Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Notices

Fees Payable in terms of the Provisions of the Medicines and Related Substances Act, 1965

5. Use of unregistered medicines
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(a)In respect of the submission of an application for the authorization of the use of an unregistered medicine:
(i)clinical trials (Companies): R9 000;
(ii)clinical trials (Institutions): R4 500;
(iii)any other clinical trial: R2 200;
(iv)any other application except for the purpose of performing a clinical trial: R300.

(b)        In respect of clinical trials amendments:

(i)        fees in respect of an application for technical amendments: R2 100 per amendment;

(ii)        fees in respect of an application for administrative amendment: R600 per amendment.