MHRA updates guidance on licensing e-cigarettes
The MHRA has published updated ‘Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines’.
The updated guidance comes after a consultation with the E-Cigarette Expert Working Group, a group of UK experts who provided independent oversight and advice to the MHRA.
The MHRA says it is responding to the Department of Health's 2017 Tobacco Control Plan and supports the government’s vision for a smoke-free generation by encouraging safe, high-quality e-cigarette products to be licensed as medicines.
The MHRA is responsible for regulating nicotine-containing products (NCPs) as medicinal products in the UK. These are intended to relieve or prevent craving and nicotine withdrawal symptoms when tobacco smokers wish to quit or reduce smoking.
Dr June Raine, chief executive of the MHRA, said: “The evidence is clear that e-cigarettes are less harmful to health than smoking tobacco and that nicotine-containing e-cigarettes can help people quit smoking for good. The updated guidance on licensing requirements is a strong first step towards availability of safe and effective licensed e-cigarette products.”
The option to obtain a marketing authorisation for e-cigarettes has been available for some time, but no manufacturer has yet taken it up.
Following a press release about the updated guidance from the DHSS and the new Office for Health Improvement and Disparities, a number of national media outlets have reported that England could be the first country in the world to prescribe medicinally licensed e-cigarettes to help reduce smoking rates.