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.
Important Stakeholder Meeting for the Registration of Medicines
On the 19th of October 2020, BoMRA hosted a human medicine stakeholder meeting. This meeting was critical and was aimed at clearing the regulatory fog of human medicine in Botswana. The meeting brought light into both logistical and technical expectations of BoMRA...
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....
Is BoMRA Accepting Human Medicines Registration Applications During the COVID-19 Lockdown?
Yes, BoMRA has indicated that they will continue accepting, evaluating and registering human medicinal products during the COVID-19 lockdown. Submissions and all correspondence may only be sent electronically. Applicants may not submit samples until further notice....
President Masisi Declares a State of Emergency in Response to COVID-19
In response to three confirmed cases and one death due to COVID-19, and returning citizens and residents to Botswana from highly effected countries, President Masisi declared the State of Emergency. In his speech, he outlined the following: From April 2nd midnight,...
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...
Mandatory 14 Day Quarantine for Travelers from South-Africa.
To date, Botswana has not recorded any Coronavirus cases. The country is determined to keep this record for as long as possible. The Botswana Ministry of Health has decided that only citizens and residents will be allowed to enter the country following a mandatory 14...
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...
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...
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...
The Transfer of Regulatory Services from DRU to BoMRA.
On November 14th, 2018, The Ministry of Health (MOH) informed all stakeholders that all regulatory functions will be transferred from the Drugs Regulatory Unit (a MOH Unit) to the newly formed Botswana Medicines Regulatory Authority (BoMRA). This will effect on...