Zambia

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Zambia is regulated by the ZAMRA (Zambia Medicines Regulatory Authority). 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

ZAMRA (Zambia Medicines Regulatory Authority)

Regulatory Pathways (1)

ZAMRA Special Import Permit – Zambia 30 days

Zambia Medicines Regulatory Authority special import permit for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: ZAMRA Special Import Form

Legal Basis: Medicines and Allied Substances Act

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

Reference: ZAMRA Drug Import Guidelines

Zambia

ISO Code	`ZM`
Region	Africa
Regulatory Authority	ZAMRA (Zambia Medicines Regulatory Authority)
Pathways	1 documented
Drugs Available	0 documented