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
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S/N
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NAME
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SUBJECT
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REMARKS
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1.
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The Tanzania Medicines and Devices (Orphan Drugs) Regulation, GN. 412 OF 2018
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Orphan Drugs
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Currently enforced
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2.
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The Tanzania Medicines and Medical Devices (Registration of Medicinal Product) Regulation GN. 314, 2015
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Registration of Medicinal Product
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Currently enforced
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3.
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The Tanzania Medicines and Medical Devices (Good Manufacturing Practice Enforcement) Regulations, GN. 295, 2018
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Good Manufacturing Practice Enforcement
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Currently enforced
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4.
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The Tanzania Medicines and Medical Devices (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) GN. 312 Regulation 2010
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Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials
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Currently enforced
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5.
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The Tanzania Medicines and Medical Devices (Control of Drug and herbal Drugs Promotion) GN. 159 Regulation 2010
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Control of Drug and herbal Drugs Promotion
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Currently enforced
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6.
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The Tanzania Medicines and Medical Devices (Pharmacovigilance) GN. 296 Regulation, 2018
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Pharmacovigilance
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Currently enforced
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7.
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The Tanzania Medicines and Medical Devices (Fees and Charges) GN. 464 Regulation, 2015
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Fees and Charges
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Currently enforced
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8.
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The Tanzania Medicines and Medical Devices (Scheduling of Medicine) GN. 63 Regulation, 2015
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Scheduling of Medicine
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Currently enforced
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9.
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The Tanzania Medicines and Medical Devices (Clinical Trial Control) GN. 53 Regulation, 2013
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Clinical Trial Control
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Currently enforced
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10.
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The Tanzania Medicines and Medical Devices (Control of Medical Devices) Regulation, GN. 315, 2015
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Currently enforced
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11.
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The Tanzania Medicines and Medical Devices (The Recall, Handling and Disposal of Unfit Medicines and Cosmetics) GN. 313 Regulations, 2015
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The Recall, Handling and Disposal of Unfit Medicines
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Currently enforced
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12.
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The Tanzania Medicines and Medical Devices (List of Registered Human Medicinal Product Veterinary Pharmaceutical and Medical Devices) GN. 283 Regulation, 2016
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List of Registered Human Medicinal Product Veterinary Pharmaceutical and Medical Devices
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Currently enforced
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13.
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The Tanzania Medicines and Medical Devices (List of Registered Human and Veterinary Medical Products and Withdrawn Medicinal Products) GN. No. 160 Notice, 2018
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List of Registered Human and Veterinary Medical Products and Withdrawn Medicinal Products
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Currently enforced
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16.
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The Tanzania Medicines and Medical Devices (Delegation of Powers and Functions) GN. 476, 2015
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Delegation of Powers and Functions
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Currently enforced
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17.
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The Tanzania Medicines and Medical Devices (Delegation of Powers and Functions) GN. 19, 2017
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Delegation of Powers and Functions
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Currently enforced
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18.
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Pharmaceutical and poisons Orders, 2001 (List of Human Drugs List (Notification), List of Human Notified Drugs Veterinary Drugs List (Notification)
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Human and Veterinary Drugs Notification
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Currently enforced
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19.
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The Tanzania Medicines and Medical Devices (List of Registered and Cancelled Medicines). Notice 2020 GN. 187, 2020
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List of Registered and Cancelled Medicines
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Currently enforced
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20.
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The Tanzania Medicines and Medical Devices (Appointment of Inspectors) Order, 2020 GN NO. 257, 2020
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Appointment of Inspectors
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Currently enforced
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21.
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The Tanzania Medicines and Medical Devices (Appointment of Inspectors) Order, 2020 GN. No. 191, 2020
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Appointment of Inspectors
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Currently enforced
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22.
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The Tanzania Medicines and Medical Devices (appointment of Inspectors) Order, 2016 GN No. 275, 2016
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Appointment of Inspectors
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Currently enforced
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23.
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The Tanzania Medicines and Medical Devices (appointment of Analysts) Order, 2016 GN. 270, 2016
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Appointment of Analysts
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Currently enforced
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24.
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The Tanzania Medicines and Medical Devices (appointment of Inspectors) Order, 2020 GN No. 1009, 2020
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Appointment of Inspectors
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Currently enforced
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25.
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The Tanzania Medicines and Medical Devices (appointment of Inspectors and analysts) Order, 2011 GN No. 209, 2011
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Appointment of Inspectors
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Currently enforced
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