Botswana Medicines Regulatory Authority

04/09/2026

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 listed below are currently OUT OF REGULATORY SCOPE and DO NOT require BoMRA import clearance, permits, or registration prior to entering Botswana:

https://www.bomra.co.bw/clarification-on-medical-devices-and-laboratory-equipment-currently-out-of-regulatory-scope-for-import-control/

03/09/2026

BoMRA CEO ENGAGES KEY VETERINARY INDUSTRY STAKEHOLDERS ON NEW MEDICINES AND RELATED SUBSTANCES ACT AND DRAFT REGULATIONS.

The Chief Executive Officer of BoMRA, Dr Seima Dijeng, convened a meeting with a select group of key veterinary industry stakeholders to discuss the draft veterinary regulations under the new Medicines and Related Substances Act (MRSA).

The engagement is part of a broader, ongoing stakeholder consultation on the Medicines and Related Substances Act (MRSA and its regulations, with particular focus on the new Act's purpose, key changes, and the material distinctions from the repealed Act.

In his opening remarks, the CEO thanked the stakeholders for honouring the invitation despite the short notice. He explained that this session was a targeted engagement ahead of a wider veterinary stakeholder consultation scheduled for today, Thursday, 03 September 2026, noting that it was important to meet with representatives of key institutions first, before the broader engagement.

He emphasised that the purpose of the session was to help stakeholders understand and appreciate the new MRSA and its draft regulations — distinguishing what is new from what has been retained and highlighting how each provision would support their businesses and operations going forward.

He added that the new Act addresses many of the legal gaps present in the old Act, making it essential for stakeholders to understand its provisions fully.

The discussions centred on an overview of the key changes introduced by the Act, including, among others:

• The scheduling of veterinary medicinal products (VMPs) a provision that did not exist under the previous legislation.
• Supervision of VMP premises, and the dispensing and prescribing of veterinary medicinal products
• Strengthened veterinary supervision over the handling of these products.
• New regulatory measures for the responsible use of antibiotics and vaccines, including provisions to address misuse, promote best practice, and maintain an appropriate balance in their application.

The CEO further noted that this engagement is part of BOMRA's broader contribution to the national agenda, particularly the government's drive to grow the country's cattle herd to five million as directed by the Presidency.

He stated that sound regulation of veterinary medicines is central to this agenda, as it protects animal health and supports Botswana's beef export market, all of which underpin the success of the national herd-growth target.

The meeting was attended by representatives from key players in the veterinary industry, including the Botswana Veterinary Council, the Botswana Veterinary Association, the Botswana Vaccine Institute, and the Botswana Agricultural Marketing Board.

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02/09/2026

02/09/2026

BoMRA CALLS ON INDUSTRY PARTICIPATION AS NEW LEGISLATION TAKES SHAPE

The Chief Executive Officer of the Botswana Medicines Regulatory Authority (BOMRA), Dr Seima Dijeng, has called on the pharmaceutical industry to actively participate in the ongoing consultations on the new Medicines and Related Substances Act and its accompanying draft regulations.

Speaking during a consultative meeting attended by pharmaceutical industry executives, Market Authorisation Holders, Manufacturers and Distributors, Dr Dijeng took stakeholders through the Authority's legislative journey, from the shortcomings of the founding 2013 framework to the passage of the new MRSA assented to in 2025. He outlined its key features and set out clear expectations for stakeholders as the regulations move toward finalisation.

Why the law had to change

According to Dr Dijeng, the limitations of the 2013 framework had become increasingly evident as key product categories — including traditional and complementary medicines, cosmetics and diagnostics outpaced the regulator's legal mandate.

Botswana, a country heavily reliant on imported medical products, also had no statutory basis for relying on the assessments of other regulators. Its appeal route ran through the courts, while its enforcement tools could not adequately deter repeat offenders.

By 2019, after several years of operation, the gaps were visible. Dr Dijeng explained that the Authority triggered a bill-drafting process shaped by three converging forces: the African Union's model law on medical products regulation, the SADC Medicines Regulatory Harmonisation initiative and the African Continental Free Trade Area, alongside Botswana's own national priorities.

The result was a deliberately measured legislative journey. Public comments were invited on a draft bill in 2021. Engagement sessions followed in 2023, with revised drafts issued that October. The bill was revised, reissued and eventually passed in 2025. In April this year, nine draft regulatory instruments were released for public comment, with Wednesday's consultation marking the next step in the process.

Dr Dijeng said consultation had run alongside drafting at every stage, pushing back on any suggestion that the regulations had been introduced without industry engagement. He pointed to consultations in 2021, 2023, April to May 2026, and the latest meeting as evidence of the Authority's continued engagement.

The scale of the change partly explains the timeline, with the Act expanding from 13 parts to 23. He said that while legislative drafting capacity in Botswana is limited, the Authority made a deliberate choice to consult properly at each stage rather than rush the process.

Dr Dijeng stressed that inclusive stakeholder participation is essential to ensuring the legislation serves and protects the interests of both the regulator and the industry it governs. He noted that a law shaped through genuine consultation is one the industry can own, rather than one simply imposed upon it.

2025
.co.bw

02/09/2026

Dear Stakeholder,

We are pleased to inform you that following a prolonged technical fault, BoMRA’s telephone lines have now been fully restored and are operational.

We sincerely thank you for your patience and understanding during the period of disruption. We apologise for any inconvenience this may have caused and appreciate your continued cooperation.
Stakeholders may now reach us through the following numbers:

+267 373 1727
Toll-Free: 0800 600 216

28/08/2026

Day 5 at the Gaborone Consumer Fair!

Visit us at the Ditshupo Hall, Stalls D5 & D6 to learn more about medicines regulation, safe use of medicines, and how regulation helps protect consumers.

Come chat with us we’d love to see you!

26/08/2026

Hosts World Health Organization Botswana (WHO) Training.

Botswana, through BoMRA, has taken its fight against poor-quality medical products to the world stage. The Botswana National Regulatory Authority is hosting an expanded, hands on training with the World Health Organisation (WHO), bringing together laboratory analysts from across Africa and, for the first time, South-East Asia. The mission of the exercise is to better detect deadly chemicals hiding in everyday medicines, including the cough syrups millions of families rely on.

Five months ago, BoMRA led groundbreaking regional training on detecting two dangerous industrial chemicals, Ethylene Glycol and Diethylene Glycol, in liquid medicines. The Authority is back at the frontline this time on a much bigger stage.

This week, BoMRA's laboratory is hosting a hands-on practical training bringing together up to 16 analysts from across the WHO African Region (AFRO) and, for the first time, the WHO South-East Asia Region (SEARO).

It's a major step up from March's training, which involved five countries: Botswana, Congo, Gambia, Namibia, and Sierra Leone.
This is also the first time this kind of training has brought together laboratories from more than one WHO region, strengthening testing capacity well beyond where it started.

The March 2026 training introduced laboratories to the testing method and showed how it works through a live demonstration. This time, participants are going a step further, getting hands-on experience running the actual tests themselves, guided by WHO technical experts, using two techniques recommended internationally for detectin contamination in medicines.

The timing couldn't be more important. International testing standards were recently updated to include a more advanced version of this testing method, meaning laboratories now need real, practical experience to use it confidently, not just knowledge of how it's supposed to work.

BoMRA is doing more than just taking part in global efforts to keep medicines safe , it's becoming a trusted center for this kind of expertise in the region. As more laboratories gain these skills, more countries can protect their people

26/08/2026

We prioritise the interests of our clients and the safety of those who use medical products and cosmetics. Visit us at the Gaborone Consumer fair, Ditshupo Hall, Stall D5 and D6

25/08/2026

Day 2 at the Gaborone Consumer fair. Visit us at the Ditshupo Hall Stall D5 & D6 to learn more about medicines regulation