Nicotine-containing products (NCPs) that are presented for cutting down, quitting and reducing the harms of smoking are considered to be medicinal products. MHRA is responsible for regulating NCPs that are medicinal products, including electronic cigarettes.
We are encouraging companies to submit medicines licence applications for NCPs. We will use the flexibilities within the existing licensing framework to enable products that meet medicinal standards to be available.
We have produced guidance note on the licensing procedure for electronic cigarettes and other NCPs (86Kb). This guidance note is being updated and a revised version will be available in Autumn 2014.
Any NCP product licenced as a medicine by MHRA can be advertised within its licensed claims and its rational use must be promoted. Electronic cigarettes which have a marketing authorisation can be recommended to those who seek advice through smoking cessation clinics, in line with NICE guidance.
The European Tobacco Products Directive (TPD) (external link) came into force in May 2014 and member states have until May 2016 to transpose the new rules into national law. In the UK, implementation of the TPD is the responsibility of the Department of Health. Article 20 of the TPD specifies a number of regulatory controls for electronic cigarettes which will apply to those electronic cigarette products that do not fall under the definition of a medicinal product. Electronic cigarettes regulated as medicines could be available in strengths greater than those permitted under the TPD (ie more than 20mg/ml), as well as lower-strength products.