Acts and Regulations

Acts

TMDA is an organization which operates as a Regulatory Authority and an Executive Agency. It was established as the Regulatory Authority under Section 4 (1) of the Tanzania Medicines and Medical Devices Act, Cap 219 and as the Executive Agency under Section 3 (1) of the Executive Agencies Act, Cap 245.

Historically, laws for regulating medicines and food products in Tanzania began in 1978 when the Pharmaceuticals and Poisons Act of 1978 and the Food (Control of Quality) Act of 1978 were enacted by the Parliament. The Pharmaceuticals and Poisons Act established the Pharmacy Board which was mandated to regulate medicines and the Food (Control of Quality) Act established the Food Control Commission which regulated food products. In 2003, the two legislations were merged to form Tanzania Food, Drugs and Cosmetics Act of 2003 which established Tanzania Food and Drugs Authority (TFDA). TFDA was mandated to regulate, medicines, food, cosmetics and medical devices.

In 2019, the Tanzania Food, Drugs and Cosmetics Act was again amended and renamed to Tanzania Medicines and Medical Devices Act which also established TMDA to regulate medicines, medical devices and diagnostics only. The amendments were made to streamline processes, reducing duplication of efforts and minimizing the number of permits issued by different regulators in Tanzania to bolster the business environment including promoting manufacturing.

The renaming and shifting of responsibilities were made through the Finance Act, No. 8 of 2019 which also amended the Standards Act, Cap 130 to allow for the Tanzania Bureau of Standards TBS) to regulate food and cosmetics. TBS has now assumed all regulatory functions for regulating food and cosmetics to include registration of food and cosmetic products, licensing of premises, import and export control, inspection of premises, disposal of unfit products, recall from the market, post marketing surveillance, food borne diseases surveillance and control of advertisements.

  • The Pharmaceuticals and Poisons Act of 1978 can be referenced by Click here.
  • The Food (Control of Quality) Act of 1978 can be referenced by Click here.
  • The Tanzania Food, Drugs and Cosmetics Act, Cap 219 of 2003 can be seen by Click here.
  • The Tanzania Medicines and Medical Devices Act, Cap 219 of 2019 can be accessed by Click here.
  • The Standards Act, Cap 130 can be obtained by Click here.
  • The Finance Act, No. 8 of 2019 can be obtained by Click here.

Regulations

REGISTER FOR TMDA REGULATIONS
S/N NAME SUBJECT REMARKS
1. The Tanzania Medicines and Devices (Orphan Drugs) Regulation, GN. 412 OF 2018 Orphan Drugs Currently enforced
2. The Tanzania Medicines and Medical Devices (Registration of Medicinal Product) Regulation GN. 314, 2015 Registration of Medicinal Product Currently enforced
3. The Tanzania Medicines and Medical Devices (Good Manufacturing Practice Enforcement) Regulations, GN. 295, 2018 Good Manufacturing Practice Enforcement Currently enforced
4. The Tanzania Medicines and Medical Devices (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) GN. 312 Regulation 2010 Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials Currently enforced
5. The Tanzania Medicines and Medical Devices (Control of Drug and herbal Drugs Promotion) GN. 159 Regulation 2010 Control of Drug and herbal Drugs Promotion Currently enforced
6. The Tanzania Medicines and Medical Devices (Pharmacovigilance) GN. 296 Regulation, 2018 Pharmacovigilance Currently enforced
7. The Tanzania Medicines and Medical Devices (Fees and Charges) GN. 464 Regulation, 2015 Fees and Charges Currently enforced
8. The Tanzania Medicines and Medical Devices (Scheduling of Medicine) GN. 63 Regulation, 2015 Scheduling of Medicine Currently enforced
9. The Tanzania Medicines and Medical Devices (Clinical Trial Control) GN. 53 Regulation, 2013 Clinical Trial Control Currently enforced
10. The Tanzania Medicines and Medical Devices (Control of Medical Devices) Regulation, GN. 315, 2015 Currently enforced
11. The Tanzania Medicines and Medical Devices (The Recall, Handling and Disposal of Unfit Medicines and Cosmetics) GN. 313 Regulations, 2015 The Recall, Handling and Disposal of Unfit Medicines Currently enforced
12. The Tanzania Medicines and Medical Devices (List of Registered Human Medicinal Product Veterinary Pharmaceutical and Medical Devices) GN. 283 Regulation, 2016 List of Registered Human Medicinal Product Veterinary Pharmaceutical and Medical Devices Currently enforced
13. The Tanzania Medicines and Medical Devices (List of Registered Human and Veterinary Medical Products and Withdrawn Medicinal Products) GN. No. 160 Notice, 2018 List of Registered Human and Veterinary Medical Products and Withdrawn Medicinal Products Currently enforced
14. The Tanzania Medicines and Medical Devices (appointment of Inspectors) GN No. 275, 2016 Appointment of Inspectors Currently enforced
15. The Tanzania Medicines and Medical Devices (appointment of Analysts) GN. 270, 2016 Appointment of Analysts Currently enforced
16. The Tanzania Medicines and Medical Devices (Delegation of Powers and Functions) GN. 476, 2015 Delegation of Powers and Functions Currently enforced
17. The Tanzania Medicines and Medical Devices (Delegation of Powers and Functions) GN. 19, 2017 Delegation of Powers and Functions Currently enforced
18. Pharmaceutical and poisons Orders, 2001 (List of Human Drugs List (Notification), List of Human Notified Drugs Veterinary Drugs List (Notification) Human and Veterinary Drugs Notification Currently enforced
19. The Tanzania Medicines and Medical Devices (List of Registered and Cancelled Medicines). Notice 2020 GN. 187, 2020 List of Registered and Cancelled Medicines Currently enforced
20. The Tanzania Medicines and Medical Devices (Appointment of Inspectors) Order, 2020 GN NO. 257, 2020 Appointment of Inspectors Currently enforced
21. The Tanzania Medicines and Medical Devices (Appointment of Inspectors) Order, 2020 GN. No. 191, 2020 Appointment of Inspectors Currently enforced