Drug Regulators, MHRA, Publish Consultation Letter MLX 364, The Regulation of Nicotine Containing Products.

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The MHRA are writing to consult you on whether to bring all nicotine containing products (NCPs) – with the exception of tobacco and tobacco products – within the medicines licensing regime, which would require all currently unlicensed NCPs on the market, such as electronic cigarettes containing nicotine and nicotine gels, to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a medicines marketing authorisation (MA).
This consultation should be read in conjunction with the draft Impact Assessment (IA). We would welcome views on whether to bring unlicensed NCPs within the medicines licensing regime. All replies will be considered before a final decision is made.

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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