Rechtliche Abgrenzung von Arznei- und Lebensmitteln Dr. Dorith Stauch-Steffens pst GmbH, Rheinbach The insurance companies are no longer willing to reimburse OTC-drugs because of a gradually changing increasingly restrictive health policy. As hurdles for the approval of a medicinal product have been climbing continuously higher it became more expensive and more time-consuming obtaining an approval and maintaining it. For saving costs and for opening new markets, many companies try to put old or new products as food supplement on offer. In the last four years, many items in the area of legislation and jurisdiction have changed in Europe. In 2002, a unified European legislation concerning foodstuffs has been realized based on Regulation 178/2002 laying down the general principles and requirements for food law and Directive 2002/46 on the approximation of the laws of Member States relating to food supplements. Furthermore, in June 2005 the European Court of Justice decided in the case of doubts for a product to be a foodstuff or a medicinal product clearly in favour of the medicinal product. The article deals with the demarcation of foodstuffs/food supplements and medicinal products, provides examples of actual decisions in jurisdiction and shows problems of border line products. |
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pharmind 2007, Nr. 9, Seite 1042
