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Regulatory framework What is the applicable regulatory framework for the authorisation, pricing and marketing of pharmaceutical products, including generic drugs? The Medicines and Related Substance Act, No. 101 of 1965, as amended (the Medicines Act), as well as the regulations promulgated under the Medicines Act regulate the authorisation, pricing and marketing of pharmaceutical products. Read more
Authors: Peter Leon, Ernst Muller and Natasha Rachwal Negotiators have an opportunity to fashion a regime that supports modern investment policies by promoting sustainable development. With less than three months before the expected conclusion of negotiations on the African Continental Free Trade Area’s (AfCFTA) protocol on investment increasing attention is being paid to the protocol’s … Read more
Authors: Stewart Payne and Natasha Rachwal, with supervision by Nick Altini and Leana Engelbrecht Following the declaration of a national state of disaster in terms of the Disaster Management Act No. 57 of 2002 (as amended), the concerning escalation in the number of confirmed COVID-19 infections in South Africa prompted the National Coronavirus Command Council … Read more
Authors: Jean Meijer and Stewart Payne Following our recent post on COVID-19 and its impact on competition law in Europe, South Africa has added its name to the list of countries using competition laws as a tool both to facilitate the healthcare response to the pandemic and protect consumers from exploitation. On 15 March 2020, … Read more
Authors: Silke Goldberg, Ben Rubinstein and Dr Matthew Burnell In a 2019 global survey, 1,250 CEOs rated environmental / climate change risk the single biggest threat to business growth.1 DOWNLOAD THE GUIDE The race is on for businesses to understand their environmental impact and to manage the legal risks to succeed in a lower-carbon future. … Read more