Nowadays there are a lot of medicinal products on the European Community market with the evidence of long tradition of use in particular indications. Unfortunately the simpli ed registration procedure could be used only in case of traditional medicinal products which ful ll a de nition of herbal medicinal product. This situation may provide to a danger of disappearance of traditional medicinal products which do not ful ll a de nition of herbal medicinal products. Worse, it may be also situation that those products can be classi ed in other categories like cosmetics or food supplements. It may occur in minimize of control of their safety, quality and e cacy. The extension of the scope of the simpli ed registration procedure would improve patient safety and public health.
Keywords: traditional medicinal products, simpli ed registration procedure, extension of directive 2004/24/WE, European Community law.