Check Out
Frequently Asked Questions FAQ
1. 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
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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
8. 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.
9. 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.
10. 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.
