Product Evaluation & Registration department is responsible for protecting and promoting human and veterinary public health by ensuring that medical products; that is, human, veterinary and complementary medicines, medical devices, and cosmetics approved for use in Botswana are safe, efficacious and of good quality.
Submit a full dossier for evaluation.
The dossier is first submitted for screening together with the applicable fee.
BoMRA assessors will screen the dossier to determine whether all the appropriate sections of the dossier have been submitted.
Applicants submit samples of the product
Applicants will be advised to pay application fees after passing screening.
For outstanding information, communication will be sent and an updated dossier will be requested
An application form signed by the applicant.
Applicant will receive a letter communicating any outstanding issues with a deadline to respond after evaluation.
Application is presented before the Registration Committee