Information and Instructions for the 2026 Single Exit Price Adjustment (SEPA) Submissions |
DEPARTMENT OF HEALTH
MEDICINES AND RELATED SUBSTANCES ACT, (ACT NO. 101 OF 1965)
....................2025
No. R. .......
INFORMATION TO BE PROVIDED BY MANUFACTURERS AND OR IMPORTERS OF MEDICINES AND SCHEDULED SUBSTANCES WHEN APPLYING FOR THE SINGLE EXIT PRICE ADJUSTMENT FOR 2026
I, DR SSS BUTHELEZI, Director-General, have determined in accordance with Regulation 21 of the Regulations Relating to a Transparent Pricing System for Medicines and Scheduled Substances published in Government Gazette number 28214 of 11 November 2005, that the information required in the submissions for the 2026 SEP adjustment as determined by the Minister be submitted to the Directorate: Pharmaceutical Economic Evaluation (PEE) within the National Department of Health by a manufacturer or importer of the medicine or scheduled substance, who is the applicant of the medicine, in accordance to the information and instruction document appended to this Notice.
Such information should be submitted electronically to [email protected]. The submission should include information containing the applicant's entire portfolio; including the medicines for which the applicant is not requesting an adjustment of the SEP.
Dr SSS Buthelezi
Director-General: Health
Date: 27/10/2025
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