ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

14^th July, 2025

PAYMENT OF ANNUAL RETENTION FEES FOR THE YEAR 2026

1. The Tanzania Medicines and Medical Devices Authority (TMDA) wishes to remind its esteemed stakeholders that, pursuant to Section 55 (b) of the Tanzania Medicines and Medical Devices Act, Cap 219, the retention of products in the Register of registered products is upon payment of a prescribed fee.
2. A proforma invoice of all registered medicinal products shall be generated on 1^st of October and communicated to all Marketing Authorization Holders (MAHs) by 2^nd of October of each calender year through their trader portal accounts. The MAHs shall be required to scrutinize the issued proforma invoice and submit a list of products they wish to continue marketing in Tanzania to the Authority by 1^st November of each calender year.
3. Based on the submitted list, the Authority shall generate the invoices of all listed medicinal products and communicate to all MAHs by 30^th November through their trader portal accounts.
4. The Retention Fee is required to be paid without penalty by the 31^st of January and with a penalty by the 31^st of March of each calendar year as prescribed in the Tanzania Medicines and Medical Devices (Fees and Charges) Regulations, 2021.
5. The registration of all non-declared/listed medicinal products shall be suspended by 30^th November of every calendar year, and by 1^st April for all declared/listed medicinal products with pending retention fees in line with Section 24 (1)(d) of the Tanzania Food, Drugs, and Cosmetics (Registration of Medicinal Products) Regulations, 2015;
6. The registration of all medicinal products that have been suspended for more than 12 months from the date of suspension shall be automatically revoked/cancelled from the register in line with Section 24 (1)(d) of the Tanzania Food, Drugs, and Cosmetics (Registration of Medicinal Products) Regulations, 2015 and Section 53 (7) of the Tanzania Medicines and Medical Devices Act, Cap. 219;
7. Please note that importation permits of non-declared/listed medicinal products as well as those with pending retention fees, shall not be issued with effect from 1^st April of each calendar year.
8. MAHs are therefore advised to adhere to the prescribed procedure and timelines to avoid any inconveniences that may arise from failing to pay the retention fees on time.