Meat Safety Act, 2000
R 385
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), 20257. Fees for clinical trials (Human and Veterinary) |
Fees payable:
| (a) | In respect of the submission of an application for the authorisation of the use of an unregistered medicine, medical devices and IVD's for clinical trials: |
| (i) | Clinical trial application (Safety and efficacy): R33 700, |
| (ii) | Clinical trial application (Bioequivalence study): R31 700, |
| (iii) | Clinical trial application (Postgraduate study) with pharmaceutical company involvement: R11 200 and |
| (iv) | Phase 4 Clinical Trial Application and any other clinical trial application, including university involved postgraduate qualification and/or pre consultation of clinical trials (i and ii above): R5 100. |
| (b) | In respect of clinical trials amendments and other S21 applications: |
| (i) | Fees in respect of an application for technical amendments: R7 200 per amendment, |
| (ii) | Fees in respect of an application for administrative amendment: R4 200 per amendment and |
| (iii) | Any other application except for the purpose of performing a clinical trial: R400. |
