Nicaragua

Latin America

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Nicaragua is regulated by the MINSA (Ministerio de 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

MINSA (Ministerio de Salud)

Regulatory Pathways (1)

Nicaragua MOH Named Patient Authorization 45 days

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

Application Form: MOH Nicaragua Named Patient Form

Legal Basis: Regulated

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

Nicaragua

ISO Code	`NI`
Region	Latin America
Regulatory Authority	MINSA (Ministerio de Salud)
Pathways	1 documented
Drugs Available	0 documented