Abstract:

The simplified registration procedure clarifies differences and uncertainties in the status of traditional herbal medicinal products and facilitates the free movement of these products through harmonised rules.

The registration procedure is intended for herbal medicinal products with a long tradition of medicinal use (at least 30 years, including 15 in the EU), which do not fulfil the "well established use" requirements for marketing authorisation, i.e. published scientific literature on recognised efficacy and safety.

With regard to the manufacturing and quality of traditional herbal medicines, applications for registration of these products have to fulfil the same requirements as applications for a marketing authorisation.