Regulation of herbal medicinal products in the EU: An up-to-date scientific review

A new European legislation on herbal medicinal products (HMPs) was developed, in order to harmonise the use of HMPs in the 28 member states of the European Union, according to Directive 2004/24/EC which amended the basic legislation laid down in Directive 2001/83/EC. 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: (a) well-established use HMPs, which can be granted a marketing authorisation; and (b) traditional herbal medicinal products which can be granted a registration based on their long-standing safe and efficient use. The Committee on Herbal Medicinal Products was established at the European Medicines Agency in 2004, in order mainly to provide community monographs and list entries on herbal substances and preparations. 120 monographs have been published since then, which offer a scientific and regulatory standard for their safety and efficacy, during their use as medicinal products. The HMPs can be placed in the market after quality, efficacy, and safety have been assessed according to the provisions of the legislation (Directive 2004/24/EC and Directive 2001/83/EC), with adequate labeling information to patients and health care professionals, distinguishing them from other product categories containing herbs like: foods, food supplements, medical devices and cosmetics.