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S.L. 315.10 · Manufacture, Presentation And Sale Of (S.L. 315.10)

S.L. 315.10 чл. 17Notification of novel tobacco products.

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(1) Manufacturers and importers of novel tobacco products shall submit a notification to the Superintendent of any such product they intend to place on the national market. The notification shall be submitted in electronic form six months before the intended placing on the market. It shall be accompanied by a detailed description of the novel tobacco product concerned as well as instructions for its use and information on ingredients and emissions in accordance with regulation 5. The manufacturers and importers submitting a notification of a novel tobacco product shall also provide the Superintendent with:

(a) available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco 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, including young people and current smokers;

(c) other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.

(2) Manufacturers and importers of novel tobacco products shall transmit to the Superintendent any new or updated information on the studies, research and other information referred to in sub-regulation (1)(a) to (c). The Superintendent may require manufacturers or importers of novel tobacco products to carry out additional tests or submit additional information. All information received pursuant to this regulation shall be made available to the Commission.

(3) Novel tobacco products placed on the market shall respect the requirements of these regulations.