- Power of Attorney issued by the manufacturer to the authorized company for carrying out registration process on the territory of the Russian Federation.
- The Certificate of Pharmaceutical Product (CPP).
- The Free Sales Certificate (FSC).
- The license of pharmaceutical manufacture.
- The GMP (Good Manufacturing Practice) certificate.
- 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.
- The original of Certificate of analysis of the active substance and subsidiary components.
- The Certificate of registration in other countries.
- Information about the price of the product (forecast of the price CIP Russia and existing price in the country of original).
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.
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).
- The stability data of three drug series confirmed the declaring use-by date.
- The information of the material used for package: Certificates of the packaging materials and package, allowed use it for medical purposes.
- The color design of the consumer primary, secondary package (original + project of packing in Russian version)
- Samples of the substance and standard samples (RS) for pharmaceutical (laboratory) expertise.