Since 2004 the regulatory framework within the European Union has a specific assessment procedure for herbal medicinal products, with a medicinal use based on traditional practice. The main requirement concerning the traditional use is focussed on the period of time for medical use: at least 30 years, including 15 years in the EU. In addition to requirements for quality and safety, an evaluation of pharmacological effects or efficacy based on long-standing use, is a main objective. "Traditional Use" however encompasses European, and non-European traditional use. Outside the EU, the medicinal use of herbal substances, preparations, and combinations is well-known, with a long history, which is well-documented in the different systems of medical practice. This has been addressed by WHO, but it has been acknowledged also by European Commission that herbal products from other systems of medicine, can be subject to the procedure for traditional herbal medicinal products. This paper will focus on the possibilities, restraints, and challenges of regulatory practice in the European Union regarding these category of medicinal products.
European Union Humans