BoMRA
Overview
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, which includes both human and veterinary medicines, medical devices, and cosmetics in Botswana.
The Authority’s key functions are stated under Section 4 of the MRSA and include:
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.
The Department of Product Evaluation and Registration
The Department of Licensing and Enforcement
The Department of Pharmacovigilance and Clinical Trials (PVCT)
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.
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.
Pharmacovigilance and Clinical Trials
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.
