Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended (hereinafter referred to as the “Act on Pharmaceuticals”), stipulates the duty of the State Institute for Drug Control to decide in the cases of doubts as to whether a product is a medicinal product or an active substance, or a medicinal product subject to marketing authorisation or another product, or where applicable, a homeopathic product, either upon request or on its own initiative (Section 13, paragraph 2, letter h).
Where SÚKL concludes that the product in question is a medicinal product:
The product shall be subject to regulation as stipulated by the Act on Pharmaceuticals. It may be placed on the market only after marketing authorisation pursuant to the Act on Pharmaceuticals and relevant implementing regulations is granted (unless a product not subjected to marketing authorisation is concerned, as stipulated by Section 25, paragraph 2 of the Act on Pharmaceuticals). Where the applicant wishes to trade a product subjected to marketing authorisation, offer it via the internet, etc., the product must be first authorised, i.e. the applicant has to submit to SÚKL an application for marketing authorisation with the relevant dossier. Where the applicant fails to do so, he/she breaches the Act on Pharmaceuticals, as he/she places on the market a product without marketing authorisation, and penalties laid down by the Act shall apply to him/her. Information regarding marketing authorisation of a product as a medicinal product, relevant guidelines, requirements for submitted documentation and other information on the marketing authorisation procedure may be found in the "Marketing authorisation of pharmaceuticals" section.
Where SÚKL concludes that the product in question is not a medicinal product:
Further procedure depends on the category in which the applicant intends to place the examined product (dietary supplements, cosmetics, etc.), and on whether the concerned product complies with the definition of the particular product category and with the relevant legal regulations. Categorisation has a major impact upon the method of placing the product on the market, its regulation and surveillance over it. Regulation of these products is outside the powers of SÚKL, and the concerned authorities therefore have to be contacted. The most relevant contacts are provided below:
Foodstuffs intended for particular nutritional uses, dietary supplements:
National Institute of Public Health (NIPH), Šrobárova 48, 100 42 Praha 10
- Ing. Daniela Winklerová tel. 267 082 341
- Ing. Michaela Kubíková tel. 267 082 335
Ministry of Health, Palackého nám. 4, 128 01 Praha 2
- Ing. Silvie Slavíková tel. 224 972 188
- National Institute of Public Health (NIPH), Šrobárova 48, 100 42 Praha 10
National Institute of Public Health (NIPH): Šrobárova 48, 100 42 Praha 10
- MUDr. Dagmar Jírová, CSc. tel. 267 082 439
- National Institute of Public Health (NIPH): Šrobárova 48, 100 42 Praha 10