Acts Online
GT Shield

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

3. Category D medicines (Human medicines)

 

Human medicines, 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) Products submitted with clinical and or toxicological data (first strength, first dosage form): R12 400 per application;
(ii) Strengths and dosage forms other than those referred to in subparagraph (i): R3 900 per application;
(iii) Products submitted with no clinical or toxicology data (first strength, first dosage form): R5 500 per application;
(iv) Strengths and dosage forms other than those referred to in subparagraph (iii): R1 800;
(v) Screening fee on receipt of an application: R1 600;
(vi) Evaluation of additional submitted clinical data (pre-registration): R2 500;
(vii) An application in terms of Section 15C of the Act: R30 000;
(viii) Of any medicine in accordance with an expedited registration procedure in terms of Section 15(2)(b) of the Act: R9 000.
(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 and in respect of which an application fee has been paid: R950 for each registration;
(ii) Evaluation of request for rescheduling of products: R5 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 000;
(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): R650: 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).