Human medicines, including Biologicals, compounded in its entirety in the RSA or not, 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) | New Chemical Entities, including highly technological products, and new biotherapeutics other than vaccines, which have been processed by the abbreviated registration process (first strength, first dosage form): R49 000 per application; |
| (ii) | Strengths and dosage forms other than those referred to in subparagraph (i): R21 000 per application; |
| (iii) | New Chemical Entities, including highly technological products, and new biotherapeutics other than vaccines (first strength, first dosage form): R54 000 per application; |
| (iv) | Strengths and dosage forms other than those referred to in subparagraph (iii): R27 000 per application; |
| (v) | Biological products e.g. (vaccines and biosimilars), excluding new biotherapeutics: R43 000 per application; |
| (vi) | Strengths and dosage forms other than those referred to in subparagraph (v): R 13 500 per application; |
| (vii) | Generic products (pharmaceutical, analytical and bioavailability evaluated) and all other dental and radio pharmaceutical products (first strength, first dosage form): R27 000 per application; |
| (viii) | Strengths and dosage forms other than those referred to in subparagraph (vii): R9 500; |
| (ix) | Generic products with clinical data: R44 000; |
| (x) | Strengths and dosage forms other than those referred to in subparagraph (ix): R13 500 per application; |
| (xi) | Screening fee on receipt of an application: R1 600; |
| (xii) | Evaluation of additional submitted clinical data (pre-registration): R2 700; |
| (xiii) | An application in terms of Section 15C of the Act: R32 700; |
| (xiv) | Of any medicine in accordance with an expedited registration procedure in terms of Section 15(2)(b) of the Act: R9 800. |
| (b) | Any medicine, the registration of which has been approved by the Council 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 600 for each registration; |
| (ii) | Evaluation of request for rescheduling of products: R5 400; |
| (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 500; |
| (iv) | Annually, in respect of the retention of the registration of a medicine, the registration of which has been approved by the Council in terms of Section 15(3): R1 100: 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 Council 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). |
