TFDA Highligts
Posted On: May 20, 2019
New Guidelines For Registration Of Human Vaccines, Biotherapeutics, Similar Biotherapeutic Products and Variation Of Registered Medicines

Tanzania Food and Drugs Authority would like to inform its esteemed stakeholders that four (4) new guidelines for registration of medicines have been approved for use.

The approved guidelines are:

a) Guidelines on Submission of Documentation for Marketing Authorization of Human Vaccines, First Edition of March 2019.

b) Guidelines on Submission of Documentation for Marketing Authorization of Biotherapeutic Products, First Edition of January 2019.

c) Guidelines on Submission of Documentation for Marketing Authorization of Similar Biotherapeutic Products, First Edition of January 2019.

d) Guidelines on Variation of Registered Medicinal Products, Second Edition of January 2019.

Please note that the guidelines on Vaccines, Biotherapeutics and Similar Biotherapeutic Products supersedes the Guideline for Application for Registration of Biologicals, First Edition, April 2004 whereas the guidelines on variation supersedes the Application Guidelines for Variation of Registered Human Medicinal Products, First Edition, November 2008.

This notice is to inform you that, the Guideline for Application for Registration of Biologicals, First Edition of April 2004 as well as the Application Guidelines for Variation of Registered Human Medicinal Products, First Edition of November 2008 shall no longer be in use as of 30th June 2019. Therefore, from 1st July 2019 all submissions for registration of vaccines, biotherapeutics, biosimilars and variations should be made in accordance to the requirements prescribed in the new guidelines.

For more information, please contact the Authority through the following addresses:

Acting Director General,

Tanzania Food and Drugs Authority,

Mwanza Avenue, Block T,

Plot No. 6, P.O. Box 1253,

Dodoma, Tanzania.

Phone No (landline): +255 26 320156

Phone No (mobile): +255 658 445222/+255685 701735

Website: www.tfda.go.tz