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...
During the recent webinar engagements, we have had several applicants raise questions seeking clarity around the appropriate process to follow for submitting Responses to queries that have been shared by SAHPRA for their review, action and response – for either new medicine applications or variation...
We want to provide a general update on the progress of the RIMS deployment that commenced at the end of March 2024. We have completed our migration processes for all eCTD applications and the priority eSubmission applications that were a work in progress – with some...
This document is intended to provide communication to industry on the changes of EDQM CEP and implementation of CEP 2.0 for all other new applications for orthodox medicines. This will be a “living document” and will be updated in line with changes observed from the...
As you are aware, SAHPRA has been focused on progressing the digital transformation of the organisation over the past few years. We have different initiatives underway to digitalise our business processes....
SAHPRA has launched an Online Medicines Directory. Please visit: www.medsinfo.sahpra.org.za The Online Medicines Directory has been launched for Schedule 0-2. The job is to increase awareness and use of the directory amongst consumers, patients and healthcare providers. This toolkit provides Market Authorisation Holders (MAH) and SAHPRA...
