Act No. 29 of 2025

Botswana's new medicines statute, assented to on 24 December 2025 and published as Act No. 29 of 2025. It continues the Botswana Medicines Regulatory Authority, restates its functions, and — the reason it is here — carries an express reliance power at section 109 ("Recognition and reliance on regulatory decisions") alongside section 108 (international cooperation) and section 110 (recognition and reliance on laboratory results), plus Part XII (Vigilance and Post-Market Surveillance) and Part XIII (Recall and Disposal of Unfit Products). Scheduling and classification sit in Part XV: section 79 (medicines), section 80 (medical devices) and section 81 (in-vitro diagnostics), and IVDs and medical devices fall in scope through the definition of "medical product". The Act is NOT in force: its own section 1 says it "shall come into operation on such date as the Minister may, by Order published in the Gazette, appoint", and the copy states "Date of commencement: ON NOTICE". It repeals Cap. 63:04 (s.124) and saves subsidiary legislation made under the repealed Act (s.125). The gazette copy's own arrangement page for Parts V and VI sits under a bad OCR text layer ("PART Y - Chief Executive 0//i, (, 011<1 <Jt 11i'I Staff of Authority"); the body pages extract cleanly and are ingested as published, not repaired.

Act No. 29 of 2025 is the official identifier BoMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.