The recent amendments to the Tobacco Law have brought about substantial changes in the regulation of tobacco and related products in the Republic of Serbia. Enacted through the Law on Amendments and Supplements to the Tobacco Law (“Official Gazette of the Republic of Serbia”, No. 92/2023 – hereinafter: the Law), these changes, effective from November 4, 2023, aim to enhance public health, mitigate the adverse effects of smoking, and fortify tobacco control efforts. Notably, the Law aligns with the legal provisions of the European Union, specifically Directive 2014/40/EU (hereinafter: Directive), with the goal of fostering a predictable business environment, establishing a legal framework for new products, and improving conditions for company operations.
One of the key changes is the introduction of a new category of electronic cigarettes and related products as distinct product categories, regardless of whether they contain nicotine or not. This category includes various types of electronic cigarettes, such as disposable and refillable vape electronic cigarettes, e-liquids for electronic cigarettes, herbal smoking or heating products, nicotine pouches, and water pipe products.
To oversee the production and import of related products, the amendments establish new registers:
- Register of Producers of Related Products;
- Register of Importers of Related Products;
- Record of Retailers;
The management of these registers and a record fall under the jurisdiction of the Tobacco Department within the Ministry of Finance.
The overarching objective of these regulatory changes include improving public health, reducing smoking-related harm, and fostering a more controlled and transparent environment for the tobacco industry in line with EU standards.
Expansion of existing and introduction of new prohibitions in tobacco and related product trade
The Article 71 of the Law introduces new prohibitions regarding the sale of tobacco and related products. Notably, the legislation prohibits the sale these products to minors and online sales after November 4, 2023. Specifically, the online ordering of electronic liquids, nicotine bases, disposable e-cigarettes, and filled cartridges is prohibited, while devices, batteries, and spare parts remain permissible for online purchase. The law also explicitly prohibits the sale of tobacco and related products in pharmacies and specialized medical supply stores.
Furthermore, the regulatory framework outlines that permits for retail traders and registration in the Register of Related Products will be issued for a specific period. Business activity permits will be issued for a duration of two years, and registration decisions will be valid for a period of five years.
Marking of tobacco products and related products in accordance with Directive
The Law recognizes and regulates the labeling requirements for related products, including their visual elements, text, and the placement of health warnings. What is interesting is that the Law, when prescribing obligation of labeling on related products, makes a distinction between those containing nicotine and those without it. However, regardless of nicotine content, both types of related products are mandate to bear a health warning regarding their harmful nature. Moreover, the labeling requirements for tobacco products align with the Directive, encompassing a range of health warning, including general warnings, informative messages, and textual and combined health warnings.
In conclusion, the Law introduces several new legal provisions and amends existing ones, which will significantly impact the regulated domain. We mentioned some of the main changes and amendments which are designed to enhance public health and reduce the negative effects of smoking, and bring about regulatory order to the market of tobacco and related products in the Republic of Serbia.