Detailed GuideMHRA
Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
First published: Dec 14, 2017Last updated: Nov 3, 2022Changes: 2
Latest change: We have updated the Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines. The key changes made relate to guidance on the quality standards for dose uniformity, non-clinical toxicological data requirements, and the design of the clinical pharmacokinetic studies. The updates also reflect changes to the regulatory environment post-Brexit
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