On March 25, 2025, the President of Ukraine signed Law of Ukraine "On Amendments to Certain Laws of Ukraine on Improving the Regulation of Production and Circulation of Dietary Supplements and Settlement of Other Issues in the Healthcare Sector” No. 4122-IX of December 5, 2024 (hereinafter referred to as the Law).
Key regulatory changes stipulated by the Law are as follows:
(1) the definition of “dietary supplement” (hereinafter referred to as DS) is set out in a new revision;
(2) the obligation of market operators to send to the State Service of Ukraine on Food Safety and Consumer Protection a notification in paper or electronic form of the intention to first place a DS into circulation at least 10 business days before placing the DS to the market has been introduced;
(3) the obligation of market operators to submit a notification to the State Service on Food Safety and Consumer Protection of Ukraine within 6 months of the Law's enactment, indicating intention to first place a DS on the market if it was already available in the territory of Ukraine before the Law took effect and is planned to be put into circulation after the Law is implemented;
(4) it is determined that only substances included in the list of vitamins, minerals and other components and their maximum allowable doses for use in DS may be used in DS production;
(5) new offenses related to the production and circulation of DS have been determined.
Once signed by the President of Ukraine, the Law shall be published in official printed publications of legislative entities.
The Law shall come into effect the day after its publication, however shall be fully enforced only 6 months after it takes effect (with certain exceptions).
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