.
vi © ISO 2017 – All rights reserved

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
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 %)];
2 © ISO 2017 – All rights reserved

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
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.
4 © ISO 2017 – All rights reserved

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
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 moieties with a corresponding strength)
(cardinality relationship: 1.*) as it relates to the strength of one to many active substances/specified
substances (cardinality relationship: 1.*).
6.5 Representation of strength concentration
For liquid preparations, strength shall be represented by both the total volume of the container
as authorised by a Medicines Regulatory Authority using strength (presentation) and strength
concentration per unit volume (e.g. 1 ml) using strength (concentration). For PhPID generation and
assignment, the strength shall be expressed per total volume per container (MPID and PCID) with the
corresponding strength concentration per unit volume represented in every instance of PhPID Levels 2
and 4. Both representations shall be considered mandatory elements when illustrating the strength of
a pharmaceutical product.
The strength concentration per unit volume shall be calculated from the strength per total volume of
the container and presented at all PhPID levels where strength is represented in accordance with the
product authorisation by a Medicines Regulatory Agency.
A PhPID shall be generated to represent a strength concentration per unit volume regardless of whether
this unit volume is additionally represented as strength per an actual volume within a container
presentation. This PhPID will be an abstract PhPID and shall be referred to as a pharmaceutical product
concept code (PPCC). The PPCC is necessary to support e-prescribing/e-dispensing activities in cases
where what is prescribed is simply a given strength concentration per unit volume with no reference to
the strength per total volume per container as authorised by a Medicines Regulatory Agency.
The strength per unit volume shall be included as a data element and mapped to the strength per total
volume at all applicable PhPID levels to support the interoperability and exchange of pharmaceutical
product data.
The calculation and mapping of strength concentration per unit volume to the strength per total volume
at all applicable PhPID levels shall be addressed during regional implementation and maintenance of
this document.
See Annex D for examples of representation of strength.
6.6 Pharmaceutical product identifier (PhPID)
The PhPID is a globally unique identifier assigned at the level of the pharmaceutical product and
utilises the identifying characteristics as outlined below. For products that need to be reconstituted
in accordance with the authorisation by a Medicines Regulatory Authority before they can be
administered, the PhPID shall refer to the characteristics of the product after reconstitution.
6 © ISO 2017 – All rights reserved

Figure 1 — Detailed model of the pharmaceutical product identification (PhPID)
NOTE For more detailed information regarding the specific data elements classifying a particular
substance(s) and specified substance(s), see ISO 11238 and ISO/TS 19844. The details of these elements are
defining attributes for pharmaceutical product identification and assignment of PhPIDs.
6.7 PhPID algorithm and product code concept
The PhPID algorithm can be created by computing the MD5 digest over a data structure describing the
identifying characteristics for pharmaceutical product identification as described in ISO 11616 and this
document. MD5 hash codes are a 128 bit (16 byte) number which, in hexadecimal presentation, is 32
digits long. The hexadecimal digits are formatted in groups of 8-4-4-4-12 digits separated by hyphens.
To generate a single, unique PhPID, it is necessary to define rules for each of the elements to be used
as inputs.
Figure 2 shows a conceptual representation of the PhPID algorithm. Please note that this conceptual
representation does not represent all inputs (e.g. adjuvants or devices) which are also defining PhPID
generation as applicable. The conceptual representation, illustrating an MD5 digest, is a pipe-delimited
sequence of form code (dose form), followed by the active ingredients separated by the “pipe delimiter”
(“|”) in alphabetic order of their substance code (e.g. UNII). Each active ingredient is represented by the
active ingredient code and the strength.
The non-proprietary name shall be included as part of the PhPID substance level nomenclature.
The human readable PhPID nomenclature shall be represented by the non-proprietary name (e.g. INN,
USAN) of the pharmaceutical product, active substance(s), pharmaceutical dose form, strength, and
reference strength. In addition, the adjuvant and device name can be described as part of the PhPID
nomenclature as applicable.
NOTE For examples of PhPID for products containing adjuvant(s) and device(s), please refer to regional
implementation guides.
Figure 2 — Conceptual representation of the PhPID construction
7 Ingredient, substance and strength
7.1 General considerations
This clause describes the ingredients of the pharmaceutical product through its representations as
the manufactured item(s) as indicated within a jurisdiction (see ISO 11615) and the pharmaceutical
product(s).
The ingredients class and associated active substance, specified substance, strength and reference
strength classes are used in the further description of manufactured item as indicated within a
jurisdiction (see ISO 11615) and pharmaceutical product class.
Any active substance(s) or specified substance(s) shall have its strength specified in accordance with
the pharmaceutical product information as applicable. Additionally, strength can be further specified
by description of reference strength. This shall be specified where applicable in accordance with the
pharmaceutical product information.
EXAMPLE Paracetamol 600 mg can be represented as 0,6 g in one jurisdiction and 600 mg in another
jurisdiction, but will be assigned identical PhPID sets as the strengths are identical but with different
representations.
When described, reference strength shall specify the active substance and specified substance that it
references.
Pharmaceutical product and their ingredients as well as the device and adjuvant ingredients of interest
are represented within the UML model in the manner shown in Figure 3.
Messaging relating to ingredient, substance and strength shall be in accordance with Annex A.
8 © ISO 2017 – All rights reserved

Figure 3 — Ingredients, substance and strength section detailed description diagram
7.2 Ingredient
There shall be one instance of the ingredient class for each actual ingredient of either the manufactured
item or pharmaceutical product.
7.2.1 Ingredient role
User guidance The role of the ingredient as part of the manufactured item/pharmaceutical
product shall be specified using an appropriate controlled vocabulary. The con-
trolled term and a term identifier shall be specified.
There is a constraint that each ingredient shall be further described as either an
active substance(s) or a specified substance(s).
Example(s) —  Active substance
—  Adjuvant
Conformance Mandatory
OID Substance/specified substance code concept per regional implementation of
ISO 11238 and ISO/TS 19844.
Table 2 lists the ingredient codes applicable to PhPID; the codes are included in the full upper case
letters exactly as specified in Table 2.
Table 2 — Ingredient roles (classCodes)
Code Description
ACTI Active ingredient — ingredient that has the pharmacological action. Use only if basis of strength
cannot be specified; otherwise, use ACTIB, ACTIM, or ACTIR.
ACTIB Active ingredient, where the entire substance is the basis of strength, e.g. propranolol hydrochloride
quantified as the propranolol hydrochloride salt.
ACTIM Active ingredient, where the active moiety is the basis of strength, e.g. amoxicillin trihydrate
equivalent to 250 mg anhydrous amoxicillin.
ACTIR Active ingredient, where another reference substance is the basis of strength, e.g. metoprolol
succinate quantified by amount of metoprolol tartrate with the equal amount of metoprolol active
moiety.
ADJV Adjuvant — ingredient which augments or promotes the pharmacological effect of the active
ingredient(s) without itself being considered active (typically used with vaccines).
7.2.2 Substance
A substance can be specified for an ingredient in the role described.
User guidance The substance shall be described in accordance with ISO 11238, ISO/TS 19844
and its resulting terminology. A term and a term identifier shall be used.
NOTE  For further details, refer to ISO 11238 and ISO/TS 19844.
Example(s) —  Insulin human
—  Amoxicillin trihydrate
Conformance Mandatory
OID Substance/specified substance code concept per regional implementation
guidelines for ISO 11238 and ISO/TS 19844.
7.2.3 Specified substance
A specified substance can be specified for an ingredient in the role described.
NOTE The overall specified substance category is optional. The conformance criteria below correspond to
jurisdictions which chose to implement specified substance category in their respective regions.

User guidance When a specified substance is described, it shall be presented in accordance
with ISO 11238, ISO/TS 19844, and its resulting terminology. A term and a term
identifier shall be used.
NOTE  For further details, refer to ISO 11238 and ISO/TS 19844.
Example(s) —  Specified Substance Group 1: simeticone
—  Specified Substance Group 2: insulin human crystalline — rDNA
manufacturer A
—  Specified Substance Group 3: water for injection (USP)
—  Specified Substance Group 4: insulin human crystalline — rDNA
manufacturer A — highly purified (USP) — produced by three critical processes
Conformance Conditional
OID Substance/specified substance code concept per regional implementation
guidelines for ISO 11238 and ISO/TS 19844.
7.2.4 Specified substance group
User guidance The group to which a specified substance is assigned in accordance with
ISO 11238, ISO/TS 19844, and its resulting terminology can be specified. A term
and a term identifier shall be used.
Example(s) —  Specified Substance Group 1
—  Specified Substance Group 2
Conformance Conditional
OID Substance/specified substance code concept per regional implementation
guidelines for ISO 11238 and ISO/TS 19844.
10 © ISO 2017 – All rights reserved

7.2.5 Confidentiality indicator
User guidance The confidentiality level of the substance/specified substance information
described for the ingredient can be specified using an appropriate controlled
vocabulary. The controlled term and a term identifier shall be specified. It is
applicable for the all the strata when the active substance(s) and specified sub-
stance(s) is determined to be confidential/trade secret.
Example(s) —  Confidential
—  Trade secret
—  No restriction
Conformance Mandatory
OID Substance/specified substance code concept per regional implementation
guidelines for ISO 11238 and ISO/TS 19844.
7.2.6 Strength
The strength of the substance or specified substance shall be specified as a quantity of the
substance/specified substance present in a given pharmaceutical product. A numerator value and
numerator unit as well as a denominator value and denominator unit shall be specified.
Strength can be expressed in two ways: strength (presentation) and strength (concentration).
When the strength of a pharmaceutical product that has undergone a transformation (e.g.
reconstitution) is to be specified, it shall be specified using the strength resulting from transformation
undertaken exactly in accordance with the regulated product information.
7.2.7 Pharmaceutical product code concept for representing the normalised strength for liquid
preparations
A product code concept PhPID as described for liquid preparations (e.g. volume per container and at the
unit level) shall be included.
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
presentation of a liquid preparation (i.e. total volume per container) as authorised by a medicines
regulatory agency.
EXAMPLE PhPID for a 5 mg/5 ml container as approved and labelled with PhPID representing the
pharmaceutical product at the 1 mg/ml unit level.
NOTE All pharmaceutical products, regardless of the total volume per container, would share the product
code concept PhPID as an addition should the concentrations be identical. The same PhPID conformance criteria
are applicable for the creation, implementation, and maintenance of the product code concept to represent
normalised strengths for liquid preparations.
7.2.8 Strength (presentation)
User guidance The strength (presentation) shall be specified. It is defined as the quantity or
range of quantities of the substance/specified substance present in the dosage
form, unit of presentation, or in the volume (or mass) of the single pharmaceuti-
cal product or manufactured item.
When required for expression of strength, the unit of presentation shall be
specified in accordance with ISO 11240, ISO 11239, ISO/TS 20440 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 pharma-
ceutical 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 vocab-
ulary shall be specified.
Example(s) —  20 mg (per “each” tablet — as a unit of presentation)
—  10 mg/5 ml
—  3,1 g/5 ml to 3,7 g/5 ml
Conformance Mandatory
Where the strength is defined on the basis of a “unit of presentation”, the term and term identifier shall
be used with the corresponding controlled vocabulary.
NOTE The “unit of presentation” is the same as the form code of the product containing the ingredient.
7.2.9 Strength (concentration)
User guidance The strength (concentration) can be specified. It is defined as a quantity or
range of quantities of the substance/specified substance present per unitary
volume (or mass). For example:
—  2 mg/ml;
—  1,55 g/ml to 1,85 g/ml.
NOTE 1  This attribute is only required when the strength (presentation) at-
tribute is valued with the denominator as a non-unitary amount. Example:
—
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