The list of necessary documents for registration of the drugs 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.
  7. Certificates of legal registration of holder of the registration in their own country.

Documents (1-7) 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.

Data of analytical control methods:

  1. Specification and the complete description of the quantitative and qualitative control methods with the references to the pharmacopoeia.
  2. Substantiation of specification;
  3. The patterns of the spectrums and chromatograms;
  4. Validation of control methods included into the normative documentation;
  5. Data on microbiological purity and determination of antimicrobial effect.
  6. The stability data of three drug series in the declaring package confirmed the declaring use-by date.
  7. The original Instruction for medical use.
  8. 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 localirritative effects)
  9. The summary information of the clinical trial report of drug (pharmacokinetic, efficacy and safety).
  10. 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
  11. see pts. 28-31)
  12. The Clinical Trial Protocol
  13. The Clinical Investigation Brochure
  14. The Patient Information Sheet
  15. Information about pays and compensations to patients and healthy volunteers.
  16. 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).
  17. Periodic safety update reports (during 5 last years).
  18. The information of the material used for package: Certificates of the packaging materials and package, allowed use it for medical purposes.
  19. The color design of internal and external packages
  20. Samples of the drug and API for the binding examination of quality (should be in the standard package) for pharmaceutical (laboratory) expertise.
  21. 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.

Documents of API:

  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.
8 comments on “The list of necessary documents for registration of the drugs at the Ministry of Health Care
  1. Елена Павлова says:

    Подскажите, пожалуйста, где можно ознакомиться с ценами за услуги в рамках регистрации ЛС, оказываемые Вашей компанией?

    • Добрый день Елена, пришлите нам конкретный запрос на наш электронный адрес. Мы пришлем расценки за наши услуги за регистрацию лекарственного средства по всем этапам. Спасибо.

  2. Александр says:

    Подскажите, пожалуйста, где можно ознакомиться с ценами за услуги в рамках регистрации ЛС, оказываемые Вашей компанией?
    Пожалуйста, пришлите расценки за ваши услуги за регистрацию лекарственного средства по всем этапам. Спасибо.

    • Добрый день, Александр,
      стоимость услуг по регистрации лекарственных средств зависит от самого лекарственного средства, об количества одновременно начатых проектов, от объема заказываемых Вами услуг.
      Пришлите конкретный запрос и мы сделаем расчет по стоимости наших услуг.

  3. Диана says:

    На уже зарег-й препарат в РФ хотим дополнительно внести ещё др. производителя на все стадии производства.
    Данная подача изменения (Внесение допол. произв. площадки с фарм. экспертизой ) затронет как НД в части методик так и Инструкцию.

    какую нужно оплатить госпошлину?

    • Добрый день, Диана,
      Если будет менять информация в разделе “Состав”, госпошлина будет составлять 145000,00 рублей и 70000,00 рублей за внесение изменений в инструкцию.

  4. Юлия says:

    Вышлите, пожалуйста, на указанный электронный адрес прайс на услуги по регистрации лекарственных средств.

    Нас интересует стоимость услуг на внесение изменений в регистрационное досье, требующие проведение экспертизы качества и не требующие проведения экспертизы качества.

    • Добрый день, мы отправили на ваш адрес наш прайс, но он приблизительный, т.к. стоимость зависит от конкретно поставленной задачи.

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