Profile – Practice

Corporate Profile

Background

The Medicines Regulatory Authority (“Authority”) is a corporate body established under Section 3 of the Medicines and Related Substances Act (“MRSA”) and referred to as the Botswana Medicines Regulatory Authority or BoMRA. The Authority is responsible for ensuring the safety, efficacy, and quality of medicines and related substances, including human and veterinary medicines, medical devices, and cosmetics in Botswana.

Establishment of BoMRA and its Structures

The Medicines Regulatory Board was created in terms of Section 6 of the MRSA to supervise and control the administration and finances. management of the Authority; and to formulate policies to provide general or specific guidance to the Authority in respect of the performance of its functions under the MRSA. The Chief Executive Officer (“CEO”) is appointed by the Minister of Health and Wellness (“Minister”), on the recommendation of the Board, as per Section 5 of the MRSA, and is responsible for the management control, administration, and organization of the Authority, subject to directions of the Board. The CEO is assisted by senior officers, as the Board may appoint, on recommendation from the CEO. The CEO may further appoint officers and employees to assist in carrying out the Authority’s mandate.

Mission/Vision/Values

Our mission and vision guide us in fulfilling our commitment to protecting public health. Our Vision outlines the future we strive to create, where the safety, efficacy, and quality of regulated health products are guaranteed, enhancing the well-being of every individual in Botswana.
Our Mission defines the steps we take today to achieve that vision, focusing on rigorous regulatory practices, transparency, and collaboration to ensure the highest standards for medicines, medical devices, and cosmetics.

We regulate medicines, medical devices and cosmetics, to promote human and animal health.

Mission

The trusted Authority for excellence in medical products and cosmetics regulation.

Vision

Integrity | Customer Focus | Efficiency | Team Work | Collaboration

Values

Departments and Units

The Department of product evaluation and registration

The Department of Product Evaluation and Registration (DPER) plays a pivotal role in achieving the strategic objective of streamlining registration processes. This department focuses on implementing effective regulatory strategies for human and veterinary medical products, medical devices and cosmetics.

The Department of Licensing and Enforcement

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

The Department of Pharmacovigilance and Clinical Trials (PVCT

The Department of Pharmacovigilance and Clinical Trials (PVCT) is tasked with monitoring the safety of all medical products registered for use in Botswana. The department ensures that approved medicines, medical devices, and other regulated products continue to meet safety and quality standards throughout their lifecycle.

Units Mails

Human Medicines:

humanmeds.variations@bomra.co.bw

Veterinary Medicnes

registration.vetmeds@bomra.co.bw

Cosmetics & Complementary Products

complimentarymedicine@bomra.co.bw

Medical Devices

medicaldevices.services@bomra.co.bw

Inspection and Licensing:

inspections@bomra.co.bw

Imports and Export Services:

impex@bomra.co.bw

Enforcement:

enforcement@bomra.co.bw

pharmacovigilance:

pharmacovigilanceteam@bomra.co.bw

Clincal Trials:

clinicaltrials@bomra.co.bw

ADR monitoring centers:

reportadr@bomra.co.bw

Quality Management System

Our Quality Policy is to establish the Authority’s commitment to quality and continuous improvement. It serves as a guiding principle for all employees and stakeholders, ensuring that they fully understand the Authority’s mandate in relation to quality.