Uruguay

Latin America

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Uruguay is regulated by the URSEA (Unidad Reguladora de Servicios de Energía y Agua). 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

URSEA (Unidad Reguladora de Servicios de Energía y Agua)

Regulatory Pathways (1)

Uruguay MOH Special Import Authorization 30 days

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

Application Form: MOH Uruguay Special Import Form

Legal Basis: Regulated

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

Uruguay

ISO Code	`UY`
Region	Latin America
Regulatory Authority	URSEA (Unidad Reguladora de Servicios de Energía y Agua)
Pathways	1 documented
Drugs Available	0 documented