Guinea

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Guinea is regulated by the DNPL (Direction Nationale 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

DNPL (Direction Nationale de la Pharmacie)

Regulatory Pathways (1)

Guinea MOH Special Import Authorization 45 days

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

Application Form: MOH Guinea Special Import Form

Legal Basis: Regulated

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

Guinea

ISO Code	`GN`
Region	Africa
Regulatory Authority	DNPL (Direction Nationale de la Pharmacie)
Pathways	1 documented
Drugs Available	0 documented