State Institute for Drug Control

• The State Institute for Drug Control (hereinafter referred to as “SÚKL”), is, pursuant to Act No 40/1995 Coll., on Advertising Regulation and on amendment to Act No 468/1991 Coll., on the Operation of Radio and Television Broadcasting,  as amended (hereinafter referred to as the “Act on Advertising Regulation”), the concerned authority for the conduct of surveillance over advertising for medicinal products for human use in the Czech Republic, with the exception of advertising disseminated via radio and television broadcasting.
• SÚKL is not the concerned authority for investigating advertising for other products (such as dietary supplements).

For better understanding and orientation, all surveillance authorities, which have been appointed, together with SÚKL, to conduct surveillance over advertising are listed here, giving their specific area of surveillance as stipulated by Section 7 of the Act on Advertising Regulation:  

a) Council for Radio and TV Broadcasting: advertising  distributed via radio and TV broadcasting and sponsoring in the area of radio and TV broadcasting;

b) State Institute for Drug Control: advertising for medicinal products for human use and sponsoring in this area, with the exception of advertising disseminated via radio and TV broadcasting;

c) Ministry of Health: advertising for health care and sponsoring in this area, with the exception of powers stipulated under letter a);

d) State Phytosanitary Administration: advertising for plant protection products, with the exception of powers stipulated under letter a);

e) Institute for the State Control of Veterinary Biologicals and Medicaments: advertising for veterinary medicinal products, with the exception of powers stipulated under letter a);

f) Office for Personal Data Protection: for unsolicited commercial communications disseminated via electronic media pursuant to a special legal regulation;

g) Regional Trade-Licensing Offices: any other cases.

Simply speaking – any advertising broadcasted by radio and television is under the supervision of the Council for Radio and TV Broadcasting (RRTV); supervision over advertising in other media of communication is divided among several institutions. Advertising for medicinal products is supervised by SÚKL, advertising for health care is supervised by the Ministry of Health, advertising for plant protection products is supervised by the State Phytosanitary Administration,  advertising for veterinary medicinal products is supervised by the Institute for the State Control of Veterinary Biologicals and Medicaments, unsolicited advertising disseminated via electronic media is within the powers of the Office for Personal Data Protection, and other cases are supervised by the Regional Trade-Licensing Offices.

From the perspective of SÚKL it is important for the consumer – recipient of advertising to be able to distinguish medicinal products from food products and their special categories, such as dietary supplements and foodstuffs intended for particular nutritional uses. The following may aid in distinguishing between these various groups of products: 

• Database of authorised medicinal products, special therapeutic programmes and foods for special medical purposes – if you find the name of the product in this registry, it is a medicinal product;
• if you do not find it here, it is likely to fall within foodstuffs or its special categories (dietary supplements or foodstuffs intended for particular nutritional uses) or to be a medicinal product without marketing authorisation; 
• for further verification you may call SÚKL information centre at +420 272 185 333 or send your enquiry by e-mail to: infs@suklcz

The description of properties of the advertised product (medicinal product vs. properties of foodstuffs) does not have to be decisive for the classification of the product as a foodstuff or medicinal product, as foodstuffs are often, contrary to the law, presented as “therapeutic”. Advertising for foodstuffs has to comply with Section 5d of the Act on Advertising Regulation, and specifically: 

• advertising for foodstuffs must not be misleading by e.g. recommending foodstuffs for the prevention, care or treatment of human diseases or by advertising with references to unspecified clinical studies;
• advertising for dietary supplements must contain a clear, in printed advertisements well readable, text stating “dietary supplement”; 
• advertising for foodstuffs intended for particular nutritional uses must contain a clear, in printed advertisements well readable, text stating “foodstuffs intended for particular nutritional uses”.

For an administrative authority to be able to commence investigation of any report regarding a breach of  the Act of Advertising Regulation, it is necessary to deliver to the authority an original or copy of the advertising material and to specify where the advertisement has been placed (found or broadcasted).

Cases of radio or television advertising for medicinal products and foodstuffs should be referred to the Council for Radio and TV Broadcasting (RRTV):

Council for Radio and TV Broadcasting
Krátká 10
100 00 Praha 10
E-mail: info@rrtvcz
Web site: www.rrtv.cz

Cases of advertising for foodstuffs disseminated via other media should be referred to the Regional Trade-Licensing Offices of those regions where the alleged sponsor of the advertising (usually the person undersigned on the advertisement – a company), producer (usually an advertising agency) or distributor of the advertisement (e.g. newspapers, magazines, post office) is established.

Surveillance over compliance with legal regulations relevant to the placement of foodstuffs incl. dietary supplements and foodstuffs intended for particular nutritional uses into circulation (e.g. misleading information on the labelling of foodstuffs, attached components or written documentation accompanying the foodstuffs) is, pursuant to Act No 110/1997 Coll., on Foodstuffs and Tobacco Products   and on Amendments to Some Related Acts, as amended by Act No 119/2000 Coll. and by Act No 306/2000 Coll. (hereinafter referred to as the "Act on Foodstuffs"), within the powers of the Czech Agriculture and Food Inspection Authority, (CAFIA). Pursuant to Section 10, paragraph 1, letter b)  of the Act on Foodstuffs, it is forbidden to place into circulation foodstuffs with misleading labelling or foodstuffs offered in a misleading manner.
Complete information on the placement of dietary supplements and foodstuffs intended for particular nutritional uses (legal regulations, definition of identification elements of foodstuffs intended for particular nutritional uses and types thereof, application for approval and decision, requirements governing composition and packaging, labelling) are published on the website of CAFIA.

Reports of breach of the Act on Foodstuffs, Decree No 446/2004 Coll., on requirements governing dietary supplements, breach of Decree No 54/2004 Coll., on foodstuffs intended for particular nutritional uses, or Decree No  113/2005 Coll., on the method of labelling of foodstuffs and tobacco products should be addressed to CAFIA:

Czech Agriculture and Food Inspection Authority
Květná 15
603 00 Brno
E-mail:  sekret.oklc@szpigovcz