Human medicines for which an application for registration has been submitted as contemplated in Section 15 of the Act,
| (a) |
In respect of the submission of an application for registration of: |
| (i) |
Products submitted, with clinical and or toxicological data (first strength and dosage form) per application: R16 700, |
| (ii) |
Strengths and dosage forms other than those referred to in sub-paragraph (i) per application: R6 500, |
| (iii) |
Products submitted with no clinical or toxicology data (first strength and dosage form) per application: R8 500 per application, |
| (iv) |
Strength and dosage forms other than those referred to in sub-paragraph (iii) per application: R4 000, |
| (v) |
Evaluation of additional submitted clinical data (pre-registration) per application: R3 000 and |
| (vi) |
An application in terms of Section 15C of the: R36 100. |
| (b) |
Any medicine, the registration of which has been approved by the Authority in terms of Section 15(3) of the Act: |
| (i) |
In respect of registration of any medicine, the registration of which has been approved by the Authority in terms of Section 15(3) of the Act and in respect of which an application fee has been paid per registration: R1 900, |
| (ii) |
Evaluation of request for rescheduling of products per product registered: R6 000, |
| (iii) |
Evaluation of request to amend Professional Information in respect of which clinical data relating to safety and efficacy must be evaluated (post-registration) per application: R3 600, |
| (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): R1 900: 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), |
| (v) |
Evaluation of request for approval of once-off deviation from registered requirements per product, including Section 36 exemptions: R5 500, |
| (vi) |
Evaluation of requests for exemption from registered post-importation testing requirements per product per year the exemption is valid for: R5 500 and |
| (vii) |
Evaluation of medicine proprietary name changes (post registration) per application: R3 400. |
Meat Safety Act, 2000
