Denmark

Policy Summary: 

E-cigarettes will be regulated as medicinal products under the Danish Medicines Act if they are marketed as products for the prevention or treatment of diseases, e.g. nicotine dependence and cessation. Medicinal products must be approved by the Danish Medicines Agency or the European Commission before they can be sold, manufactured, imported or distributed in Denmark. So far no electronic cigarettes have been approved as medicinal products in Denmark. Furthermore, manufacturers and importers must carry the relevant authorizations.

E-cigarettes not considered medicines are regulated under the law on electronic cigarettes (Act no.426 of 18 May 2016) which permits the sale of e-liquids with a nicotine concentration of up to 20 mg/mL. Sale of both nicotine-containing and non-nicotine e-cigarettes to minors (under 18 years) is prohibited. Retailers who engage or want to engage in national or cross-border distance sales of nicotine-containing e-cigarettes must register with the Danish Safety Technology Authority and meet other requirements (e.g. age verification) as set up under the law.

The regulation contains a requirement to notify the Danish Safety Technology Authority prior to introducing a nicotine-containing product to the market and manufacturers and importers of nicotine-containing e-cigarettes must comply with stipulated product specifications including on pack labeling and warnings.

Advertising, promotion or sponsorship related to (nicotine-containing and non-nicotine) e-cigarettes is prohibited.

Manufacturers and importers of nicotine-containing e-cigarettes must comply with rules on quality and composition as stipulated by the Ministry of Health.

Use of non-nicotine and nicotine-containing e-cigarettes is prohibited in certain public places, including schools, childcare facilities and on public transportation. In workplaces and other areas, the law requires a written policy on the rules for e-cigarette use.

Product Classifications: 
Regulatory Mechanisms: 

Law on electronic cigarettes (Act no.426 of 18 May 2016) (http://www.webcitation.org/query?url=https%3A%2F%2Fwww.retsinformation.d...)