Tobacco Products Directive


Are you ready for the Tobacco Products Directive (TPD)?


The Tobacco Products Directive 2014/40/EU lays down the rules for the manufacture, presentation and sale of e-cigarettes.  It came into effect on 20th May 2016.

A number of restrictions are placed on products such as a limit on nicotine concentration (≤20 mg/ml) and tank volume (≤2 ml).  Also, under the new rules a pre-market notification is required. Certain information on the product must be submitted to the authorities at least 6 months before a product can be placed on the market.  The information to be submitted includes administrative, quality and safety data and will require emissions testing by an analytical laboratory and a toxicological assessment.


The new regulations have a significant impact on business, bringing new costs and major changes in operations.


Read more on the TPD Regulations


How can we help?


We offer a range of services to help companies prepare for the regulations, including:



Read our regulatory notes on Article 20 of the Tobacco Products Directive.


In the absence of guidance…


With e-cigarette regulation still in development, there are few official guidelines and no official standards. Where guidance is lacking, pharmaceutical regulatory guidelines can be used as a model. Our knowledge and experience in pharmaceutical regulatory affairs combined with knowledge on the latest developments in e-cigarette regulation allows us to help manufacturers prepare early.[/vc_column_text][/vc_column][/vc_row]