The following fees shall be payable to the Chief Executive Officer or the Director General as the case may be:
| (a) |
Application for all requests for priority review status considerations: Fee charged for a priority review status request: R11 500, |
| (b) |
For approved priority pre-registration evaluations: |
| (i) |
Priority Generic products (pharmaceutical, analytical and bioavailability evaluated) including generic dental, radio- pharmaceutical products (first strength and dosage form), including two API's and a BE study. Additional fees will be charged for in line with sub paragraph 3(a)viii and paragraph 3(g): R192 000, |
| (ii) |
Priority Generic products (pharmaceutical and analytical evaluated) including generic dental, radio-pharmaceutical products (first strength and dosage form) including two API's. Additional fees will be charged for in line with sub paragraph 3(a)viii and paragraph 3(g): R132 400, |
| (iii) |
Priority Generic products with clinical data (first strength and dosage form). Additional fees will be charged for in line with sub paragraph 3(a)x and paragraph 3(g): R188 000, |
| (iv) |
Priority New Chemical Entities, new biotherapeutics other than vaccines (first strength and dosage form), including two API's and a Final Finished Product. Additional fees will be charged for in line with sub paragraph 3(a)ii and paragraph 3(g): R300 000 and |
| (v) |
Priority Biological Medicinal Products e.g. vaccines and biosimilars (excluding new biotherapeutics). Additional fees will be charged for in line with sub paragraph 3(a)v and paragraph 3(g): R282 300. |
| (c) |
For approved priority post-registration evaluations relating to quality, including biologicals: |
| (i) |
Priority Quality Type II, major amendment: R23 000 per amendment. |
| (d) |
For approved priority post-registration evaluations relating to clinical variations, including biologicals: |
| (i) |
Priority Type II safety amendment: R29 500, |
| (ii) |
Priority Type II safety and efficacy amendment R44 900 and |
| (e) |
Request for a borderline product status review: R15 000. |
Meat Safety Act, 2000
