Sao Tome and Principe

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Sao Tome and Principe is regulated by the Ministry of Health. 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

Ministry of Health

Regulatory Pathways (1)

Sao Tome and Principe MOH Special Import Authorization 60 days

Sao Tome and Principe Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: MOH Sao Tome and Principe Special Import Form

Legal Basis: Regulated

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

Sao Tome and Principe

ISO Code	`ST`
Region	Africa
Regulatory Authority	Ministry of Health
Pathways	1 documented
Drugs Available	0 documented