Abstract

REGULATION AND REGISTRATION PROCEDURE FOR HERBAL MEDICINAL PRODUCTS IN AUSTRALIA, EUROPE UNION AND ZAMBIA

Jayeshkumar G Rathod*, Ms. Krupa C Thula, Dr. Dilip Maheshwari

ABSTRACT

Herbal medicinal products are very popular and wieldy used. Regulations of herbal medicinal products are required. Different countries have different regulation and registration procedure for herbal products.Quality of herbal products is important part of regulation in which raw material and finished products specification, analytical and in process methods, stability study are required. Australia and Europe Union are used Common Technical Document (CTD) format for registration of herbal medicines and Zambia is used its registration procedure. In this article herbal products and its classification, regulatory requirements and its registration procedure are discussed. This is usefulfor marketing herbal medicinal products inAustralia and Europe Union and Zambia.

Keywords: Herbal medicinal products, registration procedure, Quality, Common Technical Document (CTD) format.