Regulatory Functions
Access BoMRA’s regulations, guidelines, reports, and publications.
Overview
The Department of Product Evaluation and Registration (DPER) plays a pivotal role in achieving the strategic objective of streamlining registration processes. This department focuses on implementing effective regulatory strategies for human and veterinary medical products, Â medical devices and cosmetics.
Strengthening the registration framework for Veterinary Medical Products (VMPs).
Enhancing the registration processes for human medicines to ensure compliance with regulatory standards
Promoting efficiency and consistency in the evaluation and registration of medical devices and cosmetics.
Human medicines- including complementary medicines
Veterinary medicines
Medicals Devices
Cosmetics department
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.
Overview
The Department of Licensing and Enforcement is responsible for regulating the import, export, and transit of all medical and related products. It ensures that these products meet regulatory standards by inspecting and licensing premises across the supply chain.
Control of imports, exports, and transit of all regulated products.
Inspection and licensing of premises along the supply chain of regulated products.
Testing of regulated products to ensure compliance with specifications and detect substandard or falsified products.
General enforcement of the Medicines and Related Substances Act (MRSA) and its regulations.
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.
Overview
The Department of Pharmacovigilance and Clinical Trials (PVCT) is tasked with monitoring the safety of all medical products registered for use in Botswana. The department ensures that approved medicines, medical devices, and other regulated products continue to meet safety and quality standards throughout their lifecycle.
Ensure the safety and efficacy of products to protect public and animal health.
Adverse Drug Reactions (ADRs) and Vaccine-Related Events.
 Scope: Monitoring ADRs and vaccine-related adverse events.
 Ensure the safety and efficacy of medicines and vaccines used in humans.
Medical Devices – Surveillance of incidents related to medical devices.
Objective -Identify potential risks and ensure safety in healthcare settings.
Cosmetics -Focus: Monitoring adverse effects of cosmetic products.
Adverse events Reporting- Collecting and analyzing reports from healthcare professionals, manufacturers, and the public.
Evaluating risks associated with medicines, vaccines, medical devices, cosmetics, and veterinary products.
Implementing safety measures such as product recalls, label changes, or public warnings.
Stakeholder awareness.
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.