The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the use of British American Tobacco’s (BAT) e-cigarette e-Voke, in a move that enables doctors to prescribe the vaping device on the NHS as a smoking cessation aid.
More than 2 million adults use e-cigarettes in Britain, about a third of whom are ex-smokers. Big tobacco firms, including BAT, Philip Morris, Japan Tobacco and Imperial Tobacco, are jostling for position within the emerging vaping market, which is estimated at about £4.75bn ($7bn) for 2015.
The MHRA said it would “continue to encourage companies to voluntarily submit medicines licence applications for e-cigarettes and other nicotine containing products as medicines” and hoped to see more e-cigarettes and next generation nicotine delivery products manufacturers submit applications in future.
Currently electronic cigarettes are only covered by consumer product regulation, but from 20th May 2016 they will come under the revised EU Tobacco Products Directive, except where therapeutic claims are made or they contain over 20 mg/ml of nicotine, when they will require medicines authorisation under Directive 2001/83/EC.
With a rapidly evolving regulatory environment Woodley BioReg can help with the preparation and submissions of your medicines licence applications for e-cigarettes before the sector becomes saturated with approved suppliers.
Please contact us as firstname.lastname@example.org for more information.