Veterinary medicines, including Biologicals, for which Authority has determined by resolution that they are registerable:
| (a) | In respect of the submission of an application for registration of— |
| (i) | New Chemical Entities, including highly technological products, (first strength, first dosage form): R13 200 per application; |
| (ii) | Generic products (pharmaceutical, analytical and bioavailability evaluated): R12 100 per application; |
| (iii) | Generic products with clinical data: R13 200; |
| (iv) | Strengths and dosage forms other than those referred to in subparagraphs (i), (ii), (iii): R4 180; |
| (v) | Screening fee on receipt of the application: R1 760; |
| (vi) | Evaluation of additional submitted clinical data (pre-registration): R2640. |
| (b) | Any medicine, the registration of which has been approved by the Authority in terms of Section 15(3): |
| (i) | In respect of the registration of any medicine, the registration of which has been approved by the Authority in terms of Section 15(3) (in the case of medicines in minute-dose forms; the fee encompasses different dilutions and different volumes, when submitted simultaneously for the same indication or intended use) and in respect of which an application fee has been paid: R 1 760 for each registration; |
| (ii) | Evaluation of request for rescheduling of products: R5 940; |
| (iii) | Evaluation of request to amend Professional Information in respect of which clinical data relating to safety and efficacy must be evaluated: R3 850; |
| (iv) | Annually, in respect of the retention of the registration of a medicine, the registration of which has been approved by the Authority in terms of Section 15(3): R2 300: 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 Authority 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). |
