ISO/DIS 11615.2:2026(en)

ISO/TC 215

Secretariat: ANSI

Date: 2026-03-14

Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information

© ISO 2026

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.

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Contents

Foreword vi

Introduction viii

1 Scope 1

2 Normative references 1

3 Terms and definitions 2

4 Message exchange format 13

5 Conformance terminology and context as it relates to the ISO IDMP standards and corresponding IDMP technical specifications 14

6 Concepts required for the unique identification of Medicinal Products 14

6.1 General considerations 14

6.2 Authorised Medicinal Products 14

6.3 Investigational Medicinal Products 15

6.4 Concepts required for the unique identification of a Medicinal Product and the association with PhPID(s) 15

6.5 Concepts required for the unique identification of Medicinal Products and the association with the marketing authorisation number 15

6.6 Concepts required for the unique identification of Medicinal Products and the association with data carrier identifiers 16

7 Description of the information modelling principles and practices 17

7.1 General considerations 17

7.2 Conceptual overview diagrams 17

7.3 High-level diagrams 18

7.4 Detailed description diagrams 18

8 Identifying characteristics for authorised Medicinal Products 20

8.1 Primary identifiers — General considerations 20

8.2 Medicinal Product Identifier (MPID) 21

8.3 Packaged Medicinal Product Identifier (PCID) 22

8.4 Medicinal Product Batch Identifier (BAID1) 23

8.5 Medicinal Product Batch Identifier (BAID2) 23

9 Information for an authorised Medicinal Product 23

9.1 Authorised Medicinal Product — Information overview 23

9.2 Medicinal Product 25

9.3 Marketing authorisation 31

9.4 Organisation 37

9.5 Manufacturer/Establishment (organisation) 40

9.6 Packaged Medicinal Product, including manufactured item and device 41

9.7 Ingredient, substance and strength 51

9.8 Pharmaceutical product and device 54

9.9 Clinical particulars 57

10 Identifying characteristics for Investigational Medicinal Products 61

10.1 General 61

10.2 Primary identifiers 61

10.3 Investigational Medicinal Product Identifier (IMPID) 62

10.4 Investigational Medicinal Product Package Identifier (IPCID) 63

10.5 Investigational Medicinal Product Batch Identifier (BAID1) 64

10.6 Investigational Medicinal Product Batch Identifier (BAID2) 64

11 Information for an Investigational Medicinal Product 64

11.1 General 64

11.2 Conceptual overview of the information for an Investigational Medicinal Product 64

11.3 Investigational Medicinal Product 66

11.4 Clinical trial authorisation 68

11.5 Manufacturer/Establishment (organisation) 70

11.6 Investigational Packaged Medicinal Product 71

11.7 Pharmaceutical product 71

11.8 Ingredient 72

11.9 Clinical particulars 72

11.10 PhPID sets 72

11.11 Device nomenclature 72

11.12 Device batch identifier 72

11.13 Physical characteristics 72

Annex A (normative) Full model — Authorised Medicinal Products detailed diagram 73

Annex B (normative) Full model — Investigational Medicinal Products detailed diagram 74

Annex C (informative) Class name and attribute translations and synonyms for the identification of medicinal products (IDMP) 75

Bibliography 76

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).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

Any invented name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of 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 www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This third edition cancels and replaces the second edition (ISO 11615:2017), which has been technically revised. It also incorporates the Amendment ISO 11615:2017/Amd 1: 2022.

The main changes compared to the previous edition are as follows:

— clarifications on the scope of ISO IDMP, including compounding products, veterinary use, and re-use of components to avoid duplication;

— adding identifiers and descriptions for manufactured items and differentiating multi-packs,;

— normalizing strength expressions, adding quantity operators, and handling complex compositions;

— adding attributes for different types of authorisations and linking orphan designations to therapeutic indications;

— additional granularity for the identification of investigational medicinal products.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

This document was developed in response to demand across regulatory, industry, and healthcare stakeholders for internationally harmonized specifications for medicinal products. It is part of a set of five ISO Standards and four ISO Technical Specifications which together provide the basis for the unique identification of medicinal products (IDMP).

These standards and technical specifications comprise:

— ISO 11615;

— ISO/TS 20443;

— ISO 11616;

— ISO/TS 20451;

— ISO 11238;

— ISO/TS 19844;

— ISO 11239;

— ISO/TS 20440;

— ISO 11240.

These documents support the regulatory activities worldwide by regions, including the development, registration and life cycle management of medicinal products, as well as pharmacovigilance and risk management.

To meet the primary objectives of the regulation of medicines and pharmacovigilance, it is paramount to exchange medicinal product information reliably, robustly and consistently. These documents therefore support, at a minimum, interactions between:

— regulatory medicines authority to regulatory medicines authority;

— pharmaceutical company to regulatory medicines authority;

— sponsor of a clinical trial to regulatory medicines authority;

— regulatory medicines authority to other stakeholders (as applicable);

— regulatory medicines authority to worldwide-maintained data sources.

Messaging specifications necessary to support these interactions are included as non-normative components of the ISO standards on IDMP. Unique identifiers produced in conformance with the IDMP standards are intended to support applications where the reliable identification and traceability of medicinal products is required.

There are many terms in use to describe basic concepts in the regulatory, pharmaceutical and healthcare standards development domain. The terms and definitions given in this document apply to the concepts required to uniquely identify, characterize and exchange regulated medicinal products and associated information. They are intended to facilitate the interpretation and application of legal and regulatory requirements.

In the context of exchange of regulatory information, the purpose of this document is twofold:

— to specify data elements, structures and relationships between the data elements (i.e., how the data objects connect to and depend on one another) that are required to uniquely and with certainty identify medicinal products for human use;

— to specify definitions of terms for all data elements required to uniquely and with certainty identify medicinal products for human use.

Reference to the use of other normative IDMP and non-normative messaging standards for medicinal product information is included in this document to support information exchange between relevant stakeholders.

Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information

This document establishes concepts and describes data elements and their structural relationships that are required for the unique identification and the detailed description of medicinal products.

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 639‑1, Codes for the representation of names of languages — Part 1: Alpha-2 code

ISO 3166‑1, Codes for the representation of names of countries and their subdivisions — Part 1: Country code

ISO 8601‑1, Date and time — Representations for information interchange — Part 1: Basic rules

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 11616, Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information

ISO/TS 19844, Health informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 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 guidelines 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

ISO/TS 20451, 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/IEC 5218, Information technology — Codes for the representation of human sexes

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp

— IEC Electropedia: available at https://www.electropedia.org/

3.1.1

adjuvant

component that potentiates either the immune response to an antigen or modulates it towards the desired immune response, or both

[SOURCE: ISO/FDIS 22532, 3.1]

3.1.2

administrable dose form

administered dose form

pharmaceutical administrable dose form

pharmaceutical dose form (3.1.38) for administration to the patient

Note 1 to entry: Transformation of the manufactured items and their corresponding manufactured dose forms are in some cases necessary before administration

Note 2 to entry: The administrable dose form is identical to the manufactured dose form (3.1.19) in cases where no transformation of the manufactured item is necessary (i.e., where the manufactured item is equal to the pharmaceutical product)

[SOURCE: ISO/FDIS 22532, 3.2]

3.1.3

administration device

equipment intended for correct administration of the medicinal product (3.1.50)

Note 1 to entry: An administration device may be an integral part of an immediate container (3.1.27) or a closure.

[SOURCE: ISO/TS 19256:2016]

3.1.4

allergen

substance used as ingredient (3.1.28) or in a device capable of stimulating a type-I hypersensitivity and allergic reaction

[SOURCE: ISO/FDIS 22532, 3.3 – modified, Note 1 to entry has been omitted]

3.1.5

authorization date

date when the authorization was granted by a medicines regulatory agency (3.1.56) following a specific regulatory activity

3.1.6

authorization status

phase of the marketing authorization (3.1.40) during its life cycle

Note 1 to entry: The status indicates a particular moment in its life cycle.

3.1.7

batch

specific quantity of a drug or other material (3.1.47) 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

3.1.8

batch number

identifier (3.1.26) assigned to a specific batch (3.1.8) of a medicinal product (3.1.50) or item resulting from a manufacturing process at a specific point of time

3.1.9

characteristic

abstraction of a property of an object

3.1.10

clinical trial

clinical study

investigation in human subjects intended to discover or verify the clinical, pharmacological or other pharmacodynamic effects of an investigational product(s), or to identify any adverse reactions to an investigational medicinal product(s) (3.1.31), or to study absorption, distribution, metabolism and excretion of investigational medicinal product(s) (3.1.31) with the object of ascertaining its safety and/or efficacy

3.1.11

clinical trial authorization

approval given by a medicines regulatory agency (3.1.56) to conduct a clinical trial (3.1.11) in a region (3.1.73)

3.1.12

class

set of objects that share the same specifications of features, constraints, and semantics

3.1.13

combined pharmaceutical dose form

two or more manufactured items (3.1.37) that are intended to be combined in a specific way to produce a single pharmaceutical product

EXAMPLE The term “powder and solvent for solution for injection” articulates a combined pharmaceutical dose form wherein the medicinal product comprises a powder and a solvent, both intended for solution for injection. Once combined, these items produce an administrable dose form: “solution for injection”.

Note 1 to entry: includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product.

[SOURCE: ISO/FDIS 22532, 3.5 – modified – Note 1 to entry has been omitted]

3.1.14

common name

generic name

international non-proprietary name

official non-proprietary or generic name recommended by the World Health Organization (WHO), or, if one does not exist, a non-proprietary name recommended by the region (3.1.73) within which the name is used

[SOURCE: ISO/TS 5384:2024, 3.3]

3.1.15

container

item of packaging that is part of a medicinal product (3.1.50) and is used for storage, identification or transport of the components of the medicinal product

3.1.16

contraindication

situation in which use of the medicinal product (3.1.50) is considered inadvisable for safety reasons

3.1.17

controlled vocabulary

controlled terminology

finite set of values that represent the only allowed values for a data item

Note 1 to entry: The allowed values can be codes, text or numeric.

[SOURCE: ISO/FDIS 22532, 3.8]

3.1.18

device listing number

number assigned by a medicines regulatory agency (3.1.56) during registration or listing to all devices in commercial distribution, regardless of pre-market authorization requirements, per regional registration and listing requirements

3.1.19

device model number

identifier (3.1.26) assigned by a medical device manufacturer (3.1.38) to a particular design or version of a medical device (3.1.49)

3.1.20

distributor

organization in possession of a license covering the procuring, holding, supplying or exporting of medicinal products (3.1.50), apart from supplying medicinal products to the public

Note 1 to entry: This is applicable to “wholesale distribution of medicinal products”.

3.1.21

dose

specified quantity of a medicine, to be taken at one time or at stated intervals

3.1.22

global trade item number

GTIN

Global Standards 1 (GS1) unique identifier (3.1.26) of items that are traded [e.g. pharmaceuticals, medical devices (3.1.49)] in the supply chain

Note 1 to entry: 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.

3.1.23

identifier

descriptor adequate to represent an entity uniquely in a specific context, ensuring its distinction from other entities

Note 1 to entry: In the realm of medicinal products, an identifier consists of a set of identifying characteristics that, when combined, unambiguously distinguish a medicinal product, pharmaceutical product, substance, specified substance, route of administration, pharmaceutical dose form, or any other element necessitating unique recognition.

Note 2 to entry: Identifiers may be represented through various forms such as alphanumeric codes, global unique identifiers (GUID) / universally unique identifier (UUID), or other internationally accepted coding systems. When applied to organizations or locations, an international system for unique identifiers may be utilized in accordance with regional regulatory requirements.

Note 3 to entry: The purpose of an identifier is to provide clarity and precision in the tracking, regulation, and management of entities within the pharmaceutical environment, as established by recognized standards.

[SOURCE: ISO/FDIS 22532, 3.12]

3.1.24

immediate packaging

immediate container

primary packaging

container or other form of packaging directly in contact with the manufactured item (3.1.37) or pharmaceutical product

Note 1 to entry: An immediate container can be fitted with or have integrated into it an administration device (3.1.3) 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 (3.1.16).

[SOURCE: ISO 21976:2018 – Term “medicinal product” replaced with “manufactured item or pharmaceutical product”]

3.1.25

ingredient

substance utilized in the formulation of a pharmaceutical product or manufactured item, with a defined role and a defined strength

Note 1 to entry: The ingredient is part of a medicinal product (3.1.50), either alone or in combination with other ingredients. The ingredient is also a component of a pharmaceutical product. Ingredient is equal to a substance (3.1.80) with the indication of the specific role it is playing in the product.

[SOURCE: ISO/FDIS 22532, 3.13]

3.1.26

intermediate packaging

container (3.1.16) between the outer packaging (3.1.57) and the immediate packaging (3.1.27)

3.1.27

invented name

trade name

brand name

proprietary name for a medicinal product (3.1.50) as authorised by a medicines regulatory agency (3.1.56) in a region (3.1.73)

3.1.28

investigational medicinal product

IMP

pharmaceutical product, combination of pharmaceutical products, or placebo(s) subject to investigation in a clinical trial (3.1.11) and authorized for investigation by a medicines regulatory agency within a given region

Note 1 to entry: An investigational medicinal product can be an entirely new pharmaceutical product (i.e. one not having received marketing authorisation) or an already authorised product that is being explored further. Hence, this includes products with existing marketing authorisation that are being tested or used in a manner differing from the authorised form, are employed for an indication not authorised, or are under investigation to collect additional data pertaining to the authorised form.

Note 2 to entry: The investigational use of a medicinal product encompasses variations in its formulation, packaging, dosing, route of administration, or indication from those which have been authorised.

Note 3 to entry: Each investigational medicinal product is identified and characterised uniquely by an IMPID (investigational medicinal product identifier) and is authorised for investigation by a medicines regulatory agency within a given region.

[SOURCE: ISO/FDIS 22532, 3.15]

3.1.29

investigational medicinal product identifier

unique identifier (3.1.26) allocated to an investigational medicinal product (3.1.31) supplementary to any existing identifier as ascribed by a medicines regulatory agency (3.1.56) in a region (3.1.73) or jurisdiction (3.1.34) or a sponsor of a clinical trial (3.1.11)

Note 1 to entry: This is an alphanumeric text field.

Note 2 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products (3.1.50) worldwide.

3.1.30

investigational medicinal product package identifier

unique identifier (3.1.26) allocated to an investigational packaged medicinal product at package level supplementary to any existing identifier as ascribed by a medicines regulatory agency (3.1.56) in a region (3.1.73) or jurisdiction (3.1.34) or a sponsor of a clinical trial (3.1.11)

Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products (3.1.50) worldwide.

3.1.31

jurisdiction

specific geographical area within a country or region (3.1.73) or the particular domain of authority and responsibility, to which a medicines regulatory agency’s (3.1.56) oversight and regulations apply

Note 1 to entry: Jurisdiction refers to the territorial scope within which medicinal product names, marketing authorisations, and clinical trial approvals are relevant and enforceable. It defines the legal and regulatory boundaries for the medicines regulatory agency's activities.

[SOURCE: ISO/FDIS 22532, 3.16]

3.1.32

legal status of supply

classification determined by regional or jurisdictional regulation that dictates the way that a medicinal product or package can be dispensed to a patient or consumer

Note 1 to entry: The legal status of supply is a key regulatory attribute of a medicinal product that defines the conditions under which the product is made available to the public within a given jurisdiction.

Note 2 to entry: The medicinal product's legal status of supply is classified and specified by the regulatory medicines agency and is an essential element in the product's regulatory profile.

[SOURCE: ISO/FDIS 22532, 3.17, modified – Note 2 to entry has been omitted]

3.1.33

manufactured dose form

pharmaceutical dose form of a manufactured item (3.1.37) as supplied by the manufacturer

EXAMPLE: Powder for solution for injection

Note 1 to entry: The manufactured dose form is identical to the administrable dose form (3.1.2) in cases where no transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the pharmaceutical product).

[SOURCE: ISO/FDIS 22532, 3.18]

3.1.34

manufactured item

MI

<medicinal products> qualitative composition (3.1.70) and quantitative composition (3.1.71) containing one or more ingredients in specific dose form

Note 1 to entry: A manufactured item may be contained in the packaging of a medicinal product as made available to the market or investigational medicinal product as used in a clinical trial.

Note 2 to entry: A medicinal product (3.1.50) or investigational medicinal product can comprise one or more manufactured items, which may be equivalent to the final pharmaceutical product or may differ from it if further processing is required before administration to the patient.

Note 3 to entry: The manufactured item encompasses the actual physical form of the product delivered by the manufacturer, such as a tablet, capsule, liquid, or cream, and is intended to be the entity that is ultimately dispensed or used in a clinical trial.

Note 4 to entry: In instances where a transformation of the manufactured item is required, the product's final administered form, known as the pharmaceutical product, may differ from the initial manufactured item.

[SOURCE: ISO/FDIS 22532, 3.19, modified – Note 5 to entry was omitted]

3.1.35

manufacturer

establishment

organization that holds the authorization for the manufacturing process

3.1.36

manufacturing authorization

authorization provided by a medicines regulatory agency (3.1.56) to manufacture medicinal products (3.1.50) within a region (3.1.73)

Note 1 to entry: 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 is not necessarily 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 authorised in a region to carry out such processes.

3.1.37

marketing authorization

official permission issued by a medicines regulatory agency that allows a medicinal product to be placed on the market in a specific region

Note 1 to entry: This authorisation is a regulatory procedure that must be issued before a medicinal product can be marketed.

Note 2 to entry: The marketing authorisation is identified by marketing authorisation number (3.1.23), and marketing authorisation holder.

[SOURCE: ISO/FDIS 22532, 3.21, modified]

3.1.38

marketing authorization holder

organization that holds the authorization for marketing a medicinal product (3.1.50) in a region (3.1.73)

3.1.39

marketing authorization number

unique identifier assigned by a medicines regulatory agency that designates the marketing authorization granted for a medicinal product within its jurisdiction.

[SOURCE: ISO/FDIS 22532, 3.22, modified]

3.1.40

marketing authorization procedure

authorization procedure

formal procedure applied by a medicines regulatory agency (3.1.56) to grant a marketing authorization (3.1.40), amend an existing one, extend its duration or to withdraw it

3.1.41

marketing start date

date when the authorised medicinal product is marketed in a region (3.1.73)

Note 1 to entry: The date of actual marketing of a medicinal product (3.1.50) is always after a marketing authorization (3.1.40) has been granted by a medicines regulatory agency (3.1.56).

3.1.42

marketing stop date

date when the marketing of the authorised medicinal product is stopped in a region (3.1.73)

3.1.43

marketing status

specification of whether the product is actively marketed, has ceased marketing temporarily or permanently, has been withdrawn from the market, or has not been marketed within a specific country or jurisdiction

Note 1 to entry: The marketing status also reflects the legal status of supply, categorizing the medicinal product as either prescription-only or non-prescription, and any other conditions or restrictions on its distribution.

Note 2 to entry: Additional information pertaining to the marketing status may be required to address local variations within the jurisdiction, such as state, provincial, or territorial differences.

[SOURCE: ISO/FDIS 22532, 3.23, modified]

3.1.44

material

<medicinal product> entity that has mass, occupies space and consists of one or more substances (3.1.80) of which a certain packaging or device is made

Note 1 to entry: This applies to a medicinal product package item [container (3.1.16)], package (component) and device.

[SOURCE: ISO/FDIS 22532, 3.24]

3.1.45

measurement point

physical location on an administration device (3.1.3) where the quantity of the medication being delivered is measured at the time of delivery

Note 1 to entry: The measurement point is critical for certain medicinal products where the strength and efficacy are dependent on the precise location at which the dosage is quantified, such as the distance from the point of aerosolization in inhalers.

[SOURCE: ISO/FDIS 22532, 3.25]

3.1.46

medical device

instrument, apparatus, appliance, software, material (3.1.47) or other article, whether used alone or in combination, including the software intended by its manufacturer (3.1.38) 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

[SOURCE: ISO/FDIS 22532, 3.26]

3.1.47

medicinal product

pharmaceutical product or combination of pharmaceutical products that may be administered to human beings (or animals) for treating or preventing disease, with the aim and purpose of making a medical diagnosis or to restore, correct or modify physiological functions

Note 1 to entry: A medicinal product may contain in the packaging one or more manufactured items (3.1.37) and one or more pharmaceutical products. In certain regions (3.1.73), a medicinal product may also be defined as any substance (3.1.80) or combination of substances which may be used to make a medical diagnosis.

Note 2 to entry: The provisions in this document 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 authorised by a medicines regulatory agency (3.1.56). 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 [see 11.2)] and to iv) intermediate products intended for subsequent processing by an authorised manufacturer (3.1.38).

[SOURCE: ISO/FDIS 22532, 3.27]

3.1.48

medicinal product batch identifier 1

unique identifier (3.1.26) allocated to a specific batch (3.1.8) of a medicinal product (3.1.50), which appears on the outer packaging (3.1.57) of the medicinal product

Note 1 to entry: It is constructed by using the batch number (3.1.9) assigned by the manufacturer (3.1.38) 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.

3.1.49

medicinal product batch identifier 2

unique identifier (3.1.26) allocated to a specific batch (3.1.8) of a medicinal product (3.1.50), which appears on the immediate packaging, where this is not the outer packaging (3.1.57)

Note 1 to entry: It is constructed by using the batch number (3.1.9) assigned by the manufacturer (3.1.38) 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 (3.1.27).

3.1.50

medicinal product identifier

unique identifier (3.1.26) allocated to a medicinal product (3.1.50) supplementary to any existing authorization number as ascribed by a medicines regulatory agency (3.1.56) in a region (3.1.73)

Note 1 to entry: This is an alphanumeric text field.

Note 2 to entry: This is for indexing purposes and to contribute to improved patient safety by allowing for the unique identification of medicinal products worldwide.

3.1.51

medicinal product name

official designation of a medicinal product (3.1.50) as authorised by a medicines regulatory agency (3.1.56)

Note 1 to entry: A medicinal product name may consist of invented name (3.1.30), a common name (3.1.14) or scientific name with or without a trade mark, or other descriptor as appropriate.

Note 2 to entry: The medicinal product name is a principal attribute of a medicinal product and its medicinal product identifier (MPID) and is critical for its official recognition and differentiation in the marketplace.

Note 3 to entry: A medicinal product may be associated with multiple names, including proprietary and non-proprietary names, which may vary across jurisdictions and may be presented in different languages as per local regulatory requirements.

Note 4 to entry: A medicinal product name may include additional characteristics such as strength, pharmaceutical form, intended use, or an administration device, which can be represented in a structured format for clarity and precision.

Note 5 to entry: The marketing authorization, typically granted to a single marketing authorization holder, encompasses the medicinal product name, which is critical for regulatory compliance and market placement.

[SOURCE: ISO/FDIS 22532, 3.28, modified]

3.1.52

medicinal product package identifier

unique identifier (3.1.26) allocated to a packaged medicinal product (3.1.59) supplementary to any existing authorization number as ascribed by a medicines regulatory agency (3.1.56) in a region (3.1.73)

Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products worldwide.

3.1.53

medicines regulatory agency

institutional body that, according to the legal system under which it has been established, is responsible for the granting of marketing authorizations (3.1.40), clinical trial authorizations (3.1.12) and manufacturing authorizations (3.1.39) for medicinal products (3.1.50)

Note 1 to entry: In certain regions (3.1.73), 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.

3.1.54

outer packaging

external container in which a medicinal product (3.1.50) is supplied

Note 1 to entry: The manufactured item (3.1.37) or pharmaceutical product (3.1.60) is not in direct contact with the outer packaging except where the outer packaging also serves as the immediate container (3.1.27). An alternative, compatible definition of outer packaging is given in Directive 92/27/EEC.

3.1.55

package item

<container> individual, distinct item(s) contained in a packaged medicinal product (3.1.59) which act as containers (3.1.16) for manufactured item(s) (3.1.37)

3.1.56

packaged medicinal product

medicinal product (3.1.50) contained within a package, which incorporates all the packaging components and containers intended for sale or supply

Note 1 to entry: The packaged medicinal product is an entity not only encompassing the medicinal product but also the complete packaging system, any associated devices that are an integral part of the product or provided in combination with it, and the detailed ingredient information for the contained item(s).

Note 2 to entry: As an overarching class, packaged medicinal product encompasses both the regulatory dimension, describing the authorized presentation and its identification with the Package Item Identifier (PCID)), as well as the sale and supply dimension, describing the effectively manufactured packs, the package items (3.1.58), with all their attributes (such as size or data carrier identifier).

[SOURCE: ISO/FDIS 22532, 3.35, modified – notes to entry have been modified]

3.1.57

pharmaceutical dose form

dosage form

dose form

physical manifestation of a medicinal product (3.1.50) that contains the active ingredient(s) (3.1.28) or inactive ingredient(s) that are intended to be delivered to the patient

Note 1 to entry: “Pharmaceutical dose form” can refer to the administrable dose form (3.1.2) or the manufactured dose form (3.1.36).

3.1.58

pharmaceutical product

qualitative composition (3.1.70) and quantitative composition (3.1.71) of a medicinal product (3.1.50) in the administrable dose form approved for administration in line with the regulated product information

Note 1 to entry: The pharmaceutical product typically corresponds to the manufactured item (3.1.37) ready for administration; however, it can require transformation before being administration.

Note 2 to entry: A pharmaceutical product may comprise one or multiple dose forms and may include devices integral of the product or necessary for its administration.

Note 3 to entry: The pharmaceutical product is defined by its ingredients and any integral devices, and it is associated with a unique pharmaceutical product identifier (PhPID) set.

Note 4 to entry: In the context of clinical trials, the pharmaceutical product is described as per the clinical trial protocol, which may involve investigational medicinal products.

[SOURCE: ISO/FDIS 22532, 3.38, modified – Notes to entry 5 and 6 have been omitted]

3.1.59

pharmaceutical product identifier

PhPID

unique identifier (3.1.26) for a pharmaceutical product (3.1.60)

3.1.60

pharmacovigilance

process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines

Note 1 to entry: Pharmacovigilance is a key public health function which comprises:

— collecting and managing data on the safety of medicines;

— looking at the data to detect “signals” (any new or changing safety issue);

— evaluating the data and making decisions with regard to safety issues;

— acting to protect public health (including regulatory action);

— communicating with stakeholders;

— auditing of both the outcomes of action taken and the key processes involved.

Note 2 to entry: Those directly involved in pharmacovigilance include:

— patients as the users of medicines;

— doctors, pharmacists, nurses and all other healthcare professionals working with medicines and regulatory authorities responsible for monitoring the safety of medicines;

— pharmaceutical companies, and companies importing or distributing medicines.

3.1.61

physical characteristic

description of the height, weight, width, depth, volume, colour, shape, etc., of an item

3.1.62

primary identifier

each one of the unique IDMP identifiers (3.1.26)

Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products (3.1.50) worldwide.

3.1.63

procedure number

tracking or identification number assigned by a medicines regulatory agency (3.1.56) in relation to a specific medicine’s regulatory process

3.1.64

procedure type

type of legal process applied to authorise or maintain a medicinal product marketing authorization

3.1.65

product classification

categorisation or grouping of medicinal products (3.1.50) based on specific properties

3.1.66

product labelling

medicinal product information as authorised by a medicines regulatory agency (3.1.56) in a region (3.1.73)

Note 1 to entry: The product labelling content shall not be changed except with the approval of the originating medicines regulatory agency.

3.1.67

protocol number

identification or tracking number assigned to the clinical trial protocol

3.1.68

qualitative composition

composition of all the constituents of the investigational or authorised medicinal product (3.1.50), if applicable, before or after reconstitution and functioning of the constituents of:

— the substance (3.1.80) and specified substance (3.1.77) description;

— the excipients, whatever their nature or the quantity used, including colouring matter, preservatives, adjuvants (3.1.1), stabilisers, thickeners, emulsifiers, flavouring and aromatic substances, etc.

3.1.69

quantitative composition

amount of substance (3.1.80) and specified substance (3.1.77) constituents of the investigational or authorised medicinal product (3.1.50) expressed in a ratio scale

Note 1 to entry: It is necessary for the quantitative composition of the substance(s) or the specified substance descriptions of the finished investigational or authorised 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 2 to entry: Ratio scale is defined as continuous scale with equal sized scale values and an absolute or natural zero point

[SOURCE: ISO/IEC 23751:2022, 3.11]

3.1.70

reference strength

designated amount of substance, specified substance, or both, that serves as a benchmark for expressing the concentration or potency of an ingredient

Note 1 to entry: The reference strength is a quantitatively expressed per unit measure of the pharmaceutical product (3.1.60) or manufactured item (3.1.37).

Note 2 to entry: The determination of the reference strength involves the use of standardized terms and identifiers in accordance with ISO 11238, which ensures consistent terminology for regulatory purposes.

Note 3 to entry: Reference strength is typically associated with the active moiety of the ingredient, which is the component responsible for the pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure and function of the body.

[SOURCE: ISO/FDIS 22532, 3.43]

3.1.71

region

area, especially part of a country or the world having definable characteristics (3.1.10) but not always fixed boundaries

3.1.72

registration number

identifier (3.1.26) assigned to a clinical trial (3.1.11) by a medicines regulatory agency (3.1.56) in a region (3.1.73) for tracking purposes

3.1.73

regulated document

document issued in the context of the regulatory process to grant, maintain or update the authorization of a medicinal product (3.1.50) or in the regulatory process of the authorization and supervision of clinical trials (3.1.11)

3.1.74

route of administration

path by which the pharmaceutical product (3.1.60) is taken into or makes contact with the body

[SOURCE: ISO/FDIS 22532, 3.47]

3.1.75

specified substance

substance (3.1.80) defined by groups of elements that describes multi-substance materials (3.1.47) or specifies further information on substances relevant to the description of medicinal products (3.1.50)

Note 1 to entry: This could include grade, units of measure, physical form, constituents, manufacturer (3.1.38), critical manufacturing processes (e.g. extraction, synthetic or recombinant processes), specification and the analytical methods used to determine whether a substance is in compliance with a specification. There are four different groups of elements that can be used to define a given specified substance and specific relationships between each group of elements.

[SOURCE: ISO/FDIS 22532, 3.49]

3.1.76

sponsor

individual, company, institution or organization that takes responsibility for the initiation, management, financing, or any combination of these activities, of a clinical trial (3.1.11)

3.1.77

strength range

interval defined by a lower and an upper limit of the amounts of substance (3.1.80) and specified substance (3.1.77) constituents of the investigational or authorised medicinal product (3.1.50)

3.1.78

substance

matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical

Note 1 to entry: A substance can be a moiety. A moiety is an entity within a substance that has a complete and continuous molecular structure. The strength of a pharmaceutical product (3.1.60) is often based on what is referred to as the active moiety of the molecule, responsible for the physiological or pharmacological action of the drug substance. Chemically, the active moiety of a stoichiometric or non-stoichiometrical substance molecule is considered that part of the molecule that is the base, free acid or ion molecular part of a salt, solvate, chelate, clathrate, molecular complex or ester.

[SOURCE: ISO/FDIS 22532, 3.54]

3.1.79

target population

type of patients or consumers for which the indication of a medicinal product (3.1.50) is authorised or is under investigation

3.1.80

therapeutic indication

target disease or condition for which the medicinal product (3.1.50) is authorised or under investigation

3.1.81

trademark

distinctive sign or indicator used by an individual, business organization or other legal entity to identify that the associated products or services to consumers originate from a unique source, and to distinguish those products or services from those of other entities

3.1.82

unit of presentation

discrete countable entity in which a pharmaceutical product (3.1.60) or manufactured item (3.1.37) is presented, in cases where strength or quantity is expressed referring to one instance of this countable entity

Note 1 to entry: A unit of presentation can have the same name as another controlled vocabulary (3.1.18), such as a basic dose form or a container (3.1.16), but the two concepts are not equivalent, and each has a unique controlled vocabulary term identifier (3.1.26).

[SOURCE: ISO/FDIS 22532, 3.55]

3.1.83

vocabulary

terminological dictionary which contains designations and definitions from one or more specific subject fields

[SOURCE: ISO/FDIS 22532, 3.57]

In the context of this document, the non-normative message exchange formats to be utilised as reference in transactions are HL7 V3, Structured Product Labelling (SPL), and FHIR. Solutions for creating SPL files and FHIR messages range from simple software tools to fully integrated information management systems. SPL instances (code snippets) and IDMP to FHIR mappings are provided in ISO/TS 20443 to illustrate the representation of an IDMP concept within the HL7 SPL/CPM and FHIR message exchange format. Technical conformance criteria for SPL or FHIR messages are not addressed in this document nor in ISO/TS 20443 and shall be left to regional guidance and implementation per their respective requirements. A reference to the most up-to-date HL7 CPM SPL and FHIR references as a resource for IDMP implementation is accessible on the HL7 website: http://www.hl7.org.

— Mandatory: Defining elements necessary for the unique identification of medicinal products per the ISO documents on IDMP.

— 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 or pharmaceutical product. Regional implementation of the ISO documents on IDMP 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 necessary for the unique identification of medicinal or pharmaceutical products according to the ISO documents on IDMP. Regional implementation of the ISO standards on IDMP and technical specifications may change optional conformance categories to “mandatory” or “conditional” to meet regional requirements.

This document defines the concepts required for the unique identification of medicinal products at an international level, wherever such recognition is required (e.g. in the area of pharmacovigilance, worldwide adverse event reporting and risk management).

Regions have systems for issuing marketing authorization numbers, package identifiers, batch numbers, and bar codes. The additional identifiers defined in this document provide an indexing mechanism supplementary to these existing systems and do not replace them.

Such identification shall follow the principles described below.

The unique identification of authorised 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 recognise, monitor and trace the use of medicinal products;

b) the assignment of a unique medicinal product package identifier (PCID) to reliably recognise and trace medicinal products as packaged for sale or supply;

c) the assignment of a unique medicinal product batch identifier (BAID1) to reliably recognise 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 recognise 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.

The unique identification of investigational medicinal products and the description of their main characteristics shall apply the following principles:

a) the assignment of a unique investigational medicinal product identifier (IMPID) to reliably recognise, monitor and trace the use of investigational medicinal products which are studied in clinical trials;

b) the assignment of a unique investigational medicinal product package identifier (IPCID), where applicable, to reliably recognise and trace the investigational medicinal product as packaged for supply during clinical trials;

c) the assignment of a unique investigational medicinal product batch identifier 1 (IBAID1), where applicable, to reliably recognise and trace a batch number which appears on the outer packaging of the investigational medicinal product in compliance with the requirements of the clinical trial authorization;

d) the assignment of a unique investigational medicinal product batch identifier 2 (IBAID2), where applicable, to reliably recognise and trace a batch number which appears on the immediate packaging of the investigational medicinal product, where this is not the outer packaging, in compliance with the requirements of the clinical trial authorization.

This document defines the concepts required to associate regulated medicinal products (authorised or under investigation in a clinical trial) with the appropriate PhPID(s) as described in ISO 11616. Such an association shall apply all of the following principles:

a) a medicinal product may relate to one or more pharmaceutical products as part of a treatment regimen (e.g. a kit containing vaginal tablets 500 mg and a vaginal cream 10 %);

b) the characterisation of the pharmaceutical product(s) using the active substance(s) or specified substance(s), the (reference) strength thereof, the pharmaceutical (administrable) dose form(s) and any medical device being an integral part of the medicinal product (e.g. a scaffolding for cell-based medicinal product);

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 with the pharmaceutical product(s) using the PhPID(s);

e) the association of the regulated investigational medicinal product with the authorized medicinal products with the pharmaceutical product(s) using the PhPID(s).

Section 6.5 outlines the principles governing the assignment of marketing authorization numbers by medicines regulatory agencies and defines how medicinal product identifiers (MPIDs) and package identifiers (PCIDs) shall be associated with those authorization numbers.

A marketing authorization number assigned to a medicinal product by a regional medicines regulatory agency may apply in accordance with one of the following principles.

Assignment to a medicinal product without pack size differentiation

Under this approach, a single marketing authorization number refers to the medicinal product irrespective of variations in pack size. (Refer to Examples A1–A2 in Table 1.)

Assignment to a medicinal product and its package(s)

In this scenario, the authorization number supports differentiation at both the product level and the package level. Product strengths or compositions can have distinct product-level authorization numbers, while package configurations receive additional package-level identifiers. (Refer to Examples B1–B4 in Table 1.)

Assignment to each medicinal product presentation

Where regulatory policy requires individual presentations to be distinguished, each presentation (e.g., strength, pharmaceutical form, volume, container type) receives its own marketing authorization number. (Refer to Examples C1–C2 in Table 1.)

Certain medicinal products may be legally distributed without a formal marketing authorization within a region (commonly referenced as “grandfathered products”). For such products, a distribution licensing number shall be assigned. This number must appear on the package, container, or package insert.

To ensure consistent and unambiguous identification, the following principles apply regarding associations between identifiers and authorization numbers.

Association of the MPID with marketing authorization number

Each MPID shall be associated with the applicable marketing authorization number corresponding to the medicinal product it represents. (Refer to Example D1 in Table 1.)

Association of the PCID with marketing authorization number

Each PCID shall be associated with the applicable marketing authorization number corresponding to the specific package or presentation it represents. (Refer to Example D2 in Table 1.)

Table 1 — Examples illustrating marketing authorization number assignment principles

Data carrier identifiers uniquely identify items that are traded (e.g. pharmaceuticals, medical devices) in the supply chain. For example, a data carrier identifier 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.

The basic 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).

A modification to any of the basic elements that characterise a trade item usually leads to a change in the data carrier identifier. Additional data can be included with the data carrier such as batch number and expiration date. For more information, please see ISO/TS 16791 – Health informatics – Requirements for international machine-readable coding of medicinal product package identifiers.

The information modelling in this document uses the Unified Modeling Language (UML), which is maintained by the Object Management Group (OMG).

UML can say the same thing in several different ways, and there are different styles and patterns that may be followed. The use of UML in this document has been kept very simple, using classes, attributes and basic association relationships only; some constructs (such as stereotypes and complex relationships) have been avoided for this reason. In addition, colour has been used in the diagrams to help visualise groups of associated entities together with one another (see Figure 1).

This chapter aims to explain the style that has been followed in this document.

NOTE In UML, the term “multiplicity” is used to describe the allowable number of instances that may participate in a relationship. Within this document, the term “cardinality” is used as a synonym for “multiplicity” to indicate the same concept, i.e., the minimum and maximum number of occurrences of a data element or associated object in each relationship No semantic difference is intended.

Figure 1 — Legend for colour coding of model classes

The conceptual overview diagram provides a framework with which to view the more detailed descriptions of information (see Figure 2).

The medicinal product and investigational medicinal product overarching models (see Figure 5 and Figure 15) show a single representative class from each particular information section, related to the core concept (either the medicinal product or the investigational medicinal product).

Basic cardinalities between the medicinal product or the investigational medicinal product and these core classes are shown, but none of the detailed entities, relationships or attributes is described.

Figure 2 — Example conceptual overview diagram

The high-level diagrams (see Figure 3) provided at the start of each subclause of information show all the classes required to describe the information for that section and the conceptual relationships between those classes, with the starting point always as the (investigational) medicinal product.

No attributes and no detailed cardinalities are shown in these conceptual diagrams, as again their primary purpose is to provide a framework with which to view the more detailed descriptions of information that follow in the detailed description diagrams.

Figure 3 — Example high-level diagram

The detailed description diagrams (see Figure 4) for each subclause show all the classes and all the attributes required to describe the information for that section and the detail of the conceptual relationships between those classes.

Figure 4 — Example detailed description diagram

Relationships between classes are described in the context of the (investigational) medicinal product, and are described simply as associations, with no further qualification as to the role or type of the association, in order to keep the model simple.

Cardinalities on relationships are given in a single direction only: the direction with the (investigational) medicinal product always as the direct or indirect source entity. The rationale for this is that the scope of this document is to describe the (investigational) medicinal product and its associated information; therefore having the (investigational) medicinal product always as the source entity brings clarification and avoids describing complex many-to-many cardinalities that might occur in a reverse direction from an entity towards the (investigational) medicinal product.

A cardinality of “1” is synonymous with a cardinality of “1..1”.

A cardinality of “1” between entities is reflected in the text as the information for that entity shall be specified and that only one set of the entity information shall be given.

A cardinality of “1..*” between entities is reflected in the text as the information for that entity shall be specified and that one or more sets of the entity information shall be given.

A cardinality of “0..1” between entities is reflected in the text as the information for that entity can be specified and that one set of the entity information can be given.

A cardinality of “0..*” between entities is reflected in the text as the information for that entity can be specified and that one or more sets of the entity information can be given.

Some optional entities can be elevated to mandatory if some conditions are met. See Clause 5.

For clarification of the use of the term “cardinality” in this document, see Note in Clause 7.1.

Refer to ISO 21090 for more information on composition of attributes.

Attributes of a class are described using an attribute name in the model. The definition, description and example values for the attribute are given in the text following the model diagram.

An attribute showing no explicit cardinality means that the attribute shall be valued with one value (this is the equivalent to [1...1]).

An attribute showing a cardinality of [1...*] means that the attribute shall be valued with one or more values.

An attribute showing a cardinality of [0...1] means that the attribute can be valued with one value.

An attribute showing a cardinality of [0...*] means that the attribute can be valued with one or more values.

Some optional attributes can be elevated to mandatory if some conditions are met. See Clause 5.

See ISO 21090 for more information on composition of attributes.

There is one use of a generalised class in the diagrams, whereby the pattern for a set of information is described once but applied for use for several classes. For simplicity, this has not been described by using the formal UML generalisation or specialisation relationships, but by using a specialised class name.

The detailed representation of an “Organization”, its “Contact Persons” and its “Other Locations” is described once in 7.4. Then, wherever information of type “Organization” with its “Contact Person(s)” and/or “Other Locations” is required, as for example in the class “Manufacturer and/or Establishment (Organization)” or the “Medicines Regulatory Agency (Organization)” class, the “(Organization)” in the class name indicates that the information shall be described as for the generalised “Organization” class.

There is also one generalised pattern used several times in the diagrams, whereby somewhat generic classes provide the ability to describe something using (unspecified) classification or nomenclature or identification systems. To do this at the conceptual level, the model shows a class with two attributes: the first, to identify the system itself (be that a classification, nomenclature or identification system), and the second, to describe the applicable term or value from that system.

Annex C provides translations and synonyms utilized in regulatory, clinical, pharmacovigilance, healthcare and by governmental organizations for IDMP class names and attributes defined in this document on an international scale.

To satisfy the requirements as described in Clause 6, the following five identifiers shall be specified:

a) Medicinal Product Identifier (MPID);

b) Medicinal Product Package Identifier (PCID);

c) Medicinal Product Batch Identifier 1 (BAID1), allocated to a specific batch of a medicinal product, which appears on the outer packaging of the medicinal product;

d) Medicinal Product Batch Identifier 2 (BAID2), allocated to a specific batch of a medicinal product, which appears on the immediate packaging, where this is not the outer packaging;

e) serialisation, package level identification of a packaged medicinal product (including the particular package configuration). Serial numbers should be numeric (numbers) or alphanumeric (include letters or numbers, or both) and should have no more than 20 characters (letters or numbers, or both).

NOTE 1 In addition, there is an association with pharmaceutical product identifiers (PhPIDs) as defined in ISO 11616 and ISO/TS 20451.

NOTE 2 Refer to regional guidance for serialisation requirements, such as the Falsified Medicines Directive (Directive 2011/62/EU).

For each authorised medicinal product, a unique MPID shall be assigned. The MPID shall be allocated 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 improving patient safety by allowing for the unique identification of medicinal products worldwide.

The MPID shall use a common segment pattern related to a medicinal product, which when each segment is valued shall define a specific MPID concept. The pattern is:

a) country code segment (ISO 3166-1 alpha-2 code elements);

b) marketing authorization holder (organization identifier) code segment;

c) medicinal product code segment.

Any change of the values related to these three code segments shall result in the assignment of a new MPID.

General

The MPID code segments shall be generated as described in 8.2.2.2 to 8.2.2.4.

Country code segment

This code segment shall reflect the country code of that region, where the medicinal product is authorised. The ISO 3166-1 alpha-2 code elements shall be used.

Marketing authorization holder (organization identifier) code segment

This code segment shall reflect the unique identifier of the marketing authorization holder (organization) of the medicinal product. An international coding system for unique marketing authorization holders (organizations) identifiers can be applied, if available.

Medicinal product code segment

This code segment shall reflect a medicinal product code assigned to the 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, (subject also to the notes below) 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 authorization indicated in a region;

NOTE The change of a marketing authorisation (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 authorised for the medicinal product.

Depending on the regional requirements of a medicines regulatory agency, therapeutic indications such as age, or related therapeutic indications within a given pharmacological class upon where the mechanism of action or clinical significance is identical, will not necessarily warrant a different MPID. Refer to regional implementation requirements for specific guidance.

Excipients may cause a unique MPID to be assigned depending on its significance to the qualitative or quantitative composition of the product or any known sensitivities. Refer to regional guidance and implementation for regulatory practices within a respective region.

Regional implementation guides will provide more information on how to identify the appropriate pharmaceutical dose form(s) that should be used.

For a seasonal vaccine, new formulations are introduced every year regardless of whether there is a strain change. This implies that a new MPID shall be assigned by a medicines regional agency for this vaccine for each given year of formulation. If year of formulation is not a defining criterion for new MPID assignment within a region, then it shall be necessary for any strain change from year to year to be utilised as the defining input for medicinal product identification and the assignment of an MPID. Refer to regional implementation requirements for specific guidance.

This process may result in changes to the MPID for a medicinal product when existing regulatory identifiers (e.g. marketing authorization number) would not change. This document does not require such existing regulatory identifiers to be changed in step with the IDMP requirements for MPID assignment. Each region may elect to continue with its existing working practices for existing identifiers rather than adopt a new process for MPID assignment in accordance with this document. In this instance, it is required that the regional authority on the matter incorporate a Medicinal Product identification process in addition to existing practices to be in conformance with this document.

For each packaged medicinal product, a unique package identifier (PCID) shall be assigned. The PCID shall be allocated in addition to any existing authorization or 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.

Any change of the values related to these code segments shall result in the assignment of a new PCID.

The PCID code segment shall use the defining attribute sets as described below.

This code segment shall reflect a code assigned to each package presentation of a medicinal product. It shall use the following defining attribute set:

— packaged item [container(s)]: the type, quantity (items per package), material(s) and alternate material(s);

— package component(s): the type, material(s) and alternate material(s);

— manufactured item(s): the manufactured dose form, unit of presentation, quantity (items per package).

A separate unique PCID shall be assigned whenever any of the aforementioned attribute sets of a packaged medicinal product are different in any way that is relevant to the medicine’s regulatory process.

This process may result in changes to a PCID when existing regulatory identifiers (e.g. marketing authorization number) would not change. This document does not require such existing regulatory identifiers to be changed in step with the IDMP requirements for PCID assignment. Each region may elect to continue with its existing working practices for existing identifiers rather than adopt a new process for PCID assignment in accordance with this document. In this instance, it is required that the regional authority on the matter incorporate a packaged medicinal product identification process consistent with this document in addition to existing practices to be in conformance with this document.

For each authorised medicinal product, a BAID1 shall be assigned. The BAID1 shall use the batch number together with the PCID. The BAID1 shall use the batch number as it appears on the outer packaging of a specific batch of the medicinal product.

The BAID1 shall use a common attribute set related to a packaged medicinal product, which when all of them have a value, define a specific BAID1 concept:

a) PCID;

b) batch number (outer packaging);

c) expiration date.

For each authorised medicinal product, a BAID2 can be assigned. The BAID2 shall use the batch number and the expiration date together with the PCID. The BAID2 shall use the batch number as it appears on the immediate packaging, where this is not the outer packaging, of a specific batch of the medicinal product.

The BAID2 shall use a common attribute set related to a packaged medicinal product, which when all of them have a value, define a specific BAID2 concept:

a) PCID;

b) batch number or lot (immediate packaging, when not the outer packaging);

c) expiration date.

This subclause describes the medicinal product in its form as a packaged medicinal product, as authorized by the regulatory authority and presented for sale or supply.

The packaged medicinal product class serves as a collector for more detailed packaging-related classes. There is one instance of the package item class for each distinct packaged item.

The packaged medicinal product header represents the authorized presentation(s) and their associated identifier(s) issued under a marketing authorization.

The description of a packaged medicinal product shall support the representation of the entire packaging configuration, from the outer layers through any intermediate packaging, to the packaged item(s) it contains, and finally to the description of each individual item.

The package item class has a recursive relationship with itself. This is required to describe nested packaging configurations (for example, cartridges within a blister sleeve within a box). A package item can be identified by one or more data carrier identifiers.

The outermost package item (container) is the highest-level package item and is the one made available to the patient or health care professional. It includes all required regulatory information, such as labelling information, safety features, leaflet or serial number. The outermost package item (container) shall always have a quantity of "1".

Package items can include component parts such as closures. These are represented using the package (component) class.

The lowest-level package item (container) is the item in direct contact with the physical medicinal product represented in the manufactured item. Manufactured items and their ingredients, described in greater detail in ISO/TS 20443, shall be applied.

A packaged medicinal product can be accompanied by a device. An administration device (for example, an oral syringe) is represented using the device class with type “administration device”. Where a device is integrated into the packaged medicinal product, such as a pre-filled syringe, it is also represented using the device class with type “integrated device”. Device descriptions based on established device nomenclature systems are provided using the device nomenclature class, and batch information is represented using the device batch identification class.

Manufacturing operations associated with packaged medicinal product, package item, package component or devices may be described using the manufacturer structures in 9.4.

Shelf-life and storage information for a packaged medicinal product or a device can also be described.

A package item (particularly the outermost packaging), a package component, a device or a manufactured item can have their physical characteristics described, including images where required. Additional characteristics can also be associated with the packaged item (container), the device or manufactured item.

Batch identifiers (BAID1 and BAID2) can be associated with the packaged medicinal product where appropriate.

In some cases, marketing authorization information applies specifically to a packaged medicinal product. For example, different package sizes of the same medicinal product can have different legal status of supply (e.g., a pack size of five tablets does not require a prescription whereas the pack size of 30 tablets does). In such cases, marketing authorisation information can be described directly for the packaged medicinal product using the structures described in 9.4.

In addition to the primary identifiers described above, the main concepts modelled in Figure 5 and described below shall apply in order to identify and characterise an authorised medicinal product which itself is identified by the MPID or PCID.

The full model depicted in Annex A, Figure A.1, shall be applied to authorised medicinal products.

NOTE Each box shown in Figure 5 does not represent an individual class but represents all the classes related to the area named in the box. For instance, the box Packaged Medicinal Products represents all the classes related to packaged medicinal products, e.g. batch identifier, package item (container), etc.

Figure 5 — Medicinal product overarching model

This section of the data model specifies the MPID together with the information that uniquely identifies and characterises a medicinal product as authorised by a medicines regulatory agency in a region.

This subclause specifies the name of the medicinal product as authorised by a medicines regulatory agency in a region, together with an analysis of the name into various parts.

This subclause specifies 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.

This subclause specifies the characteristics of the manufacturing process and other associated operations and their authorizations as issued by a medicines regulatory agency, which grants permission to a manufacturer or an establishment to undertake manufacturing and other associated operations related to a medicinal product in a region.

This subclause specifies the information about the marketing authorization as issued by a medicines regulatory agency, which grants permission to an organization to place a medicinal product on the market in a region.

Marketing authorization type specifies the information about the type of marketing authorization (e.g., Orphan drug designation) associated with a marketing authorization as issued by a medicines regulatory agency. See more information on the use of this attribute in ISO/TS 20443.

This subclause specifies information about the packaging and container(s) of a medicinal product and any associated device(s) which are 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).

This subclause specifies information about the medicinal product in the dose form approved for administration to the patient in line with the regulated product information. It also includes the reference to the associated PhPID set(s) and the ingredient(s) for the pharmaceutical product. Where applicable, the pharmaceutical product can also include information on a medical device, if it is an integral part of the medicinal product (e.g. scaffolding or net for a cell therapy medicinal product).

This subclause specifies information on all the active ingredients, adjuvants and excipients present in the medicinal products.

This subclause specifies information about the clinical particulars of the medicinal product as described in line with the regulated product information (e.g. SmPC).

This subclause specifies the MPID together with the information that uniquely identifies and characterises a medicinal product as authorised by a medicines regulatory agency in a region.

A medicinal product has a medicinal product name, which will be applicable in one or more country or language combinations. During its life cycle, a medicinal product (MPID) has one or more versions based on its associated information and characteristics, which can change over time. One or more medicinal product classifications can be applied to the medicinal product.

General

Figure 6 is a graphical representation of the medicinal product section.

Figure 6 — Medicinal product section detailed description diagram

Medicinal product

General

This represents the medicinal product as authorised by a medicines regulatory agency in a region and has the following attributes.

NOTE Additional information on the use of this attribute ISO/TS 20443 shall be applied.

MPID

This is the MPID for the medicinal product, which shall be always specified. It is specified as text. For more information, please see section 8.2.

Combined pharmaceutical dose form

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.

Additional monitoring indicator

If the medicinal product is subject to additional monitoring, this descriptor is used to support timely reporting and assessment of suspected adverse reactions. This can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Special measures

If the medicinal product is subject to regulatory requirements or restrictions beyond standard authorization conditions, these can be specified using an appropriate controlled vocabulary. Examples of such measures include controlled distribution, prescription limitations, specific handling or storage needs, or other mandated conditions intended to ensure appropriate and safe use of the product. The controlled term and the controlled term identifier shall be specified.

Paediatric use indicator

This is a flag that indicates if the medicinal product is also authorised, suitable, or intentionally developed for use in children.

Orphan designation status

This descriptor indicates whether the medicinal product has been granted orphan status by a regulatory authority based on its intended use for the treatment of a rare disease or condition.

Domain

The domain attribute indicates the regulatory or application domain to which the medicinal product belongs. It is used to distinguish, for example, products intended for human use from those intended for veterinary use.

Note 1: Although veterinary use is outside the scope of this document, the ISO standards on IDMP serve as informative to accommodate veterinary medicinal products as they are being utilized by certain regions for veterinary use (i.e., the United States and the European Union). This attribute is included to support clear domain identification where needed and to enable potential future extensions of the IDMP data model.

Note 2: Additional domain values could be introduced in future editions or related standards, subject to consensus and use‑case development.

Orphan designation

General

This class includes several attributes required to have all the information related to a product with an orphan designation status.

NOTE Orphan designation is a marketing authorization type. See more information on other regulatory authorization types in ISO/TS 20443.

Orphan indication type

This attribute is for the type of intended use of the medicinal product, for instance disease prevention, treatment or diagnostic.

Orphan procedure number

This attribute is the procedure number for the orphan designation authorization application.

Orphan designation authorization status

This attribute is for describing the status of the orphan designation authorization, for instance granted, pending, expired or withdrawn.

Orphan designation authorization date

This attribute is for the date in which the orphan designation status was granted.

Orphan designation number

This field is to indicate the orphan designation decision number.

Product classification

General

The medicinal product can be classified according to various classification systems, which may be regional or international. One or more of these various classifications of the product can be specified in this subclause.

Code system

The medicinal product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause.

The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified.

Value

The individual value from the classification system that applies to the medicinal product shall be specified using a controlled term and a controlled term identifier.

Master file

General

This class is used to identify any type of master file related to the medicinal product, for instance pharmacovigilance system master file.

File type

This attribute is to define which kind of master file is indicated.

File code

This attribute is for a code to uniquely identify a master file.

Master file holder (organization)

This is a set of classes that are used to describe the custodian organization of the master file and the location where the master file is located. Use the same set of classes as used for describing organizations (see 9.4).

Product cross-reference

General

There can be a cross-reference between the MPIDs or PCIDs of the authorised medicinal product(s) and the related IMPIDs or 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 authorised medicinal products and their corresponding identifiers. The related medicinal products and investigational medicinal products can be specified with their corresponding identifiers.

Cross-reference

This is an attribute used to reference other IMPID(s), MPID(s) and (I)PCID(s) related to medicinal product identification.

Additional information on the use of this attribute in ISO/TS 20443 shall be applied.

Referenced product or package type

This attribute is to identify which kind of medicinal product or packaged medicinal product is cross-referenced. See more information and examples on the use of this attribute in ISO/TS 20443.

Medicinal product name

General

The medicinal product name, represented in one or more languages, is one of the defining characteristics of a medicinal product and its MPID.

The convention applied for naming a medicinal product can differ between medicines regulatory agencies in 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 INN of the active substance(s)] accompanied by a trademark or other characteristics.

Other characteristics of the name can refer to strength, pharmaceutical form, intended usage or an administration device, etc.

In addition to the full and complete medicinal product name as authorised, an analysis of the name parts can be provided in a structured format. Depending on the region, the medicinal product name shall be specified in all official languages that apply.

NOTE 1 This is to facilitate the creation of a medicinal product name index and the coding of medicinal product names, which are often incomplete in spontaneous adverse reaction reports.

NOTE 2 Due to the business requirement for the medicinal product name index as described in the NOTE 1, this is the one part of this document where translation of information is explicitly described and modelled, showing the language of the information (and the regions where it is appropriate).

Full name

The full and complete medicinal product name as approved by the medicines regulatory agency in a region shall be specified, as text.

Invented name part

The invented name (i.e. trade name) of the medicinal product without the trademark or any other similar designations reflected in the medicinal product name can be specified as text, where applicable.

Scientific name part

The scientific or common name (i.e. generic name) of the medicinal product without any other descriptors can be specified as text, where applicable.

Strength part

The strength, if reflected in the medicinal product name, can be specified as text, where applicable. This strength name part can differ from the concept of “strength” as described in 9.7.

Pharmaceutical dose form part

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.

Formulation part

The formulation, if reflected in the medicinal product name, can be specified as text, where applicable.

Intended use part

The intended use, if reflected in the medicinal product name, can be specified as text, where applicable.

Target population part

The target population, if reflected in the medicinal product name, can be specified as text, where applicable.

Container or pack part

The container or pack, if reflected in the medicinal product name, can be specified as text, where applicable.

Device part

The device, if reflected in the medicinal product name, can be specified as text, where applicable.

Trademark or company name part

The trademark, if reflected in the medicinal product name, can be specified as text, where applicable.

Time or period part

The time/period, if reflected in the medicinal product name, can be specified as text, where applicable.

Flavour part

The flavour, if reflected in the medicinal product name, can be specified as text, where applicable.

Delimiter part

A delimiter separates one composite in a segment from another or separates one subcomposite from another.

Country and Language

General

The country and optionally the region where the medicinal product name of a medicinal product is authorised shall be specified in the official language as applicable.

NOTE Regions can constrain the concepts to address their regional terminology. See more information on the use of this attribute in ISO/TS 20443.

Country

The country where the medicinal product name is applicable shall be described using ISO 3166-1 alpha-2 code elements.

Jurisdiction

The jurisdiction within the country where the medicinal product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified.

Language

The language of the medicinal product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639-1.

Header

General

The characteristics of an authorised medicinal product as defined in this document 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 as specified in Clause 8. However, the difference(s) are required to be recorded and tracked against the MPID or PCID.

Identifier

This attribute is for the unique code identifying the regulatory information submission.

Effective date

This is the date specified in the regulatory decision document by which the authorization or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601-1 date format.

Language

This attribute defines the language used for the information related to the regulatory submission.

Version number

This is a number identifying a specific version of the regulatory information submission.

Version set identifier

This is a number used to group together a set of specific versions of the regulatory information submission.

Attached document

General

Any document(s) officially submitted to a medicines regulatory agency shall be specified as a regulated document.

Identifier

The reference to the regulatory decision document related to the granting of the authorization or the latest update of the regulated product information shall be specified in text.

Effective date

This is the date corresponding to a version of a regulated document containing regulated medicinal product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601-2 date format.

NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that are captured within a regulated document.

Type

The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Content

The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations.

Language

This attribute defines the language used for the information related to the regulatory submission.

Media type

This attribute is used to define the graphic media type of the attached document.

Version number

This is a number identifying a specific version of the attached regulatory document.

Version set identifier

This is a number used to group together a set of specific versions of the same regulatory document.

This subclause specifies the marketing authorization information for a medicinal product.

The marketing authorization is issued by the appropriate medicines regulatory agency in a region. In line with the laws and regulations applicable in a region, an authorization is usually required before a medicinal product is placed on the market. For some categories of medicinal products, specific exemptions may be applicable (e.g. “grandfather” drugs). For these types of medicines, the same principles of information provision as for authorized medicinal products shall be applied as outlined in this subclause. Where no formal marketing authorization holder is established, the distributor shall be specified.

A medicinal product has a marketing authorization (even if, as for “grandfather drugs” this is not a formal marketing authorization but serves as a proxy).

This marketing authorization is issued by a medicines regulatory agency to an organization referred to as marketing authorization holder. Within the marketing authorization holder, there can be a named individual, who is responsible for the pharmacovigilance activities associated with that medicinal product (e.g. in the EU, this is the “qualified person responsible for pharmacovigilance”).

An initial marketing authorization, renewal, variation to and revocation of a marketing authorization is managed on the basis of a marketing authorization procedure, which itself is supported by a marketing authorization application.

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 shall be recorded accordingly.

The marketing status describes when a medicinal product is actually put on the market or is no longer available in a country or jurisdiction. It also indicates the legal status of supply (e.g. prescription only).

There can be circumstances where medicinal product additional information on marketing status is specific to local provisions within a jurisdiction (e.g. states, provinces or territories). This refers particularly to the legal status of supply or a marketing authorization number.

General

Figure 7 — Marketing authorization section detailed description diagram

Each medicinal product shall have the relevant marketing authorization information specified (see Figure 7).

The marketing authorization information shall also be appropriately specified for a packaged medicinal product, where applicable (see 9.3.2.2). In those situations, the information structure as follows shall be used, with the exception that the medicines regulatory agency and the marketing authorization holder information is not required to be specified again, as it is inherited from the marketing authorization information of the medicinal product.

Marketing authorization

General

A medicinal product is placed on the market when a marketing authorization or equivalent has been issued by a medicines regulatory agency.

Marketing authorization number

The number as assigned to a medicinal product by the regulatory medicines agency of a country or jurisdiction shall be specified in text. For medicinal products which allow distribution without a marketing authorization by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorization number (e.g. for “grandfather” drugs in the US).

Country

The country in which the marketing authorization has been granted shall be provided in accordance with the ISO 3166-1 alpha-2 code elements.

Legal status of supply

The legal status of supply of the medicinal product as classified by the medicines regulatory agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the medicinal product within a region to support regulatory, compliance and pharmacovigilance activities.

Authorization status

This is the status of the marketing authorization changes throughout the lifecycle of a medicinal product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Authorization status date

The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Validity period start

The beginning of the time period in which the marketing authorization is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Validity period end

The end of the time period in which the marketing authorization is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Data exclusivity start date

The “data exclusivity period” is a period of time from initial authorization of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorization.

The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Data exclusivity end date

The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Date of first authorization

This is the date when the first authorization was granted by a medicines regulatory agency.

Marketing authorization type

This indicates the type of marketing authorization granted by the competent authority. Further details and guidance as provided in ISO/TS 20443 shall be applied.

International birth date (IBD)

This is the date of first marketing authorization for a company’s new medicinal product in any country in the world.

Marketing authorization holder (organization)

Details in relation to the marketing authorization holder to which a marketing authorization in a region was granted shall be specified using an organization class as described in 9.4.

For medicinal products which allow for distribution without a marketing authorization under regional or jurisdictional law, the details of the distributor, as appearing on the package, the container or the package insert shall be provided in place of the details of the marketing authorization holder.

Small to medium enterprise (SME)

This classifies whether an enterprise is a micro, small or medium-sized undertaking according to criteria established in the European Union under Commission Recommendation 2003/361/EC. This object is included to support regulatory processes in jurisdictions where SME status influences regulatory obligations or fee structures.

SME flag

This is a flag to indicate if the organization is an SME.

Size

The size of the SME can be specified, i.e. micro, small or medium.

For the definition of the values, refer to ISO/TS 20443.

SME number

This is a unique number that it is uniquely identifying an SME.

Status date

This is the date when the SME status was granted.

Medicines Regulatory Agency (organization)

Details in relation to the medicines regulatory agency that granted the marketing authorization for a medicinal product shall be specified using an organization class as described in 9.4.

Marketing authorization procedure

General

The regulatory procedure applied to grant or amend a marketing authorization for a medicinal product shall be specified. 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.

Procedure identifier or number

The unique identifier for the specific instance of a procedure undertaken shall be provided in text.

Procedure type

The type of procedure that is followed to grant or update a marketing authorization shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Procedure date start

The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Procedure date end

The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Marketing authorization application

General

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).

Application identifier or number

A unique identifier for the specific instance of an application shall be provided in text. The application identifier or number is usually assigned by a medicines regulatory agency.

Application type

The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Application date

The date on which the marketing authorization application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Marketing status

General

This class provides information on the status of the marketing of the medicinal product.

Country

The country in which the marketing authorization has been granted shall be specified. It should be specified using the ISO 3166-1 alpha-2 code elements.

Jurisdiction

Where a medicines regulatory agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified.

Marketing status

This attribute provides information on the status of the marketing of the medicinal product. See ISO/TS 20443 for more information and examples.

Marketing start date

The date when the medicinal product is placed on the market by the marketing authorization holder (or where applicable, the manufacturer or distributor) in both a country and jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

NOTE “Placed on the market” refers to the release of the medicinal product into the distribution chain.

Marketing stop date

The date when the medicinal product is no longer available on the market in a country or jurisdiction, or both, shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

NOTE “No longer available on the market” can refer to the fact that the marketing authorization holder has taken a decision to no longer market the medicinal product or that the marketing authorization is no longer valid.

Risk of supply shortage

Indication on whether there is a risk of a product shortage in a region.

Risk of supply shortage comment

Any additional comment on supply shortage.

Status reasons

General

This class can describe the reason for a legal action taken on the marketing or on the marketing authorization and in reference to the status of these elements.

Reason

The reason for a legal action taken on the marketing or on the marketing authorization can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Reason comment

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorization.

Legal grounds

The legal grounds of the action taken on the marketing or on the marketing authorization can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Legal grounds comment

Any additional description of the action taken on the marketing or on the marketing authorization.

Restore date

The date when the marketing or the marketing authorization of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Condition to restore

The condition under which the marketing authorization or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Condition to restore comment

Additional comments on the condition to restore the marketing or the marketing authorization of the product.

Change request organization type

The organization that triggered the legal action taken on the marketing or on the marketing authorization (e.g. marketing authorization revoked by the competent authority, marketing authorization not renewed by the marketing authorization holder (MAH)) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Geographic area for action taken

The geographic area where the legal action taken on the marketing or the on marketing authorization is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Jurisdictional marketing authorization

General

This class is used to provide more information when a marketing activity is undertaken in multiple subdivisions within a country.

Country

This attribute defines the country to which the jurisdictional marketing authorization refers to.

Jurisdiction

This attribute indicates which jurisdiction the jurisdictional marketing authorization is related to.

Marketing authorization number

The number for the marketing authorization assigned by a medicines regulatory authority in the jurisdiction can be specified in text.

Legal status of supply

The legal status of supply for the medicinal product as applicable in a region or jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Whenever a class is described as an “organization”, the following general set of information shall be specified for the appropriate instance of the organization.

General

Figure 8 shows a detailed description of organization information.

Figure 8 — Organization detailed description diagram

Organization

General

This is a class that is used to define organizations.

Identifier

The unique identifier of the organization shall be provided. An international coding system for unique organization identifiers can be used.

Name

The name of the organization shall be provided in text.

Address

The address of the organization shall be provided using the standardised structured address format specified in ISO/TS 20443.

Confidentiality indicator

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.

Geographic coordinates

These are coordinates that identify precisely the location where the organization is set; they shall be provided in accordance with ISO/TS 20443.

Other locations

General

This class is used to specify one or more other significant locations of the organization and the role of that location.

A jurisdiction may further refine the requirements in relation to the other locations information at implementation so that this information is to be specified only if required.

Location name

This is to identify uniquely a location linked to a specific organization.

Location address

The address of the location of the organization shall be provided using the standardised structured address format specified in ISO/TS 20443.

Location role

The role of the location within the organization in the context of the medicinal product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Identifier

The unique identifier of the location can be provided. An international coding system for unique organization identifiers can be used.

Geographic coordinates

These are coordinates that identify precisely the location where the organization is set and shall be provided in accordance with ISO/TS 20443..

Contact

General

This class is used to specify one or more contact persons from within the organization and the role of each person. A jurisdiction may further refine the requirements in relation to the contact person information at implementation so that this information is to be specified only if required.

Name

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides.

Telecom

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using the standardised structured telecoms description format specified in ISO/TS 20443.

Role

The role of the contact person within the organization in the context of the medicinal product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Confidentiality indicator

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified.

This subclause describes the manufacturer or establishment information, or both, for a medicinal product (see Figure 9).

Figure 9 — Manufacturer or establishment (organization) section high-level diagram

The medicinal product is associated with organization information for one or more manufacturers or establishments which undertake various manufacturing operations in order to produce a medicinal product. These may be overseen by an appropriate medicines regulatory agency.

General

Figure 10 shows a detailed description of the manufacturer or establishment section.

Figure 10 — Manufacturer or establishment section detailed description diagram

A medicinal product shall be associated with one or more manufacturers or establishments (see Figure 10).

A jurisdiction may further refine the requirements in relation to the manufacturer or establishment information at implementation so that this information is to be specified only if required.

Manufacturer or establishment (organization)

The information related to the manufacturer or establishment for the organization undertaking the particular manufacturing operation shall be described using the pattern for organization described in 9.4.

Manufacturing or business operation

General

The manufacturing or business operation being undertaken by the particular manufacturer/establishment (organization) shall be specified.

Operation type

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Manufacturing authorization reference number

The reference number of the authorization for manufacturing or equivalent can be specified in text.

Start date

The start of the manufacturing authorization stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601-1 date format.

NOTE See more information on the use of this attribute in ISO/TS 20443.

End date

The end date of the manufacturing authorization stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601-1 date format.

NOTE See more information on the use of this attribute in ISO/TS 20443.

Confidentiality indicator

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified.

Medicines regulatory agency (organization)

The medicines regulatory agency which oversees a specific manufacturing operation shall be described using the pattern for organization described in 9.4.

This subclause describes the medicinal product in terms of it being a packaged medicinal product as presented for sale or supply.

The description of a packaged medicinal product shall cater for the description of the entire packaging from the outer layers down through intermediate packaging to one or more items contained within, and then to the actual description of the individual item(s).

The packaged medicinal product class acts as a collector class for more descriptive classes. In particular, there is one instance of the “package item” class for each separate item packaged.

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 manufactured item. Manufactured items are described in terms of their ingredients, which are discussed in greater detail in ISO/TS 20443.

A packaged medicinal product can be accompanied by a device. This may be an administration device such as an oral syringe. This device is described using the device class (with type “administration device”). Where a device forms an integrated part of the packaged medicinal product, such as a pre-filled syringe, this is also described using the device class (with type “integrated device”). The device as it is described by the various device coding systems can be specified using the device nomenclature class and batch information can be specified using the device batch identification class.

Any manufacturing operations associated with packaged medicinal product, package item, package component or devices may be described using the manufacturer or establishment structures described in 9.4.

The shelf-life or storage of a packaged medicinal product or a device can also be described.

A package item (and most particularly the outermost packaging) or a package component, as well as a device and a manufactured item, can have their physical characteristics described, including an image of the item as required.

In addition, the packaged item (container), the device and the manufactured item may have a set of other characteristics associated with them.

Batch identifiers, i.e. the BAID1 and BAID2, can be presented in relation to the packaged medicinal product as appropriate.

There are instances where marketing authorization information is specific to a packaged medicinal product, for example, when the legal status of supply of particular packages of a medicinal product differs (a pack size of five tablets is not subject to a prescription whereas the pack size of 30 tablets is). In these instances, marketing authorization information can be described directly for the packaged medicinal product using the structures described in 9.4.

General

Figure 11 shows a detailed description of the packaged medicinal product section.

Figure 11 — Packaged medicinal product section detailed description diagram

Packaged medicinal product

PCID

This is the unique identifier for the packaged medicinal product, constructed as described in 8.3.

Package description

A textual description of the packaged medicinal product shall be provided.

Package item (container)

General

A package item can be either a single item or package of multiple items. Those items can be of the same kind or of different kinds.

There shall be at least one package item for each distinct kind of packaged item in a packaged medicinal product. Where there are several identical package items, the number of them shall be given.

Subsequent, more detailed, descriptions in related classes shall be related to the single item only.

Where a package item contains a further package, that package item shall be nested to provide the correct representation.

Package item (container) type

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. A term and a term identifier shall be specified.

Package item (container) quantity

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”.

NOTE The identification of compounded medicinal products can be accommodated within the ISO 11615 standard for the purposes of medicinal product identification. However, the actual administration of these products to patients is considered out of scope for this document. See more information on the use of this attribute in ISO/TS 20443.

Material

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. A term and a term identifier shall be specified.

Alternate material

The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO/TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve).

NOTE Multiple alternate materials to accommodate alternate components and/or manufacturers and describe different type of components can be accommodated. See more information on the use of this attribute in ISO/TS 20443.

Data carrier identifier

General

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 data carrier identifier shall be specified as required.

Code system

The data carrier identification system itself shall be specified using an appropriate identification system.

Value

The individual value from the identification system that applies to the packaged medicinal product shall be specified.

Shelf-life or storage information for a package item (container)

The shelf-life or storage information for a package item (container) can be described using shelf-life or storage class (see 9.6.2.11).

Physical characteristics of a package item (container)

The physical characteristics (height, width, depth, weight, shape, etc.) of a package item (container) can be described using the physical characteristics class (see 9.6.2.21).

Other characteristics of a package item (container)

Other characteristics of a package item (container) can be described using the other characteristics class (see 9.6.2.22).

Batch identifier

BAID1

The BAID1, which appears on the outer packaging of a specific batch of the medicinal product, shall be specified. Since there will be many different batches of any one packaged medicinal product, and since the specification of batch identification might not always be required for each type of packaged medicinal product, the cardinality of the relationship between the packaged medicinal product and the batch identifier is given as 0...*. In situations where a packaged medicinal product contains more than one manufactured item or includes a device or both, this batch number refers to the one given on the outermost packaging.

BAID2

The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified.

Expiration date

This is the date the manufacturer guarantees the full potency and safety of a particular batch or lot of medicinal product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Package (component)

General

Any part of the packaging of a packaged medicinal product can be further described using the package (component) class. The description can be of a complete container or a part of a container, such as a closure.

Component type

The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Component material

The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified.

Component alternate material

Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified.

Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper).

NOTE Multiple alternate material components to describe different type of components can be accommodated. See more information on the use of this attribute in ISO/TS 20443.

Physical characteristics of a package (component)

The physical characteristics (height, width, depth, weight, shape, etc.) of the package (component) can be described using the physical characteristics class (see 9.6.2.21). One or more images of the device can be included, if required.

Manufacturer of a package (component)

The manufacturer of a package (component) can be described using the manufacturer/establishment (organization) set of classes (see 9.5).

Shelf-life or storage

General

The shelf-life or storage information can be described using the shelf-life or storage class.

Shelf-life type

This describes 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. The shelf-life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Shelf-life numerator value

This describes the numerical value that represents the duration of the shelf-life. The shelf-life numerator value shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Shelf-life numerator unit

This describes the unit of time for the numerator value. The shelf-life numerator unit shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Operator

This describes the symbol or function that defines the relationship between the numerator and denominator values. The operator shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Shelf-life denominator value

This describes the numerical value that serves as the denominator in the shelf-life calculation. The shelf-life denominator value shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Shelf-life denominator unit

This describes the unit of time for the denominator value. The shelf-life denominator unit shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Shelf-life time period

The shelf-life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

Special precautions for storage

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Device

General

Medicinal products may be authorised with a device(s), which may be described using the device class. 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. Please note that any document(s) officially submitted to a medicines regulatory agency shall be specified as a regulated document.

NOTE 1 Attached document class is applicable to the Device class. See more information on the use of this attribute in ISO/TS 20443.

NOTE 2 The scope of devices within ISO IDMP relate to combination products regulated as medicinal products.

NOTE 3 UDI provides detailed information regarding devices and for combination products. ISO/FDIS 22532 contains a minimally defined set of device attributes for use by non-UDI regions.

Device type

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

NOTE Device class (i.e. Class I, Class II, Class III) is an attribute is applicable to the Device class. See more information on the use of this attribute in ISO/TS 20443.

Device classification

The classification of device (i.e. Class I, II, III) shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

NOTE See more information on the use of this attribute in ISO/TS 20443.

Device trade name

This can be used to specify the invented name of the device, where applicable, as text.

Device quantity

The quantity of the device present in the pack shall be specified.

Device listing number

This can be used to specify the listing number of the device, where applicable, in text.

Device identifier

A unique device identifier shall be specified.

Device model number

This can be used to specify the device model or reference number, where applicable, in text.

Sterility indicator

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Sterilization requirement indicator

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Device usage

The number of times that the device may be used as described in the regulated product information may be specified.

Device material

General

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.

Substance

The substance that composes the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology.

Alternate

This flag indicates if the substance represents an alternative material of the device.

NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon).

Allergenic indicator

This flag indicates if the substance is a known or suspected allergen.

Device nomenclature

General

There are a variety of nomenclature systems available to identify devices. This structure supports the description of the device in these nomenclature systems.

Code system

The device nomenclature system shall be specified using an appropriate identification system.

Value

The term for the device from the specified nomenclature system shall be specified.

Device batch identifier

General

This class can be used to describe the batch number or expiry date or both of a device in a packaged medicinal product.

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.

Batch number

Where applicable, the batch number for the device can be specified, in text.

Expiration date

Where applicable, the expiration date for the batch can be specified.

“Shelf-life or storage” information for a device

The shelf-life or storage information for a device can be described using the shelf-life or storage class (see 9.6.2.11).

“Physical characteristics” of a device

The physical characteristics (height, width, depth, weight, shape, etc.) of a device can be described using the physical characteristics class (see 10.6.2.21). One or more images of the device can be included, if required.

“Other characteristics” of a device

Other characteristics of a device can be described using the other characteristics class (see 10.6.2.22).

“Manufacturer” of a device

The manufacturer of a device can be described using the manufacturer or establishment (organization) set of classes (see 9.5).

Manufactured item

General

The manufactured item(s) as contained in the packaged medicinal product shall be described. This is the actual manufactured item (the tablet, liquid, cream contained within the package) as it is delivered from the manufacturer but before any transformation, if applicable, for administration to or use by the patient.

NOTE 1 The relationship between a package item (container) and a manufactured item is 0...* despite the fact that every packaged medicinal product will have at least one manufactured item. The “zero” is present because the package item (container) class recurses, and, in the common situation where there is an outer and immediate package item, the outer package item does not immediately relate to a manufactured item. The multiplicity is present for the rare cases where a single immediate package item holds more than one manufactured item, as is the case, for example, for phased combined oral contraceptives and some hormone replacement therapies.

NOTE 2 To improve data quality and reduce maintenance challenges, ISO 11615 supports the reuse of components across related medicinal products. This minimizes duplicate information by allowing the same component (e.g. active substances, manufactured items, package items with content, multi-country packs) to be referenced in multiple parts of related medicinal products through a common authorization. See more information on the use of this attribute in ISO/TS 20443.

NOTE 3 Regulatory regions can choose to apply a manufactured item identifier to the manufactured item class. See more information on the use of this attribute in ISO/TS 20443.

Manufactured item description

A textual description of the manufactured item can be provided.

NOTE See more information on the use of this attribute in ISO/TS 20443.

Manufactured dose form

This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO/TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified.

A medicinal product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “medicinal product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”.

Unit of presentation

This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO/TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified.

For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). 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.

Manufactured item quantity

The quantity (or count number) of the manufactured item shall be described. 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.

Physical characteristics of a manufactured item

The physical characteristics (height, width, depth, weight, shape, etc.) of a manufactured item can be described using the physical characteristics class (see 9.6.2.20). One or more images of the manufactured item can be included, if required.

Other characteristics of a manufactured item

Other characteristics of a manufactured item can be described using the other characteristics class (see 9.6.2.21).

Ingredients of a manufactured item

The ingredient(s) of a manufactured item shall be described using the ingredient class (see 9.7).

Physical characteristics

General

Where applicable for a package item (container), package (component), manufactured item or device, its physical characteristics can be specified. One or more images can be provided as applicable.

Height

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

Width

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

Depth

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

Weight

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

Nominal volume

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

External diameter

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

Shape

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used.

Colour

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used.

Imprint

Where applicable, the imprint can be specified as text.

Image

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations.

Scoring type

This indicates the form or pattern of scoring applied to the solid dosage unit (e.g., a single score line, multiple score lines, cross-scoring). Scoring type describes how the product is intended to be divided or broken.

Scoring number

This specifies the number of discrete scoring divisions present on the solid dosage unit. This represents how many separation segments are created by the scoring pattern.

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be provided.

Other characteristics

General

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.

Code system

The code system that is used to describe the characteristic shall be specified using an appropriate identification system.

Value

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier.

This describes the ingredients of the medicinal product through its representations as the manufactured item(s) and the pharmaceutical product(s), based on ISO 11238 and ISO/TS 19844, ISO 11239 and ISO/TS 20440, ISO 11240 and their resulting terminologies.

The ingredients class and associated substance, specified substance, reference substance and strength classes are used in the further description of manufactured item and pharmaceutical product class.

Any substance or specified substance shall have its strength specified in accordance with the regulated product information as applicable. Additionally, the strength of the reference substance can be further specified. The reference substance strength is often referred to as “reference strength”. Again, this shall be specified where applicable in accordance with the regulated product information.

General

Figure 12 shows a description of the ingredients, substance and strength section.

Figure 12 — Ingredients, substance and strength section detailed description diagram

Ingredient

General

There shall be one instance of the ingredient class for each actual ingredient of either the manufactured item or pharmaceutical product, as appropriate.

Ingredient role

Ingredient role describes the classification of the ingredient within the product, to differentiate ingredients that have pharmacological action versus other ingredients.

The role of the ingredient as part of the manufactured item or pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified.

Ingredient function

Ingredient function specifies the purpose or activity the ingredient performs within a pharmaceutical or manufactured product. It describes the reason for its inclusion and its intended role in the formulation of the product, such as its mechanism of action or contribution to product performance.

The function of the ingredient as part of the manufactured item or pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and its term identifier shall be provided.

Composition grouping

Composition grouping is a data element used to classify related substance data (substances, their roles, and associated strength) that belong to the same part of a product (manufactured item or pharmaceutical product), for the purpose of representing regulatory data. It enables the grouping of composition information by product part.

The Composition Grouping data element as part of the manufactured item or pharmaceutical product can be specified as free text.

Allergenic indicator

This flag indicates whether the ingredient is a known or suspected allergen, with the relevant regulatory definition of allergens, i.e., a substance capable of provoking IgE-mediated hypersensitivity reactions.

Substance

General

This class is for allowing the specification of one or more substances. At least one substance or specified substance must be associated to the ingredient.

Substance

A substance can be specified for an ingredient in the role described.

A substance can also be specified for a constituent of a specified substance.

The substance shall be described in accordance with ISO 11238 and ISO/TS 19844 and its resulting terminology. A term and its term identifier shall be provided.

Substance origin

Substance origin refers to the biological, biotechnological, chemical, animal, plant, human or inorganic source from which a substance is derived, including its classification as of biological, biotechnological, chemical, animal, plant, human, or inorganic origin.

A substance origin can be specified for an ingredient in the role described.

The origin of the substance as part of the manufactured item or pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and its term identifier shall be specified.

Substance role code

Substance role code specifies the functional role performed by a substance within an ingredient. A substance role code can be provided for an ingredient in the role described.

Substance role code is applicable only to a substance which has the pharmacological effect as part of the ingredient.

The role code of the substance as part of the manufactured item or pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and its term identifier shall be specified.

Reference substance

General

This class enables the specification of one or more reference substances associated within a substance.

Reference substance

A reference substance is a substance used to express the strength of another substance, when that substance is complex or defined by an active moiety. A reference substance can be specified for a substance.

The reference substance shall be described in accordance with ISO 11238 and ISO/TS 19844 and its resulting terminology. A term and its term identifier shall be provided.

Reference substance role code

Reference substance role code specifies the functional role performed by a reference substance within an ingredient. A reference substance role code can be provided for a substance that forms part of an ingredient in the role described.

Reference substance role code is applicable only to a reference substance of a substance which has the pharmacological effect as part of the ingredient.

The role code of the reference substance as part of the manufactured item or pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and its term identifier shall be specified.

Specified substance

General

One or more specified substances shall be associated to a substance.

Specified substance

When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO/TS 19844 and its resulting terminology. A term and its term identifier shall be provided.

Specified substance group

The group to which a specified substance is assigned in accordance with ISO 11238 and ISO/TS 19844 and its resulting terminology can be used. A term and its term identifier shall be provided.

Confidentiality indicator

The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used.

Strength of a substance

General

The strength of the substance or specified substance shall be specified as a quantity of the substance or specified substance present in a manufactured item or pharmaceutical product. A numerator value and numerator unit as well as a denominator value and denominator unit shall be used.

When the strength of a pharmaceutical product that has undergone a transformation (e.g. reconstitution) is specified, it shall be specified using the strength resulting from transformation undertaken exactly in accordance with the regulated product information.

Strength type

Strength can be expressed in two ways: presentation strength and concentration strength.

Presentation strength is defined as the quantity or range of quantities of a substance or specified substance present in the unit of presentation or in the volume (or mass) of the single pharmaceutical product or manufactured item.

Concentration strength is defined as the quantity or range of quantities of a substance or specified substance present per unitary volume (or mass).

This attribute is required only when the presentation strength uses a denominator expressed as a non-unitary amount.

For solid dose forms, concentration strength is generally identical to the presentation strength and therefore does not need to be provided separately; only the presentation strength is required.

The strength type shall be specified using a controlled vocabulary. The controlled term and its term identifier shall be specified.

Strength

At least one strength shall be specified for each substance or corresponding reference substance, and for each specified substance.

Strength (when strength type is ‘presentation’)

The presentation strength can be specified.

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 its 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.

Strength (when strength type is ‘concentration’)

The concentration strength can be specified.

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 its 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.

Strength qualifier

In some jurisdictions, the strength of a medicinal product is measured at a specific point. Strength qualifier specifies the reference used for certifying the strength, such as a timepoint (e.g., ‘at release’ or ‘at expiry’), a physical layer (e.g., ‘per core’ for a multi-layered tablet), or another defined reference.

The strength qualifier shall be specified using a controlled vocabulary. The controlled term and a term identifier shall be specified.

Measurement point

There are medicinal products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolization). In these instances, the measurement point can be described using text, as applicable.

Country

The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166-1 alpha-2 codes.

If a measurement point is specified, one or more countries shall be described as applicable.

This describes the medicinal product in terms of its qualitative composition and quantitative composition and in the pharmaceutical dose form approved for administration in line with the regulated product information. These characteristics of the medicinal product are referred to as “pharmaceutical product”.

For certain medicines, a device can form an integral part of the medicinal product, for example to support the administration of the medicine. In these instances, the pharmaceutical product contains the device component information as an additional characteristic. See 9.8.2.5.

A medicinal product is associated with the pharmaceutical product class, describing the product in terms of its qualitative and quantitative composition and the pharmaceutical dose form approved for administration in line with the regulated product information. It is the pharmaceutical product therefore that has route of administration information for the administration process.

The pharmaceutical product is associated with various pharmaceutical product characteristics, which can describe various aspects of the pharmaceutical product, such as its onset of action.

The pharmaceutical product may be associated with a device class, which represents information about any integral device to support the administration of the product, and therefore is of type “integrated device”. In this case, the device is in effect an “ingredient” of the pharmaceutical product. The device can have a set of physical characteristics and other characteristics associated with it.

The pharmaceutical product shall be described in terms of the ingredients it contains. The pharmaceutical product is associated with a set of PhPIDs, as documented in ISO 11616 and ISO/TS 20451.

General

Figure 13 shows a description of the pharmaceutical product and device section.

Figure 13 — Pharmaceutical product and device section detailed description diagram

Pharmaceutical product

General

A pharmaceutical product shall be described in terms of its qualitative and quantitative composition and the pharmaceutical dose form approved for administration (administrable dose form) in line with the regulated product information.

Pharmaceutical product description

A textual description of the pharmaceutical product can be provided.

NOTE More information on the use of this attribute is available in ISO/TS 20443.

Administrable dose form

This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO/TS 20440 and the resulting terminology. The term and the term identifier shall be specified.

In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out.

The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”.

Unit of presentation

The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO/TS 20440 and the resulting terminology.

For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO/TS 20440 and the resulting terminology.

Route of administration

General

The route of administration is a concept that is used to describe 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 identifier as defined in ISO 11239 and ISO/TS 20440 and its resulting terminology.

Method of administration

The method of administration is a concept that is used to describe the specific technique by which a pharmaceutical product is intended to be administered to the patient via a chosen route of administration.

The method of administration shall be specified using terms and a term identifier.

NOTE Some coding systems (e.g., European Directorate for the Quality of Medicines & HealthCare (EDQM)), include terms in the route of administration list that already incorporate the method of administration. When such a term is selected for the route of administration, care shall be taken not to enter a different or conflicting value in the method of administration attribute, to avoid duplication or inconsistency.

Pharmaceutical product characteristics

General

This class can be used to describe various characteristics of the pharmaceutical product, such as its onset of action.

Code system

The code system being used to describe the type of characteristic shall be specified using an appropriate identification system.

Value

The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier.

Status

The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending.

“Device” for pharmaceutical product

For pharmaceutical products, only those situations where the associated 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 presented as part of the medicinal product shall be described using the device, physical characteristics and other characteristics classes. For products where this occurs (e.g. the skin scaffold situation), the device is in effect being considered as an “ingredient” of the pharmaceutical product, and is therefore described here, because it will be referenced in the PhPID identification of the pharmaceutical product.

PhPID set

This class shall carry 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.

This subclause specifies information that primarily refers to the description of the clinical particulars for a medicinal product. This information shall be described for each medicinal product.

A region or jurisdiction may further refine the requirements in relation to the clinical particulars information at implementation so that this information is to be specified only if required.

A medicinal product is associated with a set of clinical particulars. These consist of information about the medicinal product’s indication(s), its contraindication(s), its undesirable effect(s) and its interactions.

Both indication(s) and contraindication(s) can be qualified by information about a specific population that any particular indication or contraindication refers to and by information about other therapy specifics, i.e. the use of the medicinal product in relation to other medication.

Undesirable effects are associated directly to the medicinal product or associated to the medicinal product but linked to a specific indication or to a specific population.

The clinical particulars class itself is a conceptual “parent” class, drawn into the high-level drawings for ease of visualization (see 9.1.1); it does not hold information in and of itself, and therefore it is not realised in the detailed description attribute model (see Figure 14).

General

Figure 14 — Clinical particulars section detailed description diagram

Therapeutic indication

General

This class shall be used to describe the authorised 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.

Indication text

The authorised therapeutic indication(s) shall be described in text.

Indication as “disease/symptom/procedure”

The underlying disease, symptom or procedure that is the indication for treatment 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.

Disease status

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.

Comorbidity

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.

Intended effect

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.

NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population.

Timing or Duration

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here.

Orphan designation status

The description of whether the medicinal product is subject to orphan designation and intended for the treatment of a rare disease shall be identified at the therapeutic indication, as applicable (conditional).

NOTE Certain regions identify orphan designation at the level of the therapeutic indication.

Contraindication

General

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.

Contraindications text

The text of the contraindication(s) in line with the regulated product information shall be described.

Contraindications as “disease, symptom or procedure”

The underlying disease, symptom or procedure of the contraindication 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.

Disease status

The status of the disease or symptom of the contraindication 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.

Comorbidity

The comorbidity (concurrent condition) or coinfection shall be specified.

Undesirable effects

General

This class shall be used to describe the undesirable effects of the medicinal product as described in the regulated product information. A jurisdiction may further refine the requirements in relation to the undesirable effects information at implementation so that this information is to be specified only if required.

Undesirable effect text

The text of the undesirable effect shall be given.

Undesirable effect as “symptom, condition or 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.

Symptom, condition or effect classification

The classification of the “symptom, condition or effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary.

Frequency of occurrence

The frequency of occurrence of the “symptom, condition or effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Population specifics

General

This class can be used to describe the population for which a particular indication or contraindication applies as authorised for the medicinal product in accordance with the regulated product information.

Age

The age of the specific population for an indication or a contraindication as authorised for the medicinal product in accordance with the regulated product information can be specified.

Either age or age range should be specified for a single indication or contraindication; both should not be specified.

Age range low

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the medicinal product in accordance with the regulated product information can be specified.

Either age or age range should be specified for a single indication or contraindication; both should not be specified.

Age range high

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the medicinal product in accordance with the regulated product information can be specified.

Either age or age range should be specified for a single indication or contraindication; both should not be specified.

Sex

The sex of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218.

Population group

The population group for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified.

Physiological condition

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.

Other therapy specifics

General

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.

Therapy relationship type

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.

Medication

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.

Interactions

General

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.

Interactions text

The text of the interaction in accordance with the regulated product information shall be provided.

Interactant

This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information.

For more information, refer to regional implementation guides.

Interactions type

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.

Interactions effect

The effect of the 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.

Interactions incidence

The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

Management actions

The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified.

This subclause describes investigational medicinal products (IMPs) that do not have a marketing authorization and which are subject to an investigation in one or more clinical trials. The subclause also applies to authorised medicinal products that are subject to investigation in a clinical trial but are used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication.

“Investigational medicinal product” refers to a medicinal product being tested in a clinical trial, including the trial medication(s), each comparator and each placebo as defined in the clinical trial protocol.

The model depicted in Annex B, Figure B.1, shall be applied to investigational medicinal products.

To satisfy the requirements as described in 6.4, the following four identifiers shall be specified:

a) Investigational medicinal product identifier (IMPID);

b) Investigational medicinal product package identifier (IPCID);

c) Investigational medicinal product batch identifier 1 (outer packaging) (IBAID1), allocated to a specific batch of an investigational medicinal product, which appears on the outer packaging of the investigational medicinal product;

d) Investigational medicinal product batch identifier 2 (immediate packaging) (IBAID2), allocated to a specific batch of an investigational medicinal product, which appears on the immediate packaging, where this is not the outer packaging.

In addition, there is an association with Pharmaceutical product identifiers (PhPIDs) as defined in ISO 11616 and ISO/TS 20451. While the elements related to the PhPID are identical for authorised medicinal products and investigational medicinal products, the regulatory information and additional characteristics may differ, which are outlined in this subclause.

Further details regarding the use of these identifiers are specified in ISO/TS 20443.

For each investigational medicinal product, a unique IMPID shall be assigned. The IMPID shall be allocated in addition to any existing identifier as ascribed by a medicines regulatory agency in a 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 investigational medicinal products worldwide.

The IMPID shall use a common segment pattern related to an investigational medicinal product, which when each segment is valued, shall define a specific IMPID concept. The pattern is:

a) country code segment (ISO 3166-1 alpha-2 code elements);

b) sponsor (organization identifier) code segment;

c) sponsor product code or regulator product code (depending on regional requirements) segment.

Any change of the values related to these three code segments shall result in the assignment of a new IMPID.

General

The IMPID code segments shall be generated as described in 10.3.2.2 to 10.3.2.4.

Country code segment

This code segment shall reflect the jurisdiction(s) where the clinical trial application is submitted to a medicines regulatory agency. The ISO 3166-1 alpha-2 code element shall be used. If there are multiple countries authorizing the clinical trial, then multiple country codes are entered into the country code segment.

Sponsor (organization identifier) code segment

This code segment shall reflect the unique identifier of the sponsor (organization) of the investigational medicinal product. An international coding system for unique sponsor (organizations) identifiers can be applied, if available.

Sponsor product code or regulator product code (depending on regional requirements) segment

This code segment shall reflect a unique investigational medicinal product identifier assigned to the investigational medicinal product. It utilises the following attributes to define a single investigational medicinal product, to which a code is assigned:

a) substances(active) or specified substances (e.g. active, adjuvant);

b) strength or reference strength of the active substance(s);

c) device(s) (where an investigational 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 investigational medicinal product);

d) therapeutic indication(s) studied in the clinical trial.

A separate unique IMPID shall be assigned whenever any of the above items of information for an investigational medicinal product are different in any way that is relevant to the medicines regulatory agency’s process.

This process may result in changes to the IMPID for an investigational medicinal product when existing regulatory identifiers would not change. This document does not require such existing regulatory identifiers to be changed in step with the IMPID. Each jurisdiction can continue with its existing working practices for existing identifiers.

Depending on regional regulatory requirements, products that differ only by target age group, or that have closely related indications within the same pharmacologic class where the mechanism of action and clinical effect are identical, can be represented under the same IMPID and need not result in assignment of a different IMPID.. Refer to regional implementation requirements for specific guidance.

For each packaged investigational medicinal product, a unique IPCID can be assigned.

The IPCID shall use a common segment pattern related to a package of an investigational medicinal product, which when each segment is valued, shall define a specific IPCID concept. The pattern is:

a) IMPID for the investigational medicinal product;

b) package description code segment which refers to a unique identifier for each package.

Any change in the values related to these code segments shall result in the assignment of a new IPCID.

The IPCID code segment shall use the defining attribute sets as described below.

This code segment shall reflect a code assigned to each package presentation of an investigational medicinal product. It shall use the following defining attribute set:

a) package item (container)(s) — the type, quantity (items per package), material(s) and alternate material(s);

b) package component(s) — type, material(s) and alternate material(s);

c) manufactured item(s) — manufactured dose form, unit of presentation, quantity (items per package).

A separate unique IPCID shall be assigned whenever any of the aforementioned attribute sets of a packaged investigational medicinal product are different in any way that is relevant to the medicine’s regulatory process.

This process may result in changes to an IPCID when existing regulatory identifiers would not change. This document does not require such existing regulatory identifiers to be changed in step with the IPCID. Each region may continue with its existing working practices for existing identifiers.

For each investigational medicinal product, an IBAID1 can be assigned. The IBAID1 shall use the batch number allocated by the manufacturer or sponsor and the expiration date together with the IPCID. The IBAID1 shall use the batch number as it appears on the outer packaging of a specific batch of the investigational medicinal product.

The IBAID1 shall use a common attribute set related to an investigational medicinal product, which when all of them have a value, define a specific IBAID1 concept:

a) IPCID;

b) batch number (outer packaging);

c) expiration date (optional attribute) (month/year) using the ISO 8601 date format.

For each investigational medicinal product, an IBAID2 can be assigned. The IBAID2 shall use the batch number allocated by the manufacturer or the sponsor and the expiration date together with the PCID. The IBAID2 shall use the batch number as it appears on the immediate packaging, where this is not the outer packaging, of a specific batch of the investigational medicinal product.

The IBAID2 shall use a common attribute set related to a packaged investigational medicinal product, which when all of them have a value, define a specific IBAID2 concept:

a) IPCID;

b) batch number (immediate packaging);

c) expiration date (optional attribute) (month and year) using the ISO 8601 date format.

In the following subclauses, information is given only where it differs from that given for the authorised medicinal product.

In addition to the primary identifiers described above, the main concepts modelled in Figure 15 and described in the text below shall apply in order to identify and characterise an investigational medicinal product which itself is identified by the IMPID.

NOTE Each box present in Figure 15 does not represent an individual class, but represents all the classes related to the area named in the box. For instance, the box investigational packaged medicinal products represents all the classes related to investigational packaged medicinal products, e.g. batch identifier, package item (container).

Figure 15 — Investigational medicinal product overarching model

This subclause 11.2.2 specifies the IMPID together with the information that uniquely identifies and characterises an investigational medicinal product as authorised for investigation in a clinical trial by a medicines regulatory agency in a region or jurisdiction.

This subclause specifies the name of the investigational medicinal product as given by a sponsor, together with an analysis of the name into various parts. There are some small differences between this subclause 11.2.3 and the equivalent subclause for the authorised medicinal product (subclause 9.2.2.9). Further differences between authorized medicinal product and investigational medicinal product subclauses are described in more detail in the following subclauses 11.2.4 – 11.2.10.

This subclause specifies the versioning of the core identifiers related to an investigational medicinal product, as well as the characteristics associated with the investigational medicinal product and the documentation that supports the versioning.

Please refer to 9.1.4 for the corresponding header of the authorised medicinal product.

This subclause specifies characteristics about the manufacturing and other associated operations and their authorizations as issued by a medicines regulatory agency, which grants permission to a manufacturer or establishment (organization) to undertake manufacturing and other associated operations related to an investigational medicinal product in a specific jurisdiction.

Please refer to 9.1.5 for the corresponding manufacturer information for the authorised medicinal product, for which the information is mandatory. In this investigational context, provision of manufacturer information is optional.

This subclause specifies the information about the clinical trial authorization as issued by a medicines regulatory agency, which grants permission to a sponsor to place an investigational medicinal product into trial in a specific region or jurisdiction.

This subclause specifies the information about the packaging and container(s) of an investigational medicinal product and any associated device(s) which are an integral part or provided in combination with the investigational medicinal product, as supplied for a clinical trial. It also specifies the ingredient information for the manufactured item(s).

Please refer to 9.1.7 for packaging information for the authorised medicinal product. In the context of an investigational medicinal product, the provision of information is considered as optional, and reference should be made to the regional implementation guidance.

This subclause specifies information about the investigational medicinal product in the dose form and route of administration(s) to be studied in line with the trial protocol. It also includes reference to the associated PhPID(s) and the ingredient(s) for the pharmaceutical product. Where applicable, the pharmaceutical product can also include information on a medical device, if it is an integral part of the investigational medicinal product (e.g. scaffolding or net for a cell therapy medicinal product).

This subclause specifies information on all the active ingredients, adjuvants and excipients present in the investigational medicinal products.

This subclause specifies information about the clinical particulars of the investigational medicinal product in line with the study protocol and the investigator’s brochure.

Please refer to the parallel object in 9.1.10 for the authorised medicinal product.

A jurisdiction may further refine the requirements in relation to the clinical particulars information at implementation so that this information is to be specified only if required.

This subclause specifies the IMPID together with the information that uniquely identifies and characterises an investigational medicinal product as approved for investigation in a clinical trial by a medicines regulatory agency in a jurisdiction.

The general pattern of information is as for an authorised medicinal product (see 9.2), with some additional attributes.

General

Figure 16 shows the description of the investigational medicinal product section.

Figure 16 — Investigational medicinal product section detailed description diagram

Investigational medicinal product

General

This represents the investigational medicinal product as authorised for use in a clinical trial by a medicines regulatory agency in a specific jurisdiction and has the following attributes.

IMPID

The identifier for the investigational medicinal product shall be always specified as text.

Combined pharmaceutical dose form

The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3.

Sponsor product code

The product code (identifier) for the investigational medicinal product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 11.3.2.2.5) shall be specified.

Regulator product code

The product code (identifier) for the investigational medicinal product as designated by the medicines regulatory agency can be specified in text. Either this code or the sponsor product code (see 11.3.2.2.4) shall be specified.

Paediatric use indicator

If the investigational medicinal product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used.

Clinical trial status

The status of the clinical trial shall be specified according to the format provided in ISO/TS 20443, where more information and examples are also available.

Orphan designation status

See 9.2.2.2.7.

Orphan designation

See 9.2.2.3.

Product cross-reference

See 9.2.2.7.

Header

See 9.2.2.10

Attached document

“Attached document” can refer to, for example, the investigator’s brochure, the clinical trial protocol and any other regulated product information (as applicable for authorised medicinal products).

Product classification

The investigational medicinal product can be classified according to various classification systems, which may be jurisdictional or international. One or more of these various classifications of the product can be specified as described in 9.2.2.4.

Investigational medicinal product name

Full name

The full and complete investigational medicinal product name as assigned by the sponsor can be specified as text. Unlike the authorised medicinal product name, this information is not mandatory for investigational medicinal products, but either this attribute or the product code attribute below shall be valued.

Code

The investigational medicinal product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable.

For all the other name part attributes, the information is as described previously in 9.2.2.8.

Country or language

See 9.2.2.9.

A clinical trial authorization is issued by the appropriate medicines regulatory agency. In compliance with the laws and regulations applicable in a jurisdiction, an authorization is required before an investigational medicinal product can be studied in a clinical trial.

General

Figure 17 shows the description of the clinical trial authorization section.

Figure 17 — Clinical trial authorization section detailed description diagram

Clinical trial authorization

General

An investigational medicinal product shall have a clinical trial authorization specified using the following information.

Registration number

The registration number (identifier) for a clinical trial in a region shall be specified.

Investigation code

The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text.

Country

The jurisdiction(s) in which the clinical trial authorization was granted shall be described using ISO 3166-1 alpha-2 code elements.

Protocol number

The number assigned to the clinical trial protocol shall be specified.

Authorization date

The date when the clinical trial authorization was granted by a medicines regulatory agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Anticipated end date

The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Local clinical trial authorization

General

Local information in relation to a clinical trial authorization (e.g. in a country within a jurisdiction) as granted by a medicines regulatory authority shall be specified, where applicable.

Local clinical trial registration number

The registration number (identifier) for a clinical trial as assigned by the regulatory medicines authority locally shall be specified in text.

Local investigation code

The “code” for an investigational medicinal product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text.

Jurisdiction

The jurisdiction(s) in which the clinical trial authorization was granted shall be described using ISO 3166-1 alpha-2 code elements.

Local authorization date

The date when the clinical trial authorization was granted locally by a regulatory medicines authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Local anticipated end date

The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Sponsor (organization)

Details in relation to the sponsor to which a clinical trial authorization in a region or jurisdiction was granted shall be specified using an organization class (see 9.4).

Medicines regulatory agency

Details in relation to the medicines regulatory agency that granted the clinical trials authorization for an investigational medicinal product shall be specified using an organization class (see 9.4).

Manufacturer or establishment (organization) shall be described as defined in 9.5.

This data object specifies information about the packaging and container(s) of an investigational medicinal product and any associated device(s) which are an integral part or provided in combination with an investigational medicinal product, as supplied by the manufacturer. It also specifies the ingredient information for the manufactured item(s). See 9.6.

This subclause describes the investigational medicinal product in terms of its qualitative and quantitative composition and in the pharmaceutical dose form studied in line with the clinical trial protocol (see Figure 18). These characteristics of the investigational medicinal product are referred to as pharmaceutical product.

For certain medicines, a device can form an integral part of the investigational medicinal product, for example to support the administration of the medicine. In these instances, the pharmaceutical product contains the device component information as an additional characteristic.

Figure 18 — Pharmaceutical product (investigational medicinal product)

See 9.8.2.2 for all classes or attributes other than dosing and route of administration which are specified in11.7.3.

General

11.7.3 describes information about the dosing of the investigational medicinal product in relation to the clinical trial in which the product is subject to investigation. All information about dose quantities and treatment periods are in the context of the route of administration specified in the first attribute. If the trial uses more than one route of administration for the administration of the investigational medicinal product, multiple instances of this class shall be used.

First dose in humans

The first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used.

Maximum single dose

The maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorization can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

Maximum dose per day

The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorization can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

Maximum dose per treatment period

The maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorization can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

Maximum treatment period

The maximum treatment period during which the investigational medicinal product can be administered as per the protocol referenced in the clinical trial authorization can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used.

See 9.7.

See 9.9.

NOTE Contraindication and undesirable effects information are optional for an investigational medicinal product, but that therapeutic indication information is mandatory.

See 9.8.2.6.

See 9.6.2.14.

See 9.6.2.15.

See 9.6.2.21.

1. 
   (normative)
   
   Full model — Authorized medicinal products detailed diagram

Figure A.1 — Full Model – Authorized medicinal products detailed diagram

1. 
   (normative)
   
   Full model — Investigational medicinal products detailed diagram

Figure B.1 — Investigational medicinal products detailed diagram

1. 
   (informative)
   
   Class name and attribute translations and synonyms for the identification of medicinal products (IDMP)

This annex describes language translation considerations and provides synonyms. An important implementation consideration is the consistent application and regional or local language translations of the semantic definitions for the class names and attributes depicted in the data model referenced in Annexes A and B. Terms and synonyms used throughout this document can be used to assist implementers and help ensure consistent semantic interpretation of the class names, attributes and data elements used in the data model.

The terms are common concepts used in IDMP use cases such as regulatory affairs, pharmacovigilance, health care and governmental organizations involved in the use of IDMP standards.

Translation is the conversion of text written in one language into another language. It always involves interpretation, because a word-for-word translation of the original document into the target document would change the meaning of the content. The most important aspect of translation is to transfer the same message contained in the original language into a different language. The translations were created under the premise that the meaning of each term is defined by the IDMP model and its relations to other terms. Therefore, it can deviate from word-for-word translations.

This annex also addresses businesses, local authorities, health insurances, hospitals, etc. seeking to implement the IDMP data model. It facilitates the understanding of the IDMP model by breaking down language barriers and ensures the consistency and validity of the different translations available.

The full list of class name and attribute translations and synonyms for the identification of medicinal products is available on the ISO Standards Maintenance Portal: https://standards.iso.org/iso/11615/ed-2/en/amd/1

Bibliography

[1] ISO/FDIS 22532, Health informatics – Identification of medicinal products – Core vocabulary for the IDMP Standards

[2] ISO 3166‑1:2020, Codes for the representation of names of countries and their subdivisions — Part 1: Country code

[3] ISO/TS 5384:2024, Health informatics — Categorial structure and data elements for the identification and exchange of immunization data

[4] ISO 8601‑1:2019, Date and time — Representations for information interchange — Part 1: Basic rules

[5] ISO 8601‑2:2019, Date and time — Representations for information interchange — Part 2: Extensions

[6] ISO/TS 16791, Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers

[7] ISO/TS 19256:2016, Health informatics — Requirements for medicinal product dictionary systems for health care

[8] ISO 21090, Health informatics — Harmonized data types for information interchange

[9] ISO 21976:2018, Packaging — Tamper verification features for medicinal product packaging

[10] ISO/IEC 23751:2022, Information technology — Cloud computing and distributed platforms — Data sharing agreement (DSA) framework

[11] Council Directive 92/27/EEC of 31 March 1992 on the labelling of Medicinal Products for human use and on package leaflets

[12] Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium- sized enterprises

[13] Directive 2011/62/EU, Falsified Medicines Directive

[14] European Directorate for the Quality of Medicines & HealthCare (EDQM). https://www.edqm.eu/en/

[15] Health Level 7 (HL7), https://www.hl7.org/index.cfm

[16] HL7 Fast Healthcare Interoperability Resources. https://hl7.org/fhir/

[17] Object Management Group (OMG). https://www.omg.org/

[18] Language U.M. (UML), https://www.omg.org/uml/