Traditional Chinese medicine — Coding rules for Chinese medicines in supply chain management

ISO 20333:2017 specifies coding rules for Chinese medicines to assist in supply chain management. The coding provides information such as the trade item, producing area, unit, grade, production date, batch number, quantity of medicines, and logistic unit. This includes Chinese Materia Medica and decoction pieces, but excludes granule forms of individual medicinals for prescriptions (GFIMP) and Chinese patent medicines (CPM).

Médecine traditionnelle chinoise — Règles de codage des médecines chinoises dans la gestion de la chaîne logistique

General Information

Status
Published
Publication Date
13-Aug-2017
Current Stage
9020 - International Standard under periodical review
Due Date
15-Jul-2022
Completion Date
15-Jul-2022
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INTERNATIONAL ISO
STANDARD 20333
First edition
2017-08
Traditional Chinese medicine —
Coding rules for Chinese medicines in
supply chain management
Médecine traditionnelle chinoise — Règles de codage des médecines
chinoises dans la gestion de la chaîne logistique
Reference number
ISO 20333:2017(E)
ISO 2017
---------------------- Page: 1 ----------------------
ISO 20333:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

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ii © ISO 2017 – All rights reserved
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ISO 20333:2017(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Coding principles ................................................................................................................................................................................................. 2

4.1 Uniqueness ................................................................................................................................................................................................. 2

4.2 Compatibility ............................................................................................................................................................................................ 2

4.3 Stability .......................................................................................................................................................................................................... 2

5 Information coding ............................................................................................................................................................................................ 3

5.1 Retail products of Chinese medicines code .................................................................................................................... 3

5.2 Medicinal code......................................................................................................................................................................................... 3

5.3 Company internal information code .................................................................................................................................... 3

5.3.1 General principles ........................................................................................................................................................... 3

5.3.2 Producing area code ..................................................................................................................................................... 3

5.3.3 Measurement unit code ............................................................................................................................................. 4

5.3.4 Grade code ............................................................................................................................................................................. 4

5.4 Code of production date .................................................................................................................................................................. 4

5.5 Code of batch number ....................................................................................................................................................................... 5

5.6 Code of batch numbers in logistic unit ............................................................................................................................... 5

5.7 Code of logistic unit............................................................................................................................................................................. 5

6 Representation of information identification ....................................................................................................................... 5

6.1 One-dimensional bar code representation ..................................................................................................................... 6

6.1.1 One-dimensional bar code representation of retail trade account ...................................... 6

6.1.2 One-dimensional bar code representation of non-retail trade account .......................... 6

6.1.3 One-dimensional bar code representation of logistic unit .......................................................... 6

6.2 Two-dimensional bar code representation .................................................................................................................... 6

6.3 Radio frequency identification (RFID) representation ........................................................................................ 7

6.3.1 Technical requirements ............................................................................................................................................. 7

6.3.2 Requirements of encapsulation material.................................................................................................... 7

Bibliography ................................................................................................................................................................................................................................ 8

© ISO 2017 – All rights reserved iii
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ISO 20333:2017(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO’s adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: w w w . i s o .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.

iv © ISO 2017 – All rights reserved
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ISO 20333:2017(E)
Introduction

The popularity of medicinal products derived from natural materials, particularly herbal materials,

is increasing rapidly. For example, the international market for medicines used in traditional Chinese

medicine (TCM) was valued at USD 16 billion and is increasing at a rate of 10 % to 20 % per year.

Most goods traded internationally use bar coding to monitor the movement and use of the products.

For example, even pencils and erasers have bar codes which permit their individual identification.

However, this does not currently apply to medicines used in TCM. While at least 70 countries now have

administrative systems in place to regulate TCM, the lack of bar coding is a barrier to the increasing

trade and to ensuring the identity and quality of ingredients and products for the well-being of

communities.

This document introduces a bar coding for TCM which is consistent with existing standards. It also

provides a basis for similar coding systems for the products of related traditional health systems.

© ISO 2017 – All rights reserved v
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INTERNATIONAL STANDARD ISO 20333:2017(E)
Traditional Chinese medicine — Coding rules for Chinese
medicines in supply chain management
1 Scope

This document specifies coding rules for Chinese medicines to assist in supply chain management. The

coding provides information such as the trade item, producing area, unit, grade, production date, batch

number, quantity of medicines, and logistic unit. This includes Chinese Materia Medica and decoction

pieces, but excludes granule forms of individual medicinals for prescriptions (GFIMP) and Chinese

patent medicines (CPM).
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO/IEC 15416, Information technology — Automatic identification and data capture techniques — Bar

code print quality test specification — Linear symbols

ISO/IEC 15418, Information technology — Automatic identification and data capture techniques — GS1

Application Identifiers and ASC MH10 Data Identifiers and maintenance

ISO/IEC 15420, Information technology — Automatic identification and data capture techniques —

EAN/UPC bar code symbology specification

ISO/IEC 15438, Information technology — Automatic identification and data capture techniques — PDF417

bar code symbology specification

ISO/IEC 16022, Information technology — Automatic identification and data capture techniques — Data

Matrix bar code symbology specification

ISO/IEC 18000-6, Information technology — Radio frequency identification for item management — Part

6: Parameters for air interface communications at 860 MHz to 960 MHz General

ISO/IEC 18004, Information technology — Automatic identification and data capture techniques — QR

Code bar code symbology specification
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

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

— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
Chinese medicine

substance or combination of substances used under the guidance of traditional Chinese medicine (TCM)

theory for medical care and the prevention and treatment of disease

Note 1 to entry: This includes Chinese Materia Medica, decoction pieces, granule forms of individual medicinals

for prescriptions (GFIMP), and Chinese patent medicines (CPM).
© ISO 2017 – All rights reserved 1
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ISO 20333:2017(E)
[SOURCE: ISO 18668-1:2016, 3.1]
3.2
supply chain

linked set of resources and processes that begins with the sourcing of raw material and extends through

the delivery of products or services to the end user across the modes of transport

Note 1 to entry: The supply chain may include vendors, manufacturing facilities, logistics providers, internal

distribution centres, distributors, wholesalers and other entities that lead to the end user.

[SOURCE: ISO 28000:2007, 3.9]
3.3
supply chain management

management primarily concerned with the efficient integration of suppliers, factories, warehouses

and stores so that the merchandise is produced and distributed in the right quantities, to the right

locations and at the right time, and so as to minimize total system cost subject to satisfying service

level requirements
3.4
global location number
GLN
GS1 identification key used to identify physical locations or parties

Note 1 to entry: The key comprises a GS1 Company Prefix, Location Reference, and Check Digit.

[SOURCE: GS1 General Specifications, modified]
3.5
application identifier
numeric prefixes describi
...

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