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
