Guatemala

Latin America

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Guatemala is regulated by the DEGUFA (Departamento de Regulación y Control de Productos Farmacéuticos). 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

DEGUFA (Departamento de Regulación y Control de Productos Farmacéuticos)

Regulatory Pathways (1)

Guatemala MOH Named Patient Authorization 30 days

Guatemala Ministry of Health named patient authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: MOH Guatemala Named Patient Form

Legal Basis: Regulated

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

Guatemala

ISO Code	`GT`
Region	Latin America
Regulatory Authority	DEGUFA (Departamento de Regulación y Control de Productos Farmacéuticos)
Pathways	1 documented
Drugs Available	0 documented