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STAATSKOERANT, 12 FEBRUARIE 2025 No. 52106 3 GOVERNMENT NOTICES • GOEWERMENTSKENNISGEWINGS DEPARTMENT OF HEALTH NO. 5856 12 February 2025 MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT No. 101 of 1965) REGULATIONS REGARDING FEES PAYABLE IN TERMS OF THE PROVISIONS OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT No. 101 of 1965) The Minister of Health, in consultation with the Minister of Finance and the South African Health Products Regulatory Authority, in terms of Section 35(1)(xxxi) and (xxxii) read together with Section 35(4) of the Medicines and Related Substances, 1965 (Act No. 101 of 1965); makes the Regulations in the Schedule. DR PAKISHE AARON MOTSOALEDI, MP MINISTER OF HEALTH DATE: 29/1/2025 This gazette is also available free online at www.gpwonline.co.za

4 No. 52106 GOVERNMENT GAZETTE, 12 FEBRUARY 2025 SCHEDULE Definitions 1. In these Regulations, any word or expression to which a meaning has been assigned in the Act shall bear such meaning and, unless the context otherwise indicates: “the Act” means the Medicines and Related Substances Act, 1965, as amended (Act No. 1 of 1965). API – Active Pharmaceutical Ingredient BE – Bio Equivalence CEP – Certificate of Suitability to the Monographs of the European Pharmacopoeia CPQ – Confirmation of WHO API Prequalification IVD – In vitro diagnostics Pre-IND – Pre-Investigational New Drug WHO – World Health Organization Fees payable to the Chief Executive Officer or Director-General 2. The following fees shall be payable to the Chief Executive Officer or the Director-General as the case may be: (a) Application for all requests for priority review status considerations: Fee charged for a priority review status request: R11 500, (b) For approved priority pre-registration evaluations: (i) Priority Generic products (pharmaceutical, analytical and bioavailability evaluated) including generic dental, radio- pharmaceutical products (first strength and dosage form), including two API's and a BE study. Additional fees will be charged for in line with sub paragraph 3(a)viii and paragraph 3(g): R192 000, (ii) Priority Generic products (pharmaceutical and analytical evaluated) including generic dental, radio-pharmaceutical products (first strength and dosage form) including two API's. Additional fees will be charged for in line with sub paragraph 3(a)viii and paragraph 3(g): R132 400, (iii) Priority Generic products with clinical data (first strength and dosage form). Additional fees will be charged for in line with sub paragraph This gazette is also available free online at www.gpwonline.co.za

STAATSKOERANT, 12 FEBRUARIE 2025 No. 52106 15 (i) Fees in respect of an application for technical amendments: R7200 per amendment, (ii) Fees in respect of an application for administrative amendment: R4 200 per amendment and (iii) Any other application except for the purpose of performing a clinical trial: R400. Fees for Licences (Including Medical Devices/IVD’s and Complementary Medicines) 8. 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, This gazette is also available free online at www.gpwonline.co.za

16 No. 52106 GOVERNMENT GAZETTE, 12 FEBRUARY 2025 (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 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) 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 licence 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 22C(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. Fees for inspections to assess quality, safety and efficacy of medicines and scheduled substances. 9. Payable fees are: (a) The charge out rate per inspector will amount to R1 660 per hour per inspector for all scheduled inspections conducted. Inspection hours and travel time will be charged for in accordance with the applicable guideline. (b) Desktop inspection to assess quality, safety and efficacy of medicines or scheduled substances, review of GMP compliance status after license amendments and medical devices: R2 200 per day per inspector. Fees for permits and certificates 10. Payable fees are as follows: (a) In respect of the issuing of a permit or a certificate: (i) Certificate [Certificate of a Pharmaceutical Product (WHO), Good This gazette is also available free online at www.gpwonline.co.za

STAATSKOERANT, 12 FEBRUARIE 2025 No. 52106 17 Manufacturing Practice (GMP) Certificate, Certificate of Free Sale]: R1 460, (ii) Import permit (holder of certificate of registration): R990, (iii) Export permit (holder of certificate of registration): R960, (iv) Any other permit or certificate: R990 and (v) Permits issued by the Director-General in terms of Section 22A of the Act, excluding government departments: R990. Amendment of information in the register 11. In respect of all applications for amendments in terms of Section 15A, the name of the medicine approved by the Authority under Section 15(5), which shall be the proprietary name, the approved name of each active ingredient of the medicine and the quantity thereof contained in a dosage unit or per suitable mass or volume or unit of the medicine, the conditions of registration, the name of the applicant, the name and address of the manufacturer, packer, final product release control, final product release responsibility: R850 per application. Transfer of certificates of registration 12. In respect of an application in terms of Section 15B: R1 100 per application. Appeal against the decision of the authority. 13. Fee payable in respect of an application in terms of Section 24 (3): R52 500 per application. Repeal of laws 14. Regulations published in Government Notice R1379 Government Gazette No. 44026 of 22 December 2020 is hereby repealed. Short Title 15. These Regulations are called Regulations regarding Fees Payable in terms of the provisions of the Medicines and related Substances Act, 1965 (Act No. 101 of 1965), 2025. This gazette is also available free online at www.gpwonline.co.za