Regulatory Authority

Federal Agency for medicine and health Products

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

Permanant Validity

2-3 Months

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.

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.