ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

29^th December, 2025

SUBMISSION OF APPLICATIONS FOR RENEWAL OF GMP COMPLIANCE FOR FOREIGN MANUFACTURERS

1. The Tanzania Medicines and Medical Devices Authority (TMDA) wishes to inform its esteemed customers that all foreign pharmaceutical manufacturing facilities with expired or non-renewed Good Manufacturing Practices (GMP) status are required to submit their renewal applications via their respective TMDA Trade Portal Account (Accessed here: https://imis2.tmda.go.tz/).
2. The applications must be submitted to TMDA within 14 days from the date of this notice. Each submission must include all supporting documentation as specified in the TMDA Guidelines for Good Manufacturing Practices Inspection of Human Medicinal Products Manufacturing Facilities, Third Edition, July 2025 and payment of the prescribed fee based on the geographical location of the facility.
3. This measure is intended to streamline the application process, enhance efficiency, and ensure timely regulatory compliance for all facilities supplying medicinal products to the Tanzanian market.
4. Crucially, any facility that fails to submit its application and the required payment by the deadline will be ineligible for importation permits for any products manufactured at that site.
5. A comprehensive list of all applicable foreign manufacturing facilities can be found at the following link: (GMP Renewal facilities).
6. Your cooperation on this matter is highly appreciated.