REPUBLIC OF LITHUANIA

LAW

ON CONTROL OF TOBACCO, TOBACCO PRODUCTS AND RELATED PRODUCTS

20 December 1995 No I-1143

Vilnius

(As last amended on 20 December 2016 – No XIII-157)

CHAPTER I

GENERAL PROVISIONS

Article 1. Purpose of the Law

1. This Law shall regulate relations incidental to the manufacture, trade, storage, transportation, entry, import, advertising, consumption, promotion and sponsorship of the purchase and/or consumption of tobacco products as well as relations incidental to the placing on the market and labelling of tobacco, tobacco products and related products, and shall establish the framework for state control of tobacco, tobacco products and related products in the Republic of Lithuania.

2. Taking account of the fact that individual and public health constitute one of the most important values of society, the provisions of this Law shall aim to reduce the consumption of tobacco products and related products in the Republic of Lithuania, their accessibility (particularly to minors) and harmful effects of the use of tobacco products and related products on human health and the economy.

3. Tobacco products and related products shall be attributed to specific products the manufacture, trade, entry, import, advertising, other activities related to such products as well as consumption thereof are subject to a special state legal regulation under this and other laws and legal acts.

4. The provisions of this Law have been harmonised with the legal acts of the European Union referred to in Annex 2 to this Law.

Article 2. Definitions

1. ‘Mobile shop’ means a registered means of transportation installed as a point of sale of food and/or non-food products where residents of townships and villages are served in accordance with the procedure laid down by the municipal council.

2. ‘Smokeless tobacco product’ means a tobacco product not involving a combustion process, including chewing tobacco, nasal tobacco and tobacco for oral use.

3. ‘General warning’ means a text on tobacco products for smoking saying ‘Smoking kills – quit now’.

4. ‘Cigar or cigarillo’ means a tobacco product that is consumed via a combustion process:

1) a roll of tobacco with an outer wrapper of natural tobacco;

2) a roll of tobacco with a threshed blend filler and with an outer wrapper of the normal colour of tobacco, of reconstituted tobacco, covering the product in full, including, where appropriate, the filter but not, in the case of a tipped cigarillo, the tip, where the unit weight, not including filter or mouthpiece, is not less than 2,3 g and not more than 10 g, and the circumference over at least one third of the length is not less than 34 mm.

5. ‘Cigarette’ means a tobacco product that is consumed via a combustion process:

1) a roll of tobacco capable of being smoked as it is and which is not a cigar or cigarillo within the meaning of paragraph 4 of this Article;

2) a roll of tobacco which, by simple non-industrial handling, is inserted into a cigarette-paper tube;

3) a roll of tobacco which, by simple non-industrial handling, is wrapped in cigarette paper.

6. ‘Tar’ means the raw anhydrous nicotine-free condensate of smoke.

7. ‘Maximum level’ means the maximum content or emission, including zero, of a substance in a tobacco product measured in milligrams.

8. ‘Electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container, or rechargeable with single use cartridges.

9. ‘Refill container’ means a receptacle that contains a nicotine-containing liquid, which can be used to refill an electronic cigarette.

10. ‘Contracting party to the Agreement on the European Economic Area’ means a Member State of the European Union or a Member State of the European Free Trade Association (EFTA), except the Swiss Confederation.

11. ‘Branch of a legal person or any other organisation established in a contracting party to the Agreement on the European Economic Area, except the Republic of Lithuania’ means a branch, representative office or any other division of a legal person or any other organisation which is of a different legal form and which is established in a contracting party to the Agreement on the European Economic Area, except the Republic of Lithuania.

12. ‘Information message’ means a text on any outside packaging of tobacco products for smoking, including on each unit packet, saying ‘Tobacco smoke contains over 70 substances known to cause cancer’.

13. ‘Health warning’ means a warning concerning the adverse effects on human health of a tobacco product or other undesired consequences of its consumption, including text warnings, combined health warnings, general warnings and information messages, as provided for in this Law.

14. ‘Outside packaging’ means any packaging (transparent wrappers are not regarded as outside packaging) in which tobacco products or related products are placed on the market and which includes a unit packet or an aggregation of unit packets.

15. ‘Emissions’ means substances that are released when tobacco, a tobacco product or related product is consumed as intended.

16. ‘Combined health warning’ means a health warning consisting of a combination of a text warning and a corresponding photograph or illustration, as provided for in this Law.

17. ‘Chewing tobacco’ means a smokeless tobacco product exclusively intended for the purpose of chewing.

18. ‘Flavouring’ means an additive that imparts smell and/or taste.

19. ‘Novel tobacco product’ means a tobacco product which does not fall into any of the following categories: cigarettes, roll-your-own tobacco, pipe tobacco, waterpipe tobacco, cigars, cigarillos, chewing tobacco, nasal tobacco or tobacco for oral use, and is placed on the market after 19 May 2014.

20. ‘Unprocessed tobacco’ means tobacco leaves and other parts of tobacco which are uncut or otherwise unprocessed, except those which, pursuant to the Law of the Republic of Lithuania on Excise Duty, are treated as manufactured tobacco.

21. ‘Nicotine’ means an alkaloid found in tobacco.

22. ‘Tobacco for oral use’ means all tobacco products for oral use, except those intended to be inhaled or chewed, made wholly or partly of tobacco, in powder or in particulate form or in any combination of those forms, particularly those presented in sachet portions or porous sachets;

23. ‘Surreptitious advertising of tobacco products and/or products related to tobacco products’ means information disseminated in any form and by any means about tobacco products and/or products related to tobacco products, manufacturers, importers or sellers of tobacco products or products related to tobacco products, their trade names, trademarks or activities in a way that may confuse advertising consumers as to the actual purpose of presentation of such information. Such presentation of information shall be considered as surreptitious advertising in all cases if it is done in return for payment or for similar consideration.

24. ‘Pavilion’ means a temporary construction works which is not subject to registration in the Real Property Register, does not have the foundation driven into the ground, is manufactured in the plant or built from prefabricated structures and has a sales area inside for providing services to customers.

25. ‘Pipe tobacco’ means tobacco that can be consumed via a combustion process and exclusively intended for use in a pipe.

26. ‘Characterising flavour of a tobacco product’ means a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or a combination of additives, including, but not limited to, fruit, spice, herbs, alcohol, candy, menthol or vanilla or their combinations, which is noticeable before or during the consumption of the tobacco product.

27. ‘Additive’ means a substance, other than tobacco, that may be added to a tobacco product, a unit packet or to any outside packaging.

28. ‘Addictiveness’ means the pharmacological potential of a substance to cause addiction, a state which affects an individual's ability to control his behaviour, typically by instilling a reward or a relief from withdrawal symptoms, or both.

29. ‘Sponsorship’ means financial or other support to an event, activity or person with the aim of promoting tobacco products and products related to tobacco products and/or encouraging their consumption.

30. ‘Herbal product for smoking’ means a product based on plants, herbs or fruits which contains no tobacco and that can be consumed via a combustion process.

31. ‘Tobacco products for smoking’ means a tobacco product that can be consumed via a combustion process.

32. ‘Social advertising’ means advertising designated to promote social wellbeing, that is a healthy lifestyle, health improvement and prevention of diseases and harmful health habits.

33. ‘Roll-your-own tobacco’ means tobacco which is used for making cigarettes by consumers or retail outlets;

34. ‘Pouch of roll-your-own tobacco’ (hereinafter: a ‘pouch’) means a unit packet of roll-your own tobacco, either in the form of a rectangular pocket with a flap that covers the opening or in the form of a standing pouch.

35. ‘Product related to tobacco products’ (hereinafter: a ‘related product’) means an electronic cigarette, a refill container for electronic cigarettes or a herbal product for smoking.

36. ‘Tobacco’ means leaves and other natural processed or unprocessed parts of tobacco plants (Nicotiana), including expanded and reconstituted tobacco.

37. ‘Ingredient of a tobacco product and/or a related product’ means tobacco, an additive, as well as any substance or element present in a finished tobacco product and/or a related product, including paper, filter, ink, capsules and adhesives.

38. ‘Tobacco product’ means a product that is intended for consumption, manufactured only from tobacco (whether genetically modified or not) or consists of tobacco.

39. ‘Tobacco products warehouse’ means premises having an independent entry and partitioned off by construction panels from the rest of the premises, or premises of a tax warehouse located in the Republic of Lithuania which are recorded in the Real Property Register as warehouses where wholesale of tobacco products is carried on.

40. ‘Import of tobacco products and/or related products’ means the entry into the territory of the Republic of Lithuania of tobacco products and/or related products from other countries, except the contracting parties to the Agreement on the European Economic Area and Turkey, unless such products are placed under a customs suspensive procedure or arrangement upon their entry into the Republic of Lithuania, as well as their release from a customs suspensive procedure or arrangement.

41. ‘Importer of tobacco products and/or related products’ means a legal person and/or a branch of a foreign legal person established in the Republic of Lithuania who brings tobacco products and/or related products into the territory of the Republic of Lithuania from other countries, except the contracting parties to the Agreement on the European Economic Area and Turkey.

42. ‘Promotion of tobacco products and/or related products and/or encouraging of their consumption’ means actions of information and persuasion, including special events, campaigns, discounts, gifts and the like, designated to promote decision-making with respect to the purchase and/or consumption of tobacco products and/or related products.

43. ‘Entry of tobacco products and/or related products’ means entry of tobacco products and/or related products into the territory of the Republic of Lithuania (except tobacco products and/or related products brought by natural persons) from the contracting parties to the Agreement on the European Economic Area and Turkey.

44. ‘Retail outlet of tobacco products and/or related products’ (hereinafter: a ‘retail outlet’) means premises in stores, kiosks, pavilions, restaurants, cafes, bars, buffets, and other places (including mobile shops) where tobacco products and/or related products are offered for sale to consumers (if customers are served outdoors, the location of the cash register is regarded as the sales outlet of tobacco products and/or related products).

45. ‘Sales outlet of tobacco products and/or related products’ (hereinafter: a ‘sales outlet’) means a retail outlet of tobacco products and/or related products as well as premises where the wholesale of tobacco products and/or related products is carried on.

46. ‘Advertising of tobacco products and/or related products’ means information about tobacco products and/or related products disseminated in any form and by any means with the aim of direct or indirect effect of promoting tobacco products and/or related products and/or encouraging their consumption.

47. ‘Control of tobacco, tobacco products and/or related products’ (hereinafter: ‘tobacco control’) means a totality of measures of state control over the consumption, manufacture, entry, import, trade, advertising, purchase, promotion and or encouraging of consumption, support of tobacco, tobacco products and/or related products; such measures are prescribed in this Law and other legal acts regulating tobacco control and intended to reduce the consumption of tobacco products and/or related products as well as the harmful effects of their use on health and the economy.

48. ‘Cross-border distance sales’ means distance sales to consumers where, at the time the consumer orders the product from a retail outlet, the consumer is located in the Republic of Lithuania and that retail outlet is established in any other contracting party to the Agreement on the European Economic Area or any other foreign country; a retail outlet is deemed to be established in a contracting party to the Agreement of the European Economic Area:

1) in the case of a natural person: if he has his place of business in that contracting party to the Agreement on the European Economic Area;

2) in other cases: if the retail outlet has its statutory seat, central administration or place of business, including a branch, agency or any other establishment, in that contracting party to the Agreement on the European Economic Area.

49. ‘Placing on the market’ means to make products, irrespective of their place of manufacture, available to consumers located in the Republic of Lithuania, with or without payment, including by means of distance sale. In the case of cross-border distance sales the product is deemed to be placed on the market in the Republic of Lithuania if the consumer is located in the Republic of Lithuania.

50. ‘Toxicity’ means the degree to which a substance can cause harmful effects in the human organism, including effects occurring over time, usually through repeated or continuous consumption or exposure.

51. ‘Nasal tobacco’ means a smokeless tobacco product that is consumed via the nose.

52. ‘Foreign legal person’ means a legal person or any other organisation established in a contracting party to the Agreement on the European Economic Area (except the Republic of Lithuania).

53. ‘Waterpipe tobacco’ means a tobacco product that can be consumed via a waterpipe. For the purpose of this Law, waterpipe tobacco is deemed to be a tobacco product for smoking. If tobacco can be used both via waterpipes and as roll-your-own tobacco, it shall be deemed to be roll-your-own tobacco.

54. ‘Unit packet’ means the smallest individual packaging of a tobacco product or related product that is placed on the market.

55. Other concepts used in this Law shall be interpreted as they are defined in the Law of the Republic of Lithuania on Excise Duty, the Law of the Republic of Lithuania on Product Safety, the Law of the Republic of Lithuania on Education and the Law of the Republic of Lithuania on Consumer Rights Protection.

Article 3. Principles of the State Policy in Respect of the Control of Tobacco, Tobacco Products and Related Products

The principles of the state policy in respect of the control of tobacco, tobacco products and related products shall be as follows:

1) to protect the right of persons to a tobacco smoke-free environment;

2) to reduce the accessibility of tobacco products and related products, particularly to minors, through taxation and other state regulatory measures;

3) to prohibit the use of state and municipal budget funds for tobacco growing and developing the manufacture, trade, import and entry of tobacco products;

4) to ensure through measures of state legal regulation that a portion of state budget funds received from the manufacture, import and trade of tobacco products and related products be allocated for designing and implementing health protection and improvement programmes;

5) to prohibit the advertising of tobacco products and related products;

6) to prohibit promotion of tobacco products and related products and/or encouraging of their consumption and support in any form or by any means;

7) to increase public awareness about the health risks of consumption of tobacco products and related products, as well as social and economic damage inflicted on the State;

8) to encourage smokers to stop smoking and assist them in doing so;

9) to exercise the control and monitoring of tobacco products and related products;

10) to support social advertising and promote non-smoking through the media;

11) to aim at creating a tobacco smoke-free work, leisure and living environment;

12) when determining and implementing tobacco control policies, to protect them from commercial and other interests.

CHAPTER II

REQUIREMENTS FOR INGREDIENT, QUALITY AND LABELLING OF

TOBACCO PRODUCTS AND RELATED PRODUCTS,

PROVISION OF INFORMATION ABOUT TOBACCO PRODUCTS,

RELATED PRODUCTS AND NOVEL TOBACCO PRODUCTS

SECTION ONE

INGREDIENT, QUALITY AND LABELLING REQUIREMENTS

FOR TOBACCO PRODUCTS

Article 4. General Ingredient and Quality Requirements for Tobacco Products

1. The ingredient and quality indications on the tobacco products manufactured and/or sold in the Republic of Lithuania shall comply with the requirements laid down in this Law.

2. The maximum emission levels from cigarettes sold or manufactured in the Republic of Lithuania or imported into or exported from it shall not be greater than: 10 mg of tar per cigarette, 1 mg of nicotine per cigarette and 10 mg of carbon monoxide per cigarette.

3. The Ministry of Health of the Republic of Lithuania (hereinafter: ‘the Ministry of Health’) shall have the right to carry out studies in order to measure emissions from cigarettes other than the emissions referred to in paragraph 2 of this Article and/or emissions from tobacco products other than cigarettes, to assess adverse health effects of such emissions, in particular if such emissions can cause addictiveness. The said studies may be carried out by laboratories specified in Article 6(1) of this Law.

4. The Ministry of Health shall notify the European Commission of any maximum emission levels of emissions from cigarettes other than the emissions referred to in paragraph 2 and/or of emissions from tobacco products other than cigarettes, if such maximum emission levels are established, and inform the Commission about the methods used to measure the maximum emission levels of emissions from cigarettes and/or emissions from tobacco products other than cigarettes.

5. An institution authorised by the Government of the Republic of Lithuania, on the basis of scientific evidence, shall have the right to prohibit the use of the ingredients that increase the addictive effect of tobacco products.

Article 41 Regulation of Ingredients of Tobacco Products

1. The Republic of Lithuania shall prohibit the placing on the market of tobacco products with a characterising flavour. This prohibition shall not apply to the use of additives which are essential for the manufacture of tobacco products, for example sugar to replace sugar that is lost during the curing process, provided those additives do not result in a product with a characterising flavour and do not increase to a significant or measureable degree the addictiveness, carcinogenic, mutagenic or reprotoxic properties (hereinafter: ‘CMR properties’) of the tobacco product. The Government of the Republic of Lithuania or an institution authorised by it shall notify the European Commission of the measures taken pursuant to this paragraph.

2. Legal acts of the European Union or legal acts adopted by the Government of the Republic of Lithuania or an institution authorised by it and implementing the legal acts of the European Union shall lay down the procedures for determining whether a tobacco product falls within the scope of paragraph 1 of this Article.

3. The Republic of Lithuania shall prohibit the placing on the market of tobacco products containing the following additives:

1) vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks;

2) caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality;

3) additives having colouring properties for emissions;

4) for tobacco products for smoking, additives that facilitate inhalation or nicotine uptake;

5) additives that have CMR properties in unburnt form.

4. The Republic of Lithuania shall prohibit the placing on the market of tobacco products containing flavourings in any of their components such as filters, papers, packages, capsules or any technical features allowing modification of the smell or taste of the tobacco products concerned or their smoke intensity. Filters, papers and capsules cannot contain tobacco or nicotine.

5. Terms and conditions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (hereinafter: ‘Regulation (EC) No 1907/2006’) shall appropriately apply to tobacco products.

6. The Government of the Republic of Lithuania or an institution authorised by it, on the basis of scientific evidence that a tobacco product concerned contains additives in quantities that increase the toxic or addictive effect, or the CMR properties of the tobacco product at the stage of consumption to a significant or measureable degree, shall have the right to prohibit the placing on the market of such tobacco product in accordance with the procedure laid down by the Government of the Republic of Lithuania or an institution authorised by it. In these cases the Government of the Republic of Lithuania or an institution authorised by it shall notify to the European Commission the measures it has taken pursuant to this paragraph.

7. Prohibitions set out in paragraphs 1 and 4 of this Article shall apply to cigarettes and roll-your-own tobacco.

8. Manufacturers and importers of tobacco products shall have the right, in accordance with the procedure and under the conditions laid down by the Government of the Republic of Lithuania or an institution authorised by it, to apply to an institution authorised by the Government of the Republic of Lithuania for assessing whether a tobacco product has a characterising flavour, whether prohibited additives or flavourings are used and whether a tobacco product contains additives in quantities that increase to a significant and measurable degree the toxic or addictive effect or the CMR properties of the tobacco product concerned.

Article 5. Documents Certifying Conformity of Tobacco Products

1. The fact that tobacco products conform to the requirements laid down in legal acts, including the requirements for tar, nicotine and carbon monoxide emissions from cigarettes, must be verified by certificates attesting conformity of tobacco products issued by the manufacturing undertaking on the basis of tests carried out by testing laboratories which are approved (accredited) by the competent authorities of the contracting parties to the Agreement on the European Economic Area or Turkey.

2. An institution authorised by the Government of the Republic of Lithuania shall lay down the procedure of and the requirements for submission of certificates attesting conformity of tobacco products referred to in paragraph 1 of this Article.

Article 6. Laboratories and Measurement Methods

1. Tar, nicotine or carbon monoxide emissions from cigarettes shall be measured in laboratories which are approved (accredited) by the competent authorities of the contracting parties to the Agreement on the European Economic Area or Turkey and which are entered on the list of laboratories of the European Commission’s Joint Research Centre. Laboratories specified in this paragraph shall be approved (accredited) and monitored in the Republic of Lithuania by an institution authorised by the Government of the Republic of Lithuania. Laboratories operating in the Republic of Lithuania and wishing to be approved (accredited) must meet the Lithuanian standards referred to in paragraph 3 of this Article.

2. Laboratories approved (accredited) in the Republic of Lithuania may not be owned and/or controlled by the tobacco industry.

3. When measuring the tar, nicotine and carbon monoxide emissions from cigarettes, laboratories referred to in paragraph 1 of this Article and approved (accredited) in the Republic of Lithuania must apply the measurement methods set out in the Lithuanian standards adopting ISO standards (ISO standard 4387 for tar, ISO standard 10315 for nicotine, and ISO standard 8454 for carbon monoxide).

4. The Ministry of Health shall communicate to the European Commission a list of laboratories referred to in paragraph 1 of this Article and approved (accredited) in the Republic of Lithuania, specifying the criteria (Lithuanian standards) used for approval (accreditation) of laboratories approved (accredited) in the Republic of Lithuania as well as the measurement methods set in paragraph 3 of this Article, applied by the said laboratories and referred to in the accreditation certificate of a laboratory approved (accredited) in the Republic of Lithuania.

5. Where laboratories referred to in paragraph 1 of this Article and approved (accredited) in the Republic of Lithuania measure emissions from cigarettes other than the emissions referred to in paragraph 3 of this Article and/or for emissions from tobacco products other than cigarettes, the Ministry of Health shall notify the European Commission of any standard, non-standard methods of measurement of those emissions applied at a laboratory approved (accredited) in the Republic of Lithuania or developed at a laboratory approved (accredited) in the Republic of Lithuania.

Article 7. Recognition of Tobacco Products as Not Conforming to Statutory Requirements for Labelling, Content and Quality

1. An institution authorised by the Government of the Republic of Lithuania shall supervise whether the labelling, ingredient and quality indicators of tobacco products conform to the requirements set out in legal acts.

2. In the event that testing laboratories, when measuring the samples of tobacco products taken on a commission of state institutions authorised in accordance with the procedure laid down by this Law and other legal acts, establish that these samples do not meet the requirements laid down in legal acts, it shall be deemed that the entire batch of tobacco products wherefrom such samples have been taken does not meet with the said requirements.

Article 8. Labelling Requirements for Tobacco Products and Related Products Intended to be Sold in the Republic of Lithuania

1. Tobacco products and related products sold in the Republic of Lithuania shall be labelled in accordance with the procedure laid down in legal acts.

2. Information appearing on unit packets of tobacco products and related products and any outside packaging may not mislead consumers.

Article 81 Health Warnings

1. When labelling tobacco products, manufacturers of these tobacco products must, besides the information set out in legal acts, place in the official language of the Republic of Lithuania health warnings provided for in this Law on each unit packet of such tobacco products and any outside packaging placed on the market.

2. Health warnings must cover the entire surface of the unit packet or outside packaging that is reserved for them and they shall not be commented on, paraphrased or referred to in any form.

3. Health warnings must be irremovably printed, indelible and fully visible, including not being partially or totally hidden or interrupted by tax stamps, price marks, security features, wrappers, jackets, boxes, or other items, when tobacco products are placed on the market. On unit packets of tobacco products other than cigarettes and roll-your-own tobacco in pouches, the health warnings may be affixed by means of stickers, provided that such stickers are irremovable. The health warnings must remain intact when opening the unit packet other than packets with a flip-top lid, where the health warnings may be split when opening the packet, but only in a manner that ensures the graphical integrity and visibility of the text, photographs and cessation information.

4. The health warnings shall in no way hide or interrupt the tax stamps, price marks, tracking and tracing marks, or security features on unit packets.

5. The dimensions of the health warnings provided for in Articles 82, 83, 84 and 85 of this Law shall be calculated in relation to the surface concerned when the packet is closed.

6. Health warnings shall be surrounded by a black border of a width of 1 mm inside the surface area that is reserved for these warnings, except for health warnings pursuant to Article 84 of this Law.

Article 82 General Warnings and Information Messages on Tobacco Products for Smoking

1. Each unit packet and any outside packaging of tobacco products for smoking must carry a general warning: ‘Smoking kills – quit now’.

2. Each unit packet and any outside packaging of tobacco products for smoking must carry the following information message: ‘Tobacco smoke contains over 70 substances known to cause cancer.’

3. For cigarette packets and roll-your-own tobacco in cuboid packets the general warning shall appear on the bottom part of one of the lateral surfaces of the unit packets, and the information message shall appear on the bottom part of the other lateral surface. These health warnings shall have a width of not less than 20 mm.

4. For packets in the form of a shoulder box with a hinged lid for cigarettes and roll-your-own tobacco that result in the lateral surfaces being split into two when the packet is open, the general warning and the information message shall appear in their entirety on the larger parts of those split surfaces. The general warning shall also appear on the inside of the top surface that is visible when the packet is open. The lateral surfaces of this type of packet shall have a height of not less than 16 mm.

5. For roll-your-own tobacco marketed in pouches the general warning and the information message shall appear on the surfaces that ensure the full visibility of those health warnings. For roll-your-own tobacco in cylindrical packets the general warning shall appear on the outside surface of the lid and the information message on the inside surface of the lid.

6. Both the general warning and the information message shall cover 50 % of the surfaces on which they are printed.

7. The general warning and information message referred to in paragraphs 1 and 2 of this Article shall be:

1) printed in black Helvetica bold type on a white background;

2) at the centre of the surface reserved for them, and on cuboid packets and any outside packaging they shall be parallel to the lateral edge of the unit packet or of the outside packaging.

8. The precise position of the general warning and the information message on roll-your-own tobacco marketed in pouches must meet the requirements set out in legal acts of the European Union determining the position of the general warning and information message on the pouches, taking into account the different shapes of pouches.

Article 83 Combined Health Warnings for Tobacco Products for Smoking

1. Each unit packet and any outside packaging of tobacco products for smoking shall carry combined health warnings. The combined health warnings must:

1) contain one of the text warnings listed in Annex I to this Law and positioned on a corresponding colour photograph as specified in the sets of pictorial warnings approved by the Government of the Republic of Lithuania or an institution authorised by it;

2) include smoking cessation information such as telephone numbers, e-mail addresses or Internet sites intending to inform consumers about the programmes that are available to support persons who want to stop smoking;

3) cover 65 % of both the external front and back surface of the unit packet and any outside packaging. Cylindrical packets shall display two combined health warnings, equidistant from each other, each covering 65 % of their respective half of the curved surface;

4) show the same text warning and corresponding colour photograph on both sides of the unit packets and any outside packaging;

5) appear at the top edge of a unit packet and any outside packaging, and be positioned in the same direction as any other information appearing on that surface of the packaging. Where during the transitional period of three years, which ends on 20 May 2019, brand names or logos are not positioned above the health warnings, an exemption from the obligation on the position of the combined health warning shall apply as follows:

a) in those cases, where the tax stamp is affixed at the top edge of a unit packet made of carton material, the combined health warning that is to appear on the back surface may be positioned directly below the tax stamp;

b) where a unit packet is made of soft material, a rectangular area may be reserved for the tax stamp of a height not exceeding 13 mm between the top edge of the packet and the top end of the combined health warnings;

6) meet technical specifications and requirements set out in legal acts of the European Union for the format, layout and design of combined health warnings, taking into account different proportions of unit packets, as well as other technical specifications and requirements;

7) in the case of unit packets of cigarettes, respect the following dimensions: height - not less than 44 mm, width - not less than 52 mm.

2. Each set of pictorial warnings, approved by the Government of the Republic of Lithuania or an institution authorised by it, shall be used in a given year and rotated on an annual basis. The first set must be used in 2016, the second – in 2017, the third – in 2018, and again the first – in 2019, etc. Manufacturers of tobacco products must use their best efforts that each pictorial warning of a set available for use in a given year is displayed to the extent possible in equal numbers on each brand of tobacco products.

3. The content and procedure of presentation of the smoking cessation information referred to in point 2 of paragraph 1 of this Article shall lay down by the Government of the Republic of Lithuania or an institution authorised by it.

Article 84 Labelling of Tobacco Products for Smoking other than Cigarettes, Roll-your-own Tobacco and Waterpipe Tobacco

1. Tobacco products for smoking other than cigarettes, roll-your-own tobacco and waterpipe tobacco may be exempted from the obligations to carry the information message laid down in Article 82(2) of this Law and the combined health warnings laid down in Article 83 of this Law. In addition to the general warning provided for in Article 82(1) of this Law, each unit packet and any outside packaging of such products shall carry one of the text warnings listed in Annex I to this Law. The general warning specified in Article 82(1) of this Law shall include a reference to the cessation services referred to in Article 83(3) of this Law.

2. The general warning must appear on the most visible surface of the unit packet and any outside packaging. Manufactures of tobacco products referred to in this Article must use their best efforts that each text warning is displayed to the extent possible in equal numbers on each brand of these products. The text warnings must appear on the next most visible surface of the unit packet and any outside packaging. For unit packets with a hinged lid, the next most visible surface is the one that becomes visible when the packet is open.

3. The general warning referred to in paragraph 1 of this Article must cover 30 % of the relevant surface of the unit packet and any outside packaging.

4. The text warning referred to in paragraph 1 of this Article must cover 40 % of the relevant surface of the unit packet and any outside packaging.

5. Where the health warnings referred to in paragraph 1 of this Article are to appear on a surface exceeding 150 cm2, the warnings shall cover an area of 45 cm2.

6. The health warnings referred to in paragraph 1 of this Article must comply with the requirements specified in Article 82(7) of this Law. The text of the health warnings shall be parallel to the main text on the surface reserved for these warnings. The health warnings shall be surrounded by a black border of a width of not less than 3 mm and not more than 4 mm. This border must appear outside the surface reserved for the health warnings.

Article 85 Labelling of Smokeless Tobacco Products

1. Each unit packet and any outside packaging of smokeless tobacco products shall carry the following health warning: ‘This tobacco product damages your health and is addictive.’

2. The health warning referred to in paragraph 1 of this Article shall comply with the requirements specified in Article 82(7) of this Law. The text of the health warnings shall be parallel to the main text on the surface reserved for these warnings.

3. The health warning referred to in paragraph 1 of this Article must:

1) appear on the two largest surfaces of the unit packet and any outside packaging;

2) cover 30 % of the surfaces of the unit packet and any outside packaging.

Article 86 Presentation of Tobacco Products

1. The labelling of unit packets and any outside packaging and the tobacco product itself must not include any element or feature that:

1) promotes a tobacco product or encourages its consumption by creating an erroneous impression about its characteristics, health effects, risks or emissions; labels shall not include any information about the nicotine, tar or carbon monoxide content of the tobacco product;

2) suggests that a particular tobacco product is less harmful than others or aims to reduce the effect of some harmful components of smoke or has vitalising, energetic, healing, rejuvenating, natural, organic properties or has other health or lifestyle benefits;

3) refers to taste, smell, any flavourings or other additives or the absence thereof;

4) resembles a food or a cosmetic product;

5) suggests that a certain tobacco product has improved biodegradability or other environmental advantages.

2. The unit packets and any outside packaging must not suggest economic advantages by including printed vouchers, offering discounts, free distribution, two-for-one or other similar offers.

3. The elements and features that are prohibited pursuant to paragraphs 1 and 2 of this Article may include but are not limited to texts, symbols, names, trademarks, figurative or other signs.

Article 87 Appearance and Content of Unit Packets

1. Unit packets of cigarettes must have a cuboid shape. The health warning on a unit packet of a cuboid shape with rounded or bevelled edges must cover a surface area that is equivalent to that on a unit packet without such edges. Unit packets of roll-your-own tobacco shall have a cuboid or cylindrical shape, or the form of a pouch. A unit packet of roll-your-own tobacco must contain tobacco weighing not less than 30 g.

2. A unit packet of cigarettes may consist of carton or soft material and shall not have an opening that can be re-closed or re-sealed after it is first opened, other than the flip-top lid and shoulder box with a hinged lid. For packets with a flip-top lid and hinged lid, the lid shall be hinged only at the back of the unit packet.

Article 9. Reporting of Manufacturers and/or Importers of Tobacco Products about Ingredients and Emissions of Tobacco Products

1. Manufacturers and/or importers of tobacco products must submit to the Drug, Tobacco and Alcohol Control Department in accordance with the procedure laid down by the Government the following information, the format of which is laid down by the European Commission, by brand name or type:

1) a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products (hereinafter: a ‘list’), in descending order of the weight of each ingredient included in the tobacco products. The list must specify whether the said ingredients of the tobacco products have been registered under Regulation (EC) No 1907/2006 and whether they have been classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1). The list shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in the tobacco products concerned, the toxicological data regarding the ingredients in burnt or unburnt form, as appropriate, referring to their effects on the health of consumers and to any addictive effects;

2) the emission levels from cigarettes referred to in Article 4(2) of this Law;

3) where available, information on emissions from cigarettes other than the emissions referred to in Article 4(2) of this Law and on emissions from tobacco products other than cigarettes as well as the methods of measurements of emissions used;

4) sales volumes per brand and type, reported in sticks or kilograms, starting from 1 January 2015;

5) internal and external studies available to them on market research and preferences of various consumer groups, including young people and current smokers, relating to ingredients and emissions, as well as executive summaries of any market surveys they carry out when launching new products.

2. Manufacturers or importers of tobacco products must inform the Drug, Tobacco and Alcohol Control Department, if the composition of a product is modified in a way that affects the information provided in accordance with the requirements referred to in paragraph 1 of this Article.

3. For a new or modified tobacco product the information required under this Article shall be submitted to the Drug, Tobacco and Alcohol Control Department prior to the placing on the market of that product.

4. Manufacturers and importers of cigarettes and roll-your-own tobacco must, prior to the placing on the market of such products, submit to the Drug, Tobacco and Alcohol Control Department a technical document setting out a general description of the additives used and their properties and indicating the used methods of measurement of emissions other than tar, nicotine and carbon monoxide emissions.

5. The information submitted in accordance with paragraphs 1, 2 and 4 of this Article shall be made publicly available on the website of the Drug, Tobacco and Alcohol Control Department. The Drug, Tobacco and Alcohol Control Department must protect commercial (trade) secrets when making that information publicly available.

6. When submitting the information pursuant to paragraphs 1, 2 and 4 of this Article, manufacturers and importers of tobacco products must not only specify the information which they consider to constitute a commercial (trade) secret but also substantiate this fact.

7. All information to be provided under this Article shall be provided and stored in electronic form at the Drug, Tobacco and Alcohol Control Department which must ensure that the confidential information specified by the manufacturers and importers of the tobacco products would not be disclosed, with the exception of the cases where law-enforcement bodies and other institutions are entitled under legal acts to obtain access to that information; the said Department must also ensure that the European Commission and other Member States of the European Union have access to the stored information in accordance with the procedure laid down by the adopted decisions.

8. Manufacturers and importers of cigarettes and roll-your-own tobacco containing an additive that is included in priority list of additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations laid down by Commission implementing decision (EU) 2016/787 of 18 May 2016 must carry out comprehensive studies, which shall examine for each additive whether it:

1) contributes to the toxicity or addictiveness of the tobacco products concerned, and whether this has the effect of increasing the toxicity or addictiveness of any of the products concerned to a significant or measurable degree;

2) results in a characterising flavour of the tobacco products concerned;

3) facilitates inhalation or nicotine uptake;

4) leads to the formation of substances that have CMR properties, the quantities thereof, and whether this has the effect of increasing the CMR properties in any of the tobacco products concerned to a significant or measurable degree.

9. When carrying out the studies referred to in paragraph 8 of this Article account must be taken of the intended use of the tobacco products containing the additives included in the list specified in paragraph 8 of this Article and the emissions resulting from the combustion process involving the additive included in the said list shall be examined in particular. The studies must also examine the interaction of that additive with other ingredients contained in the tobacco products concerned. Manufacturers and importers using the same additive in their tobacco products may carry out a joint study when using that additive in a comparable product composition.

10. Manufacturers or importers must submit to the European Commission a report, and to the Drug, Tobacco and Alcohol Control Department a copy of a report, on the results of the mandatory studies referred to in paragraph 8 of this Article; that report must be submitted at the latest 18 months after the additive concerned has been included in the list specified in paragraph 8 of this Article. The said report shall include an executive summary, and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive.

11. The European Commission and the Drug, Tobacco and Alcohol Control Department shall have the right to request that manufacturers and importers, when submitting information as set out in paragraph 1 of this Article, submit supplementary information regarding the additive concerned. This supplementary information shall form part of the report.

Article 91. Reports on Manufacture and Sales of Tobacco Products

1. Manufacturers of tobacco products must, every quarter before the tenth day of the first month of the next quarter, submit in accordance with the procedure laid down by an institution authorised by the Government of the Republic of Lithuania a quarterly report on manufacture and sales of tobacco products to the Drug, Tobacco and Alcohol Control Department.

2. Legal persons and branches of foreign legal persons established in the Republic of Lithuania which have a tobacco products wholesale licence must, every quarter before the tenth day of the first month of the next quarter, submit in accordance with the procedure laid down by an institution authorised by the Government of the Republic of Lithuania a quarterly report on sales of tobacco products to the Drug, Tobacco and Alcohol Control Department.

CHAPTER TWO

REQUIREMENTS FOR THE CONTENT, QUALITY AND LABELLING OF ELECTRONIC CIGARETTES, REFILL CONTAINERS OR

HERBAL PRODUCTS FOR SMOKING, AND FOR THE PROVISION OF INFORMATION ABOUT ELECTRONIC CIGARETTES, REFILL CONTAINERS, HERBAL PRODUCTS FOR SMOKING AND NOVEL TOBACCO PRODUCTS

Article 92 General Requirements for the Content and Quality of Electronic Cigarettes and Refill Containers

1. Electronic cigarettes and refill containers are only placed on the market if they comply with the requirements laid down in this Law and other legal acts, except electronic cigarettes and refill containers which are entered on the Register of Medicinal Products of the Republic of Lithuania in a prescribed manner.

2. Electronic cigarettes and refill containers which are being placed on the market must comply with the following requirement:

1) nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml;

2) the nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml;

3) except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form;

4) electronic cigarettes deliver the nicotine doses at consistent levels under normal conditions of use;

5) electronic cigarettes and refill containers are child- (including warnings about health risks of electronic cigarettes for children or need to keep them out of reach of children, more sophisticated activation mechanism or other means restricting the use of electronic cigarettes by children, etc.) and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage. A refill mechanism must comply with the requirements laid down by Commission implementing decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes (OJ 2016 L 101, p. 15).

3. Only ingredients of high purity shall be used in the manufacture of the nicotine-containing liquid. Substances other than the ingredients of a product concerned (by brand name or type) and emissions resulting from the use of the product may be only present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture.

4. It shall be prohibited to place on the market electronic cigarettes and refill containers containing the following additives in nicotine-containing liquid:

1) vitamins or other additives that create the impression that electronic cigarettes and refill containers have a health benefit or presents reduced health risks;

2) caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality;

3) additives having colouring properties for emissions;

4) additives that have CMR properties in unburnt form.

Article 93 Notification of Placing on the Market of Electronic Cigarettes and Electronic Containers

1. Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the Drug, Tobacco and Alcohol Control Department in accordance with the procedure laid down by the Government of the Republic of Lithuania of any such products which they intend to place on the market. The notification shall be submitted in electronic form six months before the intended first placing on the market of electronic cigarettes and refill containers of each brand name and type. For electronic cigarettes and refill containers already placed on the market on 20 May 2016, the notification shall be submitted within six months of that date. A new notification shall be submitted for each substantial modification of the electronic cigarette and refill container.

2. The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:

1) the trade name or name, surname and contact details of the manufacturer, a responsible legal or natural person within the European Union, and, if applicable, the importer into the European Union;

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;

3) 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;

4) information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;

5) a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;

6) 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 this Law;

7) 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.

3. Where the Drug, Tobacco and Alcohol Control Department considers that the information submitted is incomplete, it shall be entitled to request the completion of the information concerned.

4. The information submitted in accordance with this Article shall be made publicly available on the website of the Drug, Tobacco and Alcohol Control Department. The need to protect trade secrets must be duly taken into account when making that information publicly available.

Article 94 Labelling Requirements for Electronic Cigarettes and Refill Containers Intended to be Sold in the Republic of Lithuania

1. Unit packets of electronic cigarettes and refill containers must include a leaflet with information on:

1) instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers;

2) contra-indications;

3) warnings for specific risk groups;

4) possible adverse effects;

5) addictiveness and toxicity; and

6) contact details of the manufacturer or importer and a legal or natural contact person within the European Union.

2. Unit packets or any outside packaging of electronic cigarettes and refill containers must include a list of all ingredients contained in the product in descending order of the weight, and an indication of the nicotine content of the product and the delivery per dose, the batch number and a recommendation to keep the product out of reach of children.

3. Without prejudice to paragraph 2 of this Article, the labelling of unit packets or any outside packaging of electronic cigarettes and refill containers shall not include any element or feature that:

1) promotes such products or encourages their consumption by creating an erroneous impression about their characteristics, health effects, risks or emissions;

2) suggests that a particular product is less harmful than others or has vitalising, energetic, healing, rejuvenating, natural, organic properties or has other health or lifestyle benefits;

3) refers to taste, smell, any flavourings or other additives or the absence thereof;

4) resembles a food or a cosmetic product;

5) suggests that a certain product has improved biodegradability or other environmental advantages.

4. The unit packets and any outside packaging must not suggest economic advantages by including printed vouchers, offering discounts, free distribution, two-for-one or other similar offers.

5. The elements and features that are prohibited pursuant to paragraphs 3 and 4 of this Article may include but are not limited to texts, symbols, names, trademarks, figurative or other signs.

Article 95 Health Warnings

1. Unit packets or any outside packaging of electronic cigarettes and refill containers must carry the following health warnings: ‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers’.

2. A health warning must:

1) be printed in black Helvetica bold type on a white background;

2) at the centre of the surface reserved for it, and on cuboid packets and any outside packaging, be parallel to the lateral edge of the unit packet or of the outside packaging;

3) on the surface reserved for the health warning, be parallel to the main text and appear on the two largest surfaces of the unit packet and any outside packaging;

4) on the surface reserved for the health warning, cover over 30 % of the surfaces of the unit packet and any outside packaging.

Article 96 Notification of Sales of Electronic Cigarettes and Refill Containers

1. Manufacturers and importers of electronic cigarettes and refill containers shall submit, annually and in accordance with the procedure laid down by the Government of the Republic of Lithuania, a notification to the Drug, Tobacco and Alcohol Control Department containing the following:

1) comprehensive 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 current users;

3) the mode of sale of the products;

4) executive summaries of any market surveys carried out in respect of the information specified in this paragraph, including an English translation thereof.

2. The Drug, Tobacco and Alcohol Control Department shall monitor, in accordance with the procedure laid down by legal acts, the market developments concerning electronic cigarettes and refill containers, including any evidence that their use is a gateway to nicotine addiction and ultimately traditional tobacco consumption among young people and non-smokers.

Article 97 Recognition of Electronic Cigarettes and Refill Containers as Not Conforming to Statutory Requirements for Labelling, Content and Quality

1. The State Consumer Rights Protection Authority shall supervise the conformity of labelling, content and quality of electronic cigarettes and refill containers to the requirements set out by legal acts.

2. Manufacturers, importers and distributors of electronic cigarettes and refill containers must collect and accumulate information about all of the suspected adverse effects on human health of electronic cigarettes and refill containers.

3. Any of the manufactures, importers or distributors of electronic cigarettes and refill containers shall immediately take the corrective action necessary to bring the product concerned into conformity with the requirements of this Law, to withdraw or to recall it, and perform other duties related to the product safety within their remit laid down in the Law of the Republic of Lithuania on Product Safety. In such cases the manufactures, importers or distributors shall also be required to immediately inform the State Consumer Rights Protection Authority, giving details, in particular, of the risk to human health and safety and of any corrective action taken, and of the results of such corrective action. The procedure for communicating such information shall be laid down by the State Consumer Rights Protection Authority.

4. The Government of the Republic of Lithuania may also request additional information from the manufactures, importers or distributors of electronic cigarettes and refill containers.

Article 98 Interim Measures

In the case of electronic cigarettes and refill containers that comply with the requirements of this Law, where an institution authorised by the Government of the Republic of Lithuania ascertains in accordance with the procedure laid down by legal acts or has reasonable grounds to believe that specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container, could present a serious risk to human health, it may temporarily prohibit in accordance with the procedure laid down by legal acts the placing on the market of the said electronic cigarettes or refill containers or take other restrictions on the marketing laid down in the Law of the Republic of Lithuania on Product Safety. An institution authorised by the Government of the Republic of Lithuania shall immediately inform in accordance with the procedure laid down by legal acts the European Commission and the competent authorities of the contracting parties to the Agreement on the European Economic Area of the measures taken and shall communicate any supporting data.

Article 99 Labelling of Herbal Products for Smoking

1. Each unit packet and any outside packaging of herbal products for smoking shall carry the following health warning: ‘Smoking this product damages your health.’

2. The health warning shall be printed on the front and back external surface of the unit packet and on any outside packaging.

3. The health warning shall comply with the requirements set out in Article 82(7) of this Law. It must cover 30 % of the area of the corresponding surface of the unit packet and of any outside packaging.

4. Unit packets and any outside packaging of herbal products for smoking must not include any of the elements or features set out in points 1, 2 and 4 of Article 86(1) of this Law and shall not state that the product is free of additives or flavourings.

Article 910 Reporting of Ingredients of Herbal Products for Smoking

1. Manufacturers and importers of herbal products for smoking must submit to the Drug, Tobacco and Alcohol Control Department in accordance with the procedure laid down by it a list (by brand name and type of each herbal product for smoking) of all ingredients, and quantities thereof that are used in the manufacture of the products placed on the market of the Republic of Lithuania. The said manufacturers and importers must also inform the Drug, Tobacco and Alcohol Control Department when the composition of a product is modified in a way that affects the information submitted pursuant to this Article.

2. The information required under paragraph 1 of this Article must be submitted prior to the placing on the market of a new or modified herbal product for smoking.

3. The information submitted in accordance with this Article (except the information specified by the manufacturers and importers which they consider to constitute a commercial (trade) secret) shall be made publicly available on the website of the Drug, Tobacco and Alcohol Control Department. Manufacturers and importers of herbal products for smoking, when submitting information under paragraphs 1 and 2 of this Article, must specify exactly which information they consider to constitute a commercial (trade) secret and substantiate this fact.

Article 911. Notification of Novel Tobacco Products

1. Manufacturers and importers of novel tobacco products must submit in accordance with the procedure laid down by the Government of the Republic of Lithuania a notification to the Drug, Tobacco and Alcohol Control Department of any such product they intend to place on the market of the Republic of Lithuania.

2. The notification referred to in paragraph 1 of this Article shall be submitted in electronic form six months before the intended placing on the market. It shall be accompanied by a detailed description of the novel tobacco product concerned as well as instructions for its use and information on ingredients and emissions in accordance with Article 9(1) of this Law.

3. The manufacturers and importers of novel tobacco products submitting a notification of a novel tobacco product shall also provide the Drug, Tobacco and Alcohol Control Department with:

1) available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular as regards its ingredients and emissions, specifying effects on human health when consuming the novel tobacco product as intended and taking into account clinical trials regarding safety or harmfulness of the product compared with other tobacco products placed on the market;

2) available studies, executive summaries thereof and market research on the preferences of various consumer groups, including young people and current smokers;

3) other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.

4. Manufacturers and importers of novel tobacco products, when placing such products on the market, must transmit to the Drug, Tobacco and Alcohol Control Department any new (not covered previously) or updated information on the studies, research and other information referred to in paragraph 3.

5. Statements and information communicated to consumers concerning a novel tobacco product must be scientifically justified, objective and not misleading, therefore, the Drug, Tobacco and Alcohol Control Department may require manufacturers or importers of novel tobacco products to carry out additional tests or submit additional information.

6. In cases where the use of additives in a novel tobacco product results in a characterising flavour of that tobacco product, such additives may not increase toxicity of aerosols of the tobacco product concerned. Moreover, such a novel tobacco product, each unit packet or any outside packaging thereof or any other information provided to consumers about the novel tobacco product may not resemble and be described by the words which are or may be linked to candies, sweets, children’s toys, cartoon characters or any other type of information promoting interests of minors in novel tobacco products or their consumption.

7. Manufacturers and importers, when transmitting information pursuant to the requirements laid down by this Article about a novel tobacco product, must specify where this tobacco product is smokeless or for smoking.

CHAPTER III

STATE LEGAL REGULATION OF ECONOMIC ACTIVITIES RELATED TO TOBACCO AND TOBACCO PRODUCTS AS WELL AS RELATED PRODUCTS

SECTION ONE

LICENSING OF TYPES OF ACTIVITY

Article 10. Licensing of Types of Activity and Types of Licence

1. The manufacture, wholesale and retail sale of tobacco products shall be allowed in the Republic of Lithuania only after a licence issued in the prescribed manner has been obtained.

2. Repealed as of 1 January 2016.

3. Following this Law, the Civil Code of the Republic of Lithuania and other legal acts the Government of the Republic of Lithuania shall approve the rules for licensing the activities specified in paragraph 1 of this Article.

Article 11. Issue of Licences, Refusal to Issue a Licence, Suspension of a Licence, Withdrawal of a Licence

1. A tobacco products manufacture licence and a tobacco products wholesale licence may be issued to legal persons and branches of foreign legal persons established in the Republic of Lithuania. Tobacco products retail licence may be issued to legal persons and branches of foreign legal persons established in the Republic of Lithuania, legal persons or other organisations and their branches established in other contracting parties to the Agreement on the European Economic Area (hereinafter collectively: ‘legal persons and branches of foreign legal persons’).

2. Licences referred to in paragraph 1 of this Article shall be issued to legal persons and branches of foreign legal persons, provided that they meet the following requirements:

1) they have no tax arrears to the state budget of the Republic of Lithuania, municipal budgets or the funds, the taxes paid whereto are administered by the State Tax Inspectorate (except for the cases of deferral of the payment of taxes, interest, fines in accordance with the procedure established by legal acts of the Republic of Lithuania or a tax dispute is held in relation to these taxes, interest, fines);

2) have no arrears to the budget of the State Social Insurance Fund;

3) there is no effective judgment of conviction, court ruling or order, an effective relevant decision issued by the customs, the State Tax Inspectorate, the police, the State Non Food Products Inspectorate under the Ministry of Economy (hereinafter: the ‘the Inspectorate’) or the Drug, Tobacco and Alcohol Control Department regarding the imposition of a penalty or a fine for the contraband of tobacco products, the sale, storage or shipment of counterfeit tobacco products, the sale, storage or shipment of tobacco products without legally valid documents certifying the purchase thereof and also for the illegal storage, shipment or sale of tobacco products without special labels (tax stamps) or not less than five years have lapsed from the date when the said judgment of conviction, court ruling or order, decision issued by the customs, the State Tax Inspectorate, the police, the Inspectorate or the Drug, Tobacco and Alcohol Control Department became effective – in respect of the legal person, branch of the foreign legal person or their heads;

4) heads of the legal person or branch of the foreign legal person are not/were not the heads or other employees of the legal person or branch of the foreign legal person where they acted on behalf or in the interests of the legal person or branch of the foreign legal person at the time when the licence held by the legal person or branch of the foreign legal person has been withdrawn on the grounds laid down in point 3 of paragraph 15, point 4 of paragraph 16 of this Article or Article 26(5) of this Law, and where the licence was withdrawn – not less than five years have lapsed from the date when the judgment of conviction, court ruling or order specified in point 3 of paragraph 2 of this Article became effective;

5) the licence has not been withdrawn for the legal person or branch of the foreign legal person over the last five years on the grounds laid down in point 3 of paragraph 15, point 4 of paragraph 16 of this Article or paragraph 5 of Article 26 of this Law;

6) the licence has not been withdrawn for the legal person or branch of the foreign legal person over the past year on the grounds laid down in point 5 of paragraph 15 or point 4 of paragraph 16 of this Article;

7) the tobacco products retail licence has not been withdrawn for the legal person or branch of the foreign legal person over the last three years for the violation of the requirements of Article 14(5)(3) of this Law in the sales outlet for which the licence is applied for;

8) wholesale trade in tobacco products will be carried out and/or tobacco products will be stored in tobacco products warehouses (this provision applies in cases where a legal person or branch of a foreign legal person established in the Republic of Lithuania applies for a tobacco products wholesale licence);

9) possess a document issued by the Service confirming that the quality indicators of tobacco products intended to be manufactured are in compliance with the safety and quality indicators set out by legal acts of the Republic of Lithuania (this provision applies in cases where a legal person or branch of a foreign legal person established in the Republic of Lithuania applies for a tobacco products manufacture licence);

10) the legal person or branch of the foreign legal person ensures that a sales outlet in which retail trade in tobacco products is intended to be carried out as well as a method of such trade have been chosen without prejudice to the prohibitions and restrictions specified in Article 15 of this Law (this provision applies in cases where a legal person or branch of a foreign legal person established in the Republic of Lithuania applies for a tobacco products retail licence).

3. The Drug, Tobacco and Alcohol Control Department shall, pursuant to the licensing rules approved by the Government of the Republic of Lithuania, issue a tobacco products wholesale licence and a tobacco products manufacture licence, warn of a possible suspension or withdrawal of such licences, suspend a licence concerned, lift the suspension of the licence or withdraw the licence.

4. The executive body of the municipality in the territory of which a legal person or branch of a foreign legal person will engage (engages) in the retail trade in tobacco products shall, acting in compliance with the licensing rules approved by the Government of the Republic of Lithuania, issue a tobacco products retail licence (including the retail trade in tobacco products in mobile shops), warn about a possible suspension or withdrawal of the licence, suspend the licence, lift the suspension of the licence or withdraw the licence; a licence to engage in retail trade in tobacco products in passenger vehicles by which a legal person or branch of a foreign legal person provides services of passenger transport by aircraft, vessels or railway vehicles (hereinafter: ‘vehicles intended for the carriage of passengers’) shall be issued by the executive body of the municipality locating the head office of a legal person or branch of a foreign legal person established in the Republic of Lithuania who wishes to engage (is engaged) in the retail trade in tobacco products in vehicles intended for the carriage of passengers.

5. Licences shall be issued for an indefinite period.

6. The Drug, Tobacco and Alcohol Control Department shall coordinate and monitor licensing procedures in municipalities.

7. A tobacco products manufacture licence or a tobacco products wholesale licence must be issued to a legal person or branch of a foreign legal person established in the Republic of Lithuania who wishes to obtain such a licence or a written reasoned refusal to issue the visa concerned must be presented to it not later than within 30 days from the receipt by a licensing authority of a licence application and all properly executed documents necessary to issue a licence. If during the said period the licensing authority does not issue a licence to the legal person or branch of the foreign legal person established in the Republic of Lithuania and does not produce a written reasoned refusal to issue the licence concerned it shall be deemed that the licence has been issued.

8. Tobacco products manufacture licences or tobacco products wholesale licences shall not be issued if:

1) not all the documents required for the issuance of the licence are submitted, and a legal person or a branch of a foreign legal person established in the Republic of Lithuania fails to meet the requirement of the licensing authority to submit the missing documents within the time limit set by the licensing authority which may not be less than five working days from the receipt of the notification of the licensing authority regarding the missing documents;

2) the submitted documents necessary for the issuance of the licence are incomplete or incorrectly filled out and a legal person or a branch of a foreign legal person established in the Republic of Lithuania fails to meet the requirement of the licensing authority to correct shortcomings within the time limit set by the licensing authority which may not be less than five working days from the receipt of the notification of the licensing authority regarding the shortcomings of the documents;

3) a legal person or a branch of a foreign legal person established in the Republic of Lithuania does not meet at least one requirement specified in points 1-6 of paragraph 2, point 8 (if the tobacco products wholesale licence is requested) or point 9 (if the tobacco products manufacture licence is requested) of this Article;

4) a legal person or a branch of a foreign legal person established in the Republic of Lithuania has failed to meet the requirements set out in the Law of the Republic of Lithuania on Fees and Charges.

9. It shall be considered that a tobacco products retail licence is issued on the day following the submission by a legal person or a branch of a foreign legal person of the notification about the intent to engage in the retail sale of tobacco products (hereinafter: a ‘notification’) to the executive authority of the municipality in whose territory this activity is intended to be carried out, and in the case of retail sale of tobacco products in vehicles used for the carriage of passengers - following the submission of the notification to the executive authority of the municipality in whose territory the head office of a legal person or a branch of a foreign legal person established in the Republic of Lithuania, wishing to engage in (engaged in) retail sale of tobacco products in vehicles used for the carriage of passengers, is located. Where the notification of a legal person or a branch of a foreign legal person specifies the date from which the launch of retail sale of tobacco products is expected and this date is later than the day following the submission of the notification, the licence shall be considered to have been issued on the date specified in the notification. Upon receiving the notification, the licensing authority must, not later than within five days from the submission of the notification, verify whether a legal person or a branch of a foreign legal person meets the requirements set out in points 5-7 and 10 of paragraph 2 of this Article and has fulfilled the requirements set out in the Law of the Republic of Lithuania on Fees and Charges, and, not later than within 20 days, must verify whether the legal person or the branch of the foreign legal person meets the requirements set out in points 1-4 of paragraph 2 of this Article.

10. A legal person or a branch of a foreign legal person must declare in the notification that it meets each of the requirements set out in points 1-7 and Item 10 of paragraph 2 of this Article and has fulfilled the requirements set out in the Law of the Republic of Lithuania on Fees and Charges. Where the notification is submitted by a legal person or any other organisation or its branch established in any other contracting party to the Agreement on the European Economic Area, the information declared in the notification that there is no effective judgment of conviction, court ruling or order, referred to in point 3 of paragraph 2 of this Article, regarding the imposition of a penalty or a fine on the legal person or any other organisation or its branch, or the heads thereof must be accompanied by the document which confirms this and which is issued by a competent authority of that contracting party to the Agreement on the European Economic Area in which the legal person or any other organisation or its branch, intending to engage in retail sale of tobacco products in the Republic of Lithuania, is established. In cases where there is an effective judgment of conviction, court ruling or order, referred to in point 3 of paragraph 2 of this Article, the date of its coming into effect must be specified in the document issued by the competent authority.

11. A legal person or a branch of a foreign legal person shall be warned about the possible suspension of the relevant licence where:

1) it transpires that the inaccurate data has been submitted for the issuance of a tobacco products manufacture licence or a tobacco products wholesale licence;

2) the legal person or the branch of the foreign legal person holding the tobacco products manufacture licence, tobacco products wholesale licence and/or tobacco products retail licence violates the requirements referred to in points 5, 6 and/or 7 of Article14(3) of this Law;

3) it transpires that the legal person or the branch of the foreign legal person which was granted the tobacco products retail licence has not been carrying out such activities for more than one year and has not applied to the licensing authority for the suspension or withdrawal of the licence within the time limit set in Article 12(9) of this Law.

12. A legal person or a branch of a foreign legal person shall be warned about the possible withdrawal of the licence where following a change of the head of the legal person or the branch of the foreign legal person it transpires that the head of the legal person or the branch of the foreign legal person fails to meet the provisions laid down in points 3 and/or 4 of paragraph 2 of this Article.

13. The licence shall be suspended where a legal person or a branch of a foreign legal person:

1) submits an application for the suspension of the licence;

2) submits an application for removal of the address of the tobacco products warehouse from the tobacco products wholesale licence and the licence contains no other addresses of tobacco products warehouses;

3) has been warned about the possible suspension of the licence pursuant to points 1 and/or 2 of paragraph 11 of this Article and has failed to eliminate the specified breaches and to inform the licensing authority of the elimination of the said breaches within the time limit set by the licensing authority which may not be less than 10 days and no more than 30 days from the receipt of the notification of the licensing authority regarding the warning about the possible suspension of the licence;

4) has been warned about the possible suspension of the licence pursuant to point 3 of paragraph 11 of this Article and has failed to inform the licensing authority that it resumed its activities within the time limit set by the licensing authority which may not be less than 10 days and no more than 30 days from the receipt of the warning of the licensing authority regarding the possible suspension of the licence;

5) submits the notification which does not comply with the requirements for the contents of the notification laid down in paragraph 10 of this Article.

14. The suspension of the licence shall be removed where a legal person or a branch of a foreign legal person:

1) whose licence was suspended pursuant to point 1 of paragraph 13 of this Article, has submitted an application for the removal of the suspension of the licence;

2) whose licence was suspended pursuant to point 2 of paragraph 13 of this Article, has submitted an application for an entry of a new address of the tobacco products warehouse on the tobacco products wholesale licence;

3) whose licence was suspended pursuant to points 3 and/or 5 of paragraph 13 of this Article, has eliminated the specified breaches which lead to the suspension of the licence and informed the licensing authority about the elimination thereof within the time limit set by the licensing authority;

4) whose licence was suspended pursuant to point 4 of paragraph 13 of this Article, has resumed its activities and informed the licensing authority thereof.

15. The tobacco products manufacture licence or the tobacco products wholesale licence shall be withdrawn:

1) if a legal person or a branch of a foreign legal person established in the Republic of Lithuania submits an application for withdrawal of the licence;

2) if it transpires that a legal person established in the Republic of Lithuania is being or has been wound up or a branch of a foreign legal person is completing or has ceased its activities and have been removed from the Register of Legal Entities;

3) if there is an effective judgment of conviction, court ruling or order, decision issued by the customs, the State Tax Inspectorate, the police, the Inspectorate or the Drug, Tobacco and Alcohol Control Department, referred to in point 3 of paragraph 2 of this Article, in respect of a legal person or a branch of a foreign legal person or their heads or other employees (who have acted in the name or the interest of the legal person or the branch of the foreign legal person) and less than five years have lapsed from the date when they became effective;

4) on the grounds established in Article 26(5) of this Law;

5) if a legal person or a branch of a foreign legal person established in the Republic of Lithuania which has been warned about the possible withdrawal of the licence or whose licence was suspended has failed to eliminate the specified breaches and to inform the licensing authority of the elimination of the said breaches within the time limit set by the licensing authority which may not be less than 10 days and no more than 30 days from the receipt of the notification of the licensing authority regarding the warning about the possible withdrawal of the licence.

16. The tobacco products retail licence shall be withdrawn:

1) if a legal person or a branch of a foreign legal person failed to meet the provisions laid down in points 1-7 and/or 10 of paragraph 2 of this Article at the time of the submission of the notification to the licensing authority as referred to in paragraph 9 of this Article;

2) if a legal person or a branch of a foreign legal person submits an application for withdrawal of the licence;

3) if a legal person is being or has been wound up or a branch of a foreign legal person is completing or has ceased its activities and have been removed from the Register of Legal Entities;

4) if there is an effective judgment of conviction, court ruling or order, decision issued by the customs, the State Tax Inspectorate, the police, the Inspectorate or the Drug, Tobacco and Alcohol Control Department, referred to in point 3 of paragraph 2 of this Article, in respect of a legal person or a branch of a foreign legal person or their heads or other employees (who have acted in the name or the interest of the legal person or the branch of the foreign legal person);

5) on the grounds established in paragraphs 5 and 7 of Article 26 of this Law;

6) if a legal person or a branch of a foreign legal person which has been warned about the possible withdrawal of the licence pursuant to paragraph 12 of this Article or whose licence was suspended pursuant to point 3 of paragraph 13 of this Article has failed to eliminate the specified breaches and to inform the licensing authority of the elimination of the said breaches within the time limit set by the licensing authority which may not be less than 10 days and no more than 30 days from the receipt of the notification of the licensing authority regarding the warning about the possible withdrawal of the licence;

7) where a legal person or any other organisation or its branch established in any other contracting party to the Agreement on the European Economic Area has failed to substantiate the claim that there is no effective judgment of conviction, court ruling or order referred to in point 3 of paragraph 2 of this Article regarding the imposition of a penalty or a fine on the legal person or any other organisation or its branch, or the heads thereof.

17. The licensing authority must suspend the licence, revoke the suspension of the licence or withdraw the licence and inform the licence holder about the suspension of the licence, the revocation of the suspension of the licence or the withdrawal of the licence not later than within five days from the emergence of the circumstances referred to in paragraphs 13, 14, 15 or 16 of this Article.

18. The licences shall be clarified and copies of the licences in paper format shall be issued based in accordance with the procedure laid down in the licensing rules approved by the Government of the Republic of Lithuania. The licensing authority shall clarify the licences and issue copies the licences in paper format.

Article 12. Conditions of Licensed Activities

1. Holders of the tobacco products manufacture licence, holders of tobacco products wholesale licence or holders of tobacco products retail licence shall be prohibited from authorising or transferring under a contract to other persons the right to engage in the activities indicated in their licences.

2. The tobacco products manufacture licence shall also grant the right to the holders of such licence to engage in the wholesale of products manufactured by them.

3. Holders of the tobacco products retail licence shall be permitted to purchase tobacco products in the Republic of Lithuania only from holders of the tobacco products manufacture licence or holders of the tobacco products wholesale licence; this provision shall not prohibit holders of the tobacco products retail licence from importing or bringing in tobacco products from other states for the activity specified in the licence.

4. Holders of the tobacco products wholesale licence shall be permitted to purchase tobacco products in the Republic of Lithuania only from holders of the tobacco products manufacture licence or holders of the tobacco products wholesale licence; this provision shall not prohibit holders of the tobacco products wholesale licence from importing or bringing in tobacco products from other states for the activity specified in the licence.

5. Holders of the tobacco products manufacture licence or holders of the tobacco products wholesale licence in the Republic of Lithuania shall be permitted to sell tobacco products only to holders of the tobacco products retail licence or holders of the tobacco products wholesale licence, to foreign legal persons or their branches which purchase and transport tobacco products from the Republic of Lithuania, as well as foreign diplomatic missions, consular posts or mission of international organisations accredited to the Ministry of Foreign Affairs of the Republic of Lithuania.

6. Repealed as of 1 January 2016.

7. Repealed as of 1 January 2016.

8. Holders of the tobacco products manufacture licence, holders of the tobacco products wholesale licence and holders of the tobacco products retail licence shall be permitted to manufacture, sell and/or store tobacco products only in those premises which are specified in the appropriate licence. Data identifying places of manufacturing, sale and/or storage of tobacco products to be entered in the licence shall be defined by the Government of the Republic of Lithuania in the licensing rules for the relevant type of activities.

9. Holders of the tobacco products retail licence who do not carry out activities indicated in the licence for a period exceeding one year must, not later than within 30 days from the day following one-year inactivity, inform the licensing authority and request the suspension of the licence (the licence shall be suspended for the period specified by its licence holder, or where such period is not specified, it shall be suspended for an unlimited period) or its withdrawal.

CHAPTER TWO

OTHER CHARACTERISTICS OF REGULATION

Article 13. Restrictions on the Assortment of Tobacco Products

The Republic of Lithuania shall prohibit the placing on the market of chewing tobacco, nasal tobacco and tobacco for oral use.

Article 14. Requirements for Selling, Purchasing, Storing and Shipping Tobacco Products

1. It shall be prohibited to sell or store tobacco products without a tobacco products manufacture licence, a tobacco products wholesale licence or a tobacco products retail licence, with the exception of the cases laid down in paragraph 2 of this Article.

2. The requirement laid down in paragraph 1 of this Article to have a licence or a copy of the tobacco products manufacture licence, the tobacco products wholesale licence or the tobacco products retail licence shall not apply where tobacco products are stored or shipped, in possession of required legally binding documents certifying the purchase of tobacco products or the relevant shipment documents, by persons providing shipping services, foreign legal persons or branches thereof carrying tobacco products in transit or delivering them to their branches or representative offices in the Republic of Lithuania or transporting them from the Republic of Lithuania as well as by foreign diplomatic missions, consular posts or mission of international organisations accredited to the Ministry of Foreign Affairs of the Republic of Lithuania.

3. Legal persons and branches of foreign legal persons shall be prohibited from selling, storing or shipping tobacco products in the Republic of Lithuania, and also from importing tobacco products to the Republic of Lithuania:

1) without legally binding documents certifying the purchase or shipment of tobacco products;

2) if such products are counterfeit;

3) if such products are contraband;

4) without special labels – tax stamps – corresponding to the model approved by the Government of the Republic of Lithuania, except where such tax stamps are not mandatory under the Law on Excise Duty and other legal acts of the Republic of Lithuania;

5) if the maximum emission levels for tar, nicotine, carbon monoxide from cigarettes exceed the levels laid down in paragraph 2 of Article 4 of this Law;

6) if the labelling of tobacco products fails to meet the requirements laid down in this Law and other legal acts;

7) if the compliance of tobacco products with the requirements set out in legal acts are not confirmed by the documents and in the manner referred to in paragraph 5 of this Article;

8) in the absence at the sales outlet and/or storing site of tobacco products or during their shipment of a copy of legally binding required documents confirming the purchase or shipment of such tobacco products.

4. Natural persons shall be prohibited from purchasing in the Republic of Lithuania tobacco products which are not labelled with special markings - tax stamps in accordance with the procedure laid down by legal acts. The procedure for storing and shipping tobacco products, applicable to natural persons, shall be laid down by the Government of the Republic of Lithuania or its authorised institution.

5. In addition, it shall be prohibited to sell in the Republic of Lithuania:

1) single cigarettes, cigarillos and papirosas;

2) cigarettes, if less than 20 are contained in a unit packet;

3) tobacco products to persons under 18 years of age. Whenever doubts arise that a person is under 18 years of age, tobacco sellers must request a document certifying the age of the buyer. Where such a person fails to present a document certifying his age, tobacco sellers must refuse to sell him tobacco products.

6. It shall be prohibited to purchase or otherwise transfer tobacco products to persons under 18 years of age.

7. Natural persons, heads of legal persons established in the Republic of Lithuania, heads of foreign legal persons or their branches, or persons authorised by them in charge of the administration of a marketplace must carry out the monitoring of that marketplace (to take all legal and organisational measures) seeking to prevent the sale of tobacco products and/or their transport, storage in the said marketplace without a tobacco products retail licence. Natural persons in charge of the administration of marketplaces, heads of legal persons established in the Republic of Lithuania, heads of foreign legal persons or their branches, or persons authorised by them must, having noticed or suspected that a legal person established in the Republic of Lithuania, a foreign legal person or its branch or a natural person sells, transports and/or stores tobacco products without holding a tobacco products retail licence, report it to the police immediately but not later than on the same working day of the marketplace administered by them.

8. It shall be permitted to sell unprocessed tobacco in the Republic of Lithuania only to holders of a tobacco products manufacture licence and legal persons or branches of foreign legal persons transporting unprocessed tobacco from the Republic of Lithuania.

Article 141 Traceability of Tobacco Products

1. Each unit packet of tobacco products must contain the number or an equivalent of the batch to which the tobacco product belongs, by which the tobacco product, its place and time of manufacturing may be identified. Where the batch number or its equivalent is encrypted and it is impossible to identify the place and/or time of manufacturing of the tobacco product, the manufacturers, importers and those entering tobacco products into the country must supply the institutions referred to in Article 26(13) of this Law with the decryption of these codes. The provisions of this paragraph shall not apply where a unit packet is marked with a unique identifier in accordance with the procedure laid down by paragraph 2 of this Article.

2. Unit packets of tobacco products to be placed on the market must be marked with a unique identifier which would allow to determine the place and time of manufacturing of the tobacco products; the manufacturing facility; the machine used to manufacture the tobacco products; the production shift or time of manufacture; the product description; the intended market of retail sale; the intended shipment route; and, where applicable, the importer into the European Union; the actual shipment route from manufacturing to the first retail outlet, including all warehouses used as well as the shipping date, shipment destination, point of departure and consignee, the identities of all the purchasers from manufacturing to the first retail outlet; the invoices or VAT invoices, order number and payment records of all purchasers from manufacturing to the first retail outlet.

3. All economic operators involved in the trade of tobacco products, from the manufacturer of tobacco products to the last economic operator before the first retail outlet, record the entry of all unit packets into their possession, as well as all intermediate movements and the final exit of the unit packets from their possession. This obligation may be complied with in accordance with the procedure laid down by the institution authorised by the Government of the Republic of Lithuania by the marking and recording of aggregated packaging such as cartons, mastercases or pallets, provided that the tracking and tracing of all unit packets remains possible.

4. Manufacturers and importers of tobacco products must conclude data storage contracts specified in paragraphs 2 and 3 of this Article with a third party independent of the manufacturers and importers of tobacco products, for the purpose of hosting the data storage facility (database) for all relevant data. The data storage facility (as well as electronic equipment for the storage of data) shall be physically located on the territory of the European Union. The suitability of the independent third party, in particular its independence and technical capacities, as well as the data storage contract, shall be approved by the European Commission.

5. Activities of the independent third party referred to in paragraph 4 of this Article shall be monitored by an external auditor, who is proposed and paid by the tobacco manufacturer or importer and approved by the European Commission. The external auditor shall submit an annual report to the institution authorised by the Government of the Republic of Lithuania and to the European Commission, assessing in particular any irregularities in relation to access.

6. The independent third party referred to in paragraph 4 of this Article must grant the institutions referred to in Article 26(13) of this Law, the European Commission and the external auditors access to the data storage facilities. Manufacturers or importers of tobacco products may be granted access to the stored data referred to in paragraphs 2 and 3 of this Article, provided that commercially sensitive information remains adequately protected in conformity with the relevant legal acts of the European Union and the Republic of Lithuania.

Article 15. Restrictions regarding Retail Outlets and Modes of Retail Sale

It shall be prohibited to sell tobacco products in the Republic of Lithuania in the following manner:

1) through automatic vending machines;

2) under distance contracts, including internal and cross-border distance sales of tobacco products;

3) at shops, kiosks and other retail outlets where the proportion of goods intended for children comprise 50 and more percent of the total turnover of retail goods;

4) at pharmacies, health care, educational and cultural establishments, internet cafes (internet clubs, etc.);

5) to persons under 18 years of age.

Article 16. Restrictions on the Sale of Goods to Be Used for Smoking Tobacco Products or Preparing to Smoke Tobacco Products

It shall be prohibited in the Republic of Lithuania to sell goods to be used for smoking tobacco products (or preparing to smoke tobacco products), i.e. pipes, cigarette holders, mouthpieces for pipes, scrapers for pipes, cigarette holders, home cigarette rolling machines, any type of cigarette (smoking) paper (cut or uncut, glued into tips, with or without filters) to persons under 18 years of age.

Article 161. Prohibition on Sales and Use of Electronic Cigarettes and Refill Containers of Electronic Cigarettes in Respect of Minors

1. In the Republic of Lithuania it shall be prohibited to sell electronic cigarettes and refill containers of electronic cigarettes to persons under 18 years of age. Whenever doubts arise that a person is under 18 years of age, Article 14(5)(3) of this Law shall apply.

2. In the Republic of Lithuania person under 18 years of age shall be prohibited to smoke (use) electronic cigarettes and to possess electronic cigarettes or refill containers of electronic cigarettes.

3. It shall be prohibited to purchase or otherwise transfer electronic cigarettes and refill containers of electronic cigarettes to persons under 18 years of age.

Article 162. Prohibition on Distance Sales of Electronic Cigarettes and Refill Containers of Electronic Cigarettes

1. Internal and cross-border distance sales of electronic cigarettes and refill containers of electronic cigarettes shall be prohibited in the Republic of Lithuania.

2. An institution authorised by the Government of the Republic of Lithuania shall cooperate with institutions authorised by the contracting parties to the Agreement on the European Economic Area with the aim of preventing cross-border distance sales of electronic cigarettes and refill containers.

CHAPTER THREE

ADVERTISING, PROMOTION AND SPONSORSHIP OF THE PURCHASE AND/OR CONSUMPTION OF TOBACCO AND RELATED PRODUCTS, \

MEASURES REDUCING THE CONSUMPTION OF

TOBACCO AND RELATED PRODUCTS

Article 17. Prohibition of Advertising of Tobacco Products

1. Advertising of tobacco products (hereinafter: ‘advertising’), except for the cases specified in paragraph 2 of this Article, and also surreptitious advertising of tobacco products shall be prohibited in the Republic of Lithuania.

2. Prohibition on advertising shall not apply to:

1) information referred to in paragraph 3 of this Article, which is presented at retail outlets where tobacco products are sold to the consumer;

2) publications intended exclusively for specialists (professionals) in the tobacco trade, and also publications printed and published in the countries other than the contracting parties to the Agreement on the European Economic Area, where such publications are not intended for the European Community market;

3) registered names and trademarks of legal persons or branches of foreign legal persons manufacturing or marketing tobacco products (if the brand name of a tobacco product, name of the tobacco product manufacturer or trademark constitutes an integral part of the registered name of such legal persons or branches of foreign legal persons) where such names and trademarks are displayed on buildings wherein the head offices or subdivision of the said legal persons or branches of foreign legal persons are located. Only the registered names of legal persons or branches of legal persons manufacturing or marketing tobacco products may be displayed on the motor vehicles managed by the legal persons or branches of the foreign legal persons;

4) repealed as of 1 January 2017.

3. Only the following information may be presented on showcases used to display tobacco products at retail outlets:

1) the name of a manufacturer or seller and the address of its head office;

2) the brand names of the tobacco products sold;

3) the words “We trade in“ or ”We sell”;

4) the indication of prices of tobacco products.

4. Information (warnings) must also be displayed, in accordance with the procedure established by the institution authorised by the Government of the Republic of Lithuania, at retail outlets regarding the harmful effects of tobacco consumption on health and the ban on the sale of tobacco products to persons under 18 years of age.

5. The information referred to in paragraph 3 of this Article may be presented only together with the tobacco products displayed. Such information may not be presented on leaflets, folders or other means of advertisement intended for take-away use by consumers; in addition, it shall be prohibited to display any imitations and pictures of tobacco products or packaging thereof at retail outlets. No visual or graphic information other than specified in paragraphs 3 or 4 of this Article regarding tobacco products may be displayed at retail outlets.

Article 171. Prohibition on Advertising of Electronic Cigarettes, Refill Containers of Electronic Cigarettes and Herbal Products for Smoking

1. Advertising of electronic cigarettes, refill containers of electronic cigarettes and herbal products for smoking as well as surreptitious advertising of electronic cigarettes, refill containers of electronic cigarettes and herbal products for smoking shall be prohibited in the Republic of Lithuania.

2. Commercial communications in Information Society services, in the press and other printed publications, with the aim or direct or indirect effect of promoting electronic cigarettes, refill containers and herbal products for smoking are prohibited in the Republic of Lithuania, except for publications that are intended exclusively for professionals in the trade of electronic cigarettes, refill containers and/or herbal products for smoking and for publications which are printed and published in third countries, where those publications are not principally intended for the market of the European Union.

3. Commercial communications on the radio, with the aim or direct or indirect effect of promoting electronic cigarettes, refillable cartridges of electronic cigarettes and/or herbal products for smoking shall be prohibited.

4. Any form of public or private contribution to radio programmes with the aim or direct or indirect effect of promoting the use of electronic cigarettes, refill containers of electronic cigarettes and/or herbal products for smoking shall be prohibited.

5. Any form of public or private contribution to any event, activity or individual person with the aim or direct or indirect effect of promoting the use of electronic cigarettes, refill containers electronic cigarettes and/or herbal products for smoking and involving or taking place in several contracting parties to the Agreement on the European Economic Area or otherwise having cross-border effects shall be prohibited.

6. Commercial audiovisual communications to which the Law of the Republic of Lithuania on the Provision of Information to the Public applies, shall be prohibited for electronic cigarettes, refill containers of electronic cigarettes and/or herbal products for smoking.

Article 18. Other Prohibitions related to Tobacco Products

1. It shall be prohibited in the Republic of Lithuania:

1) to apply fixed discounts on tobacco products for the owners of vouchers printed in the media or distributed otherwise or to treat such vouchers as an alternate means of payment;

2) to distribute free tobacco products and/or new samples thereof to the public;

3) to grant the buyer the right to, immediately or over a specified period of time after a sale and purchase contract is concluded, receive gifts or any other special offers on tobacco products;

4) to influence buyers through persistent offers of tobacco products, indicating the alleged price reductions on price lists, price labels, indoor store windows and other means or measures contrary to good morals and public order;

5) to sell tobacco products in assortment with other goods or any other goods in assortment with the tobacco products marketed;

6) to supply tobacco products as prizes in lotteries, contests, sports competitions and games or together with such prizes;

7) to organise games or competitions and lotteries, promoting the purchase and/or consumption of tobacco products;

8) to manufacture and/or sell toys, food products and other goods the design of which imitates tobacco products or unit packets thereof;

9) to sell other products (non-tobacco or related products) marked with tobacco product trademarks;

10) to enlist persons under 18 years of age in any activity promoting the purchase and/or consumption of tobacco products and related products.

2. Legal persons or branches of foreign legal persons manufacturing tobacco products and/or related products or whose principal activity is the sale of tobacco products and/or related products shall be prohibited from contributing in any form and by any means to any event, activity, person or means of the provision of information to the public in the Republic of Lithuania.

Article 19. Restrictions on the Use of Tobacco Products

1. It shall be prohibited to smoke (use tobacco products and electronic cigarettes) in the Republic of Lithuania:

1) at all educational and social services establishments providing social care and/or social guardianship services for children, at health care facilities and in their territories;

2) at indoor workplaces; Special facilities (areas) may be set up in enterprises, establishments and organisations where smoking is permitted. The requirements for setting up and operating smoking facilities (areas) shall be laid down by the Government of the Republic of Lithuania or an institution authorised by it;

3) in common residential and other common premises of a building where non-smokers may be forced to breathe tobacco smoke-polluted air;

4) in all types of public transport, with the exception of long-distance trains where individual cars must be designated for smokers and non-smokers, as well as on aircraft where separate places must be designated for non-smokers and smokers;

5) in restaurants, cafés, bars and other catering establishments, clubs, discotheques, internet cafés (internet clubs and the likes), casinos, slot machines or bingo halls and other leisure venues, premises where sporting events or other events take place, and at other premises offering services to people, with the exception of cigar or pipe clubs specially set out for this purpose. The procedure for setting out cigar and/or pipe clubs shall be laid down by the Government of the Republic of Lithuania or an institution authorised by it;

6) inside vehicles if there are any persons under 18 years of age and/or pregnant women.

2. Repealed as of 1 January 2007.

3. Municipal councils shall have the right to prohibit smoking in public places (parks, squares, etc.) and other public places falling within the scope of their competence.

4. The management bodies of a legal person must ensure that its staff members, clients and visitors are not forced to breathe tobacco smoke-polluted air; they must also ensure that non-smoking warnings or signs are displayed in visible locations and special facilities (areas) be set out for smoking with notices or signs indicating their location.

5. In the Republic of Lithuania, persons under 18 years of age shall be prohibited from smoking (consuming) tobacco products or possessing them.

6. Points 3 and 5 of paragraph 1 of this Article shall not apply to modern smokeless tobacco products.

Article 20. Tobacco Products and Calculation of Minimum Standard of Living

It shall be prohibited to include tobacco products in the food and non-food basket for the purpose of calculating the minimum standard of living.

CHAPTER FOUR

MONITORING OF TOBACCO PRODUCTS, PUBLIC AWARENESS AND EXCHANGE OF INFORMATION, PLANNING OF MEASURES ON TOBACCO CONTROL

Article 21. Monitoring of the Consumption of Tobacco Products, Its Harmful Effects on Health and the Economy

Monitoring of the consumption of tobacco products and its harmful effects on health and the economy shall be exercised in the Republic of Lithuania in accordance with the procedure laid down by the Government.

Article 22. Information to the Public about Tobacco Products and Harmful Effects of the Consumption thereof

1. Schools with formal education shall include in the general education content of an education programme the issues concerning harmful effects of the consumption of tobacco products on health, a health-friendly environment that prevents the harmful effects of smoking, and a healthy lifestyle.

2. The Ministry of Health, having obtained information from an institution authorised by the Government of the Republic of Lithuania whereto reports are submitted pursuant to Article 9 of this Law about the ingredients used in the manufacture of tobacco products intended for marketing in the Republic of Lithuania as well as information about the results of the tests referred to in Article 4(3) of this Law, shall ensure that such information and the list of ingredients for each tobacco product, indicating tar, nicotine and carbon monoxide yields, is made public and disseminated, by any appropriate means, with a view to informing the consumers. The information specified in this paragraph shall be disseminated without prejudice to the protection of any information on specific tobacco product formulae which constitutes a trade secret.

Article 23. Exchange of Information with Institutions of the European Union

Competent institutions authorised by the Government of the Republic of Lithuania to maintain contacts with the European Union must provide all the information required for the purpose of cooperating with institutions of the European Union and fulfilling the commitments of the Republic of Lithuania under this Law or at the request of the Commission of the European Communities.

Article 24. Planning of Measures on Tobacco Control

In order to implement the goals of this Law, the Government of the Republic of Lithuania, the ministries, government agencies and other bodies which have been statutorily charged with the drawing-up of strategic planning documents shall design measures on tobacco control in their strategic planning documents. In order to implement the goals of this Law, municipal institutions shall design measures on tobacco control in municipal strategic development and/or municipal strategic action plans.

CHAPTER IV

SUPERVISION OF ACTIVITIES WITH REGARDS TO TOBACCO PRODUCTS AND RELATED PRODUCTS, AND LIABILITY FOR INFRINGEMENTS OF THIS LAW

Article 25. Supervision of Activities with Regard to Tobacco Products and Related Products, and Liability for Infringements of this Law; Confiscation and Destruction of Tobacco Products

1. Supervision of activities with regard to tobacco products shall, in accordance with the provisions of the Law of the Republic of Lithuania on Public Administration, be carried out by the Drug, Tobacco and Alcohol Control Department, the State Consumer Rights Protection Authority, municipal executive bodies, the State Tax Inspectorate, customs, police and other state supervisory and law enforcement institutions.

2. Natural persons shall be held liable for the infringements of this Law in accordance with the procedure laid down by the Code of Administrative Offences of the Republic of Lithuania (hereinafter: the 'Code of Administrative Offences') and the Criminal Code of the Republic of Lithuania (hereinafter: the 'Criminal Code').

3. Contraband, counterfeit tobacco products sold, stored or shipped in the Republic of Lithuania, tobacco products without special markings – tax stamps as well as tobacco products the purchase of which is not evidenced by legally binding documents or which have been stored or sold without a licence shall be confiscated in accordance with the Code of Administrative Offences or the Criminal Code, respectively.

4. Confiscated tobacco products shall be destroyed in accordance with the procedure laid down by the Government of the Republic of Lithuania.

Article 26. Economic Sanctions

1. Legal persons and branches of foreign legal persons who infringe the requirements to submit notifications, a technical document and a report on the composition of tobacco products intended for sale in the Republic of Lithuania in accordance with the procedure laid down by paragraphs 1, 2, 4, 10 of Article 9 of this Law or the requirements to submit notifications of the composition of herbal products for smoking or notifications of novel tobacco products in accordance with the procedure laid down by Articles 910 and 911 of this Law shall be subject to a fine in the amount between two hundred and eighty-nine euros and eight hundred and sixty-eight euros.

11. Legal persons or branches of foreign legal persons who infringe the requirements for the composition of electronic cigarettes or the requirements for quality and labelling referred to in Article 92, Article 93(1) and (2) and Articles 94, 95 and 97 of this Law shall be subject to a fine in the amount between two hundred and eighty-nine euros and eight hundred and sixty-eight euros. If the infringement of the said requirements is repeated within one year after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between eight hundred and sixty-eight euros and one thousand four hundred and forty-eight euros.

2. Legal persons and branches of foreign legal persons who manufacture, store and trade in tobacco products in violation of the requirements of Article 10(1) or Article 14(1) of this Law (without a licence issued in the prescribed manner) shall be subject to a fine between two thousand eight hundred and ninety-six euros and eight thousand six hundred eighty-eight euros.

3. Legal persons and branches of foreign legal persons who infringe the prohibition to authorise or to transfer under the contract to other persons the right to engage in the licensed activity referred to in Article 12(1) of this Law or the requirements for the acquisition of tobacco products or the sale of tobacco products or tobacco referred to in paragraph 3, 4 or 5 of Article 12 of this Law, the prohibitions on sales, storage or shipment of tobacco products referred to in points 6 or 7 of Article 14(3) of this Law or the requirements referred to in Article 14(8) of this Law shall be subject to a fine in the amount between eight hundred and sixty-eight euros and one thousand four hundred and forty-eight euros. If an infringement of the said prohibitions and requirements is repeated within one year after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between one thousand four hundred and forty-eight euros and two thousand eight hundred and ninety-six euros.

4. Legal persons and branches of foreign legal persons who infringe the prohibition set out in Article 13 of this Law to sell chewing tobacco, nasal tobacco and tobacco for oral use shall be subject to a fine in the amount between one thousand four hundred forty-eight euros and two thousand eight hundred ninety six euros.

5. Legal persons and branches of foreign legal persons who infringe the prohibitions on sales, storage or shipment of tobacco products referred to in points 1, 2, 3 and 4 of Article 14(3) of this Law, with the exception of the case set out in paragraph 6 of this Article, the requirements on the traceability of tobacco products referred to in paragraphs 1, 2, 3 and 4 of Article 141of this Law, provided that this does not give rise to criminal liability shall be subject to a fine in the amount between two thousand eight hundred and ninety-six euros and eight thousand six hundred and eighty-eight euros with the withdrawal of the licence.

6. Legal persons and branches of foreign legal persons who infringe the prohibition on sales, storage or shipment of tobacco products where the value of the tobacco products sold, stored or shipped illicitly does not exceed the 0.5 of the base value of the fines and penalties referred to in Article 14(3)(1) of this Law or the prohibition on sales, storage or shipment of tobacco products referred to in Article 14(3)(8) of this Laws hall be subject to a fine in the amount between two hundred and eighty-nine euros and eight hundred sixty-eight euros. If the infringement of the said prohibitions is repeated within one year after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between eight hundred and sixty-eight euros and two thousand eight hundred and ninety-six euros. Legal persons and branches of foreign legal persons who infringe the prohibition on sales, storage or shipment of tobacco products referred to in Article 14(3)(5) of this Law shall be subject to a fine in the amount between one thousand four hundred euros and forty-eight and two thousand eight hundred and ninety-six euros. If the infringement of the said prohibition is repeated within one year after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between two thousand eight hundred and ninety-six euros and five thousand seven hundred and ninety-two euros.

7. Legal persons and branches of foreign legal persons who infringe the prohibition on sales of tobacco products referred to in Article 14(5)(1) or (2) and Article 87 of this Law shall be subject to a fine in the amount between two hundred and eighty-nine euros and eight hundred and sixty-eight euros; if the infringement of the said prohibitions is repeated within one year after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between eight hundred and sixty-eight euros and one thousand four hundred and forty-eight euros. Legal persons and branches of foreign legal persons who infringe the prohibition on sales of tobacco products referred to in Article 14(5)(3) of this Law shall be subject to a fine in the amount between eight hundred and sixty-eight euros and one thousand four hundred and forty-eight euros; if the infringement of the said prohibition is repeated at the same retail outlet within three years after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between one thousand four hundred and forty-eight euros and two thousand eight hundred and ninety-six euros with the withdrawal of the licence for the same retail outlet in which the repeat infringement has been discovered within three years of imposition of the fine. Legal persons and branches of foreign legal persons who infringe the prohibition on sales of electronic cigarettes and refill containers of electronic cigarettes referred to in Article 161(1) of this Law shall be subject to a fine in the amount between eight hundred and sixty-eight euros and one thousand four hundred and forty-eight euros; if the infringement of the said prohibition is repeated at the same retail outlet within three years after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between one thousand four hundred and forty-eight euros and two thousand eight hundred and ninety-six euros. Legal persons and branches of foreign legal persons who infringe the prohibitions on the placing on the market of tobacco products referred to in Article 41 of this Law shall be subject to a fine in the amount between one thousand four hundred and forty-eight euros and two thousand eight hundred and ninety-six euros. Legal persons and branches of foreign legal persons infringe the requirements on the labelling of herbal products for smoking referred to in Article 99 of this Law shall be subject to a fine in the amount between eight hundred and sixty-eight euros and one thousand four hundred and forty-eight euros.

8. Legal persons and branches of foreign legal persons who infringe the prohibitions on sales of tobacco products referred to in Article 15 of this Law, the prohibition on sales of goods to be used for smoking tobacco products or preparing to smoke tobacco products referred to in Article 16 of this Law or the prohibition on distance sales of electronic cigarettes and refill containers referred to in Article 162 of this Law shall be subject to a fine in the amount between two hundred and eighty-nine euros and eight hundred and sixty-eight euros. If the infringement of the said prohibitions is repeated within one year after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between eight hundred and sixty-eight euros and one thousand four hundred and forty-eight euros.

9. Legal persons and branches of foreign legal persons who infringe the prohibitions on advertising referred to in Article 17(1) and Article 171 of this Law shall be subject to a fine in the amount between one thousand four hundred and forty-eight euros and two thousand eight hundred and ninety-six euros. If the infringement of the said prohibitions is repeated within one year after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between two thousand eight hundred and ninety-six euros and five thousand seven hundred and ninety-two euros.

10. Legal persons and branches of foreign legal persons who infringe the requirements for the display of information referred to in Article 17(4) or (5) of this Law shall be subject to a fine in the amount between two hundred and eighty-nine euros and eight hundred and sixty-eight euros. If the infringement of the said requirements is repeated within one year after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between eight hundred and sixty-eight euros and one thousand four hundred and forty-eight euros.

11. Legal persons and branches of foreign legal persons who infringe the prohibitions referred to in Article 18 of this Law shall be subject to a fine in the amount between eight hundred and sixty-eight euros and one thousand four hundred and forty-eight euros. If the infringement of the said prohibitions is repeated within one year after the imposition of the fine, legal persons and branches of foreign legal persons shall be subject to a fine in the amount between one thousand four hundred and forty-eight euros and two thousand eight hundred and ninety-six euros.

12. Legal persons and branches of foreign legal persons who infringe the requirement referred to in Article 19(1)(5) of this Law shall be subject to a fine in the amount between two hundred and eighty-nine euros and one thousand four hundred and forty-eight euros.

13. Fines for the infringement of the provisions of this Law shall be imposed by:

1) the Drug, Tobacco and Alcohol Control Department for infringements of the provisions of Article 41, Article 87, paragraphs 1, 2, 4 and 10 of Article 9, Articles 93 and 96, Articles 99, 910, 911, Article 10(1), paragraphs 1, 3, 4 and 5 of Article 12, Article 13, Article 14(1), points 1, 2, 3, 4, 6 and 8 of Article 14(3), Article 14(5) and (8), paragraphs 1, 2, 3 and 4 of Article 141, Articles 15 and 16, Article 161(1), Article 162, paragraphs 1, 4 and 5 of Article 17, Articles 171 and 18, Article 19(1)(5);

2) the State Consumer Rights Protection Authority – for infringements of the provisions of Article 87, 92, 94, 95 and 97, Article 99 , Article 10(1), Article 13, paragraph 1, points 1–8 of paragraph 3, points 1 and 2 of paragraph 5 of Article 14, paragraphs 1, 2, 3, 4 of Article 141, Article 18(1)(8) and (9);

3) the State Tax Inspectorate for infringements of the provisions of points 1, 4 and 8 of paragraph 3 of Article 14, paragraphs 1, 2, 3 and 4 of Article 141;

4) municipal executive institutions for infringements of the requirements set out in Article 10(1) and Article 14(1) at retail outlets as well as for infringements of the provisions of Articles 15 and 16, Article 17(1) (in outdoor advertising), Article 17(4) and (5), Article 18(1);

5) heads of police bodies or persons authorised by them for infringements of the provisions of points 1, 2, 3 and 8 of Article 14(8) and paragraphs 1, 2 and 3 of Article 141;

6) officers of the Customs of the Republic of Lithuania for infringements of the provisions of points 1, 3 and 8 of paragraph 3 of Article 14, paragraphs 1, 2, 3 and 4 of Article 141.

14. The institutions specified in paragraph 13 of this Article shall, when imposing fines for the infringements of this Law within the scope of their competence, determine the specific amount of a fine taking into account the nature of the infringement and the circumstances mitigating or aggravating liability. In the event of mitigating circumstances, the amount of a fine imposed may not exceed the average amount of the economic sanction usually imposed for similar infringement; in the event of aggravating circumstances, the amount of a fine imposed may not be lower than the average amount of the economic sanction usually imposed for similar infringement. In the presence of both mitigating and aggravating circumstances, a fine shall be imposed taking into account the quantity and significance thereof. Any reduction or increase in a fine shall be motivated by a decision of the institution which imposes the fine for infringements of the requirements set out in this Law.

15. Mitigating circumstances shall include actions of the legal persons, branches of foreign legal persons, who committed an infringement, taken at their own initiative to prevent the harmful consequences of such infringement as well as their assistance to competent authorities in the investigation of the infringement, compensation of losses or elimination of the damage done. Aggravating circumstances shall include actions of the legal persons, branches of foreign legal persons concerned to impede the investigation procedure, conceal the infringement, continue the infringement despite the competent authority’s instructions to discontinue illegal actions. The institution which imposes a fine may recognise circumstances other than those specified in this paragraph as mitigating or aggravating.

Article 27. Record of Infringements of this Law and Time Limits for the Examination of Cases

1. Employees (officers) of authorised by the institutions referred to in Article 26(13) of this Law, having established an infringement of the provisions of this Law, shall draw up a record the content of which is in compliance with the Code of Administrative Offences.

2. The institutions referred to in Article 26(13) of this Law shall examine cases and impose economic sanctions not later than within two months from the establishment of the infringement. Sanctions for infringements of this Law may be imposed no later than within three years from the commitment of the infringement and in the case of a continuous infringement, within three years from the disclosure thereof.

Article 28. Participants in the Examination Procedure

1. Where a case is examined by an institution which imposes economic sanctions for the infringements specified in Article 26 of this Law, the parties of the examination procedure shall be as follows:

1) the person suspected of having infringed this Law (alleged offender);

2) other persons designated by a decision of the institutions specified in Article 26(13) of this Law where their interests are directly related to the case examined;

3) representatives of state and municipal institutions at their request;

4) experts, specialists and other persons at the decision of the institutions specified in Article 26(13) of this Law.

2. The persons referred to in points 1 and 2 of paragraph 1 of this Article shall be hereinafter referred to as the parties of the examination procedure.

3. The parties of the examination procedure may be represented by representatives authorised by them.

Article 29. Notice of the Opening of the Investigation of an Infringement of this Law and the Examination of a Case pertaining thereto

1. The parties of the examination procedure must be informed in writing of the opening of the investigation of an infringement of this Law no later than within three working days from the beginning of the investigation activities carried out in respect of the infringement (along with the information about the order the parties of the examination procedure may have access to the case file and an offer to present their explanations in writing).

2. Where at the beginning of the investigation activities carried out in respect of the infringement, the person suspected of having infringed this Law (alleged offender) is not known, he shall be informed of the beginning of the investigation activities carried out in respect of the infringement within three working days after such person was identified.

3. The parties of the examination procedure must be informed of the venue and time of the examination of a case and a copy of the record referred to in Article 27(1) of this Law must be submitted not later than within 10 working days before the commencement of a meeting.

Article 291. Rights of the Parties of the Examination Procedure during the Investigation of an Infringement of this Law and the Examination of a Case Pertaining thereto

1. The parties of the examination procedure shall, during the investigation of an infringement of this Law and the examination of a case pertaining thereto, have the right to access the case file, to give written and oral explanations, to present evidence and to submit requests.

2. The parties of the examination procedure may, prior to the examination of a case, submit explanations within the time limit fixed in Article 26(13) of this Law which may not be less than 14 working days from the date the person who is suspected of having infringement this Law (alleged offender) receives a notice of the infringement of this Law.

3. Where new evidence is submitted during the examination of a case, the parties of the examination procedure shall have the right to immediately access such evidence and to submit their own explanations in respect of the evidence within five working days of its receipt.

4. Where witnesses are examined during the proceedings, the parties of the examination procedure shall also have the right to pose questions to them. The parties of the examination procedure shall also have the right to call their own witnesses.

Article 30. Examination of a Case

1. Examination of a case shall be open to the public. The institutions referred to in Article 26(13) of this Law may, on their own initiative or at the request of the parties of the examination procedure, declare a meeting or a part thereof closed, if it is necessary to protect a state, official or professional secret or a commercial secret of the parties of the examination procedure.

2. A case shall be examined in the oral proceedings in the presence of the parties of the examination procedure and other participants therein.

3. Where the parties of the examination procedure are not present, the case may be examined only if there is evidence that they have been properly and timely notified of the venue and time of the examination as well as have been granted the right to access the case file and to give explanations, and only if they have not produced any documents in justifying their absence and indicating the reasons for absence which the institutions referred to in Article 26(13) of this Law recognise as important. Vacations, business trips, busy schedule and other similar circumstances shall not be considered as substantive reasons. Absence due to sickness or involvement of a representative of the party of the examination procedure in other cases shall not normally be considered as important reasons.

4. An appropriate notification about the time and venue of the examination of a case shall be considered a notification sent by registered mail to the address of the head office of the party of the examination procedure specified in the Register of Legal Entities, with the exception of the events where the party of the examination procedure indicated another mailing address, or the notification has been sent to the electronic consignment delivery address of the party of the examination procedure specified in the Register of Legal Entities, or where the party of the examination procedure has been served with the notification against its signature at the time of establishing the infringement of this Law.

Article 31. Decisions Taken upon the Examination of a Case

1. The institutions specified in Article 26(13) of this Law, having examined a case, shall take one of the following reasoned decisions:

1) apply the economic sanctions established by this Law;

2) in the absence of the grounds specified in this Law, to refuse to impose economic sanctions;

3) to dismiss the case where no infringement of this Law has been committed;

4) to refer the case back for further investigation.

2. Upon the examination of the case, the adopted decision must indicate:

1) the name of the institution which has taken the decision;

2) the date and venue of the examination of the case;

3) data on the offender;

4) circumstances of committing the infringement;

5) evidence of guilt on which the decision is based;

6) the relevant article of this Law stating liability for the infringement;

7) explanations given by the offender and their evaluation;

8) the decision taken;

9) time limits and the procedure for appealing against the decision.

3. The decisions of the institutions specified in Article 26(13) of this Law shall be sent within two working days after the taking thereof to the persons in reference to whom they were taken.

Article 32. Recovery of Fines

1. The fine imposed shall be paid to the state budget not later than within one month from the day of communication of the decision to the offenders of this Law and, in the event that the fine has been imposed by a municipal executive institution, to the respective municipal budget.

2. The unpaid fines shall be recovered by bailiffs where they enforce the decisions of the institutions specified in Article 26(13) of this Law and act in accordance with the procedure laid down in the Code of Civil Procedure of the Republic of Lithuania. A decision may be presented for execution not later than within three years of the decision.

Article 33. Appeal against Decisions regarding Application of Economic Sanctions

1. Persons who contest a decision to impose economic sanctions shall have the right to appeal, in accordance with the procedure laid down in the Law on Administrative Proceedings of the Republic of Lithuania, to court against the decision within one month from the date on which they were served with the decision.

2. A court appeal shall suspend the enforcement the decision to impose economic sanctions.

3. The court investigating an appeal shall, taking into account the nature and extent of the committed offence, mitigating and other relevant circumstances (due to which a respective fine imposed on an offender would be excessive and disproportionate to the committed offence and therefore unfair) and acting in compliance with the principles of fairness and prudence, have the right to impose a fine smaller than the minimum fine stipulated in an appropriate paragraph of Article 26 of this Law.

4. The court investigating an appeal shall, taking into account the nature and extent of the committed offence, mitigating and other relevant circumstances (due to which a respective fine imposed on an offender would be excessive and disproportionate to the committed offence and therefore unfair) and acting in compliance with the principles of fairness and prudence, have the right to decide that the withdrawal of the licence must be apply to the offender.

Article 34. Disputes regarding Infringements of this Law

Disputes regarding infringements of this Law shall be resolved in accordance with the procedure laid down by laws of the Republic of Lithuania.

I promulgate this Law passed by the Seimas of the Republic of Lithuania.

PRESIDENT OF THE REPUBLIC ALGIRDAS BRAZAUSKAS

Annex 1 to

the Republic of Lithuania

Law on Control of

Tobacco, Tobacco Products and

Related Products

LIST OF TEXT WARNINGS

1. Smoking causes 9 out of 10 lung cancers.

2. Smoking causes mouth and throat cancer.

3. Smoking damages your lungs.

4. Smoking causes heart attacks.

5. Smoking causes strokes and disability.

6. Smoking clogs your arteries.

7. Smoking increases the risk of blindness.

8. Smoking damages your teeth and gums.

9. Smoking can kill your unborn child.

10. Your smoke harms your children, family and friends.

11. Smokers’ children are more likely to start smoking.

12. Quit smoking – stay alive for those close to you.

13. Smoking reduces fertility.

14. Smoking increases the risk of impotence.

Annex 2 to

the Republic of Lithuania

Law on Control of

Tobacco, Tobacco Products and

Related Products

LEGAL ACTS OF THE EUROPEAN UNION IMPLEMENTED BY THIS LAW

1. Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by Law, Regulation or Administrative Action in Member States concerning the pursuit of television broadcasting activities (as last amended by Directive 97/36/EC of the European Parliament and of the Council of 30 June 1997) (OJ 2004 special edition, Chapter 6, Volume 1, p. 224).;

2. Directive 2003/33/EC of the European Parliament and of the Council of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products (OJ 2004 special edition, Chapter 15, Volume 7, p. 460).

3. Terms and conditions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1).

4. Commission Directive 2012/9/EU of 7 March 2012 amending Annex I to Directive 2001/37/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products (OJ 2012 L 68, p. 15), as last amended by Commission Directive (EU) 2015/1139 of 13 July 2015 (OJ 2015 L 185, p. 15).

5. Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ 2014 L 127, p. 1).