Colombia

Latin America

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Colombia is regulated by the INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos). 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

INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)

Regulatory Pathways (1)

INVIMA Special Import for Unregistered Drugs – Colombia 21 days

INVIMA special import authorization allowing physicians to import unregistered medicines for named patients with serious conditions in Colombia.

Application Form: INVIMA Special Import Form

Legal Basis: Decreto 677 de 1995

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

Reference: INVIMA Drug Import Regulations

Colombia

ISO Code	`CO`
Region	Latin America
Regulatory Authority	INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)
Pathways	1 documented
Drugs Available	0 documented