A digital form needs to be filled out and sent to HMS six months before marketing of products.

The following information needs to be included with the notification:

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 effect 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 marked and the used under normal or reasonably foreseeable conditions. 

i.   Images of the packaging of the product. 

HMS can ask for additional data should HMS determine that presented data in insufficient.