Monographs, list entries, public statements

Abstract

Results: According to Directive 2004/24/EC which amended the basic legislation laid down in Directive 2001/83/EC a new European legislation on herbal medicinal products was developed, in order to harmonize the use of herbal medicinal products in Member States of the European Union.

Conclusions: The objective of this legislation was to ensure the future existence of such products and to consider particular characteristics during the assessment of their quality, efficacy and safety, having defined two categories for herbal medicines: i) well-established use herbal medicinal products, which can be granted a marketing authorization; and ii) traditional herbal medicinal products which can be granted a registration based on their longstanding safe and efficient use.

Keywords: Community monographs; Herbal medicinal products; List entries; Public statements; TU-WEU HMPs.