Paraguay

Latin America

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Paraguay is regulated by the DINAVISA (Dirección Nacional de Vigilancia Sanitaria). 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

DINAVISA (Dirección Nacional de Vigilancia Sanitaria)

Regulatory Pathways (1)

Paraguay MOH Special Import Authorization 30 days

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

Application Form: MOH Paraguay Special Import Form

Legal Basis: Regulated

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

Paraguay

ISO Code	`PY`
Region	Latin America
Regulatory Authority	DINAVISA (Dirección Nacional de Vigilancia Sanitaria)
Pathways	1 documented
Drugs Available	0 documented