Who and how approves dietary supplements in the Czech Republic?

The regulation of dietary supplements falls within the powers of the Ministry of Health of the Czech Republic.  

The regulation of dietary supplements falls within the powers of the Ministry of Health of the Czech Republic. It is governed by Act No 110/1997 Coll., on Foodstuffs and Tobacco Products and on Amendments to Some Related Acts, as amended (hereinafter referred to as the “Act on Foodstuffs”; its full version is available from the Collection of Acts where it has been published under No. 224/2008 Coll.) and Decree No 225/2008 Coll., on the requirements for dietary supplements and fortification of foodstuffs (hereinafter referred to as the implementing legal regulation). The procedure which the manufacturer or importer has to comply with in placing the dietary supplement into circulation depends on the composition of the product

Dietary supplements containing substances listed under the implementing legal regulation: pursuant to Section 3d of the Act on Foodstuffs, manufacturers as well as importers are obliged to send to the Ministry of Health of the Czech Republic the Czech text which will be presented on the labelling of the product prior to the first marketing of the dietary supplement (so called notification).

Dietary supplements containing substances other than those listed under the implementing legal regulation:  pursuant to Section 11, paragraph 2, letter b) of the Act on Foodstuffs these products may be marketed only after a prior approval of the Ministry of Health of the Czech Republic is obtained (i.e. the Ministry of Health of the Czech Republic must authorise the products before they may be marketed). The base for the approval is an expert position issued by the National Institute of Public Health (NIPH) on the health safety of the product.