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.
Description and risks of orthomolecular medicine orthomolecular will medicine rather than a proper”medicine is viewed, but as an alternative medical approach. However, it was until now scientific proof of the efficacy of this method. Orthomolekular the term”is properly supplied with nutrients”. The view that high-dose use of vitamins and minerals can prevent diseases or treat themselves is at the heart of the village get molecular medicine. This medicine is the view that diseases cause also biochemical imbalance called a Ungleichgewicht-in the body. In addition, you could compensate this imbalance through healthy nutrition and rebuild such a balance in the body.
The person must ingest dietary supplements. The sick person must take long-term vitamins, to become healthy again. But several studies have shown that a long-term high-dose intake of vitamins can lead to health problems. The orthomolecular medicine is therefore controversial. Des Further, studies show that this medicine used can shorten the average life expectancy. The orthomolecular medicine followers are absolutely convinced that vitamins, minerals, trace elements, essential fatty acids and amino acids for the body-friendly, safer and heilsamer are regarded as herbs or also synthetic drugs. The orthomolecular medicine claims that taking vitamins leaves no permanent damage to the body. Scientific and medical findings show that one taking vitamins must be limited.
The orthomolecular medicine is another view says that any problems that they raise a higher intake of vitamins and minerals. Many critics see the orthomolecular medicine as pseudoscience. But supporters agree that calcium and vitamin D to strengthen the bones and vitamin C help prevent colds. These are almost commonplace in the population. The orthomolecular is therefore summarized Medicine of believes that the body called needs a certain amount of vitamins, minerals, trace minerals, fats, amino acids, enzymes – also vital substances, so there no diseases. Orthomol ekular medicine opponents argue that the increased intake of nutrients is very dangerous.