Mozambique

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Mozambique is regulated by the ARME (Autoridade Reguladora de Medicamentos). 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

ARME (Autoridade Reguladora de Medicamentos)

Regulatory Pathways (1)

Mozambique MOH Special Import Authorization 45 days

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

Application Form: MOH Mozambique Special Import Form

Legal Basis: Regulated

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

Mozambique

ISO Code	`MZ`
Region	Africa
Regulatory Authority	ARME (Autoridade Reguladora de Medicamentos)
Pathways	1 documented
Drugs Available	0 documented