Bhutan

South Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Bhutan is regulated by the DRA (Drug Regulatory Authority). 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

DRA (Drug Regulatory Authority)

Regulatory Pathways (1)

Bhutan MOH Special Import Authorization 45 days

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

Application Form: MOH Bhutan Special Import Form

Legal Basis: Regulated

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

Bhutan

ISO Code	`BT`
Region	South Asia
Regulatory Authority	DRA (Drug Regulatory Authority)
Pathways	1 documented
Drugs Available	0 documented