Malawi

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Malawi is regulated by the MBS (Malawi Bureau of Standards). 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

MBS (Malawi Bureau of Standards)

Regulatory Pathways (1)

Malawi MOH Special Import Authorization 45 days

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

Application Form: MOH Malawi Special Import Form

Legal Basis: Regulated

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

Malawi

ISO Code	`MW`
Region	Africa
Regulatory Authority	MBS (Malawi Bureau of Standards)
Pathways	1 documented
Drugs Available	0 documented