Guidelines for application for registration of herbal drugs

Section 51 of the Tanzania Food, Drugs and Cosmetics Act, 2003 enables the Tanzania Food and Drugs Authority (TFDA) to register a herbal drug if it is in the public interest and the product is safe, efficacious and of good quality. 

With the expansion in the use of herbal drugs worldwide, quality, safety and efficacy have become a challenge to both drug regulatory authorities and the public.  These guidelines have been developed to provide requirements in support of quality, safety and efficacy for those who wish to market herbal drugs in Tanzania. They intend to assist applicants in the preparation of acceptable application documents.

It is therefore essential that every person who intends to market any herbal drug in Tanzania reads the whole of these guidelines carefully and follows strictly the instructions prescribed herein.  Submission of applications, which do not comply with the prescribed requirements, may result in delays, queries or rejection of registration.

The guidelines have been divided into six chapters.  Chapter I gives various definitions in the context of these guidelines while chapter II provides general requirements on how to file an application, payment of relevant fees and processing of applications.  Chapter III provides requirements for summary of product characteristics and chapters IV, V and VI provide guidance on registration requirements for quality, safety and efficacy respectively.

The application form for registration of herbal drugs is provided as an appendix to the guidelines.  All applicants will be required to fill in this application form and submit it to the Authority along with other documentation as provided in the guidelines.

download the guidelines for application for registration of herbal drugs.
download the application form for registration of herbal drugs