ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

5^th July, 2021

CALL FOR SUBMISSION OF APPLICATIONS FOR MARKETING AUTHORIZATION OF VACCINES FOR PREVENTION OF COVID-19

1. TMDA would like to inform its esteemed stakeholders that, in an effort to safeguard the public health and in light of the COVID-19 pandemic, TMDA are inviting applicants interested in marketing COVID-19 vaccines to submit their applications for marketing authorization. The procedures for submitting applications is as follows:
   • 1.1 Create an online trader account using the link; while existing applicants can use the same trader account;
   • 1.2 Lodge an application for product registration;
   • 1.3 Upload the available information that should include all documents submitted during approval through WHO’s Emergency Use Listing (EUL) procedures; and
   • 1.4 Submit the application using the Online Medicine Registration Portal Registration Portal.
2. Upon receipt of the applications, TMDA will expedite the review of COVID-19 vaccines that have been authorized through the WHO’s EUL and communicate the outcome within fourteen (14) working days.
3. For vaccines that have not yet been accepted by WHO’s EUL procedure, we request the applicants to submit the applications via the Medicine Regulatory Harmonization programs in EAC, SADC and AVAREF-Africa.
4. Let’s join together to combat COVID- 19 disease.