ISO 21371:2018

Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use

ISO 21371:2018 specifies general requirements for the labelling of products intended for oral or topical use in and as traditional Chinese medicine (TCM). ISO 21371:2018 is applicable to all finished manufactured products including packaged herbs used in and as TCM. This document includes the essential and informative elements for labelling of products to assist in the choice and safe use of these products by consumers and practitioners. NOTE A list of TCM labelling requirements of the WHO and various regions and countries is given in Annex A.

Médecine traditionnelle chinoise — Exigences d’étiquetage des produits destinés à un usage oral ou topique

General Information

• Status: Published
• Publication Date: 29-Jan-2018
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 2 - Quality and safety of manufactured TCM products
• Current Stage: 9060 - Close of review
• Start Date: 02-Sep-2028

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 21371
First edition
2018-01
Traditional Chinese medicine —
Labelling requirements of products
intended for oral or topical use
Médecine traditionnelle chinoise — Exigences d’étiquetage des
produits destinés à un usage oral ou topique
Reference number
ISO 21371:2018(E)
©
ISO 2018

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ISO 21371:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018, Published in Switzerland
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ii © ISO 2018 – All rights reserved

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ISO 21371:2018(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Labelling information . 2
4.1 General . 2
4.2 Labelling elements for both packaged herbs and finished manufactured products . 3
4.2.1 Product name . 3
4.2.2 Category of the product in the marketed country or region . 3
4.2.3 Net weight/quantity . 3
4.2.4 Contact information . 3
4.2.5 Name of raw materials . 3
4.2.6 Warning statements, if any . 3
4.2.7 Expiry date . 3
4.2.8 Storage method . 3
4.2.9 Batch/lot number. 3
4.2.10 Miscellaneous . 3
4.3 Additional labelling elements for finished manufactured products only . 4
4.3.1 Common elements for all product classifications . 4
4.3.2 Elements depending on each product classification. 4
4.4 Informative elements . 4
4.4.1 Traditional Chinese medicine code . 4
4.4.2 Daily dosage . 4
4.4.3 Manufacturer . 4
4.4.4 Indication/functionality . 4
4.4.5 Information on certification acquired by manufacturer . 5
4.4.6 Notice and messages . 5
4.4.7 Country of origin . 5
5 Labelling format . 5
5.1 Language . 5
5.2 Font size and colour . 5
5.3 Location . 5
Annex A (informative) List of labelling requirements . 6
© ISO 2018 – All rights reserved iii

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ISO 21371:2018(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.
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World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
iv © ISO 2018 – All rights reserved

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INTERNATIONAL STANDARD ISO 21371:2018(E)
Traditional Chinese medicine — Labelling requirements of
products intended for oral or topical use
1 Scope
This document specifies general requirements for the labelling of products intended for oral or topical
use in and as traditional Chinese medicine (TCM).
It is applicable to all finished manufactured products including packaged herbs used in and as TCM.
This document includes the essential and informative elements for labelling of products to assist in the
choice and safe use of these products by consumers and practitioners.
NOTE A list of TCM labelling requirements of the WHO and various regions and countries is given in Annex A.
2 Normative references
There are no normative references in this document.
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 https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
label
tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed
or impressed on, or attached to the packaging or container of a finished manufactured product (3.4)
3.2
labelling
words, particulars, trademarks, brand name, pictorial m
...