Justin Malherbe (ZA)

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South African Health Products Regulatory Authority Board has been appointed

The Minister of Health has appointed the board members of the newly established South African Health Products Regulatory Authority (SAHPRA). This health agency is the successor to the Medicines Control Council (MCC) which for decades has been the only medicines regulator in South Africa. A well-resourced and streamlined regulator is seen as the first step … Continue reading

Revised competency standards for pharmacists published for comment

The South African Pharmacy Council has published revised competency standards for pharmacists for public comment. As the statutory body responsible for regulating the pharmacy profession in South Africa, the Pharmacy Council first developed a competency framework for pharmacists in 2006. Following a review process, those competency standards are now being revised to bring them in … Continue reading

Medicines Control Council, not the courts, must classify medicines and medical devices

In December 2016 the Pretoria High Court ruled that one cannot avoid regulatory oversight by the Medicines Control Council (MCC) by declaring that a health-related product is a medical device and not a medicine. That is a determination which the MCC must make. In Omegalabs (Pty) Ltd v The Medicines Control Council and Others, the … Continue reading

Office of Health Standards Compliance procedural regulations in force

The ‘Procedural regulations pertaining to the functioning of the office of health standards compliance and handling of complaints by the ombud’ (the procedural regulations) were brought into force on 13 October 2016. The Office of Health Standards Compliance (The OHSC), was established by the National Health Act. It is responsible for the monitoring and enforcement … Continue reading

UK Court rules that settlement with a concurrent wrongdoer does not release other wrongdoers unless it satisfies the whole claim

A UK High Court has decided that settlement of a claim for injuries sustained by a sub-contractor on a construction project would only extinguish a further claim against a hospital for alleged negligent treatment received following the work accident if the settlement satisfied the whole claim. The defendant hospital brought an application to declare the … Continue reading