TENDER ENQUIRY NO.: MRA-HDOC-009.0 – 2021/2022

PROVISION OF EMPLOYEE WELLNESS SERVICES FOR A PERIOD OF THREE(3) YEARS

The tender is amended as follows:

1. Additional PPADB Code: the tender is amended to include the following code:
Code: 322 – Health Care Consulting Services
Sub code: 02 – Guidance & Counselling
2. Extension of Closing date: The tender is further extended by one (1) week to a new closing
date of: 22nd October 21 at 1100hrs
All other terms and conditions remain unchanged.

 

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File name: tender-notice-addendum.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 containing details of the requirements are available for collection from Tuesday 14th September 2021. 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.

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File name: tender-notice-21sep.pdf

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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

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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

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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) 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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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 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

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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) 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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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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Exempted Covid 19 Related Medical Devices & Suppliers,

Product name: Infrared Thermometer, Face Mask, MagaBio Plus Virus DNA / RNA Nucleic PurificationKit, Multiple Real-Time PCR kit for Detection of 2019-nCoV...

 

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File name: exempted-covid-19-related-medical-devices-suppliers-16-aug-21.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 This email address is being protected from spambots. You need JavaScript enabled to view it.

COVID-19 FAQs-Extreme social distancing period

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

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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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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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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 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

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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