We are currently experiencing a technical problem with our telephone system, all our telephone lines are down.

We are working with our service provider to rectify the problem. Should you have an urgent matter, please contact us by email at info@bomra.co.bw or Facebook at Botswana Medicines Regulatory Authority and we will endeavor to help.

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File name: BOMRA-ANNOUNCEMENT-(TELEPHONES).pdf

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Reference is made to the BoMRA letter dated 2 April 2020 on the above subject matter.

The renewal of registration for products authorised more than 5 years ago commenced in April 2020. The renewal process started with antiretroviral products as the Authority is implementing a phased approach to effectively manage the number of applications.

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File name: Stakeholder-letter-Renewal-Reminder.pdf

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BoMRA launched Patient ADR reporting app .... .... ..... ...... .... ... ... ..... ..... ...

 

 

BoMRA launched Patient ADR reporting app

 

 

The Department of Product Evaluation & Registration at BoMRA will conduct stakeholder sessions to discuss the registration requirements for medical devices, veterinary medicines, human medicines and exemption from registration of human medicines

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File name: BOMRA-PRESS-RELEASE-DPER-Stakeholder-engagements-(October).pdf

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The Department of Product Registration and Registration at BoMRA has just completed week long stakeholder engagements with medical devices stakeholder in Gantsi, Maun , Francistown and Palapye.

Discussions were centered around medical devices regulation and BoMRA's intention towards listing of medical devices.All feedback has been sought and the team has committed to continuous stakeholder engagement throughout the consultation process. 

Follow us for regular updates from your trusted Authority for excellence in medical products and cosmetics regulation.

 

 

 

Regular business hours will resume on Friday, 02/10/2020

We would like to once again encourage all our clients to continually observe the COVID-19 protocols and utilise virtual platforms that are provided for convenience to access our services.
Enjoy

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File name: BoMRA-Office-Closure-Notice.pdf

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BoMRA CEO Dr Stephen Ghanie and BURS Acting Commissioner General Mr Segolo Lekau recently signed a memorandum of agreement

Your regulatory Authority continues to promote safe use of medical products by continually engaging key stakeholders from time to time. In signing the MOA, Dr Ghanie highlighted that BURS will be partnering with BoMRA to control the importation of medicines, medical devices, and cosmetics. He further said that this will ensure that only products that have undergone regulatory assessments will be imported into Botswana and used by Batswana.

Mr Lekau concluded by commending BoMRA for having seen it critical to initiate working relations with BURS agencies at ports of entry and exit for the control of imports of medicines and further promised a continual work relation.

BoMRA delivers the following health outputs:

Assess medicines. Only those that meet the standards of Quality, Safety and Efficacy are registered for your access, Inspect pharmacies and other medicine retailers to ensure compliance with good practices. Only those that meet set standards are licensed to serve you....

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File name: Regulatory-services-available-for-you.pdf

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As a follow up to our previous notice regarding BoMRA office closure, please be informed that our office will be open on Thursday, 05/11/2020 at 1200hrs.

We apologise for any inconvenience caused.

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File name: BoMRA-Office-Closure-Follow-Up.pdf

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Dear valued client,

There is essentially no end in sight for COVID-19.
We would like to once again encourage all our clients to avoid visiting the BoMRA office for general regulatory services. Instead, customers are encouraged to utilise virtual platforms that are provided for your convenience to access our services.

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File name: BoMRA-Covid-19-Office-Notice-Revised.pdf

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The Botswana Medicines Regulatory Authority would like to inform all valued clients that BoMRA office will be closed today, Wednesday, 04/11/2020 for fumigation.

The office will be open on Thursday, 05/11/2020.

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File name: BoMRA-Office-Closure-November-4th.pdf

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BAMALETE LUTHERAN HOSPITAL LAUNCH ADR MONITORING CENTER

Wednesday 9th September 2020 marked another milestone for the Botswana Medicines Regulatory Authority (BoMRA) as the third ADR Monitoring Centre was launched at Bamalete Lutheran Hospital in Ramotswa.

In his welcome remarks, Bamalete Lutheran Hospital( BLH) Acting Hospital Superintendent Dr. Mwansa, applauded the BoMRA team for their commitment towards patient safety monitoring and acknowledged that the Authority has been given a great responsibility in ensuring that medical products are of good quality, safe and efficacious. Dr. Mwansa appreciated that Bamalete Lutheran Hospital had been selected to participate as the Hospital knows the importance of Pharmacovigilance. He further called upon the staff members to fully support this needful initiative.

When delivering his keynote address WHO Country office representative Dr. Tebogo Madidimalo, described the launch as well-timed. he further commended the Authority’s efforts towards ensuring the safe use of medicines and implored on the Health Care Professionals to support ADR reporting as this places Botswana health care in a more collaborative disposition with other countries, eventually promoting global health.

BoMRA Chief Regulatory Officer Dr. Sinah Selelo reiterated that the Authority derives its mandate from the Medicines and Related Substances Act MRSA of 2013 and further reminded the attendants that BoMRA commenced its operations in January 2019. According to Dr. Selelo BoMRA is responsible for the registration of medicines, medical devices, and cosmetics, including inspection and licensing of facilities manufacturing and distributing of the mentioned products. The Chief Regulatory Officer continued to inform say that BoMRA also monitors and makes assessments on medical products before and after use. She implored on Health Care Professionals to make Pharmacovigilance part of their practice.

For his part, Dr Parthasarathi Gurumurthy, Director -Pharmacovigilance and Clinical Trials appealed to, Bamalete Lutheran Hospital team to be the ears and eyes of BoMRA to promote patient safety and ADR reporting.

He further said that Patient Safety Monitoring remains a top priority for the Botswana Medicines Regulatory Authority as the team establishes a Pharmacovigilance system in Botswana.

What steps should I follow to submit an application/dossier for renewal of a medicine?
A: You are required to submit a service request form either via email to: humanmeds.renewal@BOMRA.co.bw or submission at BoMRA offices. To download the service request form on BoMRA website www.bomra.co.bw, go to Downloads>Forms>Service request form. You shall be issued with a proforma invoice / sales order which you will use to process/make a payment for the intended service. After payment, submit the proof of payment, and the application to BoMRA. For more details visit the following guidelines:

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File name: BOMRA-FAQ-Renewal-of-Registration-for-Therapeutic-Human-Medicines.pdf

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Ref: MRA I/8/10 Vol I (32)

31 August 2020

In terms of Section 24(2) of the Medicines and Related Substances Act of 2013, an applicant shall be a company registered, licensed, or operating in Botswana. Given the feedback the Authority has received concerning the enforcement of this clause, we have suspended the implementation while we review and conduct further consultation.

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File name: Transition-to-a-new-regulatory-framework-follow-up.pdf

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BoMRA is participating in the fifth annual campaign called #MedSafetyWeek to raise awareness about the importance of reporting suspected side effects from medicines to BoMRA.

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File name: BoMRA-Press-Release-MED-Safety-Week.pdf

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The Director, Pharmacovigilance and Clinical Trial Dr Partha Gurumurthy accompanied by Pharmacovigilance Officers Mr Wapapha Nthomiwa and Ms Elizabeth Kelentse and Public Relations Officer Ms Itumeleng S. Ledimo have set out to Ngamiland DHMT in a mission to sensitise Health Care Providers on Pharmacovigilance and BoMRA services.  

Following sensitisation the team shall also launch an Adverse Drug Reaction Monitoring Centre (AMC) at Letsholathebe II Memorial Hospital on the 2nd September 2020. The centre shall be;

  •  A centralised office for the Ngami DHMT on collection, sensitisation and reporting of ADRs in the region
  •  Training of Pharmacovigilance
  •  One of the upcoming 12 centers (satellites) to be established countywide that will decentralize the mandate of BoMRA - Dept. Pharmacovigilance and Clinical Trials.

Do follow us for more updates.

BoMRA will conduct stakeholder sessions to discuss the regulatory requirements for medical devices.

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File name: BoMRA-Press-Release-Stakeholder-Engagement-November.pdf

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Following the reintroduction of a lockdown for the greater Gaborone zone on the 30th July 2020 by His Excellency the President. The Botswana Medicine Regulatory Authority would like to share the following...

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File name: BoMRA-operations-during-the-Greater-Gaborone-lockdown.pdf

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List of Exempted IR Thermometers and suppliers, Product Name: AET-RIFI Infrared Thermometer, AICARE A66 IR Thermometer, Infrared Thermometer (NX-2000), Non-Contact IR Thermometer, Dikang- Infrared Forehead Thermometer, Infrared Thermometer (Medior)....

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File name: List-of-Exempted-IR-Thermometers-and-suppliers-Rev_21-10-2020.pdf

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The matter bears reference.

Botswana Medicine Regulatory Authotity (BoMRA) is in the process of developing the legislative framework for the regulation of medical devices.

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File name: Update-Medical-Device-Regulations.pdf

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