Veterinary medicines, including veterinary 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 not previously included in a veterinary medicine for non-food producing animals, including two API's and two species per application. Additional fees will apply in line with sub-paragraph (b): R40 000, |
| (ii) |
New Chemical Entities previously included in a veterinary medicine for non-food producing animals including two API's and two species per application. Additional fees will apply in line with sub-paragraph (b): R35 000, |
| (iii) |
New Chemical Entities not previously included in a veterinary medicine for food producing animals including two APIs and two species per application. Additional fees will apply in line with sub-paragraph (b): R45 000, |
| (iv) |
New Chemical Entities previously included in a veterinary medicine for food producing animals including two API's and two species per application. Additional fees will apply in line with sub-paragraph (b): R30 000, |
| (v) |
Line extensions with additional indications for food producing animals including two API's and two species per application: R27 000, |
| (vi) |
Line extensions with additional indications for non-food producing animals including two API's and two species: R20 000, |
| (vii) |
Generic products (bio availability evaluated) including two API's and two nonfood producing species per application: R25 000, |
| (viii) |
Generics for food producing animals, including two species and two API's per application. Additional fees will apply in line with sub-paragraph (b): R30 000, |
| (ix) |
For Bio waivers (Generics) for 'food producing animals, including two species with AMR evaluation and two API's per application. Additional fees will apply in line with sub-paragraph (b): R21 900, |
| (x) |
For Bio waivers (Generics) for non-food producing animals, including two species and two API's per application. Additional fees will apply in line with sub-paragraph (b): R15 100 and |
| (xi) |
Evaluation of additional submitted clinical data (pre-registration) per application: R2 900. |
| (b) |
Fees for additional API sources and BE studies: |
| (i) |
New Chemical Entity and Generic application with more than two APl's and two species, for each additional API and API source and species: R18 600 and |
| (ii) |
Generic application with more than two BE/Bio waiver studies, for each additional BE/Bio waiver study and species: R15 100. |
| (c) |
Any medicine, the registration of which has been approved by the Authority in terms of Section 15(3): |
| (i) |
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: R1 900 for each registration, |
| (ii) |
Every five years, in respect of the renewal of a New Chemical Entity Health Product/Medicine, the registration of which has been approved by the Authority in terms of Section 15(3): R34 000 per Master application and R13 500 per Line Extension up to a maximum of two-line extensions, |
| (iii) |
Every five years, in respect of the renewal of a Generic Health Product Medicine, the registration of which has been approved by the Authority in terms of Section 15(3): R31 600 per Master application and R9 600 per Line Extension up to a maximum of two-line extension, |
| (iv) |
Evaluation of request for rescheduling of products per application: R6 400, |
| (v) |
Request to amend Professional Information in respect of which data relating to safety must be evaluated (post registration) per application: R9 400, |
| (vi) |
Request to amend Professional Information in respect of which clinical data relating to safety and efficacy must be evaluated (post registration): R16 200, |
| (vii) |
Request to amend the Innovator or Generic medicine Professional Information and where clinical data is not required (post registration): R3 300, |
| (viii) |
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 400: 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), |
| (ix) |
Evaluation of request for approval of once-off deviation from registered requirements per product, including Section 36 exemptions: R5 500, |
| (x) |
Evaluation of requests for exemption from registered post importation testing requirements per product per year the exemption is valid for: R5 500 and |
| (xi) |
Evaluation of medicine proprietary name changes (post registration) per application: R3 400. |
| (d) |
For veterinary quality variations, the fees are applicable per application number: |
| (i) |
Type II veterinary medicine variation (post registration) - Evaluation of request for major technical amendments relating to quality for the first two variations in the same application: R13 800 per application and R4 600 for the third and subsequent variation of the same application, |
| (ii) |
Type IA veterinary medicine variation (post registration) - Evaluation of request for minor technical amendments (per grouping of a maximum of three variations per application in respect of which data relating to quality must be evaluated: R3 500 and |
| (iii) |
Type IB (veterinary medicine variation (post registration) - Evaluation of request for technical amendments (per grouping of a maximum of three variations per application) in respect of which data relating to quality must be evaluated: R5 600. |
South African Revenue Service Act, 1997
