The fees payable for human medicines, including Biologicals, for which an application for registration is submitted as contemplated in Section 15 of the Act, are:
| (a) |
In respect of the submission of an application for registration of: |
| (i) |
New Chemical Entities, new biotherapeutics other than vaccines (first strength and dosage form), including two API's and a Final Finished Product. Additional API's and BE studies will be charged for in line with sub-paragraph (g): R217 200 per application, |
| (ii) |
Strengths and dosage forms other than those referred to in sub-paragraph (i): R85 400 per application, |
| (iii) |
Biological products (first strength and dosage form) i.e., vaccines (excluding new biotherapeutics): R184 400 per application, |
| (iv) |
Biological products (first strength and dosage form) i.e., biosimilars (excluding new biotherapeutics): R180 300 per application, |
| (v) |
Strengths and dosage forms other than those referred to in sub-paragraph (iii and iv): R57 300 per application, |
| (vi) |
Generic products {pharmaceutical and analytical evaluated) including generic dental and radio-pharmaceutical products (first strength and dosage form) including two API's. Additional API's will be charged 'for in line with sub-paragraph (g): R87 600 per application, |
| (vii) |
Generic products (pharmaceutical, analytical and bioavailability evaluated) inc1uding generic dental and radio-pharmaceutical products (first strength and dosage form) including two API's and a BE study, Additional API's and BE studies will charged for in line with sub-paragraph (g): R120 000 per application, |
| (viii) |
Strengths and dosage forms other than those referred to in sub-paragraph (vi and vii): R28 100 and BE studies will be charged for in line with sub-paragraph (g), |
| (ix) |
Generic products with clinical data (first strength and dosage form): R87 600 per application, |
| (x) |
Strengths and dosage forms other than those referred to in sub-paragraph (vii): R28 100 per application, |
| (xi) |
Evaluation of additional submitted clinical data (pre-registration): R5 300, per application and |
| (xii) |
An application in terms of Section 15C of the Act (supply of affordable medicines): R39 400. |
| (b) |
For the second response review of the evaluation outcome of New Chemical Entities, New Generic Medicines, and New Biological Products other than vaccines (first strength and dosage form), per evaluation outcome: |
| (i) |
Response review of major queries: R45 000, |
| (ii) |
Response review of moderate queries: R22 500 and |
| (iii) |
Response review of minor queries: R9 000. |
| (c) |
For the second response review of Clinical evaluations with clinical data: R24 700 per evaluation outcome. |
| (d) |
For the second response review of the evaluation outcome of quality variations per application number per variation queried: |
| (i) |
Response review of Type II and multiple submissions (Type IA and IB): R6 800. |
| (e) |
For the second response review of the evaluation outcome of clinical variations per application number: |
| (i) |
Response review for the evaluation outcome of Type IB, clinical variation application substantiated with data: R7 200, |
| (ii) |
Response review of Type IB: R3 000 and |
| (iii) |
Response review of Type IA: R1 900. |
| (f) |
Pre-Registration Consultation Meeting for Biological Medicines Under Development and with the intention to submit for registration (Pre-IND), per application: |
| (i) |
Type A - meetings conducted before finalisation of non-clinical tests: R43 200, |
| (ii) |
Type B - meetings conducted when non-clinical development is complete and Phase 1 trials are ready for submission: R32 400 and |
| (iii) |
Type C - meetings conducted during the clinical development phase and prior to final registration application: R21 600. |
| (g) |
Fees for additional API sources (excluding CEP's and CPQ's) and additional BE studies: |
| (i) |
New Chemical Entity and new Generic Medicine applications with more than two API's, for each additional API and API source: R18 600 and |
| (ii) |
New Chemical Entity and new Generic Medicine applications with more than one BE study, for each additional BE study: R26 200. |
| (h) |
Any medicine, the registration of which has been approved by the Authority in terms of Section 15(3) of the Act |
| (i) |
In the case of medicines in minute dose form; 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: R2 100 for each registration, |
| (ii) |
Evaluation of request for rescheduling of a product: R16 600, |
| (iii) |
Evaluation of request to amend Professional Information and Patient Information Leaflets in respect of which data relating to safety must be evaluated (post registration) per application: R16 200, |
| (iv) |
Evaluation of request to amend Professional Information and Patient Information Leaflets in respect of which clinical data relating to safety and efficacy must be evaluated (post registration): R32 800, |
| (v) |
Evaluation of request to amend the Innovator or Generic medicine Professional and Patient Information Leaflet where clinical data is not required (post registration): R3 300, |
| (vi) |
Evaluation of request for approval of once-off deviation from registered requirements per product, including Section 36 exemptions: R5 500, |
| (vii) |
Evaluation of requests for exemption from registered post-importation testing requirements per product per year the exemption is valid for: R5 500, |
| (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): R5 200: 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) |
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, |
| (x) |
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 extensions, |
| (xi) |
Evaluation of medicine proprietary name changes (post registration) per application: R3 400 and |
| (xii) |
Authorised Prescribers Amendment per application: R35 800. |
| (i) |
For quality variations of any medicine, the registration of which has been approved by the Authority in terms of Section 15(3) of the Act, the fees are applicable per application: number: |
| (i) |
Type II Level 1 (post registration) - Evaluation of request for major technical amendments in respect of which data relating to quality must be evaluated for the first two variations in the same application: R29 700 per variation and for the third and subsequent variation of the same application: R4 600, |
| (ii) |
Type II Level 2 (post registration) - Evaluation of request for major technical amendments in respect of which data relating to quality must be evaluated for the first two variations in the same application: R13 800 per variation and for the third and subsequent variation of the same application: R4 600, |
| (iii) |
Type II Level 3 (post registration) - Evaluation of request for major technical amendments in respect of which data relating to quality must be evaluated for the third and every subsequent Type II Level 1and Level 2 variations in the same application: R4 600, |
| (iv) |
Type IA (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 |
| (v) |
Type IB (post registration) - Evaluation of request for minor technical amendments (per grouping of a maximum of two variations per application) in respect of which data relating to quality must be evaluated: R5 600. |
| (j) |
In respect of the testing of a human vaccine for purposes of batch release by the National Control Laboratory: |
| (i) |
New applications per batch: R70 000 and |
| (ii) |
Re-release per batch (previously tested): R35 000. |
Meat Safety Act, 2000
