BoMRA Updates

The regulation of medicines, medical devices, and cosmetics has recently transitioned from Botswana’s Ministry of Health to the new Botswana Medicines Regulatory Authority (BoMRA). This has led to a frequently changing regulatory environment in Botswana, which can be difficult for companies to navigate.

As changes are made, BoMRA provides important updates to stakeholders.

To help you stay up-to-date with changes and how they’ll impact your product registrations, you’ll find a short summary of each update and a link to its full text here.

Botswana’s economy reopened

After 49 days of extreme social distancing and the close of all non-essential services across the country, the government of Botswana authorized all services to reopen on May 21st, 2020. To date, Botswana has only registered 35 confirmed cases of Covid-19 and 1 death....

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Three Covid-19 Cases Confirmed in Botswana

Three Covid-19 Cases Confirmed in Botswana

On March 30, Botswana confirmed the first 3 cases of Covid-19 cases after testing 191 people - two men and one woman. The government reported that two of the three patients recently been in Thailand and one in the UK. The three patients are isolated in a hospital and...

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BoMRA Response to COVID-19

This is an outline of BoMRA's plan for the ongoing management of the medical supply chain and interactions with stakeholders during the COVID-19 pandemic. We recommend reading the entire publication. Please take special note of the following: All meetings scheduled...

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BoMRA Introduces Paid Regulatory Services

Since the introduction of the regulation of medicines in Botswana in 1993, almost all regulatory services have been free. The only paid service was the evaluation of dossiers which costed P500 per application. On the 06 of January 2020, BoMRA made an announcement of...

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BoMRA Intensifies their Vigilance on the Market

For many years, counterfeit, unregistered and falsely labeled products have been populating the Botswana market. The market for authentic products was taken and replaced by adulterated products. This has been a concern to many prescribers, pharmacists, distributors...

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