OrphanDrug
OrphanDrug
Pharma Knowledge Base
VE

Venezuela

VE

Latin America

Contents

  1. 1. Regulatory Overview
  2. 2. Regulatory Pathways

Regulatory Overview

Venezuela is regulated by the INHRR (Instituto Nacional de Higiene Rafael Rangel). 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

INHRR (Instituto Nacional de Higiene Rafael Rangel)

Regulatory Pathways (1)

Venezuela MOH Special Import Authorization 45 days

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

Application Form: MOH Venezuela Special Import Form
Legal Basis: Regulated
Eligibility: Serious or life-threatening condition with no locally registered alternative
VE
Venezuela
ISO CodeVE
RegionLatin America
Regulatory AuthorityINHRR (Instituto Nacional de Higiene Rafael Rangel)
Pathways1 documented
Drugs Available0 documented