The list of necessary documents for the registration of substances at the Ministry of Health Care

  1. Power of Attorney issued by the manufacturer to the authorized company for carrying out registration process on the territory of the Russian Federation.
  2. The Certificate of Pharmaceutical Product (CPP).
  3. The Free Sales Certificate (FSC).
  4. The license of pharmaceutical manufacture.
  5. The GMP (Good Manufacturing Practice) certificate.
  6. Certificates of legal registration of manufacturer 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 original of Certificate of analysis of the active substance and subsidiary components.
  2. The Certificate of registration in other countries.
  3. Information about the price of the product (forecast of the price CIP Russia and existing price in the country of original).
  4. Data of the substance manufacturing.

    • Summary scheme of the manufacturing process and in-process control methods.
    • Analytical methods of control of manufacturing stages and intermediary products.
    • Validation and/or classification of the process.
    • Substantiation of choice of the manufacturing method.
  5. Data of analytical control methods.

    • The complete description of the quantitative and qualitative control methods with the references to the pharmacopeia and specification. The patterns of the spectrums and chromatograms.
    • Validation of control methods included into the normative documentation.
    • Substantiation of the specification (substantiation of the list of quality indices and methods of control).
  6. The stability data of three drug series confirmed the declaring use-by date.
  7. The information of the material used for package: Certificates of the packaging materials and package, allowed use it for medical purposes.
  8. The color design of the consumer primary, secondary package (original + project of packing in Russian version)
  9. Samples of the substance and standard samples (RS) for pharmaceutical (laboratory) expertise.

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