Registration of Drugs in Russian Federatrion should be performed in accordance to Federal Law 61.
Who: Ministry of Health is responsible for registration of drugs in Russian Federation.
Duration of registration of drugs in Russia:
- 160 business days
- 80 business days (orphan, first 3 Generics, Medicines intended only for kids (up to 18 years old).
Registration dossier: Dossier should be provided in CTD format (Like in EU).
Full list of documentation needed for registration of Medicines in Russia you can get here.
From 2016 one of mandatory documents which must be provided – GMP certificate isuued by Russian Health authority.
State Fee for registration:
- approx 5 k$
Note: Real time of registration is approx 12 months (due to time needed for samples & standards and answers to defficiency letters).
State register of registered drugs in Russia (http://grls.rosminzdrav.ru/)
Russian Drug Law – is Federal Law #61.