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FINAL 2024/25ANNUAL PERFORMANCE PLAN DATE OF TABLING: MARCH 2024SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAH PRAS) GENERAL INFORMATION Physical Address:Building A Loftus Park 402 Darkness
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South African health products refer to pharmaceuticals, medical devices, and healthcare goods that are regulated by the South African Health Products Regulatory Authority (SAHPRA) to ensure safety, efficacy, and quality.
Manufacturers, importers, distributors, and marketers of health products in South Africa are required to file with SAHPRA to ensure compliance with regulations.
To fill out the filing for South African health products, entities must complete the prescribed application forms provided by SAHPRA, along with necessary documentation such as product information, safety data, and clinical trial results.
The purpose of South African health products is to promote public health by ensuring that all products are safe, effective, and of good quality for consumers.
The information that must be reported includes product details, manufacturer information, safety and efficacy data, labeling content, and any adverse event reporting.
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