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Guidelines for the Appropriate use of Herbal Medicines
(1998; 88 pages)
Table of Contents
View the documentForeword
Open this folder and view contents1. Introduction
Open this folder and view contents2. Goals and objectives of the guidelines
View the document3. Definitions
Open this folder and view contents4. National policy development
Open this folder and view contents5. Development of a national programme on herbal medicines
Open this folder and view contents6. Regulation of practitioners
Open this folder and view contents7. Regulation of the manufacture and distribution of medicinal herbal products
Open this folder and view contents8. Regulation of herbal medicines
View the document9. Use of the guidelines
View the documentAnnex 1: Report of the meeting of the working group on herbal medicines
View the documentAnnex 2: List of temporary advisers, consultants, observers and secretariat
View the documentAnnex 3: Agenda
View the documentAnnex 4: Opening Speech of Dr S.T. Han, WHO Regional Director for the Western Pacific Region Working Group on Herbal Medicines, 8 December 1997, Manila, Philippines
View the documentAnnex 5: Closing Remarks of Dr S.T. Han, WHO Regional Director for the Western Pacific Working Group on Herbal Medicines, 12 December 1997, Manila, Philippines
View the documentReferences
 

3. Definitions

The following terms are used as working definitions in this document:

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.

 

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