Niger

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Niger is regulated by the DGPSA (Direction Générale de la Pharmacie). 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

DGPSA (Direction Générale de la Pharmacie)

Regulatory Pathways (1)

Niger MOH Special Import Authorization 45 days

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

Application Form: MOH Niger Special Import Form

Legal Basis: Regulated

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

Niger

ISO Code	`NE`
Region	Africa
Regulatory Authority	DGPSA (Direction Générale de la Pharmacie)
Pathways	1 documented
Drugs Available	0 documented