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Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Notices

Fees Payable in terms of the Provisions of the Medicines and Related Substances Act, 1965

2. Category C medicines

 

Veterinary medicines, including Biologicals, whether compounded in the RSA or not and for which Council has determined by resolution that they are registerable:

(a) In respect of the submission of an application for registration of—
(i) New Chemical Entities, including highly technological products, (first strength, first dosage form): R12 000 per application;
(ii) Generic products (pharmaceutical, analytical and bioavailability evaluated): R11 000 per application;
(iii) Generic products with clinical data: R12 000;
(iv) Strengths and dosage forms other than those referred to in subparagraphs (i), (ii), (iii): R3 800;
(v) Screening fee on receipt of the application: R1 600;
(vi) Evaluation of additional submitted clinical data (pre-registration): R2 400.
(b) Any medicine, the registration of which has been approved by the Council in terms of Section 15(3):
(i) In respect of the registration of any medicine, the registration of which has been approved by the Council in terms of Section 15(3) (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 000 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: 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): R850: 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).