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

Notice No. 29

23 January 2019

GG 42183

Department of Health

I, DR A 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 to a maximum of 3.78% of the SEP of medicines and their related pack sizes that was available as at 21st December 2018; regardless of how that SEP was arrived at for the 2018 cycle. Applications for adjustments of the SEP may only be submitted for the first time in 2019 from 11th January 2019 and by no later than 22nd February 2019,.

All medicines and their related pack sizes with SEP approved with an effective date later than 21st December 2018 are not eligible for SEPA 2019. An applicant may only submit once in the 2019 cycle unless a resubmission is made for eligible medicines that have not been previously approved for an adjustment in 2019 period in which an application was made. The final date for resubmissions will be 01st March 2019.

An adjustment in the Single Exit Price 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 A Motsoaledi, MP

Minister of Health

Date: 30/11/2018