Menu
Notifications
Manufacturers or importers must submit notifications to HMS if they intend to place nicotine products, e-cigarettes or refills containing nicotine on the Icelandic market. HMS reserves the right to reject notifications of products if the applicable criteria is not fulfilled.
Products that need to be notified are nicotine products, refills that contain nicotine, MODs, PODs, tanks, coils, cartridges, and batteries that are meant for e-cigarettes. There is no need to notify nicotine free refills, batteries that are also used in different kinds of products and spare parts for e-cigarettes such as -rings, spare glass tubes etc. All nicotine products that are not categorized as medicines or food or are meant for inhalation must be notified before marketing.
Retail license
Retailers are required to apply for a special retail permit before any marketing of nicotine product, e-cigarettes or refill. The license applies to any kind of store, be it specialty stores, general stores, or online retailers. The licence is valid for four years but can be valid for a shorter period should applicants wish, but no shorter than a year.
Importers, distributors, and manufacturers are not allowed to sell or provide anyone other than those that have a license with such products. In turn, retailers cannot sell products that have not been notified.
Retail licenses can only be granted to Icelandic businesses, operated within Iceland and to owners or operators who have an Icelandic ID number (kennitala).
Manufacturers or importers who intend to notify, or retailers who intent to sell, nicotine products, nicotine refills or and e-cigarettes on the Icelandic market, shall fill out the form and send the e-mail address: hms@hms.is.
Notification form for e-cigarettes and refills
Notification form for nicotine products
Application for retail license
The following information, as applicable, needs to be included with notifications:
a. The name and contact details of the manufacturer, a responsible legal or natural person, and, if applicable, the importer.
b. The EC-ID of the product.
c. A list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof.
d. 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, inter alia, any addictive effect.
e. Information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions.
f. A description of the components of the products; including where applicable, the opening and refill mechanism of the electronic cigarette or refill containers.
g. A description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements of Acts 87/2018 and 134/1995.
h. 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.
i. Images of packaging of the product.
The following data needs to be included with applications for retail license:
a. Certificate of legal compitence.
b. Proof of registration in the firm- or company directory.
c. Information on the place of retail.
d. Information on the applicant.
e. The type of retailer applied for.
f. Information on online store, if applicable.
Invoice, payment instructions and confirmation of notification
When HMS receives a notification, the authority will assess the number of the product lines and fees to be paid for the notification. Once the preliminary assessment has been made the authority will inform the notifying party of its finding and send an invoice.
Further processing of the notification will only take place after confirmation of payment according to the invoice has been sent to HMS. If no payment has been made 3 months after the invoice is issued the request for notification will be closed and marketing of the products remains prohibited.
A fee is not refundable if a notification is denied.
HMS determines, after receiving the notification forms, the amount to be paid by the notifying party.
Fee for nicotine products
One fee of 75.000 ISK is to be paid for each product line of nicotine products containing the same mg/g of nicotine.
Example: A manufacturer submits seven nicotine pouches of their products line; five contain 16 mg/g and 20 mg/g. These are two product line and results in two fees, or 150.000 ISK.
Fee for nicotine containing refills
One fee of 75.000 ISK is to be paid for each product line of e-liquids containing the same amount of nicotine.
Example: A manufacturer that will submit ten liquid of their product line; five with 3 mg/ml of nicotine, with five different flavours, would normally result in payment for 2 products or 150.000 ISK.
Fee for electronic cigarettes – device and components
One fee for and e-cigarette and its components is 75.000 ISK. That applies to e-cigarettes equipment and components, such as single MOD, a coil, and a tank.
A submission fee of 75.000 ISK shall be paid for components that are produced to be used for e-cigarettes and have not been notified as a component for another device.
Example A: A manufacturer notifies an e-cigarette including a tank and coils from the same product line This notification results in one submission fee of 75.000 ISK.
Example B: An importer submits a notification for a tank that does not belong to a product line that has been submitted before. That notification results in one fee of 75.000 ISK.
Example C: A manufacturer submits a notification for eight disposable e-cigarettes. Four contain 20 mg/ml nicotine and four contain 10 mg/ml nicotine. In this case there are two product lines, and the fee would be 150.000 ISK.
Invoice and payment of retail license fees
After receiving an application for a retail license HMS will send an invoice for the licence fee.
Licensing fee for each location of sale is comprised of 27.224 ISK processing fee as well as a surveillance fee. The surveillance fee is comprised of an hourly specialist fee of 18.216 ISK/hr as well as other applicable fees, such as travel expanses. Once the retail location has been inspected applicants will receive an invoice. If the invoice is not paid within three month the amount will be sent to debt collection.
The fee is not repaid if the application is rejected.
After receiving a proof of payment, HMS will review the notification of the application for retail license. Once the reviewing process is complete the notifying party/applicant will receive a confirmation of results.
Borgartúni 21, 105 Reykjavík.
Ártorgi 1, 550 Sauðárkróki.
Hafnarstræti 107, 600 Akureyri.
kt: 581219-1480
Mán til fim frá kl. 9:00 – 16:00
Fös frá kl. 9:00 – 14:00