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Regulation
Regulatory Areas
Comprehensive oversight of medicines, medical devices, and cosmetics to ensure safety, quality, and compliance.
Services
What We Can Help You With
Services designed to protect public health
Transparency
Your Request, Step by Step
We are committed to transparency. Every submission follows a clear, accountable process.
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Most requests are acknowledged within 2 working days and resolved within 14 working days.
Service Commitment
Our team consists of highly skilled and knowledgeable professionals, dedicated to providing exceptional service with a deep understanding of regulatory requirements and industry standards. In line with our commitment to effeciency, we continuously invest in training and professional development to ensure that our team remains at the forefront of industry best practices.
Objectives
Strategic Objectives
As a trusted Authority for excellence in medical products and cosmetics regulation we;
Operationalize a Fully Functional Regulatory System
- Enhance clinical trials controls to ensure good pharmaceutical processes are adhered to
- Establish post-marketing surveillance to monitor and quality of the medicines in the market
- Strengthen Inspection and Licensing of pharmaceutical premises and Import/Export Controls
- Establish Laboratory Services
- Establish and implement a Quality Management System
- Leverage ICT Services to enable efficiency
- Enhance the registration function
- Strengthen Inspection and Licensing of Premises and Import and Export controls
Been affected by a violation?
Reduced incidences of substandard and falsified medicines and related substances.​​
- Educate the public on effective, safe and quality human and animal medicines and their regulation
- Facilitate stakeholder compliance
- Establish strategic partnerships and collaborations
- Establishing a robust Institutional Framework and Good Governance
Been affected by a violation?
Scale up current institutional capacity to deliver the full spectrum of regulatory services.​​
- Enhance its HR Management System
- Attract build and retain critical competencies to deliver on the regulatory requirements
- Improve sustainability to eventually become less reliant on government for its operations
- Implement prudency in its Financial Management
- Maintain institutional resources so they remain effective​
Been affected by a violation?
Events
Upcoming Events
Events, workshops, and upcoming activities.
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Upcoming Events
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Awareness Video
Promoting safe practices for a healthier community.
Building a healthier tomorrow together.
Collaborating for safer medicines and stronger communities.
Events
Upcoming Events
News, regulations, notices, and press releases.
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There are currently no upcoming events. Please check back later for updates.
Awareness Video
Promoting safe practices for a healthier community.
Building a healthier tomorrow together.
Collaborating for safer medicines and stronger communities.
Events
Upcoming Events
News, regulations, notices, and press releases.
Awareness Video
Promoting safe practices for a healthier community.
Building a healthier tomorrow together.
Collaborating for safer medicines and stronger communities.
Downloads
Recent Documents
Find most recent documents and most downloaded below
Pharmacovigilance Guidance document for MAHs -PCT-PV-P01-G02 Iss5.0
Human medicines (Registered medicines and B-listed products)
Guideline for Variation of Human Medicines - ER-MD-P04-G03 - Iss3
Medicines-and-Related-Substances-Act-2013
Guidelines for Import_Export of Medicines
News & Updates
Latest from BoMRA
News, regulations, notices, and press releases.
We’re Taking a Few Steps in a New Direction!
Effective 1 November 2026, the Licensing & Enforcement Department will temporarily operate...
Read Full ArticleEmergency BRIMS System Upgrade and Anticipated Downtime
The Botswana Medicines Regulatory Authority (BoMRA) wishes to inform all stakeholders that...
Read Full ArticleBoMRA Celebrates Academic Excellence at the 2026 University of Botswana Graduation Ceremony
The Botswana Medicines Regulatory Authority (BoMRA) is proud to have sponsored the...
Read Full Article