State registration of food (dietary) supplements (passing sanitary-epidemiological expertise) in Ukraine
Import and sale of food (dietary) supplements in Ukraine without positive conclusion of sanitary-epidemiological expertise and approval of labeling by the Ministry of health is forbidden. State registration of food (dietary) supplement is proved by positive conclusion of sanitary expertise. Then food (dietary) supplement is included into the State Register of food products of dietary consumption, functional products and dietary supplements. The certificate’s details are to be printed on the food (dietary) supplement’s label. According to the Ukrainian legislation it takes up to 3 months to obtain registration of food (dietary) supplement in Ukraine.
To register the food supplement (special food product), it is required to preliminary obtain veterinary or phytosanitary permit and customs code confirmation. Legal presence in Ukraine is not required for registration.
Food (dietary) supplements are not subject to mandatory certification. Therefore, certification may be conducted voluntarily.
The list of documents (registration dossier) required to complete state registration of food (dietary) supplements (pass sanitary-epidemiological expertise) includes:
- an application for registration;
- an explanatory note (specification) to the application with detailed information on food (dietary) supplement (physical-chemical and biological requirements (appearance, average weight, microbiological purity etc.);
- official documents of the country of the manufacturer certifying the required safety parameters, minimum quality specifications, information about specific effects, food (dietary) supplement composition (certificate of analysis, manufacturer declaration, registration data from the manufacturer or other similar documents from the country of manufacture, GMP, ISO or similar documents);
- text of labeling in Ukrainian language and instruction for use (e.g. recommendations for use, side effects, precautions, storage conditions and shelf-life, composition should be specified for one unit of the finished product: tablet, capsule etc., including all components. If product has “E” index, it should be specified), pictures of inner and outer package;
- scientific report, research results issued by authorized institutions on basic components (microbiological, chemical, biological, scientific reports, trial protocols, toxicological test, results of preclinical and clinical studies, certificate of quality, declaration of radiological control and control of pesticides for products of herbal origin);
- samples of food (dietary) supplements (at least 300 grams, which are imported based on special permission of MOZ);
- a power of attorney, certified by apostille;
- documents proving state registration of foreign company applicant (company or court register, notification issued by chamber of commerce, etc.);
- description of legal relations between manufacturer and distributor (if food supplement sold not by manufacturer), e.g. letter of authorization, distribution contract, etc;
- list of countries where food supplement (dietary supplement) is registered and copies of such certificates;
- description of production process, technical conditions (flow-chart) and quality control process (applicant takes responsibility for quality and safety of the product), licenses or permissions for manufacture of food supplements, parapharmaceutical products;
- risk assessment for products containing genetically modified organisms. (declaration that product contains no GMO). copyrigt Marketplace UkrRos LLC www.kpl.net.ua