European regulation of herbal medicinal products on the border area to the food sector.

This article summarizes the regulation of herbal medicinal products in the EU with emphasis on traditional herbal medicinal products (THMP) and provides an evaluation of the borderline between medicine and food. Differences in the regulation of THMP with influence on the harmonization are revealed. With regard to the borderline between medicine and food, THMP may not be medicinal products by function but by presentation. The thesis is established that depending on the presentation, the product can be medicine (THMP) as well as food. To avoid shifting into the food sector the regulatory system of THMP is evaluated with regard to its attractiveness to applicants. Recommendations to achieve a better harmonization of THMP in the EU and to increase the attractiveness of the simplified registration procedure are given.