Medicines and Supplements Registration

Registration of medicines and dietary supplements

Medicines and dietary supplements cannot be imported and placed on the market without permit procedures, and these differ. We determine what exactly your goods need — state registration, a license or a notification — and arrange the paperwork. The service is for companies and sole proprietors across Ukraine — Kyiv, Odesa, Kharkiv, Dnipro.

Medicines and supplements — different regimes

The key thing to understand: a medicinal product and a dietary supplement are different categories. A medicine goes through state registration in the Ministry of Health system, while a dietary supplement is a food product that is not registered but requires a notification. A category error is a common cause of delays at the border, so that is where we start.

State registration of medicines

A medicinal product is allowed on the market only after state registration. The materials are assessed by the State Expert Center of the Ministry of Health (SEC), after which the product is entered into the State Register of Medicinal Products of Ukraine. Without this, the product cannot be imported or sold.

License for the import of medicines

In addition to registration of the product itself, the import of medicinal products (except active pharmaceutical ingredients) requires an import license. It is issued by the State Service of Ukraine on Medicines, which licenses the production and import of medicines. This is a procedure separate from state registration.

Dietary supplements: notification of market placement

Dietary supplements are not registered. Instead, the market operator submits a “Notification of intention of first placement on the market” of a dietary supplement to the State Service for Food Safety and Consumer Protection. Under the new legislation, submitting such a notification is mandatory from 27.09.2025.

Procedure and terms of notification

The notification is submitted in electronic or paper form. Within 10 working days from receipt, the State Service enters the supplement into the official list on its website. Together with the notification, a sample of the label or sticker in Ukrainian is submitted.

Labelling requirements for supplements

A dietary supplement label must contain the composition, the recommended daily portion, warnings and a mandatory note that it is not a medicine. Incorrect or incomplete labelling is grounds for problems on import, so it is prepared in advance.

Baby and special-purpose food

A similar notification regime applies to baby food, food for special medical purposes and weight-control products. These categories are also overseen by the State Service for Food Safety, and they too require a notification before market placement.

International safety certificate on import

On import, dietary supplements are accompanied by an international safety certificate confirming the quality of the product in the country of origin. We assemble the document set for a specific shipment in advance so the cargo does not stop at customs. The UKT ZED code helps determine the category of goods.

Documents and customs

The registration certificate, license or confirmation of the supplement’s entry into the list go to customs together with the invoice, foreign-trade contract and certificates. For goods that overlap with food regulation, a sanitary-epidemiological conclusion may also be required. The consistency of the set and clearance are handled by our customs broker.

How we handle registration

Frequently asked questions

Registration of medicines and supplements with Trans-Hope

Trans-Hope determines the category of goods, prepares registration of a medicine via the SEC or a notification for a dietary supplement, arranges the import license and handles clearance. Send the description and composition of the goods — we will tell you which procedure is needed and arrange it.