PUBLIC NOTICE 20 SEPTEMBER 2022 - SHELF-LIFE EXTENSION OF COVID-19 APPROVED VACCINES

Botswana Medicines Regulatory Authority (BoMRA) is the National Regulatory Authority established in term of the Medicines and Related Substances Act (2013) to provide for the monitoring and evaluation, regulation, investigation, inspection, registration and control of medicines, schedules substances, clinical trials, and medical devices, and other related substances in the public interest. The application of this mandate can never be compromised and it is implemented independently by a team of qualified professionals.

The Botswana Medicines Regulatory Authority (“BoMRA)” would like to inform the public that, when the COVID-19 pandemic was declared a public health emergency by the World Health Organisation (WHO), several mechanisms were put in place to try and respond to the pandemic situation and curb the rapidy increasing incidence of serious illness and loss of life.

Download Now

File name: public-notice-20-september-2022-16-sep.pdf

453 29

Public Notice 25 August - Intravenous (IV) Rehydration Therapy

This public notice is issued jointly by the Botswana Medicines Regulatory Authority and the Botswana Health Professions Council after noting with concern the rise in the use of certain medicines, in particular intravenous vitamin infusions (IV vitamins), minerals and amino acids for both medical and cosmetic purposes for which they are not indicated. It is claimed that these IV nutrients are used to: cure hangovers, clear your complexion, help you lose weight, alleviate chronic pain, detox your body, increase your fitness performance and recovery, slow or reverse ageing, enhance energy and focus, as well as to improve your immunity and boost your libido.

BoMRA and BHPC wish to reassure the public and all stakeholders that the regulators have been following critical leads, gathering more information regarding the availability of these products in the market, including allegations of sales and promotion by some healthcare practitioners on public platforms.

Download Now

File name: joint-notice-bhpc-03-august.pdf

895 50

PUBLIC NOTICE 25 AUGUST 2022 - INTRAVENOUS (IV) REHYDRATION THERAPY

This public notice is issued jointly by the Botswana Medicines Regulatory Authority and the Botswana Health Professions Council after noting with concern the rise in the use of certain medicines, in particular intravenous vitamin infusions (IV vitamins), minerals and amino acids for both medical and cosmetic purposes for which they are not indicated. It is claimed that these IV nutrients are used to: cure hangovers, clear your complexion, help you lose weight, alleviate chronic pain, detox your body, increase your fitness performance and recovery, slow or reverse ageing, enhance energy and focus, as well as to improve your immunity and boost your libido.

BoMRA and BHPC wish to reassure the public and all stakeholders that the regulators have been following critical leads, gathering more information regarding the availability of these products in the market, including allegations of sales and promotion by some healthcare practitioners on public platforms.

Download Now

File name: joint-notice-bhpc-25-august-2022-03-august.pdf

418 11

 

TENDER DOCUMENTS: Tender documents containing details of the requirements are available for collection from Monday 01st August 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.

Download Now

File name: tender-notice-10-august.pdf

1091 46

PUBLIC NOTICE 12 AUGUST 2022 - PERSONAL LUBRICANTS AND “VAGINAL CARE PRODUCTS”

The Botswana Medicines Regulatory Authority (“BoMRA”) has noted with concern the rise in the sale, promotion, and advertisement of products particularly personal lubricants and “vaginal care products” in both the formal and informal sectors. Members of the public and Healthcare Practitioners are advised that these products that are regulated by BoMRA in line with the Medicines and Related Substances Act (“MRS Act”).

Any person who wishes to advertise or promote a medical product must submit advertising and promotional materials to the Authority for approval before use. This includes social media advertisements and promotions. The adverts for medical products shall not contain promises that have not been scientifically proven and shall not make reference to symptoms in a manner likely to mislead the public.

Download Now

File name: Public Notice 12 August 2022

409 12

Covid-19 RTPCR Kit, Powder Free Nitrile Examination Gloves, COVID-19 PCR Kit, Covid-19 Testing machine, Infrared thermometer, Face Shield, Latex Examination Gloves Powdered, Oxygen Concentrator...

Download Now

File name: List of Exempted Devices and Suppliers 07-2022

1160 82

PUBLIC NOTICE 16 SEPTEMBER - VIRTUAL STAKEHOLDER ENGAGEMENTMEDICAL DEVICES INCLUDING IN VITRO DIAGNOSTICS

The Department of Product Evaluation & Registration at BoMRA will conduct virtual stakeholder sessions to discuss the medical devices including in vitro diagnostics (IVDs) processes and guidelines: registration, risk classification, labelling, clinical evaluation, registration timelines and fees. The stakeholder engagement targets all relevant stakeholders inclusive of; manufacturers, importers, distributors, local re resentatives, associations and facilities.

The sessions will be scheduled as follows:

SESSION 1: Tuesday 18th October 2022 from 0830 – 1300 hours
SESSION 2: Wednesday 19th October 2022 from 0830 – 1300 hours

Download Now

File name: medical-devices-14-september.pdf

558 41

The Botswana Medicines Regulatory Authority (BoMRA) through the department of Product Evaluation & Registration will conduct a virtual stakeholder engagement session to update the relevant stakeholders on listing of medical devices, including In-Vitro Diagnostics (IVDs) devices.

Download Now

File name: medical-devices-06-july-ii.pdf

1936 117

The Botswana Medicines Regulatory Authority (BoMRA) will be conducting a virtual stakeholder engagement to update all its valued stakeholders on Registration Processes and Procedures.

The sessions will be scheduled as follows:

SESSION 1: Tuesday 20 September 2022 from 0900 – 1200 hours
SESSION 2: Tuesday 20 September 2022 from 1400 – 1700 hours

Please RSVP by the 15th September 2022 to humanmeds.newapp@bomra.co.bw. Please note that the content for the two (2) sessions is the same, and kindly indicate the slot you would want to be registered in for planning purposes. The detailed information and agenda regarding each stakeholder engagement session will be communicated directly to the confirmed attendants

Download Now

File name: registration-process-18-august-002.pdf

749 54

Organisational Development Specialist, and Project Assistants - Medicines Register Update X2 (12 months fixed term)

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: recruitment@bomra.co.bw Please indicate the Position applied for in the Subject of the email.

All application letters are to be addressed to:
Director- HR & OD
P O Box 2
Gaborone Station

Closing Date for Submissions: 18 July 2022. Only short-listed candidates will be contacted. If you are not contacted within 1 month from the closing date, consider your application unsuccessful.

Download Now

File name: bomra-july-7-vacancies.pdf

2018 96

 

The Botswana Medicines Regulatory Authority (BoMRA), referred to herein as the Authority, would like to notify all its valued stakeholders that the Medicines and Related Substances Act (MRSA) of 2013, Section 24 stipulates that "Where the Authority registers a medicine or cosmetic , the person who applied for the registration shall submit information to the Authority annually, in the prescribed manner accompanied by a prescribed fee" and that the Medicines and Related Substances Regulations (MRSR) of 2019, regulation 4 states that "A registration certificate issued in terms of regulation 3 shall be valid for five years subject to annual submission of information accompanied by a fee set in Schedule 5". Please note that the Authority has not been implementing these provisions of the legislation, having adopted a staged approach to implementation of the Act since commencing operations in 2018. Stakeholders are hereby notified that the Authority has decided to initiate implementation of the annual retention of the medicinal products, effective January 2023.
 
Download Now

File name: notice-to-stakeholders_call-for-annual-retention-fees_05.2022.pdf

717 42
 

1. Dossier Assessor- Complemetary Medicines & Cosmetics

Reports To: Manager Complementary Medicines & Cosmetics

JOB PURPOSE:

The Specialist’s overall responsibility is to ensure that complementary medicines and cosmetics that are authorized to be in the market comply with legal and regulatory requirements in Botswana with respect to quality, safety, and efficacy.

2. Systems Administrator

Reports To: ICT Manager

JOB PURPOSE:

Systems administrators ensures all systems have secure connections and perform smoothly to serve the needs of employees. To perform day-to-day maintenance and repairs, including software and computer installations and upgrades, routine automation, security maintenance, troubleshooting, training, and technical support for all users and projects of the organization.

Kindly send your application, latest CV and certified copies of certificates and two(2) current referee’s details to: recruitment@bomra.co.bw

BOMRA
P.O Box 2, Gaborone Station
Gaborone

ATT: HR Manager

Closing Date for Submissions: 14 June 2022. Only short-listed candidates will be contacted

Download Now

File name: vacancy-advert.pdf

2382 110

 

The Botswana Medicines Regulatory Authority (BoMRA), referred to herein as the Authority, would like to notify all its valued stakeholders that the Medicines and Related Substances Act (MRSA) of 2013, Section 4 (d) stipulates that "The functions of the Authority shall be to - grant, renew, suspend or cancel, after due assessment, marketing authorisations for medicines. whether locally manufactured or imported and whether intended for local use or export." and that the Medicines and Related Substances Regulations (MRSR) of 2019, regulation 4 and 5 (1) and (2)(b) & (c) states that "A registration certificate issued in terms of regulation 3 shall be valid for five years subject to annual submission of information accompanied by a fee set out in Schedule 5. A person may apply to the Authority for renewal of registration of medicines. An application under sub-regulation I shall be - accompanied b a renewal fee set out in Schedule 5; and submitted to the Authority not later than six (6) months before before the expiry date of registration".
 
Download Now

File name: call-for-submission-renewal-of-applications.pdf

699 45

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

 

Download Now

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

2511 66

 

TENDER DOCUMENTS:

Tender documents containing details of the requirements are available for collection from Wednesday 07th September 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.

Download Now

File name: tender-notice-05-september.pdf

750 37

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
Download Now

File name: listing-of-cosmetics-listing.pdf

7638 132
Fri26Aug2022

Tender Notice: Provision Of Transactional Advisory Services For BoMRA PPP Project

This addendum follows the Invitation for Bids for the above project that have already appeared in the Daily News 10 August 2022, Sunday Standard 14 August 2022 and Business Weekly 19 August 2022 and on the BoMRA Website.

Please be informed that this is a notice of closing date from 15th September 2022 to a new closing date of 28th September 2022 at 1100hrs.

Download Now

File name: 10x11.pdf

917 29

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...

Download Now

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

3122 507

Lubes Public Notice 12 AUGUST - PERSONAL LUBRICANTS AND “VAGINAL CARE PRODUCTS”

The Botswana Medicines Regulatory Authority (“BoMRA”) has noted with concern the rise in the sale, promotion, and advertisement of products particularly personal lubricants and “vaginal care products” in both the formal and informal sectors. Members of the public and Healthcare Practitioners are advised that these products that are regulated by BoMRA in line with the Medicines and Related Substances Act (“MRS Act”).

Any person who wishes to advertise or promote a medical product must submit advertising and promotional materials to the Authority for approval before use. This includes social media advertisements and promotions. The adverts for medical products shall not contain promises that have not been scientifically proven and shall not make reference to symptoms in a manner likely to mislead the public.

Download Now

File name: lubes-public-notice-40x7-12-august.pdf

927 33

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:

Download Now

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

5350 194