Armenia

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Armenia is regulated by the SMSS (State Medical and Scientific Standards). 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

SMSS (State Medical and Scientific Standards)

Regulatory Pathways (1)

Armenia MOH Special Import Authorization 30 days

Armenia Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: MOH Armenia Special Import Form

Legal Basis: Regulated

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

Armenia

ISO Code	`AM`
Region	Europe
Regulatory Authority	SMSS (State Medical and Scientific Standards)
Pathways	1 documented
Drugs Available	0 documented