Level of purification of extracts to be considered as herbal preparations

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Reflection paper

Reference numberEMEA/HMPC/186645/08
KeywordsHerbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extracts, HMPC, quality
DescriptionThis 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.

Document history

First version

Current version

Reflection paper

Overview of comments

Draft reflection paper

Published: 03/01/2011

Published: 05/06/2015

Published: 06/11/2008

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