TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

NEW GUIDELINES ON APPLICATIONS FOR VARIATION OF REGISTERED VACCINES

1. Tanzania Medicines and Medical Devices Authority (TMDA) would like to introduce to its esteemed stakeholders, the First Edition of the Guidelines on Variations of Registered Vaccine. This is the first publication of guidelines developed to provide instructions on how to apply for variations of registered vaccines.
2. This new publication provides guidance to applicants on classification of changes as well as the technical requirements to support the requested variations. Applicants are encouraged to consult the guideline prior to lodging applications for variation of a registered vaccine. The guideline should be read in conjunction with other applicable guidelines including the Guidelines on Submission of Documentation for Marketing Authorization of Human Vaccines. and Guidelines on Submission of Documentation for Registration of Immunological Veterinary Products.
3. This notice is to inform you that, with effect from 1st April 2021, all submissions for variations of vaccines should be made in accordance to the requirements prescribed in these guideli
4. For more information, please contact the Authority.