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.