Mongolia

East Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Mongolia is regulated by the MFRC (Medical Products Quality Regulatory Center). 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

MFRC (Medical Products Quality Regulatory Center)

Regulatory Pathways (1)

Mongolia MOH Special Import Authorization 45 days

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

Application Form: MOH Mongolia Special Import Form

Legal Basis: Regulated

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

Mongolia

ISO Code	`MN`
Region	East Asia
Regulatory Authority	MFRC (Medical Products Quality Regulatory Center)
Pathways	1 documented
Drugs Available	0 documented