Notification on electronic cigarettes and refill containers

Product notification and annual reporting obligation

E-cigarettes and refill containers intended for consumers in Sweden must be notified to us before they can be sold. In Sweden, both manufacturer and importers of the product must submit the product notification and fulfill the annual reporting obligation. This means that the product must be notified by each individual importer, even if it already has been notified by the manufacturer. Each year there also is an annual reporting obligation.

Fees for product notification

We charge mandatory fees:

• SEK 10,500, for the notification of each brand and type of e-cigarettes and refill containers. It is the manufacturer or importer that notify the product that must pay the fee:
  • The first time a product is notified to Sweden.
  • When a product is relaunched on the Swedish market after it has been withdrawn from this market.
  • When a new notification is submitted for a rejected product.
  • When a substantial modification is submitted, which modifies the composition of a notified product in a way that affects the previously provided information.

We will send you a payment instruction the month after the notifications has been submitted in EU-CEG. This payment instruction will state how much you must pay and to which account the payment must be made. The payment must be made within 30 days from the day the payment instruction was issued.

Information about invoicing

The Public Health Agency of Sweden would like to inform you, as a manufacturer or importer of products in EU-CEG, that the Agency has implemented a new financial system.

For notified products submitted in EU-CEG during the period of June to October, we plan to send invoices in November 2024. Note that the new invoices will have a different layout and will be sent from ekonomi@folkhalsomyndigheten.se.

Unpaid fee may lead to rejected product notification

If we have not received payment within 30 days from the date the payment instruction was issued, the product notification may be rejected. If the product notification is rejected, the product may not be made available to consumers on the Swedish market.

Product notification

The submission must be submitted via EU-CEG 6 months prior to the placing on the Swedish market of a new or modified product. When you no longer provide a product in Sweden, remember to withdraw the Swedish product presentation in EU-CEG.

Information in the product notification

A product notification must contain the following information depending on whether the product is an e-cigarette or a refill container:

• The name and contact details of the manufacturer, a responsible legal or natural person within the European Union and, if applicable, the importer into the European Union.
  • It is important that the submitter details in EU-CEG are complete and accurate, such as e-mail address and postal address. We will use this information in our communication with you.
• 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, referring in particular to their effects on the health of consumers when inhaled and taking into account any addictive effects.
• Information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions.
• A description of the components of the product, including where applicable, the opening and refill mechanism of the e-cigarette or refill container.
• A description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements for e-cigarettes and refill containers.
• A declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.

You have the option to mark any information that you consider to be confidential or a trade secret in your submission. At our request, you must substantiate these claims.

Annual reporting obligation

Manufacturer and importer of e-cigarettes and refill containers 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:

• Comprehensive data on sales volume in Sweden, by brand name and type of the product.
• Information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users.
• The mode of sale of the product.
• Executive summaries of any market surveys carried out in respect of the above, including an English translation thereof.

We recommend that you submit this information about the product via EU-CEG.

Publicly available information on e-cigarettes and refill containers

Publicly available information on electronic cigarettes and refill containers

Submitter ID and EU-CEG

You need an EU Login account and an EU-CEG Submitter ID in order to submit a product notification via EU-CEG to us. You apply for an EU-CEG Submitter ID on the European Commission website EU Common Entry Gate (EU-CEG).

EU Login (webgate.ec.europa.eu)

EU Common Entry Gate (EU-CEG) (health.ec.europa.eu)

EU-CEG Industry Stakeholders (circabc.europa.eu)