Characterizing compound or marker

a natural constituent of a plant part that may be used to assure the identity or quality of a plant material or preparation, but is not necessarily responsible for the plant's biological or therapeutic activity.

Herbal medicines

plant-derived materials or products with therapeutic or other human health benefits which contain either raw or processed ingredients from one or more plants. In some traditions, materials of inorganic or animal origin may also be present, although for the purpose of this document, the focus will be on plant materials only.

Under this definition, there are three kinds of herbal medicines: raw plant materials, processed plant materials and medicinal herbal products. The definition does not apply where the active component has been identified, and either isolated or synthesized as a chemical component of a drug product.

Ingredient

the substance in the herbal formulation which may not be a purified chemical component.

Medicinal herbal products

finished, labelled pharmaceutical products in dosage forms that contain one or more of the following: powdered plant materials, extracts, purified extracts, or partially purified active substances isolated from plant materials. Medicines containing plant material combined with chemically defined active substances, including chemically defined, isolated constituents of plants, are not considered to be herbal medicines.

Medicinal plant

a plant which has been used for medical purposes at one time or another, and which, although not necessarily a product or available for marketing, is the original material of herbal medicines.

Processed plant materials

plant materials treated according to traditional procedures to improve their safety and efficacy, to facilitate their clinical use, or to make medicinal preparations.

Raw plant materials

fresh or dry plant materials which are marketed whole or simply cut into small pieces.

Therapeutic compound

a constituent which is responsible for the intervention of a plant, that results in the amelioration of the manifestations of human disease.

Traditional use

the use of herbal medicines by practitioners of a traditional system of medicine, where:

(a) the use is well-established and widely acknowledged, i.e., the use represents the accumulated experience of many practitioners over an extended period of time;

(b) the use of the herbal medicine, including dosage, indication, and administration route is well-established and documented; and

(c) the use is generally and currently regarded as safe.