Retail sales licence for nicotine products

The sale of nicotine replacement therapy products elsewhere than in pharmacies requires a retail licence. The municipality of the retail site issues the licence.

A retail sales licence for nicotine replacement therapy products that help to quit or reduce smoking can be granted for tobacco-selling shops, service stations, kiosks and eating and drinking establishments. Selling nicotine replacement therapy products in vending machines is prohibited.

Apply for a licence by submitting a free-form, written application to the municipality in which your retail sites are located. In your application, clarify how you will ensure that your retail sites comply with the provisions of law regarding the retail sale of nicotine replacement therapy products.

The application must include

• your or your company’s name and contact information, business ID and the addresses of the retail sites of nicotine replacement therapy products
• an account of the storage of the NRT products, such as monitoring of the cold chain and last date of sale
• an account of how the sales is supervised, such as how the products are placed in the shop and how age restrictions are monitored
• the name and contact information of the person in charge of the sales
• an account of the number and location of sales points in the sales site.

The preferred way to apply for a licence is to use the printable application form for a licence to sell nicotine products. You can also submit the application and its appendices to Rovaniemi’s environmental health care by email.

A person who has been granted a retail licence must also notify the environmental health care of any changes in the information provided in the licence application and of the cessation of sales. Environmental health care reports the information to Fimea.

Selling nicotine replacement therapy products in shops requires that

• the entrepreneur has a retail licence issued by the municipality in which the retail site is located
• the products are sold in the site listed on the licence
• the products are only sold to persons who are 18 and over
• the sales person can oversee the sale of the products
• the products are not sold in vending machines.

The municipality will issue the licence if the entrepreneur has the capacity to store and sell the products pursuant to the Medicines Act. The entrepreneur must notify the municipality of any changes to the information listed in the licence application and the termination of the products' sale.

The storage, retail sale and marketing of NRT products must comply where applicable with the provisions of the Medicines Act. The sold NRT products must have a sales permit granted by either the European Commission or the Finnish Medicines Agency (Fimea). The sold NTR products may only be procured from pharmaceutical wholesale licence holders to which Fimea has granted wholesale licences.

If the entrepreneur has established itself in another country in the European Economic Area and temporarily offers services in Finland, the same permits are required as from entrepreneurs established in Finland.

According to the Medicines Act, nicotine products can only be sold in retail stores, kiosks, service stations and restaurants that sell tobacco, due to which the point of sale must have a retail sales licence for tobacco products.