Human medicines, including Biologicals, for which an application for registration is submitted as contemplated in Section 15 of the Act,
| (a) |
in respect of the submission of an application for registration of— |
| (i) |
New Chemical Entities, including highly technological products and new biotherapeutics other than vaccines, which have been processed by the abbreviated registration process [AMRP] (first strength, first dosage form): R53 900 per application; |
| (ii) |
Strengths and dosage forms other than those referred to in subparagraph (i): R23 100 per application; |
| (iii) |
New Chemical Entities, including highly technological products, other than vaccines (first strength, first dosage form): R59 400 per application; |
| (iv) |
Strengths and dosage forms other than those referred to in subparagraph (iii): R29 700 per application; |
| (v) |
Biological products e.g. vaccines and biosimilars (excluding new biotherapeutics): R47 300 per application; |
| (vi) |
Strengths and dosage forms other than "those referred to in subparagraph (v): R14 850 per application; |
| (vii) |
Generic products (pharmaceutical, analytical and bioavailability evaluated) including generic dental and radio pharmaceutical products (first strength, first dosage form): R29 700 per application; |
| (viii) |
Strengths and dosage forms other than those referred to in subparagraph (vii): R10 450; |
| (ix) |
Generic products with clinical data: R48 400; |
| (x) |
Strengths and dosage forms other than those referred to in subparagraph (ix): R14 850 per application; |
| (xi) |
Screening fee on receipt of a Common Technical Document (CTD) format application: R1 760 per sequence; |
| (xii) |
Screening fee on receipt of an electronic Common Technical Document (eCTD) format application: R1 760 per sequence; |
| (xiii) |
Evaluation of additional submitted clinical data (pre-registration): R2 970; |
| (xiv) |
An application in terms of Section 15C of the Act: R35 970; |
| (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 Council in terms of Section 15(3) of the Act (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: R1 760 for each registration; |
| (ii) |
Evaluation of request for rescheduling of products: R15 000; |
| (iii) |
Evaluation of request to amend package insert in respect of which clinical data relating to safety and efficacy must be evaluated (post registration): R3 850; |
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): R15 000;
| (iv) |
Evaluation of request to amend Generic medicine package insert and Patient Information Leaflets where clinical data are not required (post registration): R2 500; |
| (v) |
Evaluation of request for major technical amendments of which data to quality must be evaluated (post registration): R15 000; |
| (vi) |
Evaluation of request for approval of once-off deviations from registered requirements: R5 000; |
| (vii) |
Evaluation of request for exemption from registered post-importation testing requirements per product: R5 000; |
| (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 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). |
| (c) |
In respect of the testing of a human vaccine for purposes of batch release by the National Control Laboratory: R22 000 per batch. |
South African Institute for Drug Free Sport Act, 1997
