OrphanDrug
OrphanDrug
Pharma Knowledge Base
CD

Congo (Democratic Republic)

CD

Africa

Contents

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

Regulatory Overview

Congo (Democratic Republic) is regulated by the DPM (Direction de la Pharmacie et du Médicament). 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

DPM (Direction de la Pharmacie et du Médicament)

Regulatory Pathways (1)

Congo (Democratic Republic) MOH Special Import Authorization 60 days

Congo (Democratic Republic) Ministry of Health special import authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: MOH Congo (Democratic Republic) Special Import Form
Legal Basis: Regulated
Eligibility: Serious or life-threatening condition with no locally registered alternative
CD
Congo (Democratic Republic)
ISO CodeCD
RegionAfrica
Regulatory AuthorityDPM (Direction de la Pharmacie et du Médicament)
Pathways1 documented
Drugs Available0 documented