Patient safety resonates with SAHPRA’s mission of ensuring that the public is protected by registering and regulating all health products so that they comply with SAHPRA’s pillars of safety, quality, efficacy and performance. This involves ensuring that stringent regulatory requirements are followed before any health product is made...
In February 2019 the South African Health Products Regulatory Authority (SAHPRA) received reports suggesting fraudulent activity implicating a small sector of the authority and an external stakeholder. SAHPRA’s acting-CEO, the Board and the Health Minister reported the allegations to the Special Investigating Unit (SIU) and...
10 May 2019 SAHPRA is the South African Health Products Regulatory Authority. It is a Section 3A public entity that was formed by the South African government to oversee the regulation of health products which includes medicines, medical devices, in-vitro diagnostic tests and devices, radiation emitting...
The Medicines Control Council (MCC) of South Africa wishes to alert healthcare professionals that the use of oral cough and cold medicines containing certain ingredients is now contraindicated in children under the age of two years. This decision is in line with international recommendations regarding the...
The Medicines Control Council (MCC) wishes to alert healthcare professionals and consumers to the risk of adverse events associated with the prolonged or repeated use of gamma benzene hexachloride (lindane)-containing shampoos (Gambex® and Quellada® Shampoos). After a review of the risk-benefit profile of these products, the...
The Medicines Control Centre (MCC) wishes to draw the attention of all health care professionals to the correct route of administration of Rotarix Vaccine. Rotarix Vaccine is indicated for the prevention of gastroenteritis caused by Rotavirus, G1 and non- G1 serotypes (such as G2, G3, G4...
The Medicines Control Council alerts all health care professionals to safety information regarding the potential risk of interactions when domperidone is administered concomitantly with ketoconazole or possibly with other concomitantly administered medicines. QT prolongation, ventricular tachyarrhythmias and sudden deaths have been reported following intravenous administration of...
The Medicines Control Council (MCC) wishes to alert healthcare professionals and consumers to the risk of adverse events associated with the prolonged or repeated use of gamma benzene hexachloride (lindane)-containing shampoos (Gambex® and Quellada® Shampoos). After a review of the risk-benefit profile of these products, the...
