TENDER DOCUMENTS:

Tender documents containing details of the requirements are available for collection from Tuesday 17th May 2022. All Payment must be made in the form of bank transfer to the following banking details and quoting the Tender Ref No and Bidder Name.

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

 

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File name: bomra-tenders-2022-may.pdf

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The Botswana Medicines Regulatory Authority (BoMRA) communicated in the press release issued on the 17th of March 2021, Ref MRA 1/8/5 Vol 11 (153) that BoMRA intends on embarking on a cosmetic listing process for cosmetics. This process will be used to collate information on all cosmetics that are available in Botswana for sale.

The Cosmetics Listing exercise ends on the 28th of February 2022. For any further inquiries, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

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File name: cosmetics-regulatory-update-1.9.2021.pdf

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JOB TITLE:

Director- Product Evalaution & Registration, Finance & Administration, Quality Assurance Officer, Enforcement Officer (x2), Regulatory Officer – Inspections & Licensing and Pharmacovigilance Officer.

 

If you have the above capabilities, meet the minimum requirements and believe that you can grow with BOMRA, kindly send your application, latest CV and certified copies of certificates and two(2) current referee’s details to: This email address is being protected from spambots. You need JavaScript enabled to view it.

Closing Date for Submission: 28 March 2022. Only short-listed candidates will be contacted

 

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File name: bomra-vacancy-adverts.pdf

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The Botswana Medicines Regulatory Authority would like to advise all our valued stakeholders that our offices will be closed from Friday 02nd July- Monday OSth July 2021.

Normal business will resume on Tuesday 6th July 2021.

We apologise for any inconvenience caused.

Rea Leboga

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File name: BoMRA office closure 2 July 2021

5779 162

Covid-19 RTPCR Kit, Powder Free Nitrile Examination Gloves, Detection kit, Covid-19 Testing machine, Covid-19 Test kit reagent, Infrared thermometer, Face Shield, Surgical Mask, Latex Examination Gloves Powdered....

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File name: list-of-exempted-devices-and-suppliers-03-2022.pdf

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The Botswana Medicines Regulatory Authority (BoMRA) wishes to inform the public, healthcare practitioners, importers, and distributors that ALL Grand-Pa pain relief products (powder and tablets ) remain suspended from registration and therefore are not allowed in Botswana.

The suspension follows a decision by the Market Authorization Holder GlaxoSmithKline CH South Africa to temporarily halt the supply of these products to Botswana and other markets.

 

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File name: Grand-Pa Products are not Allowed In Botswana

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BoMRA has received several inquiries concerning the process. The Authority ould provide clarity on the following commmonly asked questions;

  1. Will stakeolders receieve a registration certificate after listing the cosmetics?
    The Listing process is not a registration, certification nor verification of your cosmetics. the exercise is aimed at providing the cosmetic products on the market. There currently is no registration requirement for cosmetics to enter the Botswana market.
  2. Please clarify the company registration process and listing process as well as the reasons for embarking  on these processes. This will assist in a uniform response to enquiring member companies
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File name: listing-of-cosmetics-listing.pdf

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Please be informed that the VET Stakeholder Engagement that was scheduled for the 14-15 of June 2021 has been postponed to the 12-13 of July 2021.

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File name: vmp-stakeholder-engagement-postponed.pdf

6040 161

The Online Registration Platform for Complementary Medicines

BoMRA has developed an online registration platform for low-risk complementary medicines as a way to improve efficiencies in the registration process. The platform is a cloud-based system that is accessible from anywhere, any time and on any electronic device through internet, and it allows applicants to submit applications (including attaching the required supporting documentation), receive responses to their applications, submit responses and receive regulatory decisions on their products.

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File name: expression-of-intrest-25-feb.pdf

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In response to the request for extension of the date of submission of comments from stakeholders and to ensure comprehensive and thorough coverage of stakeholders' concerns, the Authority

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File name: Notice of Extension of Deadline for Submission of Comments - MRS Bill 2021

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TENDER DOCUMENTS:

Tender documents containing details of the requirements are available for collection from Tuesday 22nd February 2022. All Payment must be made in the form of bank transfer to the following banking details and quoting the Tender Ref No and Bidder Name.

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

Due to the Covid 19 Pandemic and with most organizations working home, proof of payment can be emailed to the email address provided below and tender document will then be sent through email after receipt of payment proof.

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File name: tender-notice-18-feb.pdf

2003 213

 

The Botswana Medicines Regulatory Authority ("BoMRA") is a statutory body established under the Medicines and Related Substances Act No.8 of 2013 ("MRSA") with the mandate to regulate the supply chain of medicines, medical devices, and cosmetics in Botswana to ensure their quality, safety, and efficacy

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File name: Invitation-MRS-Bill-comments.pdf

6719 279

Medical Gloves, Oxygen Concentrator, Covid-19 rapid antigen test kit, Fingertip Pulse Oximeter, Covid 19 AG Test Kit, Viral Transport Media Kit, COVID-19 RT-PCR Detection Kit, Continuous Positive Airway Pressure Machine, Handheld Pulse Oximeter, Medical PSA Oxygen Generator...

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File name: list-of-exempted-devices-and-supplier-01--02-2022.pdf

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The Botswana Medicines Regulatory Authority (BoMRA) will conduct virtual stakeholder sessions to discuss the registrability of medicines and listing requirements for cosmetics. The engagements will be scheduled as follows:

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File name: Stakeholder-engagement-Complementary-medicines-and-cosmetics.pdf

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The Botswana Medicines Regulatory Authority (BoMRA) will be conducting virtual stakeholder engagements to discuss the MRS ACT, Medical Devices Regulatory Framework, Medical Devices Exemptions and update on Listing exercise. The roles played by Healthcare Facilities and Procurement Entities in ensuring that safe Medical Devices and IVDs are imported into the country, services availed by BoMRA for facilities and more will be discussed. The sessions will be scheduled as follows:

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File name: bomra-medical-devices-stakeholder-engagement-notice.pdf

4401 191

 

Tozinameran (BNT162B2) COVID-19 mRNA Vaccine concentrate for dispersion for injection, AZD1222 COVID-19 Vaccine (ChAdOx1-S [recombinant]), ChAdOxI nCoV-19 Corona Virus Vaccine (Recombinant), COVID-19( vaccine (Ad26.COV2-S, recombinant), Whole Virion, Inactivated Corona Virus Vaccine Bulk, COVID-19 Vaccine (Vero Cell), Inactivated

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File name: Human-Medicines-Database-for-Emergency-Use_16-04-2021.xlsx

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The Botswana Medicines Regulatory Authority (BoMRA) would like to inform relevant stakeholders that; All COVID-19 related medical devices and IVDs should go through an exemption process before they can be imported into the country.

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File name: public-notice-covid-19-related-medical-devices-exemptions-requirements.pdf

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The Botswana Medicines Regulatory Authority (BoMRA) is pleased to inform relevant stakeholders that the deadline for the listing of Medical Devices and In-Vitro Diagnostics devices (IVDs) is extended from the 31st of March to 30th April 2021 as requested.

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File name: Extension-of medical-devices-listing-deadline.pdf

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The Botswana Medicines Regulatory Authority (BoMRA) would like to inform relevant key stakeholders that the consolidation of listed Medical Devices and In-Vitro Diagnostics devices (IVDs) is currently ongoing.

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File name: public-notice-sep-2021-update-on-listing-of-medical-devices.pdf

4645 217

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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