Legal Updates – Regulatory – Electronic Cigarettes

Regulatory Law – Medicines – Medicines and Healthcare products Regulatory Agency – MHRA – Electronic Cigarettes – Nicotine Containing Products

The UK Government recently decided that all nicotine-containing products (“NCPs”), which include electronic cigarettes, are to be regulated as medicines by the Medicines and Healthcare products Regulatory Agency (“MHRA”).

The main argument for the UK Government’s decision is to ensure that such products are safer and more effective. It is hoped that the regulation of products such as electronic cigarettes as medicines, will reduce the harms of smoking by delivering quality products helping smokers to quit, which is a key priority of the UK Government.

The decision comes after public consultation, in which we were involved, and a long period of further research commissioned by the MHRA. It is expected that the European Commission will take the above into account when revising the Tobacco Products Directive, which is expected to come into effect in the UK in 2016.

More information can be found on the MHRA’s website.

What does this mean?

The bottom line is that once the Tobacco Products Directive comes into effect, electronic cigarettes must be licensed.

It is prudent for manufacturers to start working towards licensing their products as medicines by obtaining marketing authorisation as early as possible.

How can we help?

If you need advice and/or assistance with the preparation of your marketing authorisation, RT Coopers can assist you. Having advised businesses on the legality of electronic cigarettes and having been involved in the MHRA’s consultation process, we are poised to advise businesses and manufacturers in this area.

For any queries on regulatory law issues, you may contact us by email [email protected]. Visit http://www.rtcoopers.com/practice_regulatory.php.

© RT COOPERS, 2013. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.