Maldives

South Asia

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Maldives is regulated by the MFDA (Maldives Food and Drug 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

MFDA (Maldives Food and Drug Authority)

Regulatory Pathways (1)

Maldives MOH Special Import Authorization 45 days

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

Application Form: MOH Maldives Special Import Form

Legal Basis: Regulated

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

Maldives

ISO Code	`MV`
Region	South Asia
Regulatory Authority	MFDA (Maldives Food and Drug Authority)
Pathways	1 documented
Drugs Available	0 documented