Madagascar

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Madagascar is regulated by the AMDM (Agence du Médicament de Madagascar). 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

AMDM (Agence du Médicament de Madagascar)

Regulatory Pathways (1)

Madagascar MOH Special Import Authorization 45 days

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

Application Form: MOH Madagascar Special Import Form

Legal Basis: Regulated

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

Madagascar

ISO Code	`MG`
Region	Africa
Regulatory Authority	AMDM (Agence du Médicament de Madagascar)
Pathways	1 documented
Drugs Available	0 documented