TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

PUBLIC NOTICE

22^th April, 2022

WITHDRAWAL OF APPLICATIONS FOR REGISTRATION OF MEDICINAL PRODUCTS SUBMITTED THROUGH EAC JOINT ASSESSMENT PATHWAY WITH PENDING QUERY RESPONSES FOR MORE THAN SIX (6) MONTHS

1. The Tanzania Medicines and Medical Devices Authority (TMDA) on behalf of the EAC Secreatariat and the National Medicines Regulatory Authorities of EAC Partner States would like to inform all applicants on the intention to discontinue the processing and subsequently withdrawal of applications for registration of medicinal products which are still pending for more than six (6) months without official communication from the applicant.
2. All applicants who have not submitted responses to raised queries for more than six (6) months have been granted an additional three (3) months from the date of this notice to submit their responses or notify the TMDA in writing stating the reasons for failing to do so within the extended timelines.
3. Failure to do so will necessitate withdrawal of the applications and applicants will be required to submit fresh applications.
4. In addition, the authority would also like to remind all applicants that responses to queries are supposed to be submitted within six (6) months from the date of a query letter. In case the applicant requires more time than the prescribed timelines, an application for an extension should be requested in writing at the earliest.
5. We thank you for your continued cooperation.