Brunei Darussalam

Southeast Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Brunei Darussalam is regulated by the Pharmaceutical Services, Ministry of Health. 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

Pharmaceutical Services, Ministry of Health

Regulatory Pathways (1)

Brunei MOH Special Import Authorization 45 days

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

Application Form: MOH Brunei Special Import Form

Legal Basis: Regulated

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

Brunei Darussalam

ISO Code	`BN`
Region	Southeast Asia
Regulatory Authority	Pharmaceutical Services, Ministry of Health
Pathways	1 documented
Drugs Available	0 documented