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

Notice No. 6881

28 November 2025

GG 53729

Department of Health

I, Dr PA Motsoaledi, the Minister of Health, has determined on recommendation of the Pricing Committee, in terms of Regulation 8(1) of the Regulations relating to a Transparent Pricing System for Medicines and Scheduled Substances published in terms of the Medicines and Related Substances Act, (Act 101 of 1965), that the Single Exit Price (SEP) of Medicines and Scheduled Substances may be adjusted  by not greater than 1.47% of the SEP of medicines and their related pack sizes that was available as at 22nd December 2025 regardless of how that SEP was arrived at in the 2025 cycle. Applications for adjustments of the SEP may only be submitted for the first time in 2026 from 7th January 2026 and by no later than 13th February 2026.

All medicines and their related pack sizes with SEP approved with an effective date later than 22nd December 2025 are not eligible for SEPA 2026. An applicant may only submit once in the 2026 cycle unless a re-submission is made for eligible medicines that have not been previously approved for an adjustment in 2026 period in which an application was made. The final date for re-submissions will be 01st April 2026.

An adjustment in the SEP in terms of this Notice may only be implemented by the manufacturer or importer of the relevant medicine or scheduled substance, no later than 32 working days after the date that the manufacturer or importer has communicated the information requested by the Director-General in terms of the Notice published in terms of Regulation 21 of the Regulations Relating to a Transparent Pricing System for Medicines and Scheduled substances.

Dr PA Motsoaledi, MP

Minister of Health

Date: 20/10/2025