Article 19 of the European Union Tobacco Products Directive (the "TPD") sets forth notification requirements for the commercialization of novel tobacco products in the Member States. Specifically, Article 1 states that manufacturers and importers must submit a notification to the Member States' competent authorities of any novel tobacco product they intend to place on the national market concerned.
The notification must be submitted electronically and at least six months prior to the intended date for placing the product on the market. Such notification must include a detailed description of the novel tobacco product and instructions for its use. Additionally, specific information regarding ingredients and emissions must be included as detailed in Article 5 of the TPD.
Moreover, notification submissions for novel tobacco products must provide competent authorities with the following information:
(a) available scientific studies on toxicity, addictiveness and attractiveness of the product, in particular as regards its ingredients and emissions;
(b) available studies, executive summaries thereof, and market research on the preferences of various consumer groups, which includes young people and current smokers;
(c) other available and relevant information, including a risk/benefit analysis of the product, its expected effects on initiation and cessation of tobacco consumption, and predicted consumer perception.
Manufacturers and importers shall submit to Member States’ competent authorities any new or updated information referred to in points (a) to (c) above. Member States may require manufacturers or importers to carry out additional tests or submit additional information.
The Scientific Dossier and its appendices summarize the above based on PMI’s scientific assessment program and include the results of the assessment program for THS as of May 2016.