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Planta Med 2012; 78(12): 1311-1316
DOI: 10.1055/s-0031-1298578
Perspectives
Georg Thieme Verlag KG Stuttgart · New York

Regulation of Medicinal Plants for Public Health – European Community Monographs on Herbal Substances

Werner Knöss
1   Federal Institute for Drugs and Medical Devices, Bonn, Germany
,
Ioanna Chinou
2   Division of Pharmacognosy and Chemistry of Natural Products, Department of Pharmacy, University of Athens, Athens, Greece
› Author Affiliations
Further Information

Publication History

received 08 March 2012
revised 20 April 2012

accepted 25 April 2012

Publication Date:
22 May 2012 (online)

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Abstract

The European legislation on medicinal products also addresses the medicinal use of products originating from plants. The objective of the legislation is to ensure the future existence of such products and to consider particular characteristics when assessing quality, efficacy, and safety. Two categories are defined: i) herbal medicinal products can be granted a marketing authorisation; and ii) traditional herbal medicinal products can be granted a registration based on their longstanding use if they are complying with a set of provisions ensuring their safe use. The Committee on Herbal Medicinal Products (HMPC) was established at the European Medicines Agency (EMA) to provide monographs and list entries on herbal substances and preparations thereof. Meanwhile, approx. 100 monographs have been published, which define a current scientific and regulatory standard for efficacy and safety of herbal substances and herbal preparations used in medicinal products. This harmonised European standard will facilitate the availability and adequate use of traditional herbal medicinal products and herbal medicinal products within the European Union. Consequent labelling shall also enable patients and health care professionals to differentiate medicinal products from other product categories like cosmetics, food supplements, and medical devices.

Key words

HMPC - monographs - list entries - herbal medicinal product - traditional herbal medicinal product - well-established use
 

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