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