Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations regarding Fees Payable in terms of the provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), 20205. Fees for Inspections to assess the quality, safety and efficacy of medicines or scheduled substances |
| (a) | Local manufacturing site: R1 600/h; (Travel time to be charged). |
| (b) | International manufacturing sites: R1 600/h; (Travel time to be charged) |
| (c) | Wholesale sites: R1 600/h. |
| (d) | Distributor sites, Local: R1 600/h. |
| (e) | Clinical trial site; Local: R1 600/h. |
| (f) | International clinical trial site: R1 600/h. |
| (g) | Local pharmacovigilance inspection: R1 600/h. |
| (h) | International pharmacovigilance inspection: R1 600/h. |
| (i) | Desktop inspection to assess quality, safety and efficacy of medicines or scheduled substances: R2 100. |