For better orientation please refer to the SÚKL position regarding distinction between dietary supplements and medicinal products.
This section describes only the major difference between the said types of products, and information regarding their labelling as implied by effective legal regulations (Act No 110/1997 Coll. on Foodstuffs and Tobacco Products, as amended, Decree No 225/2008 Coll., on the requirements for dietary supplements and fortification of foodstuffs (hereinafter referred to as the implementing legal regulation), Act No 378/2007 Coll. on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), Decree No 228/2008 Coll. on marketing authorisation of medicinal products):
- Efficacy is assessed only for medicinal products.
- In dietary supplements, only safety and not efficacy is assessed. This means that the statements on the labelling and package inserts for dietary supplements are not expertly assessed (e.g. whether the plant contained in the dietary supplement truly has the effects declared by the manufacturer or whether the product may indeed have beneficial effects on the problems specified by the manufacturer). Effective legislation stipulates that the labelling of dietary supplements must not attribute properties relevant to the prevention, treatment or cure of human diseases to dietary supplements nor refer to these properties (Section 3, paragraph 5of Decree No 225/2008 Coll.)
- The labelling of dietary supplements bears the statement “dietary supplement” as part of the name (Section 4 , paragraph 1, letter a) of Decree No 225/2008 Coll.).
- The labelling of medicinal products bears so called authorisation number in a predefined format (e.g. 95/312/99-C) (Annex 4 and 5 to Decree No 288/2004 Coll. refers).