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), 20203. Fees for Clinical Trials |
| (a) | In respect of the submission of an application for the authorisation of the use of an unregistered medicine for clinical trials: |
| (i) | Clinical trial application (Safety and efficacy): R32 400.00; |
| (ii) | Clinical trial application (Bioequivalence study): R30 400; |
| (iii) | Clinical trial application (Postgraduate study): R10 800; |
| (iv) | Any other clinical trial application: R5 000. |
| (b) | In respect of clinical trials amendments: |
| (i) | Fees in respect of an application for technical amendments: R7 000.00 per amendment; |
| (ii) | Fees in respect of an application for administrative amendment R4 100 per amendment; and |
| (iii) | Any other application except for the purpose of performing a clinical trial: R350. |