Cuba

Caribbean

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Cuba is regulated by the CECMED (Centro para el Control Estatal de Medicamentos). 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

CECMED (Centro para el Control Estatal de Medicamentos)

Regulatory Pathways (1)

Cuba MOH Special Import Authorization 45 days

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

Application Form: MOH Cuba Special Import Form

Legal Basis: Regulated

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

Cuba

ISO Code	`CU`
Region	Caribbean
Regulatory Authority	CECMED (Centro para el Control Estatal de Medicamentos)
Pathways	1 documented
Drugs Available	0 documented