Timor-Leste

Southeast Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Timor-Leste is regulated by the 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

Ministry of Health

Regulatory Pathways (1)

Timor-Leste MOH Special Import Authorization 60 days

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

Application Form: MOH Timor-Leste Special Import Form

Legal Basis: Regulated

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

Timor-Leste

ISO Code	`TL`
Region	Southeast Asia
Regulatory Authority	Ministry of Health
Pathways	1 documented
Drugs Available	0 documented