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Registration of Food Supplement in Belarus

Regulatory Authority

Federal Agency for medicine and health Products

Regulatory Website

https://minzdrav.gov.by/en/

License Validity

Permanant Validity

Fees

BYN 608.

Registration Timeline

2-3 Months

Registration Procedure

There are two stages to the state registration process:

  1. Submission of the application, necessary documentation, and the expert conclusion to the Republican Center for Hygiene, Epidemiology, and Public Health of the Republic of Belarus to obtain a registration certificate;

  2. Submitting the necessary documentation to the accredited institution for carrying out the complex studies to obtain an expert conclusion.

Documents Required for Food Supplement in Belarus

1) Application form and documents attached:

  • Authorized Power of Attorney from the applicant to the representative;
  • Certified copies of the GMP Certificates for all manufacturing sites involved in the manufacturing process issued by the competent authorities of countries-manufacturers (if available);
  • Certified copies of the documents pertaining to the production of a food supplement (standards, technical conditions, regulations, technological instructions, specifications, recipes, composition information);
  • Certified copies of the manufacturer’s
  • Declaration regarding the presence of GMOs, nanomaterials, hormones, and pesticides in food supplements.
  • A certified copy of the usage instructions or a description of the product’s attributes, such as its composition, form, shelf life, and storage requirements;
  • A certified copy of the free sale certificate, material safety data sheet, quality certificate, or certificate of analysis;
  • Approved prototypes that are suggested for the Belarusian market;
  • Certified copies of papers pertaining to a dietary supplement’s specific activity (for goods with unknown ingredients or unofficial prescriptions); certified copies of the registration certificate granted by the applicant’s or manufacturer’s nation of jurisdiction; and study procedures.

2) Samples of food supplement for conducting the required studies.

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