Botswana’s medicines regulator has opened draft regulations under the Medicines and Related Substances Act 2025 for stakeholder comment, setting the operational requirements that will govern registration, licensing, importation and post-market obligations.
Companies supplying Botswana should read the drafts now and respond. Two sets are in circulation — the General Regulations and the Fees, Levies and Penalties Regulations — and BoMRA has said explicitly that comment is easier to incorporate before implementation than after. The fees instrument in particular will set the cost of registration and licensing, which is the number every commercial team will want ahead of budgeting. Under the draft General Regulations all regulated products must be registered before sale, import or dispensing, and manufacturers, wholesalers, pharmacies and importers must hold the appropriate licences and meet set standards, subject to BoMRA inspection.
The Act, passed by Parliament in December 2025, expands the framework from 69 sections to 125 and from 13 parts to 23. It extends regulation to medical devices, in vitro diagnostics, blood products, traditional and complementary medicines, food and related substances, cosmetics and cannabis products — categories that in many cases were not previously covered, meaning suppliers of devices, diagnostics and cosmetics face registration and licensing obligations they have not had before.
New mechanisms include reliance on decisions by trusted authorities, mutual recognition agreements, mandatory lot release for high-risk products, haemovigilance, and an authorisation framework for online sales. Reliance and mutual recognition are the provisions most likely to shorten timelines for products already approved by a recognised regulator; mandatory lot release adds a step for high-risk products, though the drafts as described do not specify which products fall into that category.
BoMRA chief executive Dr Seima Dijeng said the Authority’s mission is to safeguard the safety, efficacy and quality of regulated medical products, spanning human and veterinary medicines, biologicals, vaccines, devices, diagnostics and cosmetics.
Dr Partha Sarathi Gurumuthy, acting chief regulatory officer, said the Act establishes the foundation while the subsidiary legislation determines the practicalities of product registration, premises licensing, importation, clinical research and post-market responsibilities, and invited candid feedback.
Legal officer Tinky Peter, introducing the draft General Regulations, said oversight continues after approval through post-market surveillance, with powers to act on safety or quality issues including recalls, and that the regulations set requirements for accurate advertising. Legal and corporate secretary Nonofo Thipe distinguished the instruments: the Act sets legal principles, regulations define operational requirements, and guidelines carry technical detail that can be updated more quickly.
Source: Botswana Medicines Regulatory Authority — https://www.bomra.co.bw/bomra-ushers-in-new-era-of-safer-medical-products-with-landmark-regulatory-reform/
