Registration of pharm products


To register a medicinal product in Russia, one has to do the following:

  1. Ask the manufacturers if they are prepared for GMP Inspection of their facility by Russian inspectors in conformity with the new requirements of Russian legislation (they shall be visited by Russian inspectors only!) (see GMP Inspection Section)


    The cost of this procedure is about 2 million rubles. Execution time is 6-8 months (inspection itself takes 2-3 days but submission of documents and a long waiting list for the inspection take 4-6 months)
  2. If the company is ready for such Inspection, it is then specified if clinical or pre-clinical study is required in Russia for the products planned for registration (Clinical study section). Cost of clinical study or bioequivalence study and of the whole Marketing Authorization procedure for the particular medicinal product is negotiated
  3. Putting together documents, submitting them and appointing a date of manufacturer(s) inspection for the compliance to GPM requirements
  4. Preparing documents, obtaining authorization for CS/BS and conducting CS/BS.
  5. Putting together Registration Dossier.
  6. Submitting Registration Dossier to the Ministry of Public Health for registration (the Dossier shall already include Russian GMP Certificate and Clinical Study/Bioequivalence Study in Russia Report).
  7. Passing medicinal product quality evaluation report and Benefit-Risk evaluation report.
  8. Issue of Marketing Authorization.

On the average, period of obtaining Marketing Authorization (from i.6 to i.8) ) takes 10-12 months (including stop-times for answers to requests from the Russian Ministry of Public Health). Pre-registration procedures (i.1-5) on the whole take 8-12 months and are conducted concurrently.

More detailed information on the registration of medicinal products see in MP Registration Section.

Total period of obtaining Marketing Authorization for one medicinal product is 22 -24 months.