[22 mаrks]Rаcetаm® is a newly registered anticоnvulsant medicine, authоrised in 2020 fоr the management of epilepsy in South Africa. In accordance with regulatory requirements, the holder of a certificate of registration (HCR) must provide updates at defined intervals to SAHPRA to ensure that the benefit–risk balance of Racetam® remains favourable during its life cycle. During the review of the most recent periodic safety update report (PSUR), severe respiratory depression was identified as an important identified risk. Populations considered to be at increased risk include individuals with compromised respiratory function, pre-existing neurological or respiratory disease, renal impairment, those on concomitant central nervous system (CNS) depressants, and the elderly. Additionally, Racetam® has been noted to have potential off-label use in the management of nerve pain, insomnia, and anxiety, raising concern over unsupervised use and possible adverse outcomes.5.1 Discuss the role of the PSUR in monitoring and analysing new or emerging information on the risks and benefits of Racetam®. Your response should explain the regulatory purpose of the PSUR in post-marketing surveillance and how it supports detection and assessment of new safety signals, such as severe respiratory depression. (8 marks)5.2 Propose routine and additional risk minimisation measures that could be applied for all patients and for specific high-risk groups to minimise the risk of severe respiratory depression associated with Racetam®. Your response should also explain how these measures are documented, monitored and updated. (14 marks)