Level of purification of extracts to be considered as herbal preparations - Scientific guideline

This document considers aspects related to different levels of purification of extracts. It provides criteria to distinguish between extracts that may be considered as herbal preparations and those that might be classified as isolated herbal constituent or purified mixtures of herbal constituents. It aims to clarify which existing guidance documents should be used for different herbal refined extracts.

Keywords: Herbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extracts, quality