Сonsultation

Dietary supplements: notification and other requirements of the new Law

We would like to remind you that on 27 March 2025, a new law on dietary supplements was adopted (Law of Ukraine No. 4122-IX “On Amendments to Certain Laws of Ukraine Aimed at Improving the Regulation of the Manufacture and Circulation of Dietary Supplements and Addressing Other Issues in the Healthcare Sector”). The law entered into force six months later, on 27 September 2025, and introduced several transitional provisions: 

  • from 27 September 2025, market operators must notify the competent authority of their intention to place each dietary supplement on the market by submitting a notification;
  • until 27 March 2026, dietary supplements that comply with the requirements of the “old” legislation but do not yet meet the requirements of the “new” legislation may be placed on the market. Such dietary supplements may remain on the market until the minimum durability date or “use by” date, but no later than 27 March 2028;
  • from 27 March 2026, the composition and labelling of all dietary supplements placed on the market must comply with the requirements of the new Law.

Products that are notified and placed on the market must meet the applicable requirements, in particular regarding:

  • composition,
  • mandatory labelling information,
  • health-related claims.

The notification must include information on the composition and a graphic file of the labelling.

The lists of substances permitted for use in dietary supplements, as well as substances prohibited or restricted for use, and the lists of permitted health claims are currently under review.

Please note that compliance of dietary supplements with legislative requirements is monitored not only by the competent authority (the State Service of Ukraine on Food Safety and Consumer Protection), but also by the Antimonopoly Committee of Ukraine (AMCU) for compliance with the Law of Ukraine “On Protection Against Unfair Competition.” In 2024–2025, the AMCU imposed significant fines on market operators for disseminating false information about the properties of dietary supplements, both on labelling and in advertising.

We professionally provide regulatory and legalization services for dietary supplements, baby food, food for special medical purposes, and weight control products. Our team possesses the required knowledge, experience, and skills, and our specialists are fluent in English.

We offer:

  • Evaluation of product composition with in-depth analysis of its formulation and assessment of compliance with legislation and relevant category;
  • Review or development of labeling and instructions for use (leaflet);
  • Arrangement of laboratory testing to verify compliance with safety requirements and obtain a product safety report;
  • Preparation and submission of notification for placing on the market dietary supplements, baby food, food for special medical purposes, and weight-control products;
  • Development and implementation of HACCP / ISO 22000 systems;
  • Legal and consulting support for manufacturers and importers.

We provide initial consultations free of charge. Call us at +38 (068) 064-78-31 or +38 (044) 223-61-67, email us at info@cratia.ua, or visit us in our office for a personal meeting.

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We professionally perform registration of medicines, conformity assessment of medical devices, certification of cosmetics, disinfectants and special food products in Ukraine.
Our partners, international corporations and national manufacturers can best tell about our expertise and quality of work. For more than 15 years of work we have performed works for:

  • more than 150 manufacturers of medicines and active substances,
  • more than 800 manufacturers of medical devices and equipment,
  • more than 300 manufacturers of special food products and cosmetics.
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