ISO 21371:2018 PDF

Name: ISO 21371:2018 — Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
SKU: ISO 21371:2018
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Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use

Название (английский):

ISO 21371:2018

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 6
Дата публикации:: 30 января 2018 г.
Издание:: ISO IS 21371 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

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.

Abstract

Похожие стандарты

Другие стандарты ISO

Overview

ISO 21371:2018 - Traditional Chinese medicine (TCM) - Labelling requirements of products intended for oral or topical use - defines general labelling requirements for finished manufactured TCM products and packaged herbs. The standard specifies essential and informative label elements to help consumers and practitioners choose and use TCM products safely. It applies to products intended for oral or topical use and covers labelling visibility, legibility and format.

Key topics and requirements

ISO 21371:2018 outlines mandatory and optional labelling content and format. Key topics include:

Essential labelling elements (both packaged herbs and finished products):

Product name (brand)
Category of the product as defined in the marketed country/region (e.g., pharmaceutical, supplement, food)
Net weight/quantity (mass or volume units: kg, g, L, mL as appropriate)
Contact information (name, full address - not PO box - and telephone of distributor/importer; previous distributor info if changed in last 12 months)
Name of raw materials with Latin (scientific) name plus part used (e.g., liquorice (Glycyrrhiza uralensis) root)
Warning statements where applicable (e.g., for children, pregnant women)
Expiry date based on stability data or scientific rationale, legible without opening packaging
Storage method (special conditions before opening)
Batch/lot number (with allowed prefixes)

Additional elements for finished manufactured products:

Excipients listed separately from active ingredients
Administration method
For extracts: formula name, amounts, constituent raw materials and extraction method (including solvent)
For single-herb extracts: extract name, amount, raw material weight, extraction method
For non-extract products: herbal name and amount

Informative elements (optional but recommended):

TCM product/raw material codes, daily dosage or range, manufacturer name/address, permitted indications/functionality (subject to market rules), certification claims (e.g., GMP, HACCP), notices, country of origin.

Format requirements: labelling must be in the official language of the sale country, legible font size and colour, and located on the outside packaging so it’s readable without opening.

Applications and who uses it

ISO 21371:2018 is used by:

TCM manufacturers and contract packagers to design compliant labels

Quality managers and regulatory affairs teams to ensure market entry compliance

Distributors and importers for traceability and adverse-event reporting

Packaging designers and print vendors for format and legibility specifications

Regulators and testing bodies for conformity checks Benefits include improved consumer safety, traceability (batch/lot), clearer ingredient disclosure (Latin names), and smoother international trade compliance.

Related standards and references

Annex A of ISO 21371:2018 lists related labelling requirements and guidance, including:

WHO Guidelines for the Appropriate Use of Herbal Medicines

EU/EC regulations (e.g., EC Reg. No.1223/2009, No.655/2013, EU Directive 2001/83/EC)

National regulatory frameworks (examples in Annex A: Germany, UK) These references help align TCM labelling with regional regulatory requirements and claims rules.

ISO 21371:2018 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and who uses it

Related standards and references

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