The public, healthcare practitioners, importers and distributors are informed that registrations of Grand-Pa Headache products (Powder and tablets) have been suspended from the Botswana market with immediate effect. This 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. This means that importation of new stock into the country is prohibited, however, the stock currently available in Botswana may be used.

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File name: Suspension-Of-Registration-of-GrandPa-Products.pdf

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BoMRA e gakolola Sechaba go nna podimatseba kgatlhanong le bangwe ba ba bapatsang le go rekisa melemo....

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File name: Tlhagiso-ya-botlhokwa.pdf

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Invitation For Expression Of Interest (EOI) To Serve In The Pharmacovigilance Committee Of Botswana Medicines Regulatory Authority

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File name: Expression-Of-Interest-Pharmacovigilance-Committee.pdf

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Response to coronavirus  (covid-19)

Medicine supply challenges and interaction with stakeholders.

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File name: Covid-19-Response.pdf

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Botswana Medicines Regulatory Authority (BoMRA) is calling on all entities trading in medical devices to register with the Authority.
This notice affects entities or individuals who manufacturer, distribute, sell, import & export medical devices including Personal Protective Equipment used in the detection, prevention, and control of COVID -19.

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File name: Call-for-Registration-Medical-devices.pdf

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The Authority will accept submissions for application for human and complementary medicines.

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File name: Stakeholders-engagement-sessions-Registration.pdf

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BoMRA commenced receipt of new applications for registration of medicines in February 2020 and owing to anticipated influx of applications, submissions were limited to 5 applications per institution per month. Please be informed that the number of submissions per company are now unlimited with immediate effect.

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File name: Number-of-New-Applications--Stakeholders.pdf

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Alert!!!! All are expected to familiarise themselves with the provisions of the MRSA

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File name: Compliance with MRSA and Regulations.pdf

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Botswana Medicines Regulatory Authority (BoMRA) reminds consumers to be cautious of stores and websites selling products that claim to prevent, mitigate, treat, diagnose or cure serious illnesses, including Covid-19. Some of the fake products claim to kill disease agents such coronavirus, the agent that causes the Covid-19 disease.

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File name: Important-Public-Warning.pdf

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The Authority will accept submissions for application for human and complementary medicines.

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File name: Registration-of-human-and-complementary-medicines.pdf

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 It is important to verify the safety (composition and concentrations of ingredients), efficacy of these products and any claims made for these products.

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File name: Form-Application-for-Registration_Exemption_–_Wholesale_ER-EX-P01-F01_Iss1.docx

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File name: Guideline_for_Exemption-of-Human-Use-Antiseptic-Products_ER-EX-P01-G01_Iss1.pdf

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You now have access to the BoMRA regulations and services fees. The Authority recently released a stakeholder update on regulatory services. Reference is made to out letter dates 6th Jan with the above matter.

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File name: BoMRA-Regulatory-Services-Stakeholder-Update.pdf

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The Botswana Medicines Regulatory Authority (BoMRA) is a new Authority that has been set up under the Medicines and Related Substances Act (MRSA) of 2013 and was established to regulate the supply chain of medicines and related substances, cosmetics and medical devices to ensure their quality, safety and efficacy. The Authority hereby invites expressions of interest from suitable and interested candidates to be considered for appointment to one of its technical committees.

 

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File name: Expression-of-Interest-Licensing-Committee.pdf

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The Minister of Health and Wellness Hon Dr Lemogang Kwape, together with the Assistant Minister of Health and Wellness Hon Sethomo Lelatisitswe officially launched two platforms for reporting Adverse Drug Reactions.

The launch was attended by health professionals as well as other key stakeholders such as the World Health Organisation representatives.

Patient safety is in your hands. Report Adverse Drug Reactions.

 

In the advent of the extreme social distancing period , kindly note that the Accounting department is working from home, therefore customers are advised that the Point of Sale transacting (swipe machine) will not be available and as such all Import and Export Permits customers are advised to deposit money into the BOMRA bank account through Electronic Funds Transfer(EFT).

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File name: Customer-advances-(Import-Export-permits).pdf

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BoMRA in collaboration with key stakeholders in a continuous effort to ensure the use of safe medicines in promoting human and animal health. World Antibiotic Awareness Week Commemoration in Medie.

We are all advised to put a stop to excessive and careless use of antibiotics as the more often antibiotics are used, the greater the chance that they will become resistant.

 

Pharmacists, like other frontline healthcare professionals, are risking their lives for the well-being of their patients during COVID-19 pandemic. Here is what you can do to protect them.

 

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File name: Ask Pharmacist PSB-BoMRA.pdf

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The Honourable Minister of Health and Wellness, Dr Lemogang Kwape together with his Assistant Minister, Honourable Sethomo Lelatisitswe as well as the Ministry management hosted a ‘Meet and Greet’ for health partners.

The purpose of the session was to create a healthy environment to engage in as key partners of health. Members of the diplomatic core, CEO’s, Board of Directors, Ministry management, Registrars, Academia, as well as the fourth Estate graced the session.

 

Botswana Medicines Regulatory Authority (BoMRA) reminds consumers to be cautious of stores and websites selling products that claim to prevent, mitigate, treat, diagnose or cure serious illnesses, including COVID-19.

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File name: Public-warning-Unfounded-claims.pdf

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