Product Evaluation and Registration

BoMRA

Product Evaluation and Registration

Mandate

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.

Organogram

  • CEO
    Head of Department
    • Main
      Supervisor
      • Mid
        Staff
      • Mid
        Staff
      • Mid
        Staff
    • Main
      Supervisor
      • Mid
        Staff
      • Mid
        Staff
      • Mid
        Staff

Registration Procedure

To register your product, you will be required to submit a full product dossier for evaluation to determine whether the medicine is safe, of good quality and efficacious. The dossier is first submitted for screening together with the applicable fee. Our assessors will screen the dossier to determine whether all the appropriate sections of the dossier have been submitted. This is not a full assessment but checking for completeness of the submission. If there is outstanding information, communication will be sent and an updated dossier will be requested. After passing screening, applicants will be advised to pay application fees, submit samples of the product and an application form signed by the applicant. Please refer to our Service Standards for the timelines. After evaluation, you will receive a letter communicating any outstanding issues with a deadline to respond. Once all queries are addressed, the application is presented before the Registration Committee who will make a regulatory decision based on the provided quality, safety and efficacy data.
To register your product, you will be required to submit a full product dossier for evaluation to determine whether the medicine is safe, of good quality and efficacious. The dossier is first submitted for screening together with the applicable fee. Our assessors will screen the dossier to determine whether all the appropriate sections of the dossier have been submitted. This is not a full assessment but checking for completeness of the submission. If there is outstanding information, communication will be sent and an updated dossier will be requested. After passing screening, applicants will be advised to pay application fees, submit samples of the product and an application form signed by the applicant. Please refer to our Service Standards for the timelines. After evaluation, you will receive a letter communicating any outstanding issues with a deadline to respond. Once all queries are addressed, the application is presented before the Registration Committee who will make a regulatory decision based on the provided quality, safety and efficacy data.