Decree No. 37 / 2017 Coll.
Decree on electronic cigarettes, refills and herbal products intended for smoking
Valid
Effective from 01.03.2017
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37
DECLARATION
of 2 February 2017
on electronic cigarettes, refills and herbal products intended for smoking
According to Article 19 (4) of Act No. 110 / 1997 Coll., on Food and Tobacco Products, and amending and supplementing certain related acts, as amended by Act No. 180 / 2016 Coll., ("the Act '):
Subject matter
This decree implements the relevant provisions of the European Union1) and provides for
(a) the composition, appearance, quality and characteristics of electronic cigarettes and their substitutes;
(b) the labelling of electronic cigarettes and their substitutes and herbal products intended for smoking, including prohibited elements and features;
(c) the manner, time-limits and scope of the notification obligations of manufacturers and importers of electronic cigarettes, their substitutes and herbal products intended for smoking; and
(d) the scope of the data required for registration for the cross-border sale of electronic cigarettes and their distance refills and the way in which they are carried out.
Definition of terms
For the purposes of this decree:
(a) a common electronic gateway for the submission of information, which is an electronic information portal established and operated by the European Commission to ensure a uniform way of notification and replacement of electronic cigarettes and herbal products intended for smoking;
(b) a health warning regarding the adverse effects of an electronic cigarette or a replacement refill into it or an herbal product intended for smoking on human health;
(c) by a retailer, any retailer, including any natural person, who places electronic cigarettes or substitutes in them or herbal products intended for smoking on the market;
(d) the characteristic flavour clearly identifiable or taste of coffee, tea, tobacco, mint and other plants, including their fruits, flowers, seeds, leaves and extracts thereof or their combinations.
General requirements for electronic cigarettes and refills
(1) Electronic cigarettes and refill cartridges must be:
(a) tampering by children and any unwanted handling which would in particular undermine the integrity of the product and be contrary to the purpose for which electronic cigarettes and spare fillings are intended;
(b) protected against breakdown and leakage of fluid;
(c) provided with a mechanism providing re-filling without leakage of fluid pursuant to Section 4, where rerefillable electronic cigarettes are involved; and
(d) in accordance with Part 3, point 3.1.2, or 3.1.3 of Annex II to Regulation (EC) No 1272 / 20082 of the European Parliament and of the Council), providing for resealing and resealing packaging, which shall apply to all electronic cigarettes and replacement fillings under the law.
(2) Electronic cigarettes containing nicotine or nicotine salt must release doses of nicotine or nicotine salts equally under normal conditions of use.
(3) Only high-purity ingredients shall be used in the manufacture of liquid cartridges for electronic cigarettes. Substances other than those listed in § 6 (1) (a) may be contained in the liquid filling in trace quantities only if such trace quantities are technically unavoidable during the production of liquid filling in electronic cigarettes.
(4) The components listed in Annex 1 to this Decree shall not be used in the manufacture of liquid cartridges for electronic cigarettes. The ingredients listed in Annex No 2 to this Decree may be contained in the liquid filling of electronic cigarettes not exceeding the quantities given here.
(5) Liquid refills for electronic cigarettes may contain only substances which do not pose a risk to human health in warm or unheated form, and nicotine or nicotine salt.
(6) Liquid cartridges for electronic cigarettes shall not contain:
(a) vitamins (3) or other ingredients which give the impression that liquid filling is beneficial to health or presents a reduced health risk;
(b) caffeine, taurine or other additives and stimulating ingredients associated with energy and vitality;
(c) additives the properties of which cause the colouring of emissions;
(d) additives having the characteristics of carcinogenic, mutagenic or toxic to reproduction in unburned form;
(e) sugars and sweeteners or other ingredients which produce or contribute to the formation of sweet aroma or flavour; the prohibition of such ingredients does not apply to products with a characteristic flavour,
(f) mineral or vegetable oils and fats, not even as thinner or in any other function;
(g) carbinoids and their derivatives; and
(h) psychomodulatory substances, classified psychoactive substances or addictive substances under the RH 4), listed substances of category I according to the directly applicable European Union drug precursors regulation (5), anabolic and other hormonal effects6), substances of a hormonal nature and other substances in which toxic, genotoxic, teratogenic, hallucinogenic or narcotic substances have been demonstrated in a warm or unheated form, and substances from which the heat is generated by psychomodulatory substances, classified psychoactive substances or addictive substances under the RL 4).
(7) Liquid cartridges for electronic cigarettes containing nicotine may contain a maximum of 20 mg nicotine / ml. If the liquid cartridge contains nicotine salt, then the restriction on nicotine content according to the first sentence refers to the nicotine content converted from nicotine salt.
(8) The volume of replacement refill for electronic cigarettes must not exceed 10 billion.
(9) The volume of the container or container for disposable electronic cigarettes or disposable containers shall not exceed 2 ml. A disposable electronic cigarette can only have one container or one tank.
(10) Electronic cigarettes and refills must not resemble a food, cosmetic product or toy with their shape, shape and packaging.
(11) Electronic cigarettes and refills must not allow functions other than the use of fumes.
Additional requirements for rerefillable electronic cigarettes and refills
(1) Refillable electronic cigarettes and rechargeable cigarettes may be placed on the market only if the refilling mechanism:
(a) require the use of a spare filling which has a safely fixed nozzle of at least 9 mm long and narrower than the orifice of the electronic cigarette for which it is used and which fits into the orifice and has a flow control mechanism which, in a vertical position only at an atmospheric pressure of 20 ± 5 ° C, does not release more than 20 drops of additional fluid per minute; or
(b) operate by means of a docking system which releases the additional liquid into the container of an electronic cigarette only if the electronic cigarette is associated with a spare refill.
(2) The instructions for use provided for in Section 12h (3) (a) of the Act for re-refillable electronic cigarettes and replacement cartridges must also include:
(a) guidelines for the repeated performance procedure, including drawings;
(b) in the case of the application of the mechanism referred to in paragraph 1 (a), an indication of the width of the nozzle or the width of the tank opening, as indicated, which allows the consumer to verify that the replacement cartridge and the electronic cigarette are compatible; and
(c) where the mechanism referred to in paragraph 1 is used. (b) the type of docking system with which the electronic cigarette or refill is compatible.
(3) The volume of the rerefillable electronic cigarette tank for refilling the spare refill shall not exceed 2 ml. The reusable electronic cigarette shall not contain more than three tanks or containers.
Labelling and replacement fillings of electronic cigarettes
(1) Information pursuant to § 12h (2) of the Act
(a) they must be imremovably printed directly on unit and outer packaging;
(b) be visible; and
(c) shall not be covered or interrupted when placed on the market.
(2) The components contained in the liquid content must be listed in descending order of weight in accordance with § 12h (2) (b) of the Act, using the same name, which is notified in accordance with § 6 (1) (a) of this Decree. The ingredients used in quantities of 0,1% or less in the final composition of the liquid may be considered as business secrets and may not be reported unless they are ingredients causing allergies or intolerance within the meaning of Article 9 (1) (c) of Regulation (EU) No 1169 / 20117 of the European Parliament and of the Council.
(3) The indication of the nicotine content of the product under Article 12h (2) (c) of the Act is given in mg / ml filling. The indication of the quantity of nicotine in the dose provided for in Article 12h (2) (d) of the Act shall be given in μg per dose. The dose is one draw from the refill of an electronic cigarette. If the liquid filling contains nicotine salt, then the required data shall be converted into nicotine.
(4) Health warnings on each unit pack and on any external packaging of electronic cigarettes and spare refill when the product:
(a) contains nicotine, or nicotine salt, as follows: "This product contains nicotine, which is a highly addictive substance. Its use by non-smokers is not recommended. '; or
(b) it does not contain nicotine or nicotine salt and it is an electronic cigarette placed on the market without filling or filling without nicotine or a spare cartridge without nicotine shall be stated as follows: "The use of this product is harmful to your health."
(5) The obligation to provide health warnings on electronic cigarettes referred to in paragraph 4 shall not apply to mouthpiece or any other part of this product, except for a container, tank, device without tank or container.
(6) The health warning referred to in paragraph 4 must:
(a) be parallel to the main text on the area reserved for this warning;
(b) be printed in black in bold Helvetica with the default character interpolation setting, which is 100% scale and spaces normal, on white background; point font size must be such that the text concerned occupies as much of the surface reserved for it as possible;
(c) be placed at the centre of the surface reserved for them;
(d) be parallel to the side edge of the unit pack or outer packaging on a unit pack of block shape and any outer packaging;
(e) cover 30% of the surface area of the unit pack and any outer packaging on which the health warning is printed;
(f) be indicated on the two largest surfaces of the unit pack and any outer packaging; and
(g) in the usual way of opening the unit pack, remain undisturbed.
(7) The packaging shall not contain any additional text which, in any way, would comment, paraphrase, detract or refer to the health warning referred to in paragraph 4.
(8) The health warning referred to in paragraph 4 shall not be partially or completely covered or interrupted when using a tobacco sticker.
(9) Unit packs and any external packaging of electronic cigarettes and spare fillings, the marking of the electronic cigarette itself and the replacement fillings must not contain any element or feature which:
(a) promote or promote the consumption of an electronic cigarette or substitute cigarette by creating false impression as to the characteristics of the product, its effects on health, risks and emissions;
(b) suggests that an electronic cigarette or a spare refill in it is less harmful than other products, or that its aim is to reduce the effects of certain harmful smoke constituents, or that it has vitalisation, energizing, medicinal, rejuvenating or natural effects or the characteristics of an organic farming product or other health or lifestyle benefits;
(c) resembles a foodstuff, cosmetic product or toy;
(d) suggests that an electronic cigarette or a spare refill has increased biodegradability or other environmental benefits;
(e) it is linked to illegal or dangerous substances or substances promoting socially undesirable behaviour;
(f) suggests an increased possibility of achieving social or social success;
(g) suggests or resembles vulgar expressions; or
(h) directly or indirectly target or rely on the culture of persons under the age of 18.
(10) Information on the flavour of an electronic cigarette or spare refill can only be provided by means of a text which is given by the word "flavour."
(11) The unit packaging and any external packaging of electronic cigarettes and substitutes shall not contain any element or feature indicating economic benefits, including benefits through printed vouchers, discounts, free distribution, "two-for-one 'offers or other similar offers.
(12) An element or feature prohibited under paragraphs 9 and 11 shall mean, in particular, the text, symbol, name, trade mark, subtype name, figurative or other character, even in the case of foreign language text or equivalent in the Czech language.
(13) In addition to the information provided for in Section 12h (2) of the Act, the packaging of unit and outer packaging shall be indicated in accordance with paragraph 1
(a) the identification number under which the electronic cigarette or spare refill is notified in accordance with Article 12h (4) (a) of the Act;
(b) the graphic mark together with the text "The product is not intended for persons under the age of 18." and the phrase "The product is not intended for pregnant and breastfeeding women." and "Keep out of the reach of persons under the age of 18." the image of the graphic mark "The product is not intended for persons under the age of 18." is given in Annex 3 to this decree.
(14) The packaging of unit and outer packaging may include, in addition to the information provided for in Section 12h (2) of the Act, one barcode or QR code. The QR code shall not refer to information other than barcode or legal information. The bar code or QR code shall not represent an image, pattern or symbol similar to anything other than a bar code or a QR code. The indication of the packaging by barcode or QR code does not replace the mandatory indication of the information required by the legislation.
Method of implementing the notification obligation for the placing on the market and replacement of electronic cigarettes
(1) The notification referred to in Article 12h (4) (a) and (5) of the Act shall be made by means of a portal in the format set out in the Annex to Commission Implementing Decision (EU) 2015 / 2183 and according to the brand and type of electronic cigarette or replacement refill. Such notifications shall include:
(a) a list of all components contained in liquid fillings and emissions resulting from the use of an electronic cigarette or replacement filler by brand name and type, including their quantities;
(b) toxicological data on ingredients and emissions referred to in (a), including when heated, in particular with regard to their effects on consumer health, if inhaled, and any addictive effect thereof;
(c) information on the doses of nicotine and its intake when used under normal or foreseeable conditions with regard to electronic cigarettes and replacement fillings containing nicotine or nicotine salt;
(d) a description of the components of the electronic cigarette and the replacement refill thereof, including, where appropriate, the opening and filling mechanisms of those products;
(e) a description of the production process, including information on whether the production process involves serial production and a statement that the production process ensures compliance with the requirements set out in this Decree, the law, other legislation and the directly applicable European Union law; a description of the manufacturing process, including the technological and hygienic requirements, the manner and conditions of transport, storage and handling of the product pursuant to Section 12a (1) (a) of the Act, must be provided at least within the scope of Czech technical standard ČSN EN 17647 governing the general principles for the production, filling and storage of electronic cigarettes for pre-filled containers or products,
(f) a statement that the manufacturer or importer bears full responsibility for the quality and safety of the product when it is placed on the market and when it is used under normal or foreseeable conditions; and
(g) the name and contact details of the manufacturer, the legal or commercial person responsible in the European Union and, where appropriate, the importer in the European Union.
(2) The notification by means of the portal referred to in Article 12h (4) (a) and (5) of the Act contains, in addition to the mandatory information provided for in Commission Implementing Decision (EU) 2015 / 2183
(a) the name and contact details of a legal or business natural person established in the Czech Republic who is responsible for placing the product on the market of the Czech Republic, unless it is already notified in accordance with paragraph 1; this person means an associated undertaking as defined in Part 2.2 of the Annex to Commission Implementing Decision (EU) 2015 / 2183;
(b) where the person referred to in point (a) is not established in the Czech Republic, the notification shall contain the information of the authorised representative referred to in Article 3 (12) of Regulation (EU) 2019 / 10208 of the European Parliament and of the Council or Article 3 (9) of Regulation (EU) 2023 / 9889 of the European Parliament and of the Council;
(c) for electronic cigarettes with liquid filling and for replacement cartridges for electronic cigarettes, a safety data sheet processed in accordance with the directly applicable European Union10),
(d) the date of withdrawal of the electronic cigarette or replacement refill from the market, unless the information referred to in Article 12h (4) (b) of the Act has been notified.
(3) Before the first notification pursuant to Article 12h (4) (a) of the Act, the manufacturer or importer shall request the portal operator to have his identification number (hereinafter referred to as the "promoter's identification number") created by the portal operator. The manufacturer or importer shall, upon request, submit information containing his identification data and verification of activities in accordance with the national legislation of the Member State in which he is established. The petitioner's identification number shall be used for all subsequent notifications made via the portal and for any further correspondence with the Ministry of Health.
(4) On the basis of the petitioner's identification number, the manufacturer or importer shall assign an electronic cigarette identification number or an electronic cigarette refill to each product to be notified in accordance with the procedure laid down in Commission Implementing Decision (EU) 2015 / 2183. When submitting notifications of products having the same composition and appearance, the manufacturer and importer shall use the same electronic cigarette identification number or replacement refill for the electronic cigarette, unless otherwise provided for in this Decree. This procedure shall apply irrespective of the mark and the product type and the number of markets on which the products are placed. If it is not possible to ensure that products of the same composition and appearance use the same identification number of the electronic cigarette or replacement refill for the electronic cigarette, different identification numbers of the electronic cigarette or replacement refill for the electronic cigarette allocated to those products must be provided.
(5) The notification provided for in Article 12h (4) (a) of the Act is submitted no later than 6 months before the intended placing on the market.
(6) The notification referred to in Article 12h (5) of the Act shall be submitted no later than 6 months before the marketing.
(7) The notification referred to in paragraph 2 (a) to (c) shall be submitted before the marketing, the notification referred to in paragraph 2 (d) shall be submitted in accordance with Paragraph 8 (3) of this Order.
(8) Upon submission of the notification, any information which the manufacturer and importer considers to be a business secret or otherwise confidential shall be identified and, at the request of the Ministry of Health, these claims shall be duly substantiated.
Scope of the data required for registration prior to the start of marketing of electronic cigarettes or substitutes in them by means of cross-border distance sales
(1) The notice on the basis of which registration of a retailer is carried out pursuant to Article 13c (4) and (5) of the Act contains:
(a) the name and, where applicable, the names and surname or name or business name of the retailer and the address of the place where the electronic cigarettes or refill will be delivered to them;
(b) the starting date for the offering or replacement of electronic cigarettes to consumers in cross-border distance sales through information society services; and
(c) the address of the website used for distance selling and any information necessary to identify the website.
(2) The data referred to in paragraph 1 shall be notified in electronic form by remote transmission of the data.
Notification of information on the market in electronic cigarettes and refills
(1) The notification pursuant to § 12h (4) (b) of the Act is submitted via the portal and contains:
(a) summary information on sales volume by brand name and product type;
(b) information on the preferences of different consumer groups, including young people, non-smokers and the main types of current users;
(c) information on how the products are sold; and
(d) summaries of any market surveys carried out to identify the information referred to in points (a) to (c).
(2) The information referred to in paragraph 1 (d) on electronic cigarettes and replacement fillings containing nicotine or nicotine salt shall be submitted in Czech and English. The information referred to in paragraph 1 (d) shall be submitted in the Czech language for electronic cigarettes and replacement fillings free of nicotine or nicotine salt.
(3) The information referred to in paragraph 1 shall be submitted for each calendar year by 31 May of the following calendar year at the latest.
Labelling of herbal products intended for smoking
(1) Information pursuant to § 12j (2) of the Act
(a) they must be imremovably printed directly on unit and outer packaging;
(b) be visible; and
(c) shall not be covered or interrupted when placed on the market.
(2) The health warning on each unit pack and any external packaging of herbal products intended for smoking is: "Smoking this product is harmful to your health." No additional text can be provided on the packaging according to the first sentence, which would in any way comment, paraphrase, detract or refer to it.
(3) The health warning referred to in paragraph 2 shall be printed on the front and rear of the outer surface of the unit pack and any outer packaging and shall not be partially or completely covered or interrupted when using a tobacco sticker.
(4) The health warning referred to in paragraph 2 must:
(a) be printed in black in bold Helvetica, with the default character interpolation setting, which is 100% scale and spaces normal, on white background; point font size must be such that the text concerned occupies as much of the surface reserved for it as possible;
(b) be placed at the centre of the surface reserved for them;
(c) be parallel to the side edge of the unit pack or outer packaging on a unit pack of block shape and any outer packaging;
(d) cover 30% of the surface area of the unit pack and any outer packaging on which the health warning is printed;
(e) in the normal way of opening the unit pack, remain undisturbed;
(f) be parallel to the main text on the area reserved for this warning; and
(g) be indicated on the two largest areas of unit and any outer packaging; in the case of cylindrical shape of unit or outer packaging on one of the largest surfaces of unit and any outer packaging.
(5) Unit packaging and any external packaging of herbal product intended for smoking, the designation of the herbal product itself for smoking must not contain any element or feature which:
(a) promote or promote the use of herbal products intended for smoking by creating false impression in terms of its characteristics, health, risk and emissions;
(b) suggests that a certain herbal product intended for smoking is less harmful than other products or that its aim is to reduce the effects of certain harmful components of smoke or that it has vitalizing, energizing, healing, rejuvenating or natural effects or the characteristics of an organic agricultural product or other health or lifestyle benefits;
(c) resembles a foodstuff, cosmetic product or toy;
(d) states that the herbal product for smoking does not contain any additives or flavourings;
(e) suggests that the herbal product intended for smoking has increased biodegradability or other environmental benefits;
(f) refers to the aroma, smell or flavour other than plants, herbs or fruit which are the basis of the product;
(g) it is linked to illegal or dangerous substances or substances promoting socially undesirable behaviour;
h) suggests an increased possibility of achieving social or social success;
(i) suggests or resembles vulgar expressions; or
(j) directly or indirectly targeted or based on the culture of persons under the age of 18.
(6) An element or feature prohibited under paragraphs 5 and 7 shall mean, in particular, the text, symbol, name, trade mark, subtype name, figurative or other character, even in the case of foreign language text or equivalent in the Czech language.
(7) Unit packaging and any external packaging of herbal product intended for smoking shall not contain any element or feature indicating economic benefits, including benefits through printed vouchers, discounts, free distribution, "two-for-one" offers or other similar offers.
(8) In addition to the information provided for in Section 12j (2) of the Act, the packaging of unit and outer packaging may be indicated once by barcode or QR code. The QR code shall not refer to information other than barcode or legal information. The bar code or QR code shall not represent an image, pattern or symbol similar to anything other than a bar code or a QR code. The indication of the packaging by barcode or QR code does not replace the mandatory indication of the information required by the legislation.
Method of implementing the notification obligation for the placing on the market of herbal products intended for smoking
(1) The notification provided for in Article 12j (3) of the Act is made via the portal in the format set out in the Annex to Commission Implementing Decision (EU) 2015 / 2186 and by the brand and type of herbal product intended for smoking. Such notifications shall include:
(a) the name and contact details of the manufacturer, the legal or commercial person responsible in the European Union or the importer in the European Union; and
(b) a list of all ingredients used in the manufacture of an herbal product intended for smoking by brand name and type, including their quantities.
(2) In addition to the mandatory information referred to in Commission Implementing Decision (EU) 2015 / 2186, notifications through the portal referred to in Article 12j (3) of the Act shall contain:
(a) the name and contact details of a legal or business natural person established in the Czech Republic who is responsible for placing the product on the market of the Czech Republic, unless it is already notified in accordance with paragraph 1; this person means an associated undertaking as defined in Part 2.2 of the Annex to Commission Implementing Decision (EU) 2015 / 2186;
(b) where the person referred to in point (a) is not established in the Czech Republic, the notification shall contain the information of the authorised representative referred to in Article 3 (12) of Regulation (EU) 2019 / 10208 of the European Parliament and of the Council;
(c) a description of the manufacturing process, including the technological and hygienic requirements, the manner and conditions of transport, storage and handling of the product under Section 12a (1) (a) of the Act, at least within the scope of Czech technical standard ČSN EN 17647 governing the general principles for the production, filling and storage of electronic cigarettes for pre-filled containers or products;
(d) a safety data sheet processed in accordance with the directly applicable European Union10 Regulation, if the product contains a chemical or a chemical mixture;
(e) the quantity of nicotine in emissions where the product contains nicotine or nicotine salt,
(f) data relating to sales volumes of herbal products intended for smoking by brand and type; the data of the manufacturer and importer shall be submitted for each calendar year by 31 May of the following calendar year at the latest; and
(g) the date of withdrawal of the herbal product intended for smoking from the market, unless the information referred to in (f) has been notified.
(3) Prior to the first notification pursuant to Section 12j (3) of the Act, the manufacturer or importer shall request the portal operator to provide an identification number for the promoter created by the portal operator. The manufacturer or importer shall, upon request, submit information containing his identification data and verification of activities in accordance with the national legislation of the Member State in which he is established. The petitioner's identification number shall be used for all subsequent notifications made via the portal and for any further correspondence with the Ministry of Health.
(4) On the basis of the petitioner's identification number, the manufacturer or importer shall assign to each product to be notified the herbal product identification number for smoking in accordance with the procedure laid down in Commission Implementing Decision (EU) 2015 / 2186. When submitting data on products having the same composition and appearance, the manufacturer and importer shall use the same identification number of the herbal product intended for smoking, unless otherwise provided for in this Decree. This procedure shall apply irrespective of the mark and the product type and the number of markets on which the products are placed. If it is not possible to ensure that products of the same composition and appearance use the same identification number of the herbal product for smoking, different identification numbers of the herbal product for smoking allocated to those products must be provided.
(5) The notification provided for in Articles 12j (3) and 12j (4) of the Act is submitted no later than 2 months before the intended placing on the market. The notification referred to in points (a) to (e) of paragraph 2 shall be submitted before it is placed on the market.
(6) Upon submission of the notification, any information which producers and importers consider to be business secrets or otherwise confidential shall be identified and, at the request of the Ministry of Health, these claims shall be duly substantiated.
Availability of Czech technical standards
Czech technical standards that are used under this decree are published on the website of the Czech Standardisation Agency.
Transitional provision
The notification obligations provided for in paragraphs 6 and 10 for electronic cigarettes and substitutes for cigarettes and herbal products intended for smoking placed on the market before the date of entry into force of this Decree shall be fulfilled no later than the end of the third calendar month following the date of entry into force of this Decree.
Final provision
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Efficacy
This decree shall take effect on the 15th day following its publication.
Minister:
JUDr.
Příloha č. 1
Annex No 1
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Regulation Information
| Citation | Decree No. 37 / 2017 Coll., on electronic cigarettes, refills and herbal products intended for smoking |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 14.02.2017 |
|---|---|
| Effective from | 01.03.2017 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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