Food Supplements Regulatory Support in Ukraine

Overview

A food supplement is commonly known as a dietary supplement in Ukraine. It can be defined as a product taken in addition to the regular diet and has a concentrated source of nutrients, proteins, fats, carbohydrates, vitamins and mineral substances. Food supplements are manufactured in the form of tablets, capsules, draggers, powders and liquids. The Ukraine food registration, import and sale are regulated by the Ministry of Health (MOH), Ukraine, under the following laws:

  • On Basic Principles and Requirements for the Safety and Quality of Food Products
  • On State Control over Compliance with laws on Food Products, Feedstuffs, Animal By-products, Animal Health and Well-being
  • On Information for consumers about Food Products

The MOH – Ukraine regulation is crafted in a way to ensure the safety and quality of the food products. The Ministry is constantly refining the system and bringing the Ukrainian safety legislation to international standards.

The growing population and demand for food products are resulting in forming a big market for Dietary supplements in Ukraine.

Classification of Food Supplements

According to the Ukrainian Food Safety Law, a dietary supplement is a food product consumed in small quantity in addition to the ordinary diet. It is a concentrated source of nutrients, proteins, fats, carbohydrates, vitamins and minerals. It is presented in the form of tablets, capsules, pills, powders, liquids or other orally injectable forms.

Registration of Food Supplements

Generally, food supplements are not subjected to mandatory registration in Ukraine. But, to confirm the safety & quality of the product, a Voluntary Certification should be obtained. The Voluntary Certification confirms the quality and safety of the product. Any company, resident or non-resident of Ukraine - may be an Applicant/Market Authorization Holder (MAH) for food products in Ukraine.

Steps to be followed for the Voluntary Certification:

  • Submission of Dossier along with the following documents
    • Power of Attorney – Manufacture should grant a POA to the MAH and submit it to the agency
    • Certificate of analysis, Quality certificate and production license (if applicable)
    • Certificate issued by the competent authority of the country of origin and confirming the suitability of the food for human consumption.
    • Manufacturer's registration document (MA)
    • List of ingredients on the manufacturer's letterhead
    • Certificate of analysis on the manufacturer’s letterhead (CoA)
    • Non-GMO declaration
    • Declaration of radiological and pesticide compliance
  • Laboratory analysis & obtaining an expert opinion from the laboratory
    • Submit product samples
    • Submit dossier
    • Make payments

For special food products intended for administration to children under 3 years old, for pregnant women and women planning pregnancy, it is recommended to obtain an expert opinion from the Institute of Paediatrics, Obstetrics and Gynaecology.

Freyr Expertise

  • Regulatory Consultation and Strategic Support on Submission Roadmaps and Procedures
  • Regulatory Roadmap for Market Access
  • Authorized Agent Support
  • Regulatory Affairs & Regulatory intelligence
  • End-to-end Operational Support and Food Product Registration
  • Dossier Preparation, Review and Management
  • Voluntary Certification Submissions and Approvals
  • Query Support Management till Voluntary Certification
  • Product Information Leaflet (PIL)
  • Regulatory Labeling
  • Ad-hoc Regulatory Affairs Consultation

 

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