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What manufacturers should know about the medical route for vapor products to the U.K. market.

Nicotine

Nicotine

Broughton's Head of Regulatory Affairs, Lloyd Smart has recently published an article with the leading sector publication Tobacco Reporter.

 

E-cigarettes, and the regulations surrounding them as medicinal products, were thrust into the national spotlight in the U.K. with the news that the National Health Service (NHS) could look to prescribe them to smokers in the future.

In this article, Lloyd discusses the expanded Medicines & Healthcare products Regulatory Agency (MHRA) guidance and expectations for manufacturers in the key areas of quality, safety, and efficacy.

The overriding message is still that “The MHRA seeks to encourage the licensing of electronic cigarettes (e-cigarettes) and other inhaled NCPs [nicotine-containing products] as medicines and aims to support companies to submit marketing authorization applications for these products.”

You can read the full article here.

To find out more contact us to arrange a meeting.

 

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Broughton have deep CRO capabilities and an experienced team of scientific and regulatory professionals to manage full service global regulatory projects. Our knowledge of global regulatory pathways offers significant insights that can be incorporated into your project plans. Our mission is to accelerate safer nicotine-delivery products to market; creating a smoke-free future.

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