TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

26^th March, 2020

PROCEDURES FOR REGISTRATION OF ANTISEPTICS UNDER PUBLIC HEALTH EMERGENCY PREPAREDNESS FOR PREVENTION AGAINST COVID-19 PANDEMIC DISEASE

1. Following the Coronavirus Disease 2019 (COVID-19) pandemic which is currently spreading in different countries across the globe including Tanzania, the usage of antiseptics, specifically hand sanitizers has increased. This is based on the fact that the mentioned antiseptic products have been recommended as one of the precautionary measures to prevent the spread of the Coronavirus Disease. The antiseptics which are being used include hand sanitizers containing alcohol (alcohol-based hand sanitizers), Chloroxylenol solution, and Cetrimide + Chlorhexidine gluconate solution..
2. In view of the increase in public demand for such antiseptics, the Tanzania Medicines and Medical Devices Authority (TMDA) is hereby informing its esteemed stakeholders on the procedure to be followed for registration of these products:-

2.1.Applicants are required to submit their applications for registration in accordance with the procedure of registration of antiseptics as stipulated in the "Guidelines for Submission of Documentation for Marketing Authorization of Biocidals (Antiseptic and Disinfectant) Products, First Edition, February 2015"; which is available on the TMDA's website. ( https://www.tmda.go.tz/publications/42.)
2.2. Applications should contain complete documentation in compliance with the above-mentioned guidelines. However, in the event that the documents are not available at the time of submission, the following minimum data should be provided:-

a) Application form
b) Composition formula
c) Certificate of analysis, if available
d) Container label

2.3. In addition to the above documents, applicants should submit signed and dated commitment letter with a declaration to provide the remaining data at a later stage.
2.4. In respect to the manufacturing of hand sanitizers; registered manufacturers, hospitals and pharmacies should adhere to the following guidelines, "Guidance for Production of Alcohol - Based Hand Sanitizers under Public Health Emergency Preparedness" which is also available on the TMDA's website at ( www.tmda.go.tz).
2.5. Hard copy of applications for registration should be submitted to the TMDA Sub-Head Offices, Off Mandela Road, EPI-Mabibo External, Ubungo, Dar es Salaam or at any of the Zone offices.

3. Upon receipt of the applications, TMDA will expedite the review of these applications and communicate the outcome within three (3) working days from the date of submission.
4. Let's join forces to combat Coronavirus disease