ISO 23963-2:2022

Traditional Chinese medicine - Requirements for process traceability system of Chinese materia medica and decoction pieces - Part 2: Electronic labelling

This document specifies the content of electronic labelling in the form of QR codes on the outer packing of Chinese materia medica and decoction pieces. This document is applicable to the cultivation, production, sales, use units and consumers of Chinese materia medica and decoction pieces.

Médecine traditionnelle chinoise — Exigences relatives au système de traçabilité du processus pour la Materia Medica chinoise et les décoctions — Partie 2: Étiquetage électronique

General Information

• Status: Published
• Publication Date: 31-Jul-2022
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/JWG 1 - Joint ISO/TC 249 - ISO/TC 215 WG: Informatics
• Parallel Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 01-Aug-2022
• Due Date: 18-Mar-2022
• Completion Date: 01-Aug-2022

Overview

ISO 23963-2:2022 defines the required content and management principles for electronic labelling presented as QR codes on outer packaging of Chinese materia medica and decoction pieces. The standard applies across the supply chain - cultivation, production, sales, clinical use units and consumers - and supports a standardized traceability system that improves product transparency, quality assurance and consumer confidence.

Key Topics

• QR code content and format: Electronic labelling is delivered via QR codes and displays text, graphics and instructions after scanning (electronic labelling). The content must be fixed and only editable through a trusted third‑party platform independent of supply‑chain operators.
• Unique batch linkage: Each batch of materia medica or decoction pieces shall correspond to a unique electronic label. The label language must be the official language of the destination country.
• Mandatory data fields: The QR payload shall include standardized data for rapid verification and compliance. Essential items listed by the standard include:
  • Product name (per ISO 18668‑2 / ISO 18668‑3)
  • Barcode (per ISO 20333)
  • 17‑bit code for materia medica and decoction pieces (ISO 18668 series)
  • Brand and registered trademark
  • Place of origin (county level, per ISO 20333)
  • Harvest time and other product timestamps (YYYY-MM-DD)
  • Processing method, specification (g/pack), efficacy, adverse reactions and contraindications
  • Manufacturer and distributor details: registered name, full address (door number), telephone (country code–area–number) and website (standard web format)
  • Packing / product times with date format YYYY-MM-DD
  • Additional info: storage method (per ISO 22217), applied standards, product images, decocting and administration methods
• Governance rules: Organizations providing labelling must act as trusted third parties; users shall not modify label content directly. If multiple distributors exist, their information can be added.

Applications

• Enables end‑to‑end supply‑chain traceability for traditional Chinese medicine products.
• Supports regulatory compliance, internal quality control and supplier evaluation.
• Provides consumers and clinicians with accessible product information (origin, processing, usage and safety data) by scanning a QR code.
• Facilitates internationalization and standardization of Chinese materia medica and decoction pieces by harmonizing data presentation.

Related Standards

ISO 23963-2 references and is consistent with related documents used for coding and handling of TCM products:

• ISO 23963-1 - Components of the traceability system
• ISO 18668-2 / ISO 18668-3 - Coding systems for decoction pieces and materia medica
• ISO 20333 - Coding rules for supply chain management
• ISO 22217 - Storage requirements for raw materials and decoction pieces

Follow ISO 23963-2:2022 to implement robust QR-based electronic labelling that enhances traceability, consumer safety and product transparency for traditional Chinese medicine.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 23963-2
First edition
2022-08
Traditional Chinese medicine —
Requirements for process traceability
system of Chinese materia medica and
decoction pieces —
Part 2:
Electronic labelling
Médecine traditionnelle chinoise — Exigences relatives au système
de traçabilité du processus pour la Materia Medica chinoise et les
décoctions —
Partie 2: Étiquetage électronique
Reference number
© ISO 2022
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements of electronic labelling .2
5 Content of electronic labelling . 2
5.1 Basic information . 2
5.1.1 Product name . 2
5.1.2 Barcode . 2
5.1.3 Code. 2
5.1.4 Brand . 3
5.1.5 Place of origin . 3
5.1.6 Harvest time . 3
5.1.7 Processing method . 3
5.1.8 Specification . 3
5.1.9 Efficacy . 3
5.1.10 Adverse reaction. 3
5.1.11 Contraindication . 3
5.2 Manufacturer information . 3
5.2.1 Manufacturer . 3
5.2.2 Address . 3
5.2.3 Telephone number . 3
5.2.4 Website . 3
5.2.5 Product time . 4
5.3 Distributor information . 4
5.3.1 Distributor . 4
5.3.2 Address . 4
5.3.3 Telephone number . 4
5.3.4 Website . 4
5.3.5 Packing time . 4
5.4 Additional information. 4
5.4.1 Storage method . 4
5.4.2 Applied standards . 4
5.4.3 Picture . 4
5.4.4 Decocting method . 4
5.4.5 Administration method. 5
5.4.6 Other information . 5
Bibliography . 6
iii
Foreword
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electrotechnical standardization.
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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).
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
A list of all parts in the ISO 23963 series can be found on the ISO website.
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.
iv
Introduction
Chinese medicine (medicinal plants, animals and minerals) originates from a wide variety of different
sources of supply. The
...