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

Current version

Reflection paper on the level of purification of extracts to be considered as herbal preparations

AdoptedReference Number: EMA/HMPC/186645/2008Summary:

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.

Document history - First version (current)

Reflection paper on the level of purification of extracts to be considered as herbal preparations

AdoptedReference Number: EMA/HMPC/186645/2008Summary:

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.

Overview of comments on draft reflection paper on level of purification of extracts to be considered as herbal preparations

Reference Number: EMA/HMPC/435996/2009

Draft reflection paper on level of purification of extracts to be considered as herbal preparations

Draft: consultation closedReference Number: EMEA/HMPC/186645/2008