Botswana

Africa

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Botswana is regulated by the BOMRA (Botswana 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

BOMRA (Botswana Medicines Regulatory Authority)

Regulatory Pathways (1)

BOMRA Compassionate Use Authorization – Botswana 21 days

Botswana Medicines Regulatory Authority compassionate use authorization for unregistered medicines for patients with serious or life-threatening conditions.

Application Form: BOMRA CU Form

Legal Basis: Drugs and Related Substances Act

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

Reference: BOMRA Drug Access Guidelines

Botswana

ISO Code	`BW`
Region	Africa
Regulatory Authority	BOMRA (Botswana Medicines Regulatory Authority)
Pathways	1 documented
Drugs Available	0 documented