Albania

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Albania is regulated by the AKBM (Albanian Medicines 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

AKBM (Albanian Medicines Agency)

Regulatory Pathways (1)

Albania Compassionate Use Authorization 30 days

Albania regulatory authority compassionate use authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: Albania CU Application Form

Legal Basis: Regulated

Eligibility: Serious or life-threatening condition with no locally registered alternative

Albania

ISO Code	`AL`
Region	Europe
Regulatory Authority	AKBM (Albanian Medicines Agency)
Pathways	1 documented
Drugs Available	0 documented