DEPARTMENT OF HEALTH

MEDICINES AND RELATED SUBSTANCES ACT, (ACT NO. 101 OF 1965) (ANNUAL ADJUSTMENT OF THE SINGLE EXIT PRICE OF MEDICINES …ND SCHEDULED SUBSTANCES [SEPA] FOR THE YEAR 2015)

I, DR A MOTSOALEDI, the Minister of Health, have 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 only be submitted for the first time in 2015 from 12 January 2015 and by no later than 13 March 2015 to a maximum of 7.50 % of the Single Exit Price that was available as at 23 December 2014. The final date for resubmissions will be 30 April 2015.

All medicines and their related pack sizes introduced after 23 December 2014 are not eligible for SEPA 2015. An applicant may only submit once in the 2015 cycle unless a resubmission is made for a rejection.

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, 30 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 Re ulations Relating to a Transparent Pricing System for Medicines and Scheduled subst ces.

DR A MOTSOALEDI, MP
MINISTER OF HEALTH