Notification on tobacco free nicotine products
Both manufacturer and importer of tobacco free nicotine products are required to notify these products to us. Beside this, there is also an annual reporting obligation.
Product notification and annual reporting obligation
Please note that product notification and the annual reporting obligation enter into force on 1 January 2024. Tobacco free nicotine products that have been available to consumers before 1 January 2024, a product notification must be submitted no later than 1 February 2024.
Detailed rules in the Public Health Agency of Sweden's regulations on Tobacco Free Nicotine Products about product notification and the annual reporting obligation will enter into force on the 1 January 2024.
The Public Health Agency is developing the technical solution to be used for the notification of tobacco-free nicotine products. The system will be launched on 1 January 2024 when the legal requirements for the notification will apply. There will be no possibility of testing or otherwise accessing the system before then. However, in December 2023 we will publish brief instructions for how to use the system. After the launch, instructions will be available in the system.
Product notification
Both manufacturer and importer of tobacco free nicotine products are required to submit a product notification to us. This is required for products that are available to consumers in Sweden.
The submission must be made, in electronic form through the technical solution that we will provide, six months prior to the placing on the Swedish market of a new or modified product. You must also notify us, in electronic form through the technical solution that we will provide, when you no longer provide a product in Sweden, i.e. product withdrawal.
A product notification must include the following information:
- The name and contact details of the manufacturer or, if applicable the importer.
- A list of all ingredients contained in the product, by brand and type, including quantities thereof.
- Toxicological data regarding the product's ingredients.
- Information on the nicotine doses and uptake when consumed under normal or reasonably foreseen conditions.
- A description of the production process and a declaration that the production process ensures conformity with the requirements for tobacco free nicotine products.
- A declaration that the manufacturer or, if applicable the importer, bear full responsibility for the quality and safety of the product when available on the market and used under normal or reasonably foreseeable conditions.
Annual reporting obligation
Manufacturer and importer of tobacco free nicotine product must annually, no later than the 31st of March each year, referring to the previous year, submit the following information about the product to us through the technical solution that we will provide:
- Comprehensive data on the Swedish sales volume.
- Information on the preferences of various consumer groups, including young people who have not reached the age of 25.
Publicly available information on tobacco free nicotine products
We will make public the information provided in the product notification that are not considered to be trade secrets, as well as when a manufacturer or importer has fulfilled its reporting obligation.
Fees for product notification and annual reporting obligation
We may charge fees for the product notification and the annual reporting obligation. The fees has not yet been decided.
