Serbia
RSEurope
Regulatory Overview
Serbia is regulated by the ALIMS (Medicines and Medical Devices Agency). 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
ALIMS (Medicines and Medical Devices Agency)
Regulatory Pathways (1)
ALIMS Compassionate Use – Serbia 30 days
Serbia's Medicines and Medical Devices Agency (ALIMS) compassionate use authorization for unregistered medicines for patients with serious or life-threatening conditions.
Application Form: ALIMS CU Application
Legal Basis: Law on Medicines and Medical Devices (Serbia)
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: ALIMS Compassionate Use Guidelines
Serbia
| ISO Code | RS |
| Region | Europe |
| Regulatory Authority | ALIMS (Medicines and Medical Devices Agency) |
| Pathways | 1 documented |
| Drugs Available | 0 documented |