Registration of Food Supplement in Botswana

1. The application for registration of Food or Dietary Supplements (Complementary Medicines/substances) should be made to the Botswana Medicines Regulatory Authority (BOMRA), whose mandate is to implement, enforce and regulate the registration of all Drugs and Related Substances in Botswana.
2. Applicants are required to collect and complete the Registration Form for complementary medicines,Registration Form for complementary medicines
3. The declaration form must be filled in and signed by the person responsible for the manufacturing facility and applicant as specified.
4. One hard copy of the signed and completed application is requested from applicants. The soft copy of the application (in Word format on a CD) must be prepared in New Times Roman font size 12. Attachments should be scanned and included in the CD arranged as per the guideline.
5. A covering letter must be included with the completed application. The covering letter needs to list all the submission’s contents to speed up the process of unpacking documents.
6. If the labeling for marketing has not yet been finalized, applicants should provide sealed samples (at least two samples) of the finished pharmaceutical product (FPP) in its final container and labeling as intended for presentation to the Botswana market or closest reference packs. More samples for testing may be requested by BOMRA.
7. The BOMRA will inspect the establishment where the product will be manufactured or stored to determine if it complies with the current Good Manufacturing Practices (cGMP) regulation at a prescribed fee by the BOMRA.
8. The applicant will receive a copy of the report’s findings, and if any upgrading or modifications are needed, a Corrective Action and Preventive Action Report (CAPA) will be produced, and you will have to fix the issue.
9. When the CAPA is successfully implemented, the inspection team may, if appropriate, carry out a follow-up inspection to determine the efficacy of the implementation. There is a re-inspection fee.
10. The Drug Registration Committee will analyze the application file, the GMP status report, and the product’s laboratory analysis before reaching a final judgment.
11. The Drugs Regulatory Unit evaluates applications for registration. Following that, the suggestions are brought to the Board for a conclusion. The Board meets every six to eight weeks on average.
12. Applicants are notified in writing about Board resolutions, regarding their applications.
13. If the authority is satisfied that there is the need to register the product and all requirements for its registration have been met, it will be registered and you will receive with the certificate of registration, upon presenting the approval letter, identity document, and proof of payment of the registration fees to be validated by the BOMRA registrar.
14. The Authority can set terms and conditions on the registration certificate. The certificate bearer will also be under the Authority’s oversight and scrutiny.

Note:

• Foreign company manufacturers must appoint a local authorised representative.
• All documents must be in English.