Product notification and annual reporting obligation
Tobacco free nicotine products intended for consumers in Sweden must be notified to us before they can be sold. Each year there is an annual reporting obligation for each product. Manufacturer and importers of the product must submit the product notification and fulfil the annual reporting obligation via our notification system.
About the notification system
The notification system for tobacco free nicotine products is accessed through the link below.
Notification system for tobacco free nicotine products (tfn.folkhalsomyndigheten.se) (in Swedish)
Do you have questions about tobacco free nicotine products or do you experience any technical issues with the notification system?
On the login page of the notification system, you will create an account for the company that manufactures or imports tobacco free nicotine products. You will also create an administrator account, which is an account for those authorised to manage the information for your organisation. It will be possible to register multiple administrator accounts and user accounts if needed.
When creating an account, the company is assigned a unique Submitter-ID consisting of six digits, which can be used when communicating with us. It also form the basis for all your products' unique Product-ID.
Fees for product notification and annual reporting
We charge mandatory fees:
- SEK 4,200, for the notification of each brand and type of tobacco free nicotine products.
- SEK 4,200, for the annual reporting of each brand and type of tobacco free nicotine products.
Invoices will be issued at the beginning of each month and include all product notifications submitted during the previous month. You can choose whether you want to receive invoices by email or as e-invoices. The payment terms are 30 days.
Beneficiary: Folkhälsomyndigheten, Nobels väg 18, 171 82 Solna
VAT no: SE202100654501
Bank adress: Danske Bank, Box 7523, 103 92 Stockholm
Account No: 12810101868
IBAN: SE58 1200 0000 0128 1010 1868
Unpaid fee will lead to rejected product notification
If the fee is not paid, the product notification will be reject. A rejected product notification means that the product must not be sold to consumers on the Swedish market.
Manufacturers and importers of tobacco free nicotine products must notify all products they intend to provide on the Swedish market. Products sold under different brand names, flavors, or nicotine strengths should all be notified separately and are subject to the six-month waiting period.
The submission must be made, via the notification system, 6 months prior to the placing on the Swedish market of a new or modified product. You must also notify us of product withdrawal, via the notification system, when you no longer provide the product in Sweden.
This is what the product notification must include
A product notification must include the following information:
Please note that each product notification must be unique. To facilitate the notification of multiple products, you can copy an existing product notification and then adjust the information before submitting the notification to us.
Reporting of sales must be made annually
Manufacturer and importer of tobacco free nicotine product must annually, no later than 31 March each year, referring to the previous year, submit the following information about the product to us through the notification system:
- 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.
If the annual reporting is not submitted, or if the annual fee is not paid, we may prohibit the product from being provided to consumers on the Swedish market.
Please note that existing products notified in January 2024, information on sales volume and preferences among different consumer groups for the year 2023 must be reported in the system by 31 March, 2024. In the notification system there is a form for annual reporting for you to complete.
Information that is made public
Information provided in the product notification that does not constitute trade secrets will be published. Since the notification requirement applies to products intended for retail, only information about products that consumers can be expected to find on the Swedish market will be published, i.e., products where the notification fee has been paid and the launch date has been reached.
In the published information, you can also find information on when manufacturers and importers have fulfilled their annual reporting obligation.