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The Regulatory Boundary: Medicines versus Cosmetics - Navigating Act 101 and SAHPRA Compliance in South Africa
The High Cost of Unintentional Medicinal Status Imagine scaling a dermo-cosmetic formulation from the laboratory bench to a commercial batch of 20,000 units. Packaging is printed, secondary cartons are embossed, distribution agreements with national retail pharmacies are executed, and stock is staged in the warehouse. Two weeks before national distribution, an enforcement notice arrives from the South African Health Products Regulatory Authority (SAHPRA). The grounds: your fr
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