scope:

This document specifies the controlled vocabulary for formulas used in Japanese Kampo medicine with the therapeutic indications of each product according to the subset of IDMPs (ISO 11238, ISO 11615, ISO 11616^[10], ISO 19844^[15], ISO/TS 20443^[16], ISO/TS 20451^[17]).

This document is intended to be used by:

- traders and distributors of medicinal products in Kampo formulas and crude drugs used in Kampo medicine;

- terminologists and developers of new terminological resources concerning herbal medicines in Kampo medicine, and maintenance officers of existing terminological resources concerning Kampo medicine to enable their conformance;

- informaticians, developers, or managers of HIS, EMR, or EHR systems concerning Kampo medicine;

- officers, analysts or maintenance personnel of national health statistics, and policy proposal staff of national health policies;

- officers of WHO, and WHO statistics.

This edition of this document describes only medicinal products in accordance with the Kampo formula in Japan. Both OTC Kampo formula medicinal products and in-pharmacy formula medicinal products are omitted, although they are permitted under Japanese jurisdiction.

Topics considered out of scope of this document are:

- any medicinal products manufactured in accordance with the formula of traditional medicines that are not permitted under the Japanese jurisdiction;

- whole information models of medicinal products, pharmaceutical products and substances (see ISO 11238) because those are already specified in IMDPs;

- any categorical structure(s) of herbal medicaments (see ISO/TS 18062, ISO 17115^[13] and EN 12264^[18]).

The controlled vocabulary for formulas used in Japanese Kampo medicine is given in Annex A.