State registration of veterinary drugs in the Republic of Belarus

  1. Statement:
  2. Information about drugs-analogues;
  3. A report on the pilot study of the veterinary drug;
  4. The report on the study of the stability of the veterinary drug;
  5. Scientific reports, articles and reports on the application, real professionals;
  6. Description of the veterinary drug with an indication used in the production of raw material — active substances and excipients, in its composition;
  7. Instructions for use;
  8. Indicators of the quality of veterinary drugs and methods of their control;
  9. Techniques for the detection of residues of pharmacological active ingredient preparation for productive animals in biological tissues (blood, urine) and products derived from animals (milk, meat, eggs, etc.), According to which the instruction is allowed use of the drug;
  10. Samples of the veterinary drug in a series of commodity packaging of the need for testing amounts decorated selection act or an act of reception and transmission of samples;
  11. The manufacturer’s document confirming the quality of the veterinary drug;
  12. Standard samples of the active ingredients (when used in the methods of control);
  13. A document confirming registration in the country of production;
  14. Certificate certifying the production under GMP conditions (if any);
  15. The certificate of registration of the enterprise-producer and production license or other documents confirming the right to manufacture the above products;
  16. Sample ethics in Russian.

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