“BoMRA is targeting to be at WHO maturity level 3 (ML3) where 8 core regulatory functions will be operational and meet the criteria and standards set. The Authority will conduct annual WHO Global Benchmarking (GBT) self-assessments and final WHO assessments to reach ML3.BoMRA will facilitate the review of the Medicines and Related Substance Act to strengthen its scope, definitions, structures, and instruments to enable its regulatory effectiveness.”
“The Botswana Medicines Regulatory Authority will establish a Pharmacovigilance system to track and report on Adverse Drug Reactions and take any remedial action to protect human and animal health. Improved awareness and Public Trust in the Improved awareness and Public Trust in the Medical Products and Cosmetics regulatory system.”
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The Botswana Medicines Regulatory Authority (BoMRA) Was established through the Medicines and Related Substances Act of 2013. The MRSA Authorises BoMRA to perform functions given by the shareholder – The Government of Botswana. The MRSA of 2013 replaced the repealed Drugs and Related Substances Act No.
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