E-cigarette notification information

Information on the registration process for electronic cigarettes, refillable liquids and smoking imitation devices in hungary

Please note that under the current legislation in force in Hungary, no flavoured products may be placed on the market, such as electronic cigarettes, refill bottles, cartridges, electronic smoking devices, nicotine-free refill bottles or nicotine-free cartridges. Accordingly, please do not submit a notification for such products in Hungary.

Legal background to the prohibition of flavouring:

According to the Government Decree 39/2013. (II. 14) Section 19/B. (1), on the Production,

Placing on the Market and Control of Tobacco Products, on Combined Warnings, and the

Detailed Provisions on the Application of Healthcare Penalties, (hereinafter: Gov. Decree)

electronic cigarettes and refill containers can be placed on the market only without any flavouring.

Furthermore, according to Section 19/C. (1) of the Gov. Decree, electronic devices imitating

smoking and nicotine-free refill containers may be placed on the market and marketed on condition that the liquid used in the electronic device imitating smoking, and nicotine free refill containers does not contain any flavouring.

Kit-Pack distribution in Hungary:

Pursuant to Section 15/D. (10) of Act CXXXIV of 2012 on the Reduction of Underage Smoking and the Retail Sale of Tobacco Products, the sale of Kit-Packs, that is, electronic cigarettes, refill containers, cartridges, nicotine-replacement products for smoking and nicotine-free cartridges packaged together, is prohibited in Hungary.

"§ 1 (1) The following may be carried on in Hungary only in compliance with this Act

1. tobacco products,
2. cigarette tubes and cigarette papers,
3. tobacco leaf filler,
4. electronic cigarettes,
5. refill bottles, cartridges, nicotine-free refill container, nicotine-free cartridges,
6. electronic device imitating smoking,
7. smoking-substitute nicotine-containing product,
8. novel tobacco product accessory; and
9. herbal product for smoking

retail sale of tobacco products for smoking purposes.

(....)

According to the Section 15/D. (10) of Act CXXXIV of 2012, a retailer of tobacco products

may not, in the course of his business, sell without consideration tobacco product supplements

as defined in paragraph (1) of Section 1. It shall be prohibited to sell the product listed in

paragraph (1) of Section 1 together with any other product listed in paragraph (1) of Section

1, or with any product complementary to tobacco products, by means of a lottery or other

similar game or by any other means of encouraging consumption."

General provisions on notification:

The Section 7/D. (1) of the Act XLII of 1999 on the Protection of Non-Smokers and Certain

Regulations on the Consumption and Distribution of Tobacco Products (hereinafter: NSA).

provides:

„Manufacturers and importers of electronic cigarettes, refill containers and cartridges, electronic devices imitating smoking, nicotine-free refill containers, nicotine-free cartridges and nicotine-replacement products for smoking shall submit a notification to the government body in charge of the healthcare system of any such products which they intend to place on the market at least six months in advance.”

According to Section 19/A. (1) of the Gov. Decree, the notification shall be submitted to

the National Centre for Public Health and Pharmacy (hereinafter: NCPHP) through the

common entry gate (EU-CEG) provided for in Commission Implementing Decision (EU)

2015/2183, in Hungarian or English, subject to data content requirements provided for in

Commission Implementing Decision (EU) 2015/2183.

According to the Section 19/A. (2) of the Gov. Decree, the notification referred to in Subsection (1) shall contain the following information:

1. the name and contact details of the manufacturer, importer, distributor in Hungary, the submitter's identifier, the electronic cigarette identification number,
2. a list of all ingredients contained in, and emissions resulting from the use of, the product, by

• brand name and type, including quantities thereof;

1. toxicological data regarding the product’s ingredients and emissions, primarily their effects

• on the health of consumers when inhaled and taking into account any addictive effect they may
• have;

1. information on the nicotine doses and uptake when consumed under normal or reasonably

• foreseeable conditions;

1. a description of the components of the product, including the opening and refill mechanism

• of the electronic cigarette or refill containers;

1. a description of the production process, including whether it involves series production, and

• a declaration that the production process ensures conformity with the requirements set out in
• the relevant legislation; and

1. 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

When any change is made in the product affecting the information referred to in Subsection (2)

a new notification shall be submitted.

Administrative service fees for registration and notification of changes:

According to the Section 7/D. (4) of NSA, the Subsections (1) and (3) the notifier shall be

liable to pay an administrative service fee to the NNGYK, as well as for notified products

for which the NCPHP has issued a certificate, by 31 March of the reference year. From the

year following the notification the administrative service fee shall serve to maintain the

notification

According to Ministerial Decree 30/2016. (X. 3.) on the administrative service fees for the notification of the placing on the market of electronic cigarettes, refillable bottles and

electronic devices imitating smoking and related changes, the administrative service fees payable are:

For faster processing, please send the proof of payment of the fee to the NNGYK via e-mail Ez az e-mail-cím a szpemrobotok elleni védelem alatt áll. Megtekintéséhez engedélyeznie kell a JavaScript használatát. with a reference to the name of the product and the number of the product ID.

According to the Section 19/D. (1) of the Gov. Decree manufacturers and importers of

electronic cigarettes, electronic devices imitating smoking and refill containers, nicotine free refill containers, cartridges are required to submit, annually, through the common entry gate, by 31 March of the year following the given year:

1. data on sales volumes, by brand name and type of the product;
2. information on the preferences of various consumer groups, including young people, non-smokers and the main types of smokers;
3. the mode of sale of the products; and
4. executive summaries of any market surveys carried out in respect of Paragraphs a)-c), including an English translation.

The reporting period is from 1 January to 31 December of the year preceding the year in which

the lists are submitted.

The managing authority name, postal and e-mail address, telephone number and opening hours of the managing authority

Nemzeti Népegészségügyi és Gyógyszerészeti Központ 1097 Budapest, Albert Flórián Street 2-6.

Mailing address: Nemzeti Népegészségügyi és Gyógyszerészeti Központ Közegészségügyi Főosztály

1437 Budapest, Pf: 839. Phone: 06 1/476-1220

E-mail: Ez az e-mail-cím a szpemrobotok elleni védelem alatt áll. Megtekintéséhez engedélyeznie kell a JavaScript használatát.

Office Gate: NNKKOZEG, KRID ID: 369732197 Customer reception by prior arrangement by telephone.