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