Traditional-use

Designation in Phytotherapy. The Herbal Medicinal Product Committee (HMPC) of the EMA = European Medicines Agency, divides plants/drugs into well-established use and traditional-use. With Directive 2004/24/EC, the possibility was opened in the EU to register traditional herbal medicinal products in a simplified procedure. The proof of efficacy and safety is mainly based on at least 30 years of tradition of medicinal use, thereof at least 15 years in an EU country.

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

Traditional-use means, in addition to the regular marketing authorisation (Section 21 AMG), a simplified registration procedure (Section 39a) in order to be marketed 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, of which 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 traditional medicinal plants, it is assumed that their efficacy is plausible and that they do not pose a health risk, 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 bibliographic review and an expert opinion have to be submitted.

However: traditional herbal medicinal products may only be used for mild disorders of well-being. The package must be labelled: "Traditional medicinal product" "this claim is based exclusively on tradition and long experience".

For the list of traditional-use preparations: see

https://www.ema.europa.eu/en/documents/other/hmpc-monographs-overview-recommendations-uses-herbal-medicinal-products-paediatric-population_en.pdf

S. 21/81 -81/81