Communication to industry Archives - Page 15 of 23

30 Aug Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

Posted at 10:01h in

In response to the anticipated shortage of medical supplies and equipment in the health care system as a result of the outbreak of the Covid-19 pandemic, the South African Health Products Regulatory Authority (the Authority) published minimum requirements for the manufacture, importation, and distribution of...

29 Aug Missing Applications – Call to Industry

Posted at 08:49h in

Business-As-Usual (BAU) is in the process of verifying submitted/received new medicine and variation applications. Industry is kindly requested to verify/confirm if all the applications that have been submitted to SAHPRA via BAU are being processed....

12 Aug SAHPRA Digital Transformation – Deployment of a Stakeholder portal

Posted at 17:24h in

In keeping with SAHPRA’s strategic objectives – Digital Transformation has been a key focus are for SAHPRA ICT....

08 Aug Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting

Posted at 14:04h in

For over a decade, ADR reports have been submitted to the National Adverse Drug Events Monitoring Centre (NADEMC) via fax. These reports were previously captured on the ADRI database. The ADRI database restricted electronic reporting by both applicants and healthcare professionals, and direct uploading of...

02 Aug Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process

Posted at 10:01h in

In an effort to encourage widespread access to medicines in the Southern African Development Community (SADC) region, SAHPRA invites applicants to submit Expressions of Interest (EOIs) for evaluation of applications through the Zazibona collaborative process. ...

15 Jul COVID-19 Test Kits Batch Verification

Posted at 12:45h in

The COVID-19 pandemic is caused by SARS-CoV-2, a novel coronavirus that originated in Wuhan, China in late 2019. The virus has since spread around the world, with novel variants of concern causing new waves of infection. Testing is a critical component of COVID-19 control and...

22 Jun Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals

Posted at 13:23h in

This document is intended to provide communication to industry on nitrosamine review for all other new, in-process and registered products including biological medicines and all old medicines. This will be a “living document” and will be updated. It is important that Applicants adhere to the...

13 Jun Retention Fee Notification – 9 June 2022

Posted at 16:03h in

Payment of Retention Fees for the Year Ending 31 December 2022 in respect of Medicines Registered up and until 31 December 2021 and/or Various Licences...

03 Jun Communication to Industry – Applications for GMP and CPP Certificates

Posted at 14:35h in

Please be informed that all documents and queries for GMP and CPP certificates should now be emailed to a new dedicated email address - see download. ...

25 May Payment of annual retention fees for registered products

Posted at 15:40h in

The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, (“the Medicines Act”) makes provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences issued. Further to the above, Regulation...

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