Tunisia

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Tunisia is regulated by the DPM (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

DPM (Direction de la Pharmacie et du Médicament)

Regulatory Pathways (1)

Tunisia MOH Special Import Authorization 45 days

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

Application Form: MOH Tunisia Special Import Form

Legal Basis: Regulated

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

Tunisia

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