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Compliance

BoMRA operates within a comprehensive legal framework 

Overview

BoMRA operates within a comprehensive legal framework designed to ensure regulatory effectiveness and institutional integrity. We have established robust compliance policies and procedures to address key legislative requirements:

Medicines and Related Substances Act

The foundational legislation establishing BoMRA’s mandate and regulatory authority

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Data Protection Act

Comprehensive policies implemented to safeguard personal information in regulatory processes

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Employment Act

Full compliance framework established governing employment relations and workplace standards

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Financial Reporting Act

Robust financial governance policies ensuring transparency and accountability in financial management regulatory areas

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Internal Audit

The Internal Audit function operates with independence and objectivity, reporting functionally to the Chairperson of FARC and administratively to the Chief Executive Officer. This dual reporting structure standard in governance frameworks aligned to the Institute of Internal Auditors’ Standards ensures that the function’s independence is preserved and that findings are escalated directly to Board-level oversight.

The mandate of the function, as defined in the approved Internal Audit Charter, is to provide independent, objective assurance and advisory services in support of risk management, internal control, and compliance across the Authority. Building on the governance architecture established in Section 2.2 of the Authority’s Executive Summary, the Internal Audit function is one of three complementary assurance layers overseen by FARC alongside External Audit and the Quality Management System.

Internal Audit

The Internal Audit function operates with independence and objectivity, reporting functionally to the Chairperson of FARC and administratively to the Chief Executive Officer. This dual reporting structure standard in governance frameworks aligned to the Institute of Internal Auditors’ Standards ensures that the function’s independence is preserved and that findings are escalated directly to Board-level oversight.

The mandate of the function, as defined in the approved Internal Audit Charter, is to provide independent, objective assurance and advisory services in support of risk management, internal control, and compliance across the Authority. Building on the governance architecture established in Section 2.2 of the Authority’s Executive Summary, the Internal Audit function is one of three complementary assurance layers overseen by FARC alongside External Audit and the Quality Management System.

Multi-Layer Assurance Architecture

The Authority operates a multi-layer assurance architecture of which Internal Audit is one component. The table below sets out the active assurance layers that continued to operate throughout the reporting period, providing the Committee with a complete picture of assurance coverage.

Botswana Medicines Regulatory Authority
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