EMA: Scientific guideline: Reflection paper on the level of purification of extracts to be considered as herbal preparations

This reflection paper applies to extracts used as active substances in herbal medicinal products (HMPs) both for human and veterinary use and in traditional herbal medicinal products (THMPs) for human use. The purpose of this reflection paper is to consider aspects related to the different levels of purification of extracts and to provide criteria to distinguish between those extracts that may be considered as herbal preparations and those that might be, more correctly, classified as isolated herbal constituent or purified mixtures of herbal constituents, taking into account that the final decision has to be taken on a case by case evaluation.