The list of necessary documents for registration of foreign drugs on the territory of Belarus

  1. Power of Attorney issued by the manufacturer to the authorized company for carrying out registration process on the territory of Belarus (prescribed form).
  2. The Certificate of Pharmaceutical Product.
  3. The Free Sales Certificate.
  4. The copy of registration certificate in the country of original.
  5. The contract between the manufacturer and the marketing authorization holder (if it is applicable).
  6. The license on the manufacture of the drug.
  7. The GMP (Good Manufacturing Practice) Сertificate of drug.
  8. Certificates of legal registration of holder of the registration in their own country.
    Documents (1-5) should be in the notary’s copies, certified by consular establishments of the Russian Federation or with assurance the Apostille according to the Hague convention.
  9. The copy of Certificate of trade mark, patent, license agreement (if it is applicable).
  10. Information about registration of the drug in other countries.
  11. Information about composition of the drug, including excipients, staining agents, aromatizers, preservative and other components with the refer to normative documents of  quality control.
  12. The color design of internal and external packages
  13. The manufacturer’s declaration containing the data of environment risk assessment (for drug, containing the genetic modificated components)

    Data of the drugs manufacturing:

  14. Summary scheme and description of the manufacturing process
  15. Material balance (a comparison of the theoretically possible and practically received material leaving of the end product).
  16. In-process control methods of manufacturing stages and intermediary products
  17. Validation and/or classification of the process;
  18. Substantiation of choice of the manufacturing method and package.

    Data of analytical control methods:

  19. The Certificate of analysis of the finish product (full name, address, phone or fax of the manufacturer).
  20. Specifications and analytical procedures methods with the references to the pharmacopoeia.
  21. Justification of specification.
  22. The patterns of the spectrums and chromatograms.
  23. Validation of control methods included into the normative documentation.
  24. Data on microbiological purity and determination of antimicrobial effect.
  25. The stability data of two drug series in the declaring package confirmed the declaring use-by date.

    Documents of API:

  26. The Certificate of analysis
  27. Specifications and analytical procedures methods with the references to the pharmacopoeia.
  28. Monograph of Pharmacopeia, if the API is described in the Pharmacopeia.
  29. Data about of manufacturing process (Summary scheme and description of the manufacturing process, material balance).

    Documents of excipients:

  30. Specifications and analytical procedures methods.
  31. Monograph of Pharmacopeia, if the API is described in the Pharmacopeia.

    Pharmacological data:

  32. The original Instruction for medical use.
  33. The report of nonclinical study (except generic drug):
    • The report of the pharmacological (specific) activity study substantiated the indications for use which are formed and described in the instruction
    • The report of the pharmacokinetic study.
    • The test report of the drug toxicity (acute, sub acute, chronic, subchronic toxicity, cumulation).
    • The test report of the specific influences of substances and drugs (cancerogenity, mutagenic and teratogenic effects, embriotoxity, allergic and localirritative effects).
  34. The report of bioequivalence research.
  35. The report of the clinical trial report of drug.
  36. The comparison test of dissolution kinetics (for generic drug).
  37. The copies of publications of the medicine usage in clinics after its registration in the country of origin (the information which concerns only the drug which is produced by this manufacturer).
  38. Periodic safety update reports (during 5 last years).

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