{"id":6223,"date":"2026-10-07T21:10:54","date_gmt":"2026-10-07T19:10:54","guid":{"rendered":"https:\/\/www.alden.ua\/placing-dietary-supplements-on-the-market-new-market-regulations-in-ukraine\/"},"modified":"2026-10-09T00:25:37","modified_gmt":"2026-10-08T22:25:37","slug":"placing-dietary-supplements-on-the-market-new-market-regulations-in-ukraine","status":"publish","type":"post","link":"https:\/\/www.alden.ua\/en\/placing-dietary-supplements-on-the-market-new-market-regulations-in-ukraine\/","title":{"rendered":"Placing dietary supplements on the market: the regulatory framework, notification and safety requirements in Ukraine"},"content":{"rendered":"\n

The dietary supplement market in Ukraine has finally moved away from outdated authorisation mechanisms towards the European model of notification and supervision of market operators. The fundamental regulatory principle is that a dietary supplement is a food product<\/strong>, rather than a medicinal product or a substance subject to separate authorisation. <\/p>\n\n

This means that it is fully subject to the basic requirements of food legislation regarding safety, traceability, the HACCP system and registered facilities \u2014 in conjunction with specific rules on dosage, laboratory validation and prior notification to the competent authority.<\/p>\n\n

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Status of the transitional period:<\/strong> The deadline for submitting notifications regarding dietary supplements that were already in circulation prior to 27 September 2025, as set out in paragraph 2 of Part 1 of Article 32-2 of the Law of Ukraine No. 771\/97-VR, ended on 27 September 2026<\/strong>. At present, the lawful marketing of any dietary supplement is possible only provided that the current notification procedure is followed and the relevant information is included in the public Register for sale to consumers. <\/p>\n<\/blockquote>\n\n

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1. Regulatory map: current requirements and their impact on business<\/h2>\n\n
Requirement \/ Scope<\/th>A rule in force (a provision of the law)<\/th>Implications for business<\/th><\/tr><\/thead>
Market authorisation for the market (notification)<\/strong><\/td>Submission of a notice of intent regarding the first placing on the market to the State Service of Ukraine for Food Safety and Consumer Protection at least 10 working days prior to the placing on the market (Article 32-2 of Act No. 771\/97-VR <\/em>).<\/td>This procedure does not constitute registration of the medicinal product. Its placing on the market is not subject to a separate decision, but sale to the end user is permitted only after a notice has been published in the List. <\/td><\/tr>
Power registration<\/strong><\/td>The notification must include the personal registration number of the facility registered under Article 25 of Law No. 771\/97-VR ( clause 3, part 2, Article 32-2<\/em>).<\/td>Market operator power (production, storage, distribution) must be entered in the State register of capacities by the time of submission of the notification notification.<\/td><\/tr>
Formulation (vitamins and minerals)<\/strong><\/td>Only substances and forms included in the positive lists are permitted; the minimum content in a daily ration is at least 15 per cent<\/strong> of the reference value; maximum doses are determined in accordance with the following hierarchy: EFSA UL \u2192 EFSA Safe Level \u2192 annexes to the order (Ministry of Health Order No. 1114<\/em>).<\/td>Formulations require a mandatory nutrient audit. It is prohibited to declare ingredients in trace amounts (<\/td><\/tr>
Restricted and prohibited substances<\/strong><\/td>Clear limits and specific warnings regarding EGCG in green tea and red yeast rice; a ban on ephedra, yohimbe and certain aloe compounds (Ministry of Health Order No. 1613<\/em>). A ban on substances found in prescription medicines ( Clause 2.2 of Order No. 1114 <\/em>).<\/td>A mandatory inspection of complex and plant-based preparations is required prior to import or manufacture. Any breach will result in a direct fine of up to 100 minimum monthly wages. <\/td><\/tr>
Labeling <\/strong><\/td>Mandatory disclaimers, name \u2018dietary supplement\u2019 (Order of the Ministry of Health No. 1114<\/em>, Law No. 2639-VIII<\/em>); prohibition of therapeutic properties (Act No. 270\/96-Verkhovna Rada<\/em>); use of health claims exclusively in accordance with the rules of the Order of the Ministry of Health No. 1145<\/em>.<\/td>Labelling must be approved in the final layout before the notification is submitted. Any visual discrepancies between the packaging on the shelf and the published layout will result in a separate fine. <\/td><\/tr>
Laboratory justification<\/strong><\/td>The declared nutrient levels must be based on the manufacturer\u2019s laboratory analyses (paragraph 3.8 of Order No. 1114 <\/em>); compliance with standards for pollutants (Order No. 368<\/em>) and microbiology (Order No. 548<\/em>).<\/td>Tests must be carried out to confirm the actual content of active ingredients and the relevant safety parameters within the framework of HACCP.<\/td><\/tr>
Liability<\/strong><\/td>Graduated fines under Article 65 of Law No. 2042-VIII, ranging from 15 to 100 times the minimum wage (MW).<\/td>The regulatory body makes a clear distinction between procedural breaches (where a notice is issued for the first time without a report) and safety breaches at the facility (a fine without a notice).<\/td><\/tr><\/tbody><\/table><\/figure>\n\n
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2. The legal status of dietary supplements and regulatory limits<\/h2>\n\n

According to Article 1 of Law of Ukraine No. 771\/97-VR<\/strong>, a dietary supplement is defined as a food product that meets all of the following criteria:<\/p>\n\n

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  1. Intended for consumption in small, specified quantities as a supplement to the normal diet;<\/li>\n\n\n\n
  2. It is a concentrated source of vitamins, minerals or other substances with nutritional or physiological effects;<\/li>\n\n\n\n
  3. It is sold in measured doses as pre-packaged food product in forms such as capsules, lozenges, tablets, pills, ampoules containing liquids, vials with drop-type dispensers, sachets or dry\/liquid mixtures for measured consumption (Article 32-2(9) of Law No. 771\/97-VR <\/em>).<\/li>\n<\/ol>\n\n

    \u2696\ufe0f The boundary with medicinal products: legal classification<\/h3>\n\n
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    • Direct provision:<\/strong> A dietary supplement is not a medicinal product and must not be prescribed for the treatment or prevention of diseases. It is prohibited to include in its composition any substances that are active ingredients in registered prescription medicines (except in cases expressly permitted by the current lists set out in Ministry of Health Order No. 1114). <\/li>\n\n\n\n
    • Legal opinion:<\/strong> Exceeding the established maximum dose of the active substance does not automatically mean that the product is reclassified as a medicinal product<\/strong>. The direct consequence is a finding that the product does not comply with the requirements for the category of dietary supplements (unlawful marketing of a food product). Any other status of the product is determined separately under the legislation on medicinal products. <\/li>\n<\/ul>\n\n
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      3. The notification procedure and monitoring of the List<\/h2>\n\n

      The notification procedure is governed by Article 32-2 of Law No. 771\/97-VR<\/strong> and Ministry of Agrarian Policy Order No. 244<\/strong>.<\/p>\n\n\n

      \n \n \n
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      1<\/div>\n
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      Formula audit + Label designs<\/h4>\n

      Verification of composition and labelling, and label design.<\/p>\n <\/div>\n <\/div>\n\n \n

      \n
      2<\/div>\n
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      Registration of a market operator\u2019s capacity<\/h4>\n Section 25 of the Act <\/span>\n

      Compulsory state registration for food business operators.<\/p>\n <\/div>\n <\/div>\n\n \n

      \n
      3<\/div>\n
      \n

      Submission of a notification to the State Service for Food Safety and Consumer Protection<\/h4>\n
      \n \u23f3 Time taken for consideration by the authority: up to 10 working days<\/strong>\n <\/div>\n <\/div>\n <\/div>\n\n \n
      \n
      4<\/div>\n
      \n

      Entry of information and publication in the List<\/h4>\n

      Official inclusion of products\/capacities in the state register.<\/p>\n <\/div>\n <\/div>\n\n \n

      \n
      \u2713<\/div>\n
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      Lawful sale to end consumers<\/h4>\n

      Full, legal market launch of products without the risk of fines.<\/p>\n <\/div>\n <\/div>\n\n<\/div>\n\n\n