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BoMRA
The Botswana Medicines Regulatory Authority (BoMRA) was established by the Medicines and Related Substances Act of 2013. The Authority’s primary role is to administer the Medicines and Related Substances Act which is to regulate the supply chain of human and veterinary medicines, medical devices, and cosmetics to ensure that they meet the set standards of safety quality and effectiveness.
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:
Product Evaluation and Registration
Ensuring that all medicines and related substances manufactured in, imported into, or exported from Botswana are registered and conform to established criteria of quality, safety, and efficacy.
Licensing and Enforcement
Ensuring the personnel, premises, and practices employed to import, export, manufacture, promote, procure, store, distribute and sell medicines comply with defined codes of practice and other requirements.
Pharmacovigilance and Clinical Trials
Ensure the monitoring and reporting of adverse reactions to medicines and conduct post-marketing surveillance to ascertain the quality, efficacy, and safety of medicines circulating 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.
GET TO KNOW
BoMRA
The Botswana Medicines Regulatory Authority (BoMRA) was established by the Medicines and Related Substances Act of 2013. The Authority’s primary role is to administer the Medicines and Related Substances Act which is to regulate the supply chain of human and veterinary medicines, medical devices, and cosmetics to ensure that they meet the set standards of safety quality and effectiveness.
