Traditional-use

Term used in phytotherapy. The Herbal Medicinal Product Committee(HMPC) of the EMA = European Medicines Agency, divides plants/drugs into well-established use and traditional use. Directive 2004/24/EC opened up the possibility of registering traditional herbal medicinal products in a simplified procedure in the EU. Proof of efficacy and safety is primarily based on a tradition of medicinal use of at least 30 years, including at least 15 years in an EU country.

The safety of traditional herbal medicinal products is to be ensured through various requirements, for example the restriction of the type of application to oral or external use or inhalation as well as safe use in self-medication.

In addition to the regular authorization (§ 21 AMG), traditional use means a simplified registration procedure (§ 39a) in order to be placed on the market as a "traditional medicinal product". The prerequisite for this simplified procedure is that the plant or herbal preparation has been in medicinal use for at least 30 years, including at least 15 years in the European Union, and that it does not pose any health risks under the specified conditions of use. In the case of long-established medicinal plants, a plausible efficacy is assumed and it is assumed that they do not pose a risk to health, which is why experimental proof of efficacy and safety can be dispensed with. For registration as a "traditional medicinal product", efficacy and safety do not have to be proven by experimental clinical data; only a bibliographical overview and an expert opinion must be submitted.

However, traditional herbal medicinal products may only be used for mild disorders. The packaging must be labeled: "Traditional medicinal product" "this information is based exclusively on tradition and many years of experience".