Argentina

Latin America

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Argentina is regulated by the ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica). 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

ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)

Regulatory Pathways (1)

ANMAT Emergency Authorization (Uso Compasivo) – Argentina 30 days

ANMAT emergency authorization for compassionate use of unapproved medicines for patients with serious or life-threatening conditions in Argentina.

Application Form: ANMAT Compassionate Use Form

Legal Basis: Law 16.463

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

Reference: ANMAT Compassionate Use Regulations

Argentina

ISO Code	`AR`
Region	Latin America
Regulatory Authority	ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)
Pathways	1 documented
Drugs Available	0 documented