Acts and Regulations

ACTS

TMDA was established under the Tanzania Medicines and Medical Devices Act, Cap 219. The Authority operates as an Executive Agency as stipulated under Section 3 (1) of the Executive Agencies Act, Cap 245.

In Tanzania Laws regulating medicines, medical devices and diagnostics are rooted in 1978 when the parliamment enacted the Pharmaceuticals and Poisons Act of 1978 and the Food (Control of Quality) Act . The Acts resulted to the establishement of regulatory institutions that are the Pharmacy Board and the Food Control Commission respectively.

In 2003, the two legislations were merged to form Tanzania Food, Drugs and Cosmetics Act, Cap 219 which established the Tanzania Food and Drugs Authority (TFDA). The TFDC Act was later amended to Tanzania Medicines and Medical Devices Act in 2019.

REGULATIONS

The Tanzania Medicines and Medical Devices Act Cap, 219 provides for the Minister responsible for Health to issue regulations so as to provide for efficient and comprehensive regulation and control of medicines, medical devices, diagnostics and related matters.Below is the list of regulations for the control of regulated products;