Herbal product is defined by NPRA as any product used in the practice of indigenous medicine, in which the drug consists solely of one or more naturally occurring substances of a plant, animal or mineral, of parts thereof, in the unextracted or crude extract form, and a homeopathic medicine. The current perception for registration of herbal products in Malaysia is to be an easier/straight forward process compared to other classes of product registration. However, in reality, it is far different then the common perception. There can be numerous documentation requirements as compared to other countries. Further, in some cases, some of the herbs in the product are not listed in NPRA system which which warrants additional hurdle before the actual submission of the product registration. NVS’s consultant have been evaluating many herbal product dossiers over the years and has advised the companies/manufacturer on the best way/route to obtain herbal registration. NVS’s consultant has also developed our own herbal dossier template to aid in the dossier preparation by the companies/manufacturer.
It is important to note that only a local company with a QUEST3+ USB Token would be allowed for submitting for herbal product registration to NPRA. (To understand the process on obtaining a QUEST3+ USB Token, please refer to article “Registration System By NPRA”)
