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South African Health Products Regulatory Authority - SAHPRA (Loftus Park)

Arcadia, Pretoria East, Gauteng

Regulatory Authority

Building A, 2nd Floor
Loftus Park
402 Kirkness Street
Arcadia
Pretoria East
City of Tshwane
Gauteng
0083
Contact Number
012 501 0300
Email
[email protected]
Website
https://www.sahpra.org.za/

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The South African Health Products Authority (SAHPRA) - Head Office

The South African Health Products Authority (SAHPRA) is located at Loftus Park in ArcadiaPretoria, situated next to Loftus Versfeld Stadium and is Regulatory Authority of South Africa, which is responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices, radiation emitting devices and radioactive nucleides; and the conduct of clinical trials.

SAHPRA assumed the roles of both the Medicines Control Council (MCC) as well as the Directorate of Radiation Control (DRC) which were housed at the National Department of Health (NDoH). Subsequently, SAHPRA was constituted as an independent entity that reports to the National Minister of Health through its Board.

SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics (IVDs).

Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa. SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973).

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Monday to Thursday: 08:00 - 15:30
Friday: 08:00 - 12:00
Saturday: Closed
Sunday & Public Holidays: Closed

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