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10 Mar

Posted at 09:27h in

This document is intended to communicate the South African Health Products Regulatory Authority’s (SAHPRA’s) position to all applicants/Holders of Certificates of Registration (HCRs) who intend to submit/have submitted applications supported by bioequivalence studies conducted by Synapse Labs Pvt. Ltd, a Contract Research Organisation (CRO) located...

28 Jan

Posted at 20:41h in

This document is intended to communicate with the Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines.   Following the communication issued to stakeholders on 30 July 2024 regarding the ineffectiveness of oral phenylephrine preparations as nasal decongestants, HCRs for orally administered phenylephrine-containing medicines were...

22 Jan

Posted at 11:40h in

This communication is intended to provide an update to applicants on the process for the cancellation of registered health products in Specification 3.1 and as of 01 November 2024. Reference is made to ZA-SAHPRA eCTD Specification and Guidance for Module 1 and Regional Information, July 2024,...

11 Nov

Posted at 15:17h in

This document is intended to provide Communication to Industry on post-registration quality variation general announcements and submission of exception codes.   The document contains information that the applicant should consider when submitting applications for review. This document includes general information applicable to application submissions and exception codes...

07 Nov

Posted at 14:22h in

As part of the South African Health Product Regulatory Authority’s (SAHPRA) Digitalisation Project, we have launched the SAHPRA Engagement Portal on Monday, 04 November 2024. The first phase of the phased roll-out is to have all users start the User Account creation process....