Summary Analysis of Ukrainian Law No. 4122-IX dated December 5, 2024 “On Amendments… regarding improvement of regulation of production and circulation of dietary supplements…”, which comes into force on September 27, 2025
1. General Terms and Entry into Force
The Law comes into force on September 27, 2025
Some provisions come into force immediately after publication, others – within the stipulated timeframes, particularly those defined in Section II of the Law
2. Main Innovations for Business
2.1 Amendments to the Law of Ukraine “On Advertising”
Prohibition of references to therapeutic properties in advertising and promotion of dietary supplements, food products for medical purposes or weight control
These restrictions apply to all forms of marketing, sponsorship, product placement (Art. 3-1, para. 2, paragraph 5, and Art. 21, part 9 of the Law “On Advertising”) — detailed by amendments to these articles
2.2 Clarifications in the Law of Ukraine “On Safety and Quality of Food Products”
Clear requirements for dietary supplements have been defined, including:
- list of permitted ingredients and their maximum allowable doses, methodology for health impact assessment
- obligation to notify about the intention of first market introduction at least 10 working days in advance;
- maintenance of an official list of such notifications by the authority, which must publish it online
2.3 Market Operator Responsibility
Legal innovations provide fines for violations:
| Violation | Penalty |
|---|---|
| Missing notification about priority market introduction | 20 minimum wages (legal entities), 15 – individual entrepreneurs |
| Keeping prohibited or non-recalled supplements on the market | 50 MW (legal entity), 45 – individual entrepreneurs |
| Non-compliance of ingredient content with doses | 45 MW legal entity, 40 – individual entrepreneurs |
| Use of unauthorized substances/ingredients | 100 MW legal entity, 95 – individual entrepreneurs (Law of Ukraine) |
3. How This Affects the Pharmaceutical Business
Mandatory notification: To introduce a dietary supplement to the market, companies must notify the control authority in advance (at least 10 working days) and wait for inclusion in the official list.
Labeling and dosage requirements: only permitted ingredients in allowable doses.
Strict advertising policy: impossible to claim therapeutic effects in dietary supplement advertising.
Risk of fines: fines up to 100 minimum wages for gross violations.
Accountability for changes to regulatory authorities: business must promptly adapt internal procedures, including marketing, production, quality control and compliance with notification deadlines.
4. Practical Steps for Companies
- Update regulatory documents, company standards, marketing materials according to new requirements.
- Develop internal procedures: recipe verification, labeling, notification control to authorities.
- Staff training on new advertising rules.
- Control compliance of actual dietary supplement composition with that declared in the notification.
- Interaction with regulator: notification planning, receiving feedback, retention of certificates about inclusion in the notification list.
Conclusion
Law No. 4122-IX significantly changes the rules for dietary supplement circulation in Ukraine: introduces notification rules, quantitative requirements for ingredients, prohibition of therapeutic claims, strict liability for violations. Business must immediately adapt internal procedures to comply with these requirements and reduce regulatory risks.
If you need a notification template, clarifications regarding labeling or help in building policies – ready to help.
Professional Support from Dextra Law
New requirements for dietary supplements create serious challenges for the pharmaceutical business. Non-compliance can cost up to 100 minimum wages in fines and reputational losses.
The Dextra Law team provides comprehensive legal support for pharmaceutical business:
- Audit of compliance with new legislative requirements
- Development of notification templates and document flow
- Review of marketing materials for compliance with advertising restrictions
- Support of registration and notification procedures
- Development of internal policies and procedures
- Team training on new requirements
- Representation of interests in interaction with regulatory authorities
Don’t wait for problems – prepare in advance!
Learn more about our services in pharmaceuticals and medicine: https://dextralaw.com.ua/poslugi/farmacevtika-ta-medicina/
Contact us for a consultation regarding adapting your business to new requirements.