Dispute about products on the basis of the \”Graubehaarten Rock\”-medicinal product or medical device recently another judgment to the exciting demarcation of pharmaceuticals to medical devices fell. In this case, the Cologne Administrative Court ruled on the classification of two products that are intended to protect against colds and flu. These consist essentially of an extract of the plant Cistus Incanus, the \”Graubehaarten Rock\”, a 30-100 cm high shrub of the Mediterranean. The manufacturer of the products is of the opinion, we are dealing with the preparations to medical devices. This Liege on the one on the only physical operation of the products, on the other hand on the product presentation and marketing. The defendant monitoring authority and the Federal Institute for drugs and medical devices (BfArM) argued, however, that it was due to the pharmacological effects of products regulated medicines.
The Administrative Court of Cologne has attached itself to the opinion of the authorities and the products as medicines classified. Unlike the parties mainly arguing with a physiological/pharmacological effects, the court essentially turns off, that the products to cure, alleviation or prevention of human diseases or pathological symptoms are intended and thus in 2 medicines Act (AMG) anchored the first alternative the definition of medicinal product of the so-called medicinal product presentation meet, namely. Then drugs are \”substances or preparations from materials, to the application in the or are intended on the human or animal body and are intended as having properties to cure or relief or for the prevention of human or animal diseases or pathological symptoms\”. The Court granted looks at these conditions. According to leaflets and packaging of the products this is among other things a preventive as well as accompanying effect of treatment for colds, viral diseases and inflammatory conditions in the mouth and throat. Thus, the products are undoubtedly as a means for preventing and treatment of diseases.