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The MHRA is today announcing an extended indication for nicotine replacement therapy (NRT), to include harm reduction, which has been granted for an (NRT) inhalator, available through general sales outlets.
This a new element to the indication for ‘harm reduction’ and reflects the fact that it has become widely accepted that there are no circumstances in which it is safer to smoke than to use NRT.
The extension of the indication for NRT to include harm reduction also raises the question of the regulation of other unlicensed nicotine-containing products on the market, for example electronic cigarettes, which have not been assessed for safety, quality, and efficacy. The MHRA has launched a public consultation on whether/how to bring these products into regulation.
The links below set out the background to these two issues:
Public consultation (MLX 364): The regulation of nicotine containing products
MHRA Public Assessment Report
(65Kb)
Extracts from the minutes of the Expert Working Group on nicotine replacement therapy (NRT) (56Kb)
Extracts from the minutes of the Commission on Human Medicines (24Kb)
Article which will appear in the MHRA's Drug Safety Update (25Kb)
