Russia
RUEurope
Regulatory Overview
Russia is regulated by the Roszdravnadzor (Federal Service for Healthcare Supervision). The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
Roszdravnadzor (Federal Service for Healthcare Supervision)
Regulatory Pathways (1)
Russian Federal Law No. 61-FZ on Medicines Circulation Article 47 allows use of unregistered medicinal products for individual patients with serious or life-threatening conditions under Ministry of Health permission.
Application Form: MOH Russia Application
Legal Basis: Federal Law No. 61-FZ on Medicines Circulation
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: Federal Law No. 61-FZ
Drugs Available (1)
| Drug | Access Route | Status | Lead Time |
|---|---|---|---|
| Cerebrolysin | — | — | — |
Russia
| ISO Code | RU |
| Region | Europe |
| Regulatory Authority | Roszdravnadzor (Federal Service for Healthcare Supervision) |
| Pathways | 1 documented |
| Drugs Available | 1 drug(s) |