The MHRA has today released new guidance to help companies to submit marketing authorisation applications for electronic cigarettes and other nicotine containing products to be licensed as medicinal products.
Nicotine-containing products (NCPs) that are marketed to help smokers give up smoking or reduce the number of cigarettes they smoke are considered to be medicinal products so they must be registered as medicinal products and granted a marketing authorisation by the MHRA.
We are now coming to the end of the transition period. Any product being sold prior to 20th May 2016 that the producer intended to continue selling after 19th November 2016 had to be notified to the MHRA by this date. Producers cannot manufacture product that is not compliant with the Tobacco Product Directive 2014/14/EU after 19 November 2016 but, provided a notification was made, they may sell any remaining stocks of such product until 20 May 2017.
The latest guidance is presented as a series of questions and answers. These include explaining what is required for the various parts of a marketing authorisation application, how the medical devices regulations might affect an application and the requirements for manufacture, import, export and wholesaling of the products.
To access the latest guidance, please click here.
If you require support with your NCP application, responding to questions received from the MHRA, meeting the drug safety obligations that come with holding a marketing authorisation or complying with GDP and GMP requirements, please get in touch via our contacts page.