Bolivia

Latin America

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Bolivia is regulated by the AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud). 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

AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud)

Regulatory Pathways (1)

Bolivia MOH Special Import Authorization 45 days

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

Application Form: MOH Bolivia Special Import Form

Legal Basis: Regulated

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

Bolivia

ISO Code	`BO`
Region	Latin America
Regulatory Authority	AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud)
Pathways	1 documented
Drugs Available	0 documented