In South Africa, the pharmaceutical market is a highly regulated entity where medicines are kept under strict schedules. Recent amendments to the legislation include the under strict schedules. Recent amendments to the legislation include the Medicines and Related Substances Amendment Act, No 72 of 2008 to be read in conjunction with the Medicines and Related Substances Amendment Act, No 14 of 2015, and these amendments have furthered tightened the regulatory framework surrounding pharmaceuticals in South Africa – not limited to and including complementary medicines and medical devices.
It also established the South African Health Regulatory Products Authority, a juristic person with the ability to set out fees, licences and registrations for existing and new medicines. Since the inception of these amendments, the law and matters related to pharmaceuticals fall under the purview of this authority.
Although pharmaceutical law in South Africa is regulated by legislation, one must not overlook the case law aspect of it. Such as the groundbreaking judgment surrounding cannabis for medicinal use.
Of course, there is also the Pharmacy Act53 of 1974, which sets out the rules for good pharmacy practice in South Africa – and it serves as the code of conduct that pharmacists live by.
Because medicines and medicinal breakthroughs are constantly evolving, so will the law and maters surrounding pharmaceuticals in South Africa. If you need any advice regarding pharmaceuticals, ranging from registration and licencing to dispensing and schedules please do not hesitate to reach out to us and we will refer your query to a legal professional in the medical know.
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