Veterinary medicines, whether compounded in the RSA or not and for which Council has determined by resolution that they are registerable:
| (a) |
In respect of the submission of an application for registration of— |
| (i) |
Products submitted with clinical and or toxicological data, (first strength, first dosage form): R3 400 per application; |
| (ii) |
Products submitted with no clinical or toxicology data (first strength, first dosage form): R2 400 per application; |
| (iii) |
Strengths and dosage forms other than those referred to in subparagraphs (i), (ii): R1 400; |
| (iv) |
Screening fee on receipt of the application: R1 600; |
| (v) |
Evaluation of additional submitted clinical data (pre- registration): R1 300. |
| (b) |
Any medicine, the registration of which has been approved by the Council in terms of Section 15(3): |
| (i) |
In respect of the registration of any medicine, the registration of which has been approved by the Council in terms of Section 15(3) and in respect of which an application fee has been paid: R700 for each registration; |
| (ii) |
evaluation of request for rescheduling of products: R5 000; |
| (iii) |
evaluation of request to amend package insert in respect of which clinical data relating to safety and efficacy must be evaluated: R3 000; |
| (iv) |
Annually, in respect of the retention of the registration of a medicine, the registration of which has been approved by the Council in terms of Section 15(3): R430: Provided that this provision shall come into effect one year after the date on which the registration of the said medicine was approved by the Council in terms of Section 15(3): Provided further that the said fees payable during a particular calendar year shall be payable on or before the last working day of June that year, failing which the registration may be cancelled in terms of Section 16(4). |
South African Institute for Drug Free Sport Act, 1997
