Registration of dietary supplements

When a business says “register a dietary supplement,” a lawyer usually clarifies: do you mean state registration of a medicinal product, or completion of the procedures for placing it on the market as a food product? In Ukraine, dietary supplements are classified as food products, so the regulatory logic here differs from that for medicinal products. The basic rules are established by the Law of Ukraine “On the Basic Principles and Requirements for Food Safety and Quality.”

Below we explain which steps are actually required, which documents need to be prepared, and where businesses most often “stumble.”

New reality from 27.09.2025: notification of first placing on the market

From 27 September 2025, a special procedure has been introduced for dietary supplements: a market operator that places a dietary supplement on the market for the first time must submit a notification to the competent authority (the State Service of Ukraine on Food Safety and Consumer Protection) no later than 10 working days in advance.

This is not a “permit” in the classical sense, but it is a mandatory step that must be completed correctly: product name, market operator details, package of annexes, method of submission, signature (qualified electronic signature or handwritten), etc. The State Service of Ukraine on Food Safety and Consumer Protection separately clarifies the submission channels (paper/electronic) and formatting requirements.

Composition and “hygienic boundaries”: what is allowed and what is not

In addition to the general “food” law, the Hygienic Requirements for Dietary Supplements approved by Order of the Ministry of Health No. 1114 apply. These, in particular, set out approaches to safety, as well as lists/limitations for certain ingredients (vitamins, minerals and their forms, etc.).

In practice, the most high-risk areas are:

• “medical” ingredients or dosages that trigger claims from supervisory authorities regarding incorrect classification (food product vs medicinal product);
• non-compliance of the composition with the declared labeling/specification;
• lack of an evidence base regarding raw material quality and stability.

Labeling and prohibited claims: the label as a legal document

Labeling of dietary supplements must comply with the Law of Ukraine “On Information for Consumers Regarding Food Products.” The State Service of Ukraine on Food Safety and Consumer Protection also publishes practical lists of what must be included on the label (name, composition, allergens, quantity, shelf life, storage conditions, etc.).

In addition, Order of the Ministry of Health No. 1114 directly specifies special requirements for labeling dietary supplements (in particular, regarding the method of consumption/warnings).

Critically important: a dietary supplement does not treat diseases. Therefore, any “therapeutic” claims on the label, website, or in advertising often become the reason for orders, fines, and withdrawal from sale.

Market operator documentation: what is prepared before launch

In an “ideal world,” before the first placing on the market you should have a neat folder where everything is brought together into a single product history:

• specifications for raw materials and the finished product;
• contracts with the manufacturer/contract manufacturing, batch traceability;
• test reports (if necessary) and internal control procedures;
• label layouts and marketing materials checked for legal risks;
• a package for notification to the State Service of Ukraine on Food Safety and Consumer Protection (with correct details, signature, and annexes).

Inspections and liability: who supervises and what they ask about

Control in the food sector is carried out within the framework of the Law of Ukraine on state control (inspections, sampling, orders, restrictive measures).

That is, after entering the market there is no “finish line”: there is a compliance regime that must be maintained through documentation and processes.

It is also worth mentioning fines, because they are usually what “wake up” businesses from the illusion that dietary supplements are simpler. For violations of legislation in the field of food safety and quality (including placing on the market without proper notification, incorrect labeling, or dissemination of misleading information), significant financial sanctions are предусмотрені. For market operators, these may be fines ranging from tens of thousands to hundreds of thousands of hryvnias, depending on the nature of the violation, its recurrence, and its consequences.

Additionally, orders to eliminate violations, temporary bans on sales, withdrawal of product batches from circulation, and in some cases obligations to recall the product from the market may apply. In practice, this means not only direct financial losses, but also suspension of sales, disrupted contracts, and reputational risks that often cost more than the fine itself.

How we can help (turnkey support)

Legal support for registration/placing dietary supplements on the market usually includes:

• product audit: composition, positioning, risk of reclassification;
• preparation of the document package and notification to the State Service of Ukraine on Food Safety and Consumer Protection within the established deadlines;
• review of labeling and advertising materials for compliance with legal and Ministry of Health requirements;
• preparation for possible inquiries/inspections and communication with supervisory authorities.

If you are planning to launch a dietary supplement in Ukraine (or have already received comments regarding labeling/advertising), write to us: we will conduct an express risk assessment and propose a roadmap for placing it on the market.