Chile

Latin America

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Chile is regulated by the ISP (Instituto de Salud Pública). 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

ISP (Instituto de Salud Pública)

Regulatory Pathways (1)

ISP Provisional Authorization for Unregistered Products – Chile 30 days

Chile's ISP provisional authorization allowing import and use of unregistered medicinal products for patients with serious medical needs.

Application Form: ISP Provisional Authorization Form

Legal Basis: Health Code Article 100

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

Reference: ISP Drug Access Guidelines

Chile

ISO Code	`CL`
Region	Latin America
Regulatory Authority	ISP (Instituto de Salud Pública)
Pathways	1 documented
Drugs Available	0 documented