Sweden's E-Cigarette and Refill Container Product Notification and Annual Reporting Requirements

As of March 1, 2024, manufacturers and importers of e-cigarettes and refill containers in Sweden are required to submit product notifications and annual reports. Notification must be made via the EU Common Entry Gate (EU-CEG) portal at least 6 months before a new or modified product is released to the market. Each brand and type of e-cigarette, as well as refill containers, incurs a SEK 10,500 cost.

Product Notification information includes the manufacturer/importer, a list of ingredients and emissions with amounts, toxicological data, nicotine dose and absorption, a product description, and quality and safety declarations. The reporting obligation includes data on Swedish sales volume, consumer preferences, sales strategies, and market research conclusions that have been translated into English.