The introduction of medicines into the Russian market begins only after getting the registration license. The regulating department of medicine trade of Russian Ministry of Health answers to all questions about already registered formulations and registration of new ones.

Registration terms

According to the law "About medicine trade" №61-FZ, the longest registration term for original formulations can't be more than 160 working days since the moment of making an application. For simulated ones, the term is 60 days.

Registration steps

  • Preparation of all documentation, appliance to the Ministry of Health
  • Getting a permission to clinical analysis
  • Analysis of correspondence between expecting benefits and drug administration
  • Health Ministry conclusion about introduction of the formulation into the state register

Farmalfa knows the way to introduce a medicine into the Russian pharmaceutical market as quick as it's possible. Among our clients there are Russian and foreign companies looking forward to start their business in Russia.

Our main services

Registration of

  • Original forms
  • Simulated forms
  • New combinations of already registered forms
  • Already registered formulations, but in another form, for example, in new dosage
We work with medicines of the next origin
  • sinthetic
  • biological
  • homeopathic
  • radio-pharmaceutical

Other service

  • Change of medical instruction
  • Change of documentation
  • Prolonging of the license
  • Organization of preclinical and clinical analysis
  • Price registration
  • Permission to import the forms
  • Samples delivery