Snapshot

The Medicine Registration Exemption pathway has been developed by the Botswana Medicines Regulatory Authority (BoMRA) of Botswana.

This pathway can be used where Exemption from Registration may be applied for, only under special circumstances, such as when there is no registered product or, registered alternatives are unavailable, or when conventional therapies have been tried without the desired therapeutic outcomes. Where there is a registered product or registered alternatives, and for valid reasons they are not available for sale in the Botswana market, the applicant should provide evidence of unavailability from the manufacturer, applicant, or sole distributors of the registered alternative (if available) and motivate accordingly. Further to this, the authority shall also verify the unavailability of registered alternatives. Exemption from Registration may not be applied for, where a product has been denied registration due to unresolved safety, efficacy, and quality reasons. Application can either be Wholesale based or Patient based. Concerning donations, unregistered medicines that have been deemed unacceptable in the donor country for safety, quality, and efficacy-related reasons will not be eligible for exemption. Applicants must submit a donation certificate..

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Brazil Canada China Europe Japan Mexico Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Tanzania Turkey Uganda United Kingdom United States WHO Zambia Zimbabwe

The Authority will communicate the outcome of the application within 72 hours. However, where the application does not meet the Authority’s requirements, queries will be sent to the applicant within the 72 hours. Applicants will be given 48 hours to address the queries following which the Authority will make a regulatory decision.