Russian GMP inspections

From 2016 for submission of application for new registration in Russia, applicant should provide RU GMP certificate issued by Russian Authority (Minporomtorg).

Duration of RU GMP inspection procedure – approximately 10 months.

State fee – till 50 k$ (up to 5 mln Rubles)

Scheme of procedure of receiving RU GMP.

Schedule of planned GMP ispections could be find on Institute of Medicines and Good Practices site.

State register of issued GMP certificates could by find on Minpromtorg site.

List of legislation:

  1. FL-61

It could be interesting:

  1. Russian Rules of Good Manufacturing Practice (english on-line)
  2. Self-monitoring sheets (for preparation to GMP inspection)
  3. How to get Russian CPP