ABSTRACT
Regulation is one of the most complex public health activities, as it involves the interests of different bodies, including commercial, environmental and sanitary regulation. Regulating the trade of herbal medicinal products (HMPs) is even more difficult, considering the complex composition and quality control of these products. In addition, it involves diverse activities, such as regulation of cultivation and harvesting, use of pesticides and endangered species, non-clinical and clinical research and the elaboration of official methods of control, to mention a few examples. The distribution chain goes from the trade of plants in popular fairs, on the Internet, to compounding pharmacies, drugstores and pharmaceutical industries, and the possibility of prescription by different health professionals. The legislative framework that regulates this whole chain is governed by several laws, decrees, resolutions and guides published by different entities within the Brazilian legislative and executive powers, which are based on the national laws established for medicines, a fact that increases the control parameters to be ascertained. Since the publication of public policies on HMPs, many updates have been made in the Brazilian legislative framework, aiming to promote the safe and effective use of medicinal plants and HMPs and the development of their production chain.
