BS ISO 21371:2018 pdf download.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 matter or symbol relating to a product and placed on any packaging, document, notice or label (3.1) accompanying or referring to a finished manufactured product (3.4)
3.3 packaged herb
herbs pre-packaged and delivered to consumers or practitioners with labelling (3.2) that can be used for traditional Chinese medicine with simple processing such as decoction or ingestion as tea, etc.
3.4 finished manufactured product
finished product used by consumers or practitioners for oral and topical use in and as traditional Chinese medicine without further processing
Note 1 to entry: Packaged herb is also included in this term.
3.5 expiry date
<finished manufactured product> date (month and year) after which the product should not be used
3.6 active
ingredient therapeutically-active herb or other natural material in a finished manufactured product (3.4) that is responsible for its physiological or pharmacological action Note 1 to entry: In the case of “liquorice (Glycyrrhiza uralensis) root extract” or “Ephedra Decoction” extract, the chemical compound in the herb such as “glycyrrhizin” or “ephedrine” is not an active ingredient as defined in this document.
3.7 extract
substance obtained by using suitable solvent(s) for raw material(s) Note 1 to entry: It includes concentrated, dried, viscous or fluid substance.
3.8 excipient
ingredient of the finished manufactured product (3.4) other than the active ingredient (3.6) 3.9 batch specific quantity of a product that is uniform, is intended to meet specifications for identity, purity, strength and composition, and is produced to a single manufactured record during the same cycle of manufacturer from which it is possible to trace that batch through all stages of manufacture and distribution
BS ISO 21371:2018 pdf download
