Are you ready for the Tobacco Products Directive?
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.
How can we help?
We offer a range of services to help companies prepare for the regulations, including:
- E-cigarette testing: we help source a cost-effective e-cigarette testing laboratory, while ensuring minimum testing requirements are met
- Notifications: we can prepare and submit notifications for e-cigarettes and e-liquids on your behalf.
- Toxicological assessment: we advise on the toxicological requirements and can provide a toxicology expert
- TPD compliance: we will review your product to check it is TPD compliant
- Manufacturing standards: we provide an insight into the manufacturing standards before they are published
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.