Dietary supplements

The company "Vikonsalt" offers prompt and professional assistance in obtaining permit documentation for dietary supplements, or as it is customary to call a similar category of products - biologically active additives (BAA)

...our legislation uses the term dietary supplement, not dietary supplement. The need to register a dietary supplement is determined by its composition and use...

In Ukrainian legislation, there is no such concept as dietary supplement, but dietary supplement is used. These food products are intended to enrich the diet with individual nutritional elements or whole complexes of biologically active substances.

Types of dietary supplements can be, as vitamin, vitamin-mineral or herbal supplements separately and/or in combination in the form of pills, tablets, powders, taken orally with food, or added to food within physiological norms, for additional, compared to the usual diet, use of these substances; dietary supplements also contain or include various substances or mixtures of substances, including protein, carbohydrates, amino acids, edible oils and extracts of plant and animal materials, which are considered necessary or beneficial for nutrition and general human health.

BAA belong to the category of food products and fall under the scope of the Food Products Law. According to its requirements, domestic enterprises producing dietary supplements must implement a product quality management system in their production in accordance with the principles of HACCP (for more details, see the page HACCP. As for imported products, the recognition of certificates obtained by the manufacturer of the products is provided for.

Also, on March 27, 2025, the Law of Ukraine No. 4122-IX "On Amendments to Certain Laws of Ukraine on Improving the Regulation of the Production and Circulation of Dietary Supplements, and the Settlement of Other Issues in the Sphere of Health Care" (adopted on 05.12.2024) entered into force, which provides for the mandatory submission of a notification of the intention to introduce a dietary supplement into circulation - 10 working days before its release to the market, new requirements for composition, labeling, and information for consumers.

Retail chains and Pharmacies are interested in purchasing dietary supplements, the quality of which has documentary confirmation. Our company can help you with obtaining the following documents:

• Submission of a notification of the intention to introduce a dietary supplement into circulation.
• Research protocol for a batch of products - confirms the compliance of the products with the current regulatory documentation for safety indicators, in particular the content of heavy metals and microbiological indicators. In the case of import of dietary supplements, such a protocol is issued for the volume of the imported batch of products, and in the case of domestic production - for a certain amount of manufactured products.
• Label text approval - confirms the correctness of the information on the packaging and its compliance with the legislation on dietary supplements.
• Report on the classification of products as dietary supplements - confirms that your products are not just a food product, but have the properties of dietary supplements and can be used as an additional source of nutrients. Such a report contains an agreed the text of the product label, which is especially relevant for manufacturers and importers in case of questions about the correctness of the labeling and the amount of information that must be displayed on the label.
• Voluntary certificate of conformity - shows the compliance of the product with safety requirements in accordance with the current regulatory document and is issued by a competent accredited body. Such a document will be relevant for increasing the prestige of the product during sales, as well as for importing products.

To obtain such documents, it is necessary to provide samples of the dietary supplement for testing, as well as the following documents:

• statement of the established sample;
• recommendations for use (instructions);
• specification;
• documents of the country of manufacture certifying the safety and quality of the registration object;
• normative document and technical documentation according to which the object was manufactured;
• data on registration in the country of manufacture of the registration object (for foreign products) and a list of countries where it is registered;
• if available, scientific reports, research protocols and other information on the safety and quality indicators of the registration object.

All documents must be provided in the form of copies, notarization is not required. If copies are taken from originals in a foreign language, the documents must be translated into Ukrainian or Russian.

Depending on whether you are a manufacturer with specific goals and knowledge of the matter, an official representative in Ukraine, or simply an entrepreneur with an idea that you need to implement, our company also offers related services in:

• development of recipes for dietary supplements;
• development and registration of Technical Conditions (the main regulatory document) for the production of dietary supplements, with their subsequent approval by the relevant executive authorities and registration;
• obtaining an expert opinion on determining the customs code of the Ukrainian Classification of Economic Activities for products, in order for you to undergo customs control when importing products into Ukraine;
• receiving a refusal letter (clarification on the optional certification of products) - when importing products for customs; receiving special recommendations on the action and composition of the additive, if it contains substances of plant and animal origin, for which there are no Ukrainian regulations and standards.

Advantages of cooperation with our company:

• We have extensive experience and knowledge of the registration process;
• All our obligations are specified in the Agreement. High-quality and timely fulfillment of obligations for each Customer is the basis of our philosophy, and a distinctive characteristic in front of our competitors;
• Thanks to compliance with the requirements of the law and the correct submission of registration materials - we have established good relations with state authorities.

...Certification, although voluntary, is very useful for sales, etc., confirms the quality and other qualities of the product...