Last updated: May 20, 2020
Regulatory Framework
Are e-cigarettes partly or entirely regulated under tobacco control laws?
E-cigarettes use is regulated under tobacco control law under Law No. 349 of June 6, 2002 on Preventing the Consumption of Tobacco Products and Combating its Effects (as amended). E-cigarettes are regulated under Law No. 201 of 2016 on the Establishment of Conditions Concerning the Manufacture, Presentation and Marketing of Tobacco and Related Products and Amendments to Law No. 349/2002 on Preventing the Consumption of Tobacco Products and Combating its Effects for all other policy areas.
Are e-cigarettes partly or entirely regulated under medicine or pharmaceutical laws?
E-cigarettes are also regulated under medicine/pharmaceutical laws “to the extent they fulfill the conditions for authorization as medication/medical devices” under Law No. 95/2006 on the Health System Reform (as amended) and Government Resolution No. 54/2009 on the Placing on the Market of Medical Devices (as amended).
Are e-cigarettes partly or entirely regulated under any other laws?
Within the EU, e-cigarettes are also regulated under the following legal acts, which have been transposed into national law:
- European Communities (General Product Safety) Regulations 2004
- European Union (Restriction of Certain Hazardous Substances in Electrical and Electronic Equipment) (Amendment) (No. 2) Regulations 2012
- European Union (Batteries and Accumulators) Regulations 2014, amended by the European Union (Batteries and Accumulators) (Amendment) Regulations 2014
- European Union (Low Voltage Electrical Equipment) Regulations 2016
- European Communities (Electromagnetic Compatibility) Regulations 2017
