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Public Notice – 07 November 2022

Public Notice – 07 November 2022

BoMRA Important Notice

Public Notice – 07 November 2022

The Botswana Medicines Regulatory Authority (BoMRA) on inception in 2018 inherited a backlog of open applications from the Drugs Regulatory Unit (DRU). Part of this backlog constituted of 685 Complementary medicine applications, most of which were Listed Applications submitted in 2013. These applications were submitted for registration, allowed entry into the Botswana market by way of being included on the Medicines Register, pending finalisation of the assessment process.

The Department of Product Evaluation & Registration (DPER) embarked on a strategy to finalize the said backlog applications. BoMRA has faced challenges in establishing and/or tracing applicants due to multiple reasons including obsolete contact details, possible mergers and acquisitions as well as the closure of business operations of some applicants.

The applicants responsible for the products in the Annexure 1 below are therefore requested to contact BoMRA regarding their pending applications. If no contact is made with regards to the products, the Authority will consider the products abandoned and the products will be ultimately closed.

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