In December 2012, the European Commission published a proposal to revise the Tobacco Products Directive (TPD) which aims to address a number of areas in relation to tobacco products, including nicotine containing products such as electronic cigarettes. 

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On 8 October 2013 the European Parliament voted on the draft Directive as a whole and the Commission’s proposal to regulate electronic cigarettes as medicines was not supported by a majority of MEPs.  A majority supported using a mixture of tobacco regulation (e.g. controls on promotion) and medicines style regulation (e.g. reporting of adverse reactions) for all nicotine products (including medicines), and applying medicines regulation to products (that could be the same) that make medicinal claims.  The European Parliament vote is one stage in the legislative process, which is still not complete, and there will be further negotiation.


The MHRA continues to believe that medicinal regulation of nicotine containing products is in the best way to deliver a benefit to public health. We will be continuing to encourage companies voluntarily to seek a licence for their products so that they can be seen to meet appropriate standards of safety, quality and efficacy and could be sold and supplied, including on prescription, according to the NICE public health guidance on reducing the harms of smoking.


Posted on the UK MHRA website on 9 October 2013