Privatsphäre-Einstellungen

Clarification of the Borderline between “Herbal preparations” and “Isolated Herbal Constituents”

Contribution to the discussion of the “Reflection paper on level of purification of extracts to be considered as herbal preparations” (EMEA/HMPC/186645/08)

Dr. Frauke Gaedcke

Finzelberg GmbH & Co. KG., Andernach (Germany)

Herbal medicinal products contain as herbal preparation not only simply processed preparations such as herbal drugs and herbal extracts as active substances but also purified and concentrated extracts like “refined extracts”. In some cases, however, the purification is so substantial that the question arises whether the resulting preparation has still to be considered as highly purified herbal preparation or whether it should be regarded as an isolated herbal constituent or a mixture of closely related herbal constituents as e. g. sennosides, aescin or silymarin.
The aim of the following contribution is to suggest criteria to define a borderline between the both categories “herbal preparations” and “isolated herbal constituents” having in mind that the final evaluation is a case-by-case decision.