Questions and answers about the notification system for tobacco free nicotine products

Only products covered by the Act on Tobacco Free Nicotine Products should be notified in the system, meaning products without tobacco that contain nicotine intended for consumption.

The following products are not tobacco free nicotine products and should not be notified in the Public Health Agency's system:

• Nicotine-containing products not intended for consumption.
• Tobacco products, herbal products for smoking, electronic cigarettes and refill containers.
• Tobacco free nicotine products classified as a narcotic drug or a substance harmful to health.
• Medical products or medical devices.

A tobacco free nicotine product should be notified to the Public Health Agency at least six months prior to the placing on the Swedish market.

For tobacco free nicotine products provided to consumers on the Swedish market before 1 January, 2024, a product notification must be submitted by 1 February.

A product notification must include the following information:

• A list of all ingredients in the product and quantities thereof.
• Toxicological data regarding the product's ingredients.
• Information on nicotine doses and nicotine 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 provided to consumers on the market and used under conditions that are normal or reasonably foreseeable.

No. Copies of studies or a disclosure of methods should not be attached to the product notification.

Regarding toxicological data, you must indicate for each ingredient whether it has carcinogenic, mutagenic, or reprotoxic properties.

For nicotine uptake per dose, you must disclose the proportion of nicotine absorbed by the body from the total amount of nicotine in the product. The proportion of nicotine must be stated as a percentage.

Changes to the content of a product, for example ingredients or nicotine dose, are considered to be substantial modifications. Any changes that do not affect the content or character of a product like brand name or design of the product or packaging, are not considered substantial modifications.

Yes, manufacturers and importers must notify all products they intend to make available on the market. Products marketed under different brand names, flavors or nicotine strengths must all be notified separately and are subject to the six-month waiting period.

Yes, manufacturers and importers must notify all the products they intend to provide on the Swedish market. Products marketed under different brand names, flavors, or nicotine strengths should all be notified separately and are subject to the six-month waiting period.

Information about notified products will be made public six months after the product was notified to the Agency, provided that the mandatory notification fee has been paid. If you have submitted a launch date further in time than six months, the information will be published when the launch date is reached.

For products already on the market and notified in January 2024, the information will be published when the payment for the notification fee is received by the Agency.

No. The Public Health Agency has no system for authorization and does not give advance notice on products. If any deficiencies in products are discovered within the scope of supervision, the manufacturer or importer will be contacted by the Agency.

No, the legislation does not allow exceptions to the six-month waiting period except for products already placed on the market before 1 January, 2024.

Yes, it is permitted to sell the products to other links in the distribution chain before six months have passed. But it is prohibited by law to start selling the products to consumers before six months have passed since the notification was submitted.

You need to update the information in the system if you change the name of your product. This is so that the Agency always has access to updated and correct information about your product.

A change of brand name is not considered to be a substantial modification that needs to be notified six months before launch.

Information about the product's design or packaging shall not be notified to us, and you can therefore change this without notifying us. If information about the product itself changes, such as the brand name, ingredients, or nicotine content, this must be notified to the Agency.

Yes, those who notify a product to be sold to Swedish consumers must pay a fee of SEK 4,200 to the Public Health Agency for each brand and type.

Those submitting the annual report must pay a fee of SEK 4,200 for each brand and type.