Burundi

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Burundi is regulated by the DPML (Direction de la Pharmacie et du Médicament). 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

DPML (Direction de la Pharmacie et du Médicament)

Regulatory Pathways (1)

Burundi MOH Special Import Authorization 60 days

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

Application Form: MOH Burundi Special Import Form

Legal Basis: Regulated

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

Burundi

ISO Code	`BI`
Region	Africa
Regulatory Authority	DPML (Direction de la Pharmacie et du Médicament)
Pathways	1 documented
Drugs Available	0 documented