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

Notices

Second Single Exit Price Increase [SEP] of Medicines and Scheduled Substances for the year 2023 [Top-up SEP]

Notice No. 3801 of 2023

 

Notice No. 3801

18 August 2023

GG 49140

Department of Health

 

I, Dr M.J Phaahla, the Minister of Health, have determined that the Single Exit Price (SEP) of Medicines and Scheduled Substances may be Topped-up with a SEP increase by not greater than 1.73% of the SEP of medicines and their related pack sizes that was available on the database of medicines dated 17 July 2023 regardless of how that SEP was arrived at in the 2023 cycle.  Applications for Top-up increase of the SEP may only be submitted for the first time in 2023 from 18 August 2023 and by no later than 18 September 2023.

 

All medicines and their related pack sizes with SEP approved with an effective date later than 17 July 2023 are not eligible for Top-Up SEP increase 2023.  An applicant may only submit once in the Top-Up SEP 2023 cycle unless a re-submission is made for eligible medicines that have not been previously approved for Top-Up SEPA in the 2023 period in which an application was made. The final date for re-submissions will be 18 September 2023. The contents of this notice should not be regarded as a precedent.

 

An increase  in the Top-Up 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 MJ Phaahla, MP

Minister of Health

Date: 25/07/2023