Frequently Asked Questions FAQ
Explore answers to common questions about BOMRA services.
How do I register
You would need to submit a dossier / application to BoMRA, upon payment of the requisite application fee, and the dossier / application will be evaluated by the Department of Product Evaluation and Registration (DPER) to determine product compliance with established criteria of quality, safety, and efficacy.
What steps should I follow for me to submit an application/dossier for registration/approval of a medicine?
You are required to submit a service request form either via email or submission on the integrated information management system, BRIMS. To access the service request form, click here. You shall be issued with a proforma invoice or sales order which you will use to process /make a payment for the intended service. After payment, you can submit the proof of payment, and the application to BoMRA. For more details visit the following guidelines:
- Guideline on submission of applications and BoMRA timelines
- Guideline for submission of requests for paid services
These can be accessed on the BoMRA website. You can access them at the following link
How do I know the requirements or what is needed in the dossier/application?
The guidelines and application forms are available on BoMRA website www.bomra.co.bw.
What is the Department of Product Evaluation and Registration (DPER)?
DPER is responsible for evaluating, registering, and monitoring human medicines, veterinary medicines, medical devices, and cosmetics in Botswana, ensuring they meet safety, efficacy, and quality standards.
How do I register a product with DPER?
To register a product, you must submit a comprehensive dossier containing detailed information on the product’s safety, efficacy, and quality. The dossier will undergo a scientific assessment before approval.
How long does the registration process take?
The registration process can take several months, depending on the complexity of the product and the completeness of the submitted documentation.
What happens once my product is approved?
After approval, your product will be granted Marketing Authorization (MA) and added to the national register, allowing you to market or distribute the product in Botswana.
How long is the Marketing Authorization valid?
Marketing Authorization is typically valid for 5 years. After this period, a renewal application must be submitted to maintain the product’s registration.
Can I request an exemption for an unregistered product?
Yes, you may apply for an exemption for essential unregistered medical products, particularly those urgently needed for public health. Each request will be evaluated based on the product’s necessity and benefit.
What is the difference between a variation and a renewal?
A variation refers to changes in an already registered product (such as modifications to packaging, formulation, or manufacturing process). A renewal involves reauthorizing a product after the original Marketing Authorization expires.
What are the requirements for registering veterinary medicines?
Veterinary medicines undergo a similar evaluation process as human medicines. A dossier containing data on safety, efficacy, and quality must be submitted for review and approval.
Are cosmetics regulated by DPER?
Yes, cosmetic products are regulated by DPER. While cosmetics do not require full registration, they must undergo a notification process to ensure compliance with safety standards.
What happens if my product does not meet regulatory standards?
If your product does not meet the required standards, it will not be granted Marketing Authorization. You will receive feedback outlining the issues, and you may address them before resubmitting.
What is the role of the Department of Licensing and Enforcement (DLE)?
The DLE is responsible for overseeing the control of imports, exports, and transit of all regulated products. The department also inspects and licenses premises across the supply chain to ensure compliance with regulatory standards and conducts testing to verify product quality.
How does the DLE ensure the safety of regulated products?
The DLE ensures safety by inspecting and licensing premises, testing products for compliance with established specifications, and identifying substandard or falsified products before they enter the market.
What is the process for obtaining a license for premises?
Premises involved in the storage, distribution, or sale of regulated products must apply the DLE. The application will be assessed, and a site inspection will be conducted to ensure compliance with regulatory requirements.
How can I import or export regulated products in Botswana?
To import or export regulated products, businesses must meet DLE’s documentation, registration, and inspection requirements. All products must comply with safety and regulatory standards before they can be cleared for trade.
What happens if a product fails testing or is found to be substandard?
If a product fails testing or is found to be substandard, the DLE will take necessary enforcement actions, such as product recall, suspension of licenses, or legal penalties, to protect public health and safety.
What is the Medicines and Related Substances Act (MRSA)?
The MRSA is the legislation that governs the regulation of medicines, medical devices, and related products in Botswana. The DLE enforces the provisions of this Act to ensure that only safe, effective, and high-quality products are available in the market.
Can I request an exemption from regulatory requirements for certain products?
Exemption requests may be considered on a case-by-case basis for specific circumstances, such as urgent medical needs. The DLE evaluates each request based on the product’s safety and public health benefits.
What are the penalties for non-compliance with regulatory standards?
Non-compliance with regulatory standards may result in fines, suspension or revocation of licenses, or legal action, depending on the severity of the violation. The DLE enforces the MRSA to ensure compliance and safeguard public health.
How often does the DLE conduct inspections?
Inspections are carried out regularly and as needed, based on the type of premises and the products handled. This ensures that all regulated entities remain compliant with safety and quality standards.
How can I report a suspicious or non-compliant product?
Suspicious or non-compliant products can be reported directly to the DLE through official channels, such as online forms, phone, or email. The department investigates all reports to ensure product safety and compliance.
How do I get my veterinary medicine registered/approved?
You need to submit a dossier / application to BoMRA, upon payment of the relevant fee, and the dossier will be evaluated by the DPER – Veterinary Unit to determine the suitability (quality, safety, and efficacy) of the product.
What are the requirements for registration of veterinary medicines?
The requirements for registration of veterinary medicines have been shared on BoMRA website www.bomra.co.bw. You can access the relevant guidelines on this link
Are complementary veterinary medicines registered using the same requirements?
The requirements for registration of complementary veterinary medicines, are different from the guidelines for Pharmaceutical and Immunological veterinary products mentioned above. A specific guideline for registration of complementary veterinary medicines is also available on the website..
What steps should I follow to submit an application/dossier for registration of my veterinary medicines?
You are required to submit a service request form either via email or submission on the integrated information management system, BRIMS. To access the service request form, click here. You shall be issued with a proforma invoice or sales order which you will use to process /make a payment for the intended service. After payment, you can submit the proof of payment, and the application to BoMRA. For more details visit the following guidelines:
a. Guideline on submission of applications and BoMRA timelines
b. Guideline for submission of requests for paid services
These can be accessed on the BoMRA website. You can access them at the following link
What is the format of the Dossiers for registration of Veterinary Medicines?
The dossiers for registration of pharmaceutical and immunological veterinary medicines should be in CTD format. These should be submitted as an electronic text-selectable PDF and/or Word Format. However, the dossiers for registration of complementary veterinary medicines shall not be in CTD format. The dossiers shall be compiled in accordance with the current, specific guideline for registration of complementary veterinary medicines, which is available on the website.
How long is it likely to take, from time of submission, to obtain a decision of whether my veterinary medicine is registered or rejected registration in Botswana?
BoMRA utilises different assessment pathways depending on:
1. the choice of the applicant, and
2. availability of evidence of registration of the VMPs in other jurisdictions that BoMRA recognises in line with the Recognition/Reliance Policy and procedures.
Acknowledging the general principles of FIFO, and unless in the case of a declared animal / public health emergency,
a. if a product is registered, in a country recognised by BoMRA, an abbreviated assessment pathway shall be employed. With this pathway, a regulatory decision shall be made within 6 to 12 months from date of submission.
b. in cases where the applicant chose an expedited assessment pathway, a regulatory decision shall be made within 12 months from date of submission.
c. if it is a locally (partially/fully) manufactured VMP, where there is no evidence of registration from a recognised jurisdiction, a regulatory decision shall be made within 18 months from date of submission.
d. if it is a fully foreign manufactured VMP, where there is no evidence of registration from a recognised jurisdiction, a regulatory decision shall be made within 24 months from date of submission.
NB. This timeline is subject to review
How can I follow up on the application/dossier that I submitted for registration of a veterinary product with BoMRA?
You can send an email to the Veterinary Medicines Unit on registration.vetmeds@bomra.co.bw, stating exactly what you would like to know about the product, quoting the unique reference number assigned by BoMRA. After the commissioning of the integrated regulatory information management system, applicants shall be able to access their accounts, and track or verify the status of their applications online, on the self-service portal.
How can I access the fees for registration of veterinary medicines?
The applicable fees for registration of veterinary medicines are available on the website. You can access the fees here.
Where do we go if we want to submit applications for registration of Dips and which guidelines should we use?
Regulation of Dips is currently done by the Registrar of Agrochemicals, in the Department of Crop Production, Ministry of Agriculture. A process of engagement has been initiated to determine if the regulation of dips should remain with the Ministry of Agriculture or be moved to BoMRA. Any new developments shall be communicated by way of a Notice to all Stakeholders.
How do we access a list of approved veterinary medicines in Botswana?
BoMRA publishes the register of approved veterinary medicinal products on its website www.bomra.co.bw
How can I obtain approval to import veterinary medicines that do not exist on register, but are urgently needed for use in animals in Botswana?
The Authority has developed a process for exemption of medicines from registration in accordance with the provision of the MRSA section 23 (3). Refer to the guideline for exemption from registration of VMPs available on the website for more detailed process and requirements.
If our product is on the list of approved veterinary medicines, is it possible for any company licenced/registered to operate in Botswana to import this same product and distribute it?
Yes, provided there are no exclusive distributorship rights declared.
How do I know my product qualifies for registration as a veterinary medicinal product?
Any medicinal product that is intended for use in or on an animal for the purposes of treatment, prevention, alleviating or diagnosis of a disease, clinical condition or infection by any pathogen should be registered by the Authority in Botswana. If the manufacturer, and / or potential applicant is not aware of the correct classification of their products in terms of the appropriate regulatory path to follow, there is a registrability process that the Authority, has developed. The Guideline and Registrability Application Forms are available on the website.
Are there any active substances that are prohibited for inclusion in the formulations / medicinal products intended for use in animals?
Yes, there are certain active substances that are prohibited for use in food producing animals. The reasons include the need to promote prudent AMU and management of AMR among other things. For specific details of the molecules of concern, refer to the Stautory Instrument 76 of 2020 and Statutory Instrument 103 of 1987.
Is there an essential medicines list for veterinary medicinal products?
No, currently there is no list of critical or essential medicines list for veterinary medicinal products
Which products qualifies for submission through the Veterinary Medicines ZAZIBONA?
Currently the Veterinary Medicines ZAZIBONA has made a deliberate decision to invite expression of interests to submit applications for only pharmaceutical (small molecule) formulations, as a pilot project. These were submitted, and the selection was done. However, arrangements are underway to enable submission and assessment of the selected products. Any new developments related to the progress of this process shall be communicated in due course.
What is the difference between regulatory approval and ethics approval?
Regulatory approval confirms that the clinical trial meets national regulatory requirements, including safety and scientific standards.
Ethics approval confirms that the study protects participants’ rights, dignity, confidentiality, and welfare.
Both approvals are required before a clinical trial can begin.
Who must apply for clinical trial authorization?
The sponsor or sponsor’s authorized qualifying representative is responsible for submitting a clinical trial application to the regulatory authority.
When can a clinical trial start?
Before initiating a trial, the investigator/institution should have a written and dated approval from BoMRA for the trial protocol, written informed consent form, consent form updates, participant recruitment procedures (e.g., advertisements), and any other written information intended to be provided to trial participants. And after Ethics approval has been obtained.
What documents are required for a clinical trial application?
Refer to Check list for Clinical Trial application, available on the website.
What happens if there is a change to an approved clinical trial?
Applications for amendments to clinical trial protocols and investigational product/s shall be submitted to BoMRA for approval prior to their implementation using Application for Clinical Trial Amendment Protocol form BOMRA/PCT/CT/P01/F02 with the prescribed fee. Details are available in the Guideline for Clinical Trial Application and Authorization in Botswana section 6.8.1 Clinical Trial Amendments:
What are the reporting timelines for Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reaction (SUSAR)?
Fatal or life-threatening SAEs should be reported to BoMRA within 24 hours by e-mail followed by a complete report within 72 hours.
Are clinical trials inspected?
Yes. BoMRA shall conduct clinical trial inspections to monitor clinical trials from start to finish as per inspection plan. Inspections may be routine or may be triggered by a cause like issues arising during the assessment of annual reports, protocol amendments, or by other information such as previous inspection experience. BoMRA may inspect the study site(s), the sponsor or the manufacturer of the medical products, to ensure compliance with GCP and the inspection may be done with/without notification. BoMRA and NEC (HRDC) may conduct combined inspections from time to time.
What happens if a clinical trial does not comply with requirements?
BoMRA may take regulatory enforcement/legal action. Example: Requesting corrective actions, suspending recruitment and Suspending or terminating trial.
How long does clinical trial approval take?
The review and approval process in Botswana is expected to take up to 90 working days from the time the completed application is received by BoMRA for approval. This timeline excludes the time when the applicant is addressing the queries raised. We encourage all applicants to work in coordination with BoMRA to enable the achievement of these timelines. Clinical trials for emergency preparedness, the expedited timeline for review and approval may be reduced to 15 working days subject to early submission of a complete application.
Can a clinical trial be conducted without regulatory approval?
No. Conducting an unauthorized clinical trial is a regulatory violation and may result in enforcement actions.
The conduct of the trial shall be approved by the National Medicines Regulatory Authority (BoMRA) and the Health Research and Development Committee (National Ethics Committee).
Where can applicants submit clinical trial applications?
Applicants should submit applications online through BRIMS, the system link is provided on the website.
When to Submit an Application to Conduct a Clinical Trial?
Before initiating the clinical trial (s), the sponsor (or the sponsor and the investigator, is required to submit the required application (s) to BoMRA for review, acceptance, and/or permission to conduct the trial(s). The submission should be dated, signed by the Principal Investigator, and contain sufficient information as detailed under clinical trial application checklist.
What is pharmacovigilance?
Pharmacovigilance is the science and activities used to monitor the safety of medicines and vaccines. It helps identify, assess, and prevent harmful effects that may occur when medicines are used.
What is an adverse drug reaction (ADR)?
An adverse drug reaction is an unexpected or harmful effect that happens after taking a medicine. It can happen even when the medicine is used correctly or if taken in the wrong way such as taking too much or by accident.
What types of medicines are monitored through pharmacovigilance?
BoMRA monitors the safety of all registered medicines, including prescription medicines, over-the-counter medicines, vaccines, herbal medicines and traditional medicines.
Who can report a suspected adverse drug reaction?
Anyone can report a suspected adverse drug reaction, including patients, caregivers, doctors, nurses, pharmacists, and other healthcare professionals.
What is reported?
All suspected adverse events including known and unknown adverse events, serious and non serious events, common side effects, severe events, events that resulted from medication errors, lack of efficacy and abuse/misuse of medication.
Why should I report a suspected adverse reaction?
Reporting helps BoMRA identify medicine safety problems early and take action to protect patients. Your report may help prevent harm to others.
Can I report a reaction even if I am not certain the medicine caused it?
Yes. You do not need to be certain that the medicine caused the reaction. If you suspect a medicine may have caused a problem, you should report it.
What happens after I submit an ADR report?
BoMRA reviews the information provided and may contact you if additional details are needed. The report is assessed and added to the medicine safety database for monitoring and analysis.
Will my personal information remain confidential?
Yes. All personal information is treated confidentially and is protected in accordance with applicable laws and regulations.
How does BoMRA use ADR reports?
BoMRA uses ADR reports to identify safety concerns, monitor medicine risks, investigate potential safety signals, and take appropriate regulatory actions when necessary.
How does BoMRA communicate new medicine safety information to the public?
BoMRA communicates important safety information through safety alerts, Dear Healthcare Professional Letters and the Pharmacovigilance-Newsletter published on the website and social platforms.
How do I report a suspected adverse drug reaction?
You can report a suspected adverse drug reaction by completing the e-reporting form available on the BoMRA website or by submitting a report through your healthcare professional. You can also report using the downloadable Mobile App (MedSafety App)
What if I do not have all the information when submitting a report?
You should still submit the report. BoMRA can assess the information available and may contact you if additional details are needed.
Can I submit follow-up information after making a report?
Yes. If you receive new information after submitting a report, you can provide additional details to BoMRA as a follow-up report.
Should I report known side effects that are already listed in the package insert?
Yes. Reporting known side effects helps BoMRA monitor how often they occur and identify any changes in their frequency or severity.