BoMRA

The Botswana Medicines Regulatory Authority (BoMRA) is a statutory body established under the Medicines and Related Substances Act (MRSA) of 2013. It serves as Botswana’s national regulatory authority for medicines, medical devices, and related substances, ensuring their quality, safety, and efficacy.

Core Mandate and Responsibilities

BoMRA’s primary functions include:

• Product Registration: Evaluating and authorizing human, veterinary, and complementary medicines, as well as medical devices and cosmetics, to ensure they meet safety, quality, and efficacy standards.

• Licensing and Inspections: Issuing licenses for manufacturing, wholesale, and retail premises, and conducting inspections to ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Pharmacy Practices (GPP).

• Pharmacovigilance: Monitoring and assessing adverse drug reactions (ADRs) and conducting post-market surveillance to ensure ongoing product safety.

• Clinical Trials Oversight: Reviewing and approving clinical trial applications, ensuring ethical conduct and participant safety.

• Import and Export Control: Regulating the importation and exportation of medical products through permits and collaboration with border control agencies.

• Laboratory Testing: Analyzing medicines and medical devices to verify their compliance with established standards.

Regulatory Framework and Modernization

BoMRA is undergoing a regulatory reform to align with international best practices and achieve World Health Organization (WHO) Maturity Level 3 status. This includes revising the MRSA and developing new regulations covering various aspects such as marketing authorization, licensing, vigilance, surveillance, and laboratory analysis.

International Collaboration

BoMRA has established partnerships with other regulatory authorities, such as the South African Health Products Regulatory Authority (SAHPRA), to enhance regulatory capacity, share information, and combat the circulation of substandard and falsified medical products.

Contact Information

• Website: www.bomra.co.bw

• General Inquiries: info@bomra.co.bw

• Enforcement: enforcement@bomra.co.bw

• Phone: +267 71978994