LEGISLATION AND QUALITY CONTROL OF HERBAL MEDICINES IN MERCOSUL

Abstract

This study aimed to collect data on herbal medicines in the Mercosul countries, mainly about the major marketed plants, as well as, biological systems with higher prevalence, health control, market data and key aspects related to legislation. The survey was conducted by document analysis, with a literature review on all types of production in Portuguese, English and Spanish (books, dissertations, theses, documents, laws, articles). It was noted that Brazil has a larger number of regulations on the health and quality control of herbal medicines and it is the largest country in the Mercosul. Herbal
medicines most commercialized in the country have action on the central nervous (n=6) and respiratory systems (n=6), with 32%, and with 26% (n=5), the gastrointestinal system. Most of them 63% (n=12) is formulated with dry extract. In Argentina and Paraguay, most of them have action on the gastrointestinal system, with 38% (n=16) and 50% (n=7), respectively.
It highlights the lack of studies and legislation mainly in Paraguay, Uruguay and Venezuela. Quality control is governed by regulatory issues; however, Uruguay classifies these products as medicines in general, and in Venezuela, as
natural products. The lack of specific resolutions, with the exception of Brazil and Argentina, to guide the steps of production and control of herbal medicines, may complicate to discovery process of new bioactive agents from herbal medicines.