REGULATION AND REGISTRATION PROCEDURE FOR HERBAL MEDICINAL PRODUCTS IN AUSTRALIA, EUROPE UNION AND ZAMBIA
Jayeshkumar G Rathod*1, Ms. Krupa C Thula2, Dr. Dilip Maheshwari
Journal Title:World Journal of Pharmacy and Pharmaceutical Sciences
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.