Policy Summary: 

The Act on electronic cigarettes and refill containers for electronic cigarettes, No. 87/2018 harmonized the EU directive 2014/40 regulations on e-cigarettes and came into force on March 1, 2019.

E-cigarettes are classified as consumer products if they have lower content of nicotine than 20 mg/ml. Everything over 20 mg/ml is a medicinal product. E-cigarettes classified as medicinal products would require marketing authorization that must be obtained prior to marketing these products and they must meet all requirements on sale, advertising/promotion, distribution, manufacture, importation and marketing specified in the Medicines Act. Consumer based e-cigarettes will be subject to the European Union’s consumer product laws.

Product Classifications: 
WHO Region: