The list of necessary documents for registration of medicinal immune-biological preparations (MIBP) at the Ministry of Health Care

  1. Power of Attorney issued by the manufacturer to the authorized company for carrying out registration process at the MOH (prescribed form).
  2. The Certificate of Pharmaceutical Product.
  3. The Free Sales Certificate.
  4. The license of pharmaceutical manufacture.
  5. The GMP (Good Manufacturing Practice) Сertificate of drug.
  6. The GMP (Good Manufacturing Practice) Сertificate of active pharmaceutical ingredients/intermediate of MIBP.
  7. 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.

  1. The copy of registration certificate in the country of original (notary’s copy).
  2. Information about registration of the drug in other countries.
  3. The copy of Certificate of trade mark, patent, license agreement (If it’s applicable).
  4. The original Certificate of analysis of the finish product (full name, address, phone or fax of the manufacturer) for 3-5 batches.
  5. The Certificate of analysis of all subsidiary components.

Data of the drugs manufacturing:

  1. Summary scheme of the manufacturing process and in-process control methods.
  2. Material balance (a comparison of the theoretically possible and practically received material leaving of the end product).
  3. Analytical methods of control of manufacturing stages and intermediary products
  4. Validation and/or classification of the process;
  5. Substantiation of choice of the manufacturing method.
  6. The General data on structure of a preparation with the instruction of final concentration of all reagents used in technological process and added in a preparation, with the description of methods of their control.

Data of analytical control methods:

  1. Specifications and analytical procedures:

    • -Specifications and the complete description of the quantitative and qualitative control methods with the references to the pharmacopoeia (in details).
    • -Requirements to a intermediate of MIBP, the detailed description of a quality monitoring of those parameters of the intermediate of MIBP, which cannot be certain in a ready products.
    • -The full and detailed description of a quality monitoring and requirements to quality industrial strains and substrata for manufacturing products (a line of cultures of cells, embryos, etc.).
    • -The complete description of the quantitative and qualitative control methods with the references to the pharmacopeia and specification.
  2. Substantiation of specification;
  3. The patterns of the spectrums and chromatograms;
  4. Validation of control methods included into the normative documentation;
  5. The stability data of three drug series in the declaring package confirmed the declaring use-by date.
  6. The original Instruction for medical use.
  7. The report of nonclinical study (description, results and statistic analysis of the given nonclinical study):

    • 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 local irritative effects)
  8. The summary information about drugs safety and efficiency (immunobiological, preventive, clinical, diagnostic) of the drug.
  9. The report of the results of the international multi-center clinical trials, part of which were provided in Russian Federation. (If it’s not applicable
  10. see pts. 28-31)
  11. The Clinical Trial Protocol
  12. The Clinical Investigation Brochure
  13. The Patient Information Sheet
  14. Information about pays and compensations to patients and healthy volunteers.
  15. The Protocol of their own Clinical Trials, 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).
  16. Periodic safety update reports (during 5 last years).
  17. The information of the material used for package: Certificates of the packaging materials and package, allowed use it for medical purposes.
  18. The color design of internal and external packages
  19. Samples of the drug and API for the binding examination of quality (should be in the standard package) for pharmaceutical (laboratory) expertise.
  20. The standard samples for quality control (if the usage of standard samples is stipulated for quantitative and qualitative analysis according to the normative documentation) for pharmaceutical (laboratory) expertise. If some texts of the control cannot be executed on a ready preparation, raw materials of these series are represented also.

Documents of API/intermediate of MIBP:

  1. The Certificate of analysis
  2. Monograph of Pharmacopeia, if the API is described in the Pharmacopeia.
  3. Data about of manufacturing process (Summary scheme and description of the manufacturing process, material balance).
  4. The stability data of three drug series confirmed the declaring use-by date for all kinds of packages used.
  5. The information of the material used for package.

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