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Electronic cigarettes, refill containers and nicotine-free liquid intended for vaporisation
Content of prior and modification notifications
Prior notifications and notifications on modifications must contain:
the name and contact details of the manufacturer, a responsible legal or natural person within the EU and the importer into the EU
a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof
toxicological data regarding the product’s ingredients and emissions, including when heated, particularly taking account of their effects on the health of consumers when inhaled and any addictive effect
information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions
a description of the components of the product (including a description of the product’s opening and refill mechanisms)
a description of the production process (including whether it involves serial production) and a declaration that the production process ensures conformity with the requirements of the Tobacco Act
a declaration that the manufacturer or importer bears full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.
With respect to electronic cigarettes that are sold empty, the data specified in items 2–4 above is not submitted since the emissions, toxicological data and information on nicotine delivery and uptake depend on the type of nicotine-containing liquid used in the electronic cigarette. In addition, nicotine-free liquid intended for vaporization, the data specified in item 4 above is not submitted since the product does not contain nicotine. However, if refill containers of nicotine-containing liquid or nicotine cartridges are sold in connection with empty electronic cigarettes, the information specified in items 2–4 above must be submitted.
Market research and sales volumes
Manufacturers or importers of electronic cigarettes, refill containers and nicotine-free liquid intended for vaporization must provide Valvira with the following information annually, by 20 May:
comprehensive data on sales volumes, by brand name and product type, for the previous calendar year
information on the preferences of various consumer groups
information on the modes of sale of the products
executive summaries of any market surveys carried out in respect of matters referred to in paragraphs 1–3 above, including an English translation thereof.