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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), 2025

8. Fees for Licences (including Medical Devices/IVD's and Complementary Medicines)

 

Fees payable for licences are as follows:

 

(a) An application for a new licence, including complementary medicines, in terms of Section 22C(1)(b) of the Act:
(i) Manufacture: R26 200,
(ii) Distribute: R15 600,
(iii) Wholesale: R15 600,
(iv) Import: R15 600 (Holder of certificate of registration) and
(v) Export: R15 600 (Holder of certificate of registration),

 

(b) An application for a new medical device and IVD establishment licence in terms of Section 22C(1)(b) of the Act
(i) a manufacturer licence to manufacture, import or export medical devices or IVDs: R26 200; or
(ii) a distributor licence to import, export and distribute medical devices or IVDs: R15 600; or
(iii) a wholesale licence to act as a wholesaler of medical devices or IVDs: R15 600.

 

(c) An application for the renewal of a licence, including complementary medicines, 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 900,
(ii) Distribute: R13 100,
(iii) Wholesale: R13 100,
(iv) Import: R9 600 (Holder of certificate of registration) and
(v) Export R9 600 (Holder of certificate of registration),

 

(d) An application for the renewal of a medical device and IVD establishment license 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) a manufacturer licence to manufacture, import or export medical devices or IVDs: R22 900,
(ii) a distributor licence to import, export and distribute medical devices or IVDs: R13 100 and
(iii) a wholesale licence to act as a wholesaler of medical devices or IVDs: R13 100.

 

(e) Annually, in respect of the retention of a licence issued in terms of Section 22C(1)(b) of the Act: R4 400, and this fee is payable on or before the last working day of June that year, failing which the license may be revoked.

 

(f) 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 including medical devices: R3 500.

 

(g) Application for the amendment to an existing licence to manufacture, distribute, wholesale, import or export including medical devices: R5 500.