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Declaration

Information accompanying the product and product presentation are, in terms of distinction between a medicinal product and another product truly essential, as these are the elements determining the intended use. With respect to the proposed method of use, the same product may be regarded a “non-pharmaceutical”, if no indications are specified, or a medicinal product, where indications are specified. For example, products made of substances normally used in other industries (e.g. the food-processing industry, cosmetic industry, in the production of biocides), become medicinal products if their specified purpose of use is the treatment or prevention of a disease, and in this case they are subjected to the relevant provisions of the Act on Pharmaceuticals.

In practice, problematic claims occur most frequently in dietary supplements. Pursuant to Decree No 225/2008 Coll., the labelling of dietary supplements must not attribute qualities involving the prevention, treatment or cure of human diseases to these foodstuffs nor refer to them. If the manufacturer or importer wishes to manufacture or market foodstuffs whose labelling or advertising for contains a health claim, he/she shall be obliged to proceed in compliance with Section 3d, paragraph 3 of Act No 110/1997 Coll., as amended, i.e. send to the Ministry of Health of the Czech Republic the Czech text of this claim and, upon request,  present source materials for the Regulation of the European Communities governing nutrition and health claims on the labelling of foodstuffs (Regulation no. 1924/2006 of the European Parliament and of the Council (EC)).