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Posted On: Jan 29, 2025


THE UNITED REPUBLIC OF TANZANIA

MINISTRY OF HEALTH

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY




ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

28th January, 2025

NOTICE FOR THE CANCELLATION OF MARKETING AUTHORIZATION FOR PRODUCT WITH PENDING RETENTION FEES

  1. Tanzania Medicines and Medical Devices Authority (TMDA) would like to remind all Marketing Authorization Holders (MAHs) that according to Regulation 16 of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015, annual retention fees need to be paid before 31 January of each calendar year.
  2. Furthermore, Section 55 (1)(b) of the Tanzania Medicines and Medical Devices Act, Cap. 219 and sub-regulation 19(e) of the Tanzania Medicines and Medical Devices (Registration of Medicinal Products) Regulations, 2015 empowers the Authority to cancel the marketing authorization of products whose retention fees have not been paid.
  3. In view of this, MAHs who have not paid the annual retention fees of their products are reminded to do so by 31st January 2025. Failure to do so the Authority shall be compelled to cancel the marketing authorization of all products that have not been paid for.
  4. After cancellation, the MAH who wishes to continue marketing a product marketing authorization has been cancelled will be required to make fresh applications accompanied by appropriate documentation as per current requirements and payment of fees as prescribed Fees and Charges Regulations, 2015 and its amendment Regulations of 2017.
  5. Your cooperation on this matter is highly appreciated to avoid unnecessary consequences.
Issued by:
The Director General
Tanzania Medicines and Medical Devices Authority,
P.O. Box 1253, Dodoma.
Tel; +255 222 450512/658 445222/777 700002
Email: info@tmda.go.tz
Toll-Free No: 0800110084
Website: www.tmda.go.tz