19 Nov Template – Seal Letter
Posted at 17:10h
in
This letter shows routine inspection was carried out at a premises....
Template – Seal Letter
19 Nov Template – Tech Unseal Letter
Posted at 17:07h
in
This letter grants permission to name of Technician of name of IB to remove the seal from the x-ray unit at the premises of the licence holder....
19 Nov Template – Unseal Letter
Posted at 16:58h
in
This letter grants permission to the licence holder to remove the seal from the x-ray unit at the premises in the absence of the Radiation Inspector....
11 Nov Quality Variations
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 SAHPRA Engagement Portal
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....
29 Oct Implementation of Regulatory Information Management System – Information on eCTD 3.1 Module 1 – Document Matrix
Posted at 10:08h
in
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....
25 Oct Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1
Posted at 15:07h
in
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....
14 Oct Clinical Trials Committee Meeting and Submission Dates for 2025
Posted at 11:54h
in
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. ...
11 Oct Communication to Industry – Request for Scientific Information on Yohimbine Use in Veterinary Medicine
Posted at 11:08h
in
This communication is intended to seek stakeholder input in gathering scientific information regarding the use of yohimbine in veterinary medicine....
25 Sep Consolidated Schedules (August 2025)
Posted at 10:32h
in
The Minister of Health has, in terms of section 22A(2) and 37A of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), on the recommendation of the South African Health Products Regulatory Authority (SAHPRA), made and updated the Schedules....