TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

18^th October, 2019

PRE-TESTING OF ONLINE SUBMISSION SYSTEM OF APPLICATIONS FOR REGISTRATION OF MEDICINAL PRODUCTS IN TANZANIA

1. The TMDA wishes to inform its esteemed customers and the general public that it is in the process of switching to an online submission system of applications for marketing authorization of medicinal products following successful development of the system. However, before migrating fully to the online submission system a three (3) months pre-testing period to assess stability and performance of the system under real working condition will commence from 1st November, 2019.
2. In this regard, applicants intending to submit applications for marketing authorization, renewal and variation to a registered medicine to TMDA from the date mentioned above are kindly requested to submit their applications through the new online system. Applicants or Local Technical Representatives (LTRs) may register in the system and obtain the credentials to get access to the system through the link given below: Online Portal Version Two
3. You are kindly requested to follow the instructions provided on the portal. In case of difficulties in following up the instructions, you may contact the following TMDA staff for support;
   Fabian Lwanole [Phone: +255 762 533 530, Email: fabian.lwanole@tmda.go.tz]
   Salehe Mwenyevyale [Phone: +255 753 747 474, Email: salehe.mwenyevyale@tmda.go.tz]
   Osidai Kivuyo [Phone: +255 685 998 542, Email: osidai.kivuyo@tmda.go.tz]
   Office Email: mis@tmda.go.tz
4. It should be noted that during this pre-testing phase, applicants will also be required to submit same applications physically at the TMDA Offices, EPI Mabibo External Ubungo, Dar es Salaam until when the Authority announces a full switch to an online submission system.
5. We thank you for your continued cooperation.