Following the adoption of Law of Ukraine No. 4122-IX on 27 March 2025, which entered into force on 27 September 2025, the regulatory framework for placing dietary supplements on the Ukrainian market has significantly changed. The law introduced a notification та визначив procedureand established transitional periods allowing market operators to adapt to the new regulatory requirements.
Key Dates and Transitional Provisions
1) 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.
2) Until 27 March 2026
Products that comply with the previous regulatory framework may still be placed on the market even if they are not yet fully aligned with the new requirements. Such products may remain on the market until the expiry of their minimum durability date (“best before”),but no later than 27 March 2028.
3) From 27 March 2026
All dietary supplements placed on the market must fully comply with the new requirements regarding product composition and labeling.
Documentation Submitted During Notification
When submitting a dietary supplement notification, the following documentation must be provided:
- information on the product composition;
- packaging artwork / original packaging design;
- a Ukrainian-language label;
- a copy of a notification, authorization or registration document issued in an EU country (if available).
What Businesses Should Pay Attention to Now
Beyond the formal notification procedure, products placed on the market must comply with the applicable regulatory requirements, including:
- requirements related to product composition (ingredients, dosage levels, restrictions and prohibited substances);
- mandatory labeling information;
- the accuracy and legality of health claims, both on product labeling and in advertising materials
It should also be noted that the lists of permitted, restricted and prohibited substancesas well as regulatory approaches to (health claims) may be subject to further updates and revisions. This makes regular review of product composition and marketing communications particularly important.
Regulatory Control and Enforcement: Not Only the Competent Authority
Compliance with dietary supplement requirements is monitored not only by the competent authority — the State Service of Ukraine on Food Safety and Consumer Protection.In practice, the Antimonopoly Committee of Ukraine (AMCU) also evaluates marketing claims and advertising statements for compliance with unfair competition legislationIn 2024–2025, several cases resulted in significant sanctions for the dissemination of misleading or inaccurate information regarding product properties, both on product labels and in advertising materials.
Practical Compliance Checklist for Market Operators
To minimize regulatory risks during the transition to the new regulatory framework, companies are advised to:
- conduct an audit of their dietary supplement portfolio and review product composition for potential restrictions;
- align product labeling with current regulatory requirements (mandatory information, warnings, presentation format);
- review health claims and marketing statements across all channels — labels, websites, marketplaces and social media;
- submit a dietary supplement notification.
Pharma Navigation provides comprehensive regulatory support for dietary supplements, including:
- Registration (notification) in Ukraine
- composition compliance assessment
- Labelling and packaging design development
- Obtaining a Certificate of Conformity (voluntary certification)
- Facility (warehouse) registration and obtaining an operational permit
- Market entry into the EU
- Food supplement notification in Poland
- Food supplement notification in the Czech Republic
- Food supplement notification in Moldova
- Medical and technical translation services