Policy Summary: 

E-cigarettes are regulated by the Law restricting the use of tobacco and related products of May 10, 2017, which contains a requirement to notify the Ministry of Health prior to introducing a product to the market. Notification requires compliance with a range of product specifications including on pack warnings. Manufacturers or importers must also submit an annual report to the Ministry of Health as specified in the law.

Sale of e-cigarettes to minors (under 18 years) is forbidden. Retail outlets must prominently display signage indicating the ban on sale to minors. Sale of e-cigarettes via automated vending machines is prohibited. Retailers who want to engage in cross-border sales of e-cigarettes must register with the Ministry of Health and with the competent authority in the member states in which actual or potential consumers are located, and must not transact e-cigarettes via cross-border distance sale to consumers in member states where it is prohibited to do so.

Nicotine content of e-liquid must be less than or equal to 20mg/mL. Single use e-cigarette cigarettes as well as e-cigarette tanks must not exceed 2mL, and volume of refill bottles must not exceed 10mL. E-liquid should not contain certain additives, and only high quality ingredients should be used in their manufacture. Except for nicotine, only ingredients that do not pose a risk to human health in heated or unheated form can be used in the nicotine-containing e-liquid. E-cigarettes must be able to deliver a dose of nicotine at a consistent level under normal conditions of use.

E-cigarettes and refill containers should be child- and tamper-proof, protected against breakage and leakage, and have a mechanism that ensures filling without leakage. Pack should contain a leaflet that includes, in addition to other things specified by law, a reference that the product is not recommended for use by young people and nonsmokers, a recommendation to keep the product out of the reach of children, and information on nicotine content and flavorings. The warning “Ovaj proizvod sadrži nikotin koji izaziva snažnu ovisnost” (‘This product contains nicotine which is a highly addictive substance.) must appear on 30% of each of the two largest surfaces of the unit packaging and any other packaging; must be in black Helvetica bold font on a white background; text must be centralized, occupy the greatest possible proportion of the area reserved for it, and be parallel to the main text on the surface reserved for the warning. There are provisions that restrict the use of the packaging for advertisement or promotional purposes (e.g. pack must not contain misleading elements, including elements suggesting therapeutic, health or lifestyle benefits).

There are restrictions on domestic and cross-border advertising, promotion and sponsorship related to e-cigarettes.

Use of both nicotine-containing and non-nicotine e-cigarettes in public places is prohibited.

Product Classifications: 
Regulatory Mechanisms: 

Law promulgating restricting the use of tobacco and related products (

WHO Region: