Vietnam

Southeast Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Vietnam is regulated by the DAV (Drug Administration of Vietnam). 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

DAV (Drug Administration of Vietnam)

Regulatory Pathways (1)

DAV Special Import Authorization – Vietnam 30 days

Vietnam Drug Administration special import authorization allowing access to unregistered medicines for patients with serious medical needs under physician supervision.

Application Form: MOH Vietnam Special Import Form

Legal Basis: Pharmaceutical Law 2016

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

Reference: Vietnam Pharmaceutical Law 2016

Vietnam

ISO Code	`VN`
Region	Southeast Asia
Regulatory Authority	DAV (Drug Administration of Vietnam)
Pathways	1 documented
Drugs Available	0 documented