Happy 60th Independence Day From BoMRA!
As Botswana celebrates 60 years of Independence, the Botswana Medicines Regulatory Authority (BoMRA) extends its warmest wishes to all our valued clients, stakeholders and partners. We wish you and your loved ones a peaceful, safe and enjoyable Independence holiday Please note that, in observance of the Independence Day holidays, BOMRA offices will be closed on […]
Registration Roadmap For Class A And Notifiable Medical Devices, Including In Vitro Diagnostics, Establishment Licensing, And Compliance Deadlines
The Botswana Medicines Regulatory Authority (BoMRA) wishes to inform all relevant stakeholders of the implementation of regulatory requirements for medical devices, including in vitro diagnostics (IVDs), under the Medical Device Regulatory Roadmap.The roadmap supports Botswana’s progressive strengthening of medical device regulation in line with internationally recognized regulatory principles. The framework aims to protect patients, healthcare […]
WHO and Botswana launch Good Clinical Practice (GCP) training of reviewers from Regulatory Authorities across the continent.
Gaborone, 21 September 2026 — The World Health Organization (WHO) and the Botswana Medicines Regulatory Authority (BoMRA) is hosting a Good Clinical Practice (GCP) capacity building (training) workshop aimed at strengthening research and development (R&D) in medicines, vaccines, and other health products through enhancing clinical trial regulatory systems across the African continent. The programme, organized […]
BoMRA joins the global healthcare community in commemorating World Patient Safety Day 2026 under the theme: “Safe care for noncommunicable diseases” Slogan: “Safe care for life!”
This year’s campaign highlights the importance of safe, quality and continuous care for people living with noncommunicable diseases (NCDs). At BoMRA, we remain committed to protecting patients by strengthening the safety, quality and monitoring of health products
Call For Submission Of Dossiers For Expedited Registration Of Veterinary Medicinal Products (VMPs)
The Botswana Medicines Regulatory Authority (BoMRA) invites interested principals, manufacturers and Marketing Authorisation Holders (MAHs) to submit dossiers for registration of veterinary medicinal products (VMPs) through the “reliance based” – expedited registration pathway. This initiative supports BoMRA’s ongoing efforts to enhance access to quality-assured, safe and effective veterinary medicines on the Botswana market.This pathway is […]
Clarification On Medical Devices And Laboratory Equipment Currently Out Of Regulatory Scope For Import Control
The Botswana Medicines Regulatory Authority BoMRA) wishes to inform all stakeholders, clearing agents, and port of entry authorities regarding the current regulatory scope for medical devices and related equipment under the Medicines and Related Substances Act (MRSA).To facilitate smooth cross-border trade and prevent unnecessary delays at points of entry, BoMRA clarifies that the product categories […]
BoMRA Telephone Lines Fully Restored
Dear Valued Stakeholders, We are pleased to inform you that, following a prolonged technical fault, BoMRA’s telephone lines have now been fully restored and are operational.Stakeholders may resume contacting BoMRA via our telephone lines for enquiries, assistance and other official engagements. We sincerely thank you for your patience, understanding and cooperation during the period of […]
Public Alert: Recall Of Flumed Syrup Batch 260180Manufactured By Varichem Pharmaceuticals (Pvt) Ltd
The Botswana Medicines Regulatory Authority wishes to inform the public of a recall of one (1) batch of Flumed Syrup, a product registered with BoMRA and manufactured by Varichem Pharmaceuticals (PVT) LTD, Zimbabwe. PRODUCT NAME BATCH NUMBER PACK SIZE DATE OF MANUFACTURE EXPIRY DATE Flumed (Paracetamol 120mg, Phenylephrine HCL 2.5mg, Dextromethorphan HBr 2.0mg, Chlorpheniramine Maleate […]
Call For Submission Of Qualified Person Responsible For Pharmacovigilance (QPPV) Notifications To BoMRA
Botswana Medicines Regulatory Authority (BoMRA) invites all Marketing Authorization Holders (MAHs), local technical representatives (LTRs), manufacturers and distributors of medical products to submit details of their designated Qualified Person Responsible for Pharmacovigilance (QPPV) in line with national pharmacovigilance requirements. Submission of QPPV Notifications MAHs are required to complete BoMRA QPPV Notification Form and submit the […]
Stakeholder Notice: Implementation Of The Human Medicines Assessment Backlog Clearance Plan
The Botswana Medicines Regulatory Authority (BoMRA) wishes to inform all applicants and Marketing Authorisation Holders (MAHs) that it has commenced implementation of a comprehensive Human Medicines Assessment Backlog Clearance Plan aimed at restoring regulatory timelines and improving access to medicines. Background Over the past several years, BoMRA has experienced a significant increase in the number […]