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....
This document is intended to provide an update on the progress for the Regulatory Information Management System (RIMS) deployment. In the development of the new eCTD specifications, attention has been given to global best practice and the frameworks and specifications from other Recognised Regulatory Authorities....
This communication is for Stakeholders to be aware of SAHPRA's Clinical Trials Committee meeting dates and the submission dates for the year of 2025. ...
This communication is intended to seek stakeholder input in gathering scientific information regarding the use of yohimbine in veterinary medicine....
This communication is intended to provide guidance to Applicants about investigational product import licences (clinical trial approval letters) that have been approved by the Department of Health (Medicines Control Council - MCC)....
