The checklist must be included in submissions that include variations for CTD conversions. This checklist should also be included as an annexe to the cover letter for the baseline sequence when converting from eSubmission to eCTD....
Populate this information on a document that includes your company letterhead....
This guideline is intended to provide guidance to applicants who intend to apply as co-applicants for the registration of a medicine. It represents the current thinking of the South African Health Products Regulatory Authority (SAHPRA) on managing applications for registration where there is more than...
This document is intended to provide communication to applicants on system updates regarding the Regulatory Information Management System (RIMS) Portal and the Digital Variations Portal (DVP). SAHPRA’s digital transformation has progressed as planned with submissions via the sFTP for new product applications, all variations, and renewals...
The template of Amendment Schedule to APIMF holder is for API suppliers to complete to indicate any changes in the APIMF....
The document, ZA-SAHPRA CTD eSubmission Specification June 2024, v3.0 is out for applicant comment with a response deadline of Wednesday, 03 July 2024. Download the Document for Comments here. Comments deadline: 03 July 2024...
This communication is intended to provide an update on the progress of the Regulatory Information Management System (RIMS) deployment at the South African Health Products Regulatory Authority (SAHPRA)....
To be printed on the letterhead of the Holder of the Certificate of Registration...
To be printed on the letterhead of the proposed Holder of the Certificate of Registration...
The CEP Letter of access must be drafted on the latest approved SAHPRA letterhead...