Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.

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. The MHRA seeks to encourage the licensing of electronic cigarettes (e-cigarettes) and other inhaled NCPs as medicines and aims to support companies to submit marketing authorisation applications for these products. In addition to the medicines authorisation, where the E-cigarette is refillable and re-useable it will need to meet the UK Medical Device Regulations 2002 (as amended). Potential applicants who are not familiar with medicines legislation are strongly advised to contact the MHRA for regulatory and scientific advice. The MHRA commits to provide the assistance needed to ensure that potential applicants understand the process and feel able to make applications in a timely manner which are fit for purpose. For applicants with products undergoing the US FDA premarket tobacco product application (PMTA) process, the MHRA can discuss what data may be relevant for a UK marketing authorisation application.