Peru

Latin America

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Peru is regulated by the DIGEMID (Dirección General de Medicamentos, Insumos y Drogas). 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

DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

Regulatory Pathways (1)

DIGEMID Special Authorization for Importation – Peru 30 days

Peru's DIGEMID special authorization for importation of unregistered medicines for individual patients with serious or life-threatening conditions.

Application Form: DIGEMID Special Import Form

Legal Basis: General Health Law No. 26842

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

Reference: DIGEMID Drug Import Regulations

Peru

ISO Code	`PE`
Region	Latin America
Regulatory Authority	DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)
Pathways	1 documented
Drugs Available	0 documented