TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR RENEWAL OF MARKETING AUTHORIZATION OF HUMAN AND VETERINARY MEDICINAL PRODUCTS

1. Tanzania Medicines and Medical Devices Authority (TMDA) would like to inform its esteemed stakeholders that the Guidelines on Submission of Documentation for Renewal of Marketing Authorization of Human and Veterinary Medicinal Products have been reviewed. The review introduces the requirement of submitting the Quality Information Summary (QIS) document as well as online submission of applications.
2. This notice aims to remind applicants to adhere to all the requirements of the guidelines when submitting renewal applications. To view the guidelines, please Click here
3. We thank you for your continued cooperation.