Guidelines for Registration of Herbal Products

This guideline presents a common format for presentation of a well-structured

application for registration of herbal/complementary medicines to be submitted to Pharmacy and Poisons Board. This format of technical documentation will significantly reduce the time and resources needed to compile applications for registration of herbal and complementary products and will in future ease the preparation of electronic submissions. This guideline will ensure that only good quality, safe and efficacious herbal and complementary products are available in Kenya; and to contribute towards their accessibility, cost effectiveness and appropriate use with the current state of knowledge.

This guideline has been drawn to address the many issues on the quality of herbal and complementary medicines that have been used for a long period of time in Kenya. These issues include;

a) Misconception amongst herbalists that documentation requested for by PPB is intended to steal their indigenous knowledge and thus, there has been hesitation to submit applications.

b) Lack of documented evidence on quality, safety & efficacy of Herbal and complementary products

c) Unethical practices that include:

• ▪  Adulteration of herbal and complementary products with conventional medicines
• ▪  Advertising of Herbal and complementary products in print media, electronic and billboards
• ▪  Peddling of products with no therapeutic benefits
• ▪  Unsubstantiated medicinal claims by herbal practitioners.
• ▪  Dealing with herbal products whose toxicological profile is not known

  d) Poor standards of preparation/manufacture and sale of herbal and complementary products

This guideline will focus on the manufacture and registration of herbal and complementary medicines. This guideline applies only to herbal and complementary products. In the case of other medicinal products such as conventional and borderline products, separate guidelines are available and these can be obtained from PPB offices. This guideline provides recommendations for applicants preparing applications for herbal and complementary products for submission to the Pharmacy and Poisons Board (PPB). This guideline prescribes the minimum information required for submission of dossiers, evaluation of products, variation of products, and retention of registered products.

This guideline indicates an appropriate format and organization of the data. Applicants are requested to carefully read this guideline, fill in the application form, prepare dossiers and submit them online through the Pharmaceutical Regulatory Information Management System (PRIMS).