Czech Republic

Policy Summary: 

Decree No. 37/2017 regulates e-cigarettes that contain nicotine. The Decree contains a requirement to notify the Ministry of Health prior to introducing a product to the market and notification requires compliance with a range of product specifications including on pack warnings. Manufacturers must also submit an annual report as specified in the law. Retailers who want to engage in cross-border sales of e-cigarettes must register with the Ministry of Health, 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-cigarettes as well as e-cigarette tanks must not exceed 2mL, and volume of refill bottles must not exceed 10mL. The law contains additional requirements for refillable e-cigarettes that can be used for e-liquid containing nicotine, with respect to refill mechanism, cartridge dimensions and maximum volume allowable for refill tanks. 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. Product packaging must contain health warnings and constituent information as specified in the law. The warning “Tento výrobek obsahuje nikotin, který je vysoce návykovou látkou. Jeho užití nekuřáky se nedoporučuje.” (“This product contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers”) 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 greatest possible proportion of the area reserved for it, and be parallel to the main text on the surface reserved for the warning. Warning should be placed in such a way that it is not damaged when package is opened in a normal manner.

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 environmental, economic, health or lifestyle benefits).

Product Classifications: