Botswana Medicines Regulatory Authority (BoMRA) would like to inform its valued clients, stakeholders and the general public that the Department of Licensing and Enforcement will be relocating to a new site effective 1st May 2021. The Department will be housed, at Plot 145, Unit 9; Block B First Floor Gaborone International Finance Park area.

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File name: Licensing_and_Enforcement_moving-notice.pdf

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The Authority (BoMRA) is calling on all entities trading and using cosmetics in their practices/ occupations to submit their contact details for ease of communication on regulatory updates.

This notice affects entities or individuals who manufacture, distribute, sell, import & export cosmetics including professionals and technical personnel such as dermatologists, beauticians, cosmetic scientists, etc.

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File name: BoMRA-Public-Notice-Cosmetics.pdf

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Dear valued client

We have introduced business continuity measures aimed at minimising the risk of COVID-19 transmission at BoMRA.

Here are frequently asked questions and all you need to know about operations and COVID-19 at BoMRA.

For more information contact info@bomra.co.bw

COVID-19 FAQs-Extreme social distancing period

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File name: COVID-19-VACCINE-Q-and-A.pdf

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It is because of the above that we call upon all local pharmaceutical distributors and/or importers with distributorship agreements with Market Authorization Holders or Manufactures outside of Botswana to provide the BOMRA with evidence of such agreements. This should be in the form of a letter or copy of the agreement addressed directly to BoMRA from the authorizing MAH or pharmaceutical manufacturer

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File name: Request-for-information-Pharmaceutical-importers.pdf

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Reference is made to correspondence titled, "Notice - Transition to New Regulatory framework for Medicines in Botswana" dated 5th of August 2020 sent to all stakeholders.

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File name: Use-of-guidelines_Complementary-medicines.pdf

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Reference is made to the letter dated 10 February 2020 on the above subject matter.

The Botswana Medicines Regulatory Authority (BoMRA) commenced registration of B-listed products (products denoted with “B” in the Human Medicines Register / Blue book) therefore manufacturers are required to submit applications. To allow for a phased transition, variation applications for B-listed applications will only be allowed for changes that affect the following information in the Register / Blue Book:

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File name: Stakeholders letter-B-listed-Reminder-2021.pdf

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The Botswana Medicines regulatory Authority (BoMRA) communicated in the press release issued on the 3rd September 2019, Ref MRA 1/8/5 Vol 35 that are no applicable regulatory requiments to clear, import or distribute cosmetics.

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File name: Cosmetic-regulatory-update.pdf

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Please note that, in terms of the Medicines and Related Substances Act, 2013, Section 23, the importation, distribution, sale, storage and advertising of unregistered medical products is illegal and prohibited. Any person found guilty of breaching Section 23 may be liable to a fine of up to P100,000.00 and/or imprisonment for a period not exceeding 10 years.

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File name: BOMRA-PRESS-RELEASE-on-Unregistered-Products.pdf

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The Department of Pharmacovigilance and Clinical Trials at BoMRA has just launched the EIGHTH ADR Monitoring Center on the 18th March 2021 at Sekgoma II Memorial Hospital for the Serowe – Palapye RHMT in Botswana.

In consultation with the Ministry of Health and Wellness, BoMRA has identified 12 hospitals in the country in different geographical locations to establish Adverse Drug Reaction monitoring centers (AMCs)

The Authority also looks into developing these hospitals as regional centers for training and advocacy in Pharmacovigilance.

BoMRA AMCs will work with both public and private healthcare facilities and it is a pleasure to inform you that we have already launched AMCs in Maun, Orapa, Ramotswa, Kasane, Francistown (2 AMCs) and Gaborone. 

Remember to keep reporting Adverse Drug reactions as this is important in ensuring the safety, quality and efficacy of medical products.

We value all your feedback.

#promoting_access_to_safe_medicines

 

Veterinary Ivermectin is used for control of parasites in animals and has not been approved for use in humans for Covid 19 as there has not been any research presented to the National Regulatory Authorities to demonstrate the effectiveness of the product for the condition.

The use of any medical product for indications that have not been approved may also have unwanted effects in humans which may prove detrimental to the health of the people..

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File name: Unapproved-use-of-Ivermectin-press-release-final.pdf

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ICT Supplies | ICT Technical Support Services,

Tender documents containing details of the requirements are available for collection from Monday 15th March 2021. All payments must be made in the form of bank transfer to the following banking details, quoting the Tender Ref No and Bidder Name:

Bank: First National Bank, Gaborone Industrial Branch
Branch Code: 281667
Business Cheque Account No: 62747456417

Youth companies shall purchase the tender document at 50% of the fee as per Presidential Directive CAB 14 (B) 2015.

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File name: BoMRA-Tender-notice(March-2021).pdf

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This is for purposes of identification and creating a database of medical devices and IVDs that are or will be allowed in or out of Botswana. This notice affects entities or individuals who manufacturer/distribute/sell/import/export and healthcare facilities that have inventories of medical devices.

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File name: BoMRA-Press-Release-Listing-of-Medical-Devices.pdf

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1. What is the mandate of Botswana Medicines Regulatory Authority (BOMRA)?
A To regulate medicines, medical devices and cosmetics, to promote human and animal health.

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File name: BoMRA-medical-devices-FAQs.pdf

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BoMRA wishes to inform all its stakeholders and the general public that the office will be closed from Thursday 24th December 2020 at 12h00 and re-open on Tuesday 5th January 2021.

Best Wishes for a Happy Holiday Season and a Joyous New Year.

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File name: BoMRA-CHRISTMAS-Message-2020-end.pdf

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The Department of Product Evaluation & Registration at BoMRA will conduct virtual stakeholder sessions to discuss the listing requirements for medical devices, including In-Vitro Diagnostics (IVDs) devices. The sessions will be scheduled as follows:

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File name: BoMRA-Public-notice-(medical-devices-stakeholder-engagement).pdf

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Botswana Medicines Regulatory Authority (BoMRA) and Botswana Bureau of Standards (BOBS), on the 15th of December 2020, signed a Memorandum of Understanding (MOU) to mark the beginning of a partnership through which the two organisations will work together in areas of developing standards for medical and medicinal products, and undertaking conformity assessments.

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File name: BoMRA-signs-MoU-with-BOBS.pdf

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TOZINAMERAN (BNT162B2) COVID-19 mRNA Vaccine concentrate for dispersion for injection, AZD1222 COVID-19 Vaccine (ChAdOxI-S)[recombinant])..

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File name: Human-Medicines-Database-for-Emergency-Use-2.02.2021.xlsx

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As per the latest recommendation from the WHO, the WHO pre-qualified antigen rapid test kits may be used for testing of COVID-19. These have been shown to be more specific and sensitive in the diagnosis of COVID-19. This position has been adopted by BoMRA. Therefore , BoMRA is currently accepting applications for WHO-Prequalified Rapid Antigen Test Kits.

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File name: Update-Covid-19-Rapid-Test-Kits.pdf

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The Botswana Medicines Regulatory Authority (BoMRA) wishes to inform all its valued stakeholders that the office will be closed for routine maintenance on the 12th February 2021.

Normal business shall resume on the 15th February 2021.

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File name: BOMRA-OFFICE-CLOSURE-February-12.pdf

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The Botswana Medicines Regulatory Authority ("Authority") has become aware of products circulating in the local market derived from cannabis and particularly hemp and hemp oil products. These products come in a variety of items including those for nutritional use, such as seeds and oils and cosmetic products such as shampoos and conditioners.

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File name: Notice-Prohibition-of-cannabis-and-derivative-products-including-hemp.pdf

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