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

Regulations

Regulations regarding Fees Payable in terms of the provisions of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), 2020

4. Fee for New Licences

 

(a) An application for a new licence in terms of Section 22C(1)(b) of the Act:
(i) Manufacture: R25 200;
(ii) Distribute: R15 000 [Holder of certificate of registration (HCR)];
(iii) Wholesale: R15 000;
(iv) Import: R15 000 (Holder of certificate of registration); and
(v) Export: R15 000 (Holder of certificate of registration).

 

(b) An application for the renewal of a licence in terms of Section 22D of the Act, the licensing of which has been approved by the Authority in terms of Section 22C(1)(b) of the Act:
(i) Manufacture: R22 000;
(ii) Distribute: R12 600 (Holder of certificate of registration);
(iii) Wholesale: R12 600;
(iv) Import R9 200 (Holder of certificate of registration); and
(v) Export: R9 200 (Holder of certificate of registration).

 

(c) Annually, in respect of the retention of a licence issued in terms of Section 22C(1)(b) of the Act: R4 200, and this fee is payable on or before the last working day of June that year, failing which registration may be cancelled.

 

(d) Licensing for any manufacturer, distributor, wholesale, import or export, the license of which has been approved by the Authority in terms of Section 22(1)(b) of the Act: R3 400.

 

(e) Application for the amendment to an existing licence to manufacture, distribute, wholesale, import or export R5 300.