Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsThe Authority45. Skills of staff of Authority |
| (1) | For purposes of providing monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, Scheduled substances, medical devices and IVDs, the Authority shall ensure that staff are appointed with the necessary qualification, expertise in and knowledge of— |
| (a) | clinical medicine; |
| (b) | clinical pharmacology; |
| (c) | pharmaceutical chemistry; |
| (d) | toxicology and medicine or scheduled substance safety; |
| (e) | biotechnology; |
| (f) | pharmaceutics; |
| (g) | adverse drug reactions and vigilance; |
| (h) | virology and microbiology; |
| (i) | veterinary clinical pharmacology; |
| (j) | good manufacturing practices, clinical and laboratory practices; |
| (k) | biomedical or clinical engineering; |
| (I) | medical technologist; |
| (m) | investigations on matters relating to legislation; |
| (n) | complementary medicines; or |
| (o) | other appropriate skills as required by the Authority from time to time. |
| (2) | For purposes of oversight, leadership and accountability, the Authority shall ensure that staff are appointed with the necessary qualification, expertise and knowledge relating to at least— |
| (a) | operational management; |
| (b) | supply chain and asset management; |
| (c) | financial management; |
| (d) | human resource management; |
| (e) | information and record management; and |
| (f) | knowledge in law. |