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Home Licensing & Enforcement

Licensing & Enforcement

The Department of Licensing and Enforcement

Overview

The Department of Licensing and Enforcement is responsible for regulating the import, export, and transit of all medical and related products.

It ensures that these products meet regulatory standards by inspecting and licensing premises across the supply chain.

BoMRA regulatory excellence

Responsibilities

Control

Control of imports, exports, and transit of all regulated products.

Inspection and Licensing

Inspection and licensing of premises along the supply chain of regulated products.

Testing

Testing of regulated products to ensure compliance with specifications and detect substandard or falsified products.

General Enforcement

General enforcement of the Medicines and Related Substances Act (MRSA) and its regulations.

Scope

Clinical Trials

PVCT oversees clinical trials, ensuring they are conducted ethically and in compliance with regulatory requirements.

Post-Marketing Surveillance

Post-marketing surveillance maintains the quality of registered products and prevents substandard or falsified medicines from entering the supply chain.

Processes

ADR Reporting

Collecting and analysing reports of adverse drug reactions from healthcare professionals, manufacturers, and the public. Reports are evaluated and acted upon to protect patient safety.

Clinical Trial Oversight

PVCT ensures all clinical trials conducted in Botswana are reviewed, approved, and monitored for ethical compliance and adherence to regulatory requirements throughout the trial period.

Surveillance

Ongoing monitoring of medicines, medical devices, cosmetics, and veterinary products in the market to identify and address safety signals and prevent harm.

Botswana Medicines Regulatory Authority
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