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Food Supplement Registration in Ukraine

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Food Supplement Registration in Ukraine

Regulatory Authority

State Service of Ukraine on Medicines and Drugs Control (SMDC)

Regulatory Website

https://www.dls.gov.ua/en/

Registration Timeline

6 Months-1 year

A dietary supplement is defined by the Ukrainian Food Safety Law as a food product that is consumed in small amounts in addition to an ordinary diet. It is a concentrated source of nutrients, such as vitamins, minerals, proteins, fats, and carbohydrates (this list is not exhaustive), and it can take the form of tablets, capsules, pills, powders, liquids, or other forms.

Food Supplement Registration in Ukraine

Dietary supplements do not need to be registered. A Free Sale certificate, a certificate of analysis, or a certificate from the responsible authority of the food’s place of origin attesting to its appropriateness for human consumption can be used to secure customs clearance.

However, getting an expert assessment from the Centers for Disease Control and Prevention that verifies safety for end-user consumption is advised to help simple customs clearance and distribution of specialty food products.

Documents for Food Supplement Registration in Ukraine

(i) The results of laboratory tests to certify the product’s quality;

(ii) A declaration of followed sales areas (for example: pharmacies, specialized stores);

(iii) A confirmation of the product’s classification as «dietary supplement», «food for special medical purposes» or «weight control product».

The dossier to obtain the expert report should include the following documents:

(i) A list of ingredients on the manufacturer’s letterhead;

(ii) Certificate of analysis on the manufacturer’s letter held;

(iii) A non-GMO declaration;

(iv) A declaration of radiological and pesticide compliance;

Labelling

In Ukraine, dietary supplement labeling is governed by Order No. 2639-VIII of 2019 concerning consumer food information.

The following must be included on mandatory labeling, which must be in Ukrainian:

(i) Name of the product and its category (“dietary supplement”).

(ii) The manufacturer’s trademark, which must be transliterated if it is not a registered trademark.

(iii) An ingredient list that is arranged by weight or percentage and includes food additives. The auxiliary ingredients may be listed individually in descending weight or percentage order (per dosage, per 100 g, or per milliliter). The name “Composition should appear before the ingredient list.

(iv) The product unit’s weight and volume as well as the packaging’s weight and volume.

(v) Use-related recommendations.

(vi) The energy value and nutritional makeup (proteins, fats, and carbs) per 100 g of the product.

(vii) Posology and the recommended daily dosage.

(viii) Conditions for storage.

(ix) Net weight of a single tablet, capsule, or dose.

(x) “Expiration date (hours, days, months, or years)” or “expiration (hours, days, months, or years)” is the expression used to describe shelf life.

(xi) Side effects (where applicable), cautions, and contraindications (for specific types of disorders)

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