Traditional medicinal use

The 14th amendment of the AMG (December 2005) has created the possibility of having herbal medicines go through a simplified registration procedure as traditional medicines (¤ 39a) in addition to the regular authorisation (¤ 21 AMG). To do this the medicinal product must have been in medical use for at least 30 years, including at least 15 years in the European Union, and be harmless under the specified conditions. The pharmacological effects or efficacy of the drug must be plausible because of the long-standing use and experience of the drug. No experimental data must be presented to demonstrate its efficacy and safety, just a bibliographic review and an expert opinion. This is based on the assumption that the effectiveness is plausible and it is also not expected that the tried and tested medicinal plants pose health risks, so experimental evidence of safety and efficacy can be dispensed with. The packaging must bear the words: "Traditional Medicines" and the area of use must read something like this: "traditionally used", "to support or strengthen the...", "to improve the condition of..."," to support the organ function of the ...", "to prevent ..."," mildly effective as a medicine in ...".

The HMPC decides on the classification of the area of use of a drug category, either "well-established medicinal use" (approved) or "traditional use "(registration). This was already done in Germany as part of the renewed authorisation since the 5th amendment of the German Medicines Law in 1994 (at that time ¤ 109a AMG). The BfArM then put the corresponding drugs and the possible traditional areas of use into a list (traditional use acc. to ¤ 109a), which was published in the Federal Gazette. Traditional herbal medicines of the German market registered during the period 1994 to 2005 according to ¤109a, must now be reassessed according to ¤ 39a AMG.