This document is intended to provide communication on the revised Regulation Regarding Fees Payable in Terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)....
This document is intended to provide an update on the document matrix to be utilised by all applicants submitting applications for the Renewal of the certificate of registration from 22 January 2025. The Document Matrix location is as follows: https://ectd.sahpra.org.za/ Reference is made to ZA-SAHPRA eCTD...
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...
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,...
This document is intended to provide communication on conditions for Veterinary X-Ray Licence Holders. ...
The South African Health Product Regulatory Authority (SAHPRA) wishes to inform stakeholders that Border Medicines Control Technicians (BMCT) will not be physically present at the ports of entry on 29 November 2024 due to an Annual General Meeting at SAHPRA’s Head Office in Pretoria....
Attn: Board/Committee Members/Evaluators: Please take note of the dates for submission of claims for the remainder of the 2024/25 financial year....
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...
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....
This document is intended to provide an update on the document matrix to be utilised by all applicants from 01 November 2024 (eCTD 3.1 go-live date). The Document Matrix location is as follows: ectd.sahpra.org.za....