Notice on Withdrawal of Dormant Applications for Registration of Medicinal Products

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

   

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

13th July, 2020

NOTICE ON WITHDRAWAL OF DORMANT APPLICATIONS FOR REGISTRATION OF MEDICINAL PRODUCTS

1. The Tanzania Medicines and Medical Devices Authority (TMDA) would like to inform all applicants on its intention to discontinue the processing and consequently withdrawal of applications for registration of medicinal products which are still pending because neither reasons in writtings nor query responses have been received by the Authority for more than six (6) months since the date of the last communication with applicant.
2. It should be noted that, pursuant to sub-regulation 11 (4) of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015; if no written responses are received by the Authority within six (6) months from the date of issuance of queries, the applications shall be deemed withdrawn.
3. Therefore, this is to inform all applicants who have not submitted responses for a period of more than six (6) months that, an additional grace period of three (3) months from the date of this notice is given to submit the pending responses or where appropriate notify the Authority in writings stating the reasons for not responding to the queries within the provided additional time. Failure to do so will necessitate withdrawal of the applications and the same will only be considered upon submission of fresh applications.
4. In addition, the Authority would also like to remind all applicants to always submit the responses on time or in the event that the responses require more than six (6) months to be compiled; extension of time should be requested at earliest.
5. We thank you for your continued cooperation.

Issued by:
Acting Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
PSSSF House, 10th Floor,Makole Street,
P. O. Box 1253, Dodoma Or
P. O. Box 77150, Dar es Salaam
Phone: +255 22 2452108/2450512/2450751
Fax: +255 22 2450793
Hotline: 0800110084