H-1135 Budapest, Szabolcs utca 33.

Tel.: (1) 8869-300, General information: 1812

E-mail: info@egeszsegvonal.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Mellékhatás bejelentő
NOR keresőfelület Minőségi kifogás
magisztrális gyógyszerek

Electronic Cigarettes

A list of products which have been notified to OGYÉI (National Institute of Pharmacy and Nutrition) via the EU-CEG is available here

Refill containers without nicotine 

In Hungary, the National Institute of Pharmacy and Nutrition (hereinafter referred to as OGYÉI) assess the notifications of the manufacturers and importers of electronic cigarettes and refill containersaccording to provision laid down in Article 7/D of the Act XLII of 1999 on the Protection of Non-Smokers and Certain Regulations on the Consumption and Distribution of Tobacco Products(hereinafter referred to as Nvt.). The Nvt.,the Government Decree 39/2013(II.14.)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 andDecree 30/2016 (X. 3.) of the Ministry of Human Capacities on the Administrative Service Fees Charged in Connection with Notifications for Placing Electronic Cigarettes, Refill Containers and Electronic Devices Imitating Smoking on the Market and for the Related Changescontains the related regulations compatible with Directive 2014/40/EU of the European Parliament and the Council of 3 April 2014. 

According to the above mentioned regulations those refill containers or cartridges, which are not containing nicotine don’t need to be notified and therefore OGYEI will remove these products from its relevant list 

We would like to inform you that disposable electronic cigarettes without nicotine are still need to be notified.

Sales datas

In Hungary, the National Institute of Pharmacy and Nutrition (hereinafter referred to as OGYÉI) assessed the notification according to provision in Article 7/D. of the Act XLII of 1999. (hereinafter referred to as Nvt.). The Nvt. and the government regulation 39/2013. (II.14.) 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 contains regulations compatible with the Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014. 

Connect to the 39/2013 (II.14) regulation:

Section 19/D[1], Article 1: Manufacturers and importers of electronic cigarettes, electronic devices imitating smoking and refill containers are required to submit, annually, through the common entry gate, by 31 March of the year following the given year:

a) data on sales volumes, by brand name and type of the product;

b) information on the preferences of various consumer groups, including young people, non-smokers and the main types of smokers;

c) the mode of sale of the products; and

d) executive summaries of any market surveys carried out in respect of Paragraphs a)–c), including an English translation thereof;

with the provision that the reference year begins on 1 January and ends on 31 December of the year preceding the date when the lists are submitted.

10. Closing provisions, Section 21/A, the Article 9: In the case of electronic cigarettes, refill containers and electronic devices imitating smoking already placed on the market by 19 May 2016 the data disclosure obligation under Section 19/D, as established by the Amending Decree, shall be met for the first time by 31 December 2017.

 

Therefore we kindly ask please fill in into EU CEG system the above mentioned datas in every product id’ cases connect to 2016 year.



[1] Enacted by Section 16 of Government Decree 239/2016 (VIII. 16.), effective as of 20 August 2016.


Last updated: 2018.09.30 12:18