Russian BE requirement [Regulatives / Guidelines]

posted by mittyri – Russia, 2016-05-18 09:09 (2871 d 03:54 ago) – Posting: # 16320
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Hi Rasha_J,

If you need to register your MP as BEQ product in Russia, you need more than just to be an approved CRO.
I would suggest the following plan:
  1. to discuss with your Russian registration department or company which can do the registration steps in Russia the Plan of Drug investigation
  2. to contact with Russian CRO
Please note that it is impossible to register the MP in Russia without conducting the study in Russia. Most of BEQ sites are affiliated with the CROs and only russian CROs know all tricks and traps of study submission to MOH (yeah, a lot of!). If you don't have an experience of study submission in Russia, don't waste your money and efforts and delegate it.
Good luck (you'll need it)!

Kind regards,
Mittyri

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