Submission of Business as Usual (BAU) registration and variation applications

01 Aug 2019

Business-As-Usual (BAU) process have been amended to be in line with new regulatory processes emanating from the Backlog Clearance Programme (BCP) pilot lessons and findings.

BAU applications are those applications received by SAHPRA from 1st February 2018. This includes variation applications received from 1st February 2018, which do not have any other variations that are part of the BCP.

 From 1st August 2019, SAHPRA will be accepting only eSubmission and eCTD applications. Applicants should familiarise themselves with the latest relevant guidelines and templates published on the SAHPRA website.

BAU resubmissions

 The BAU process requires that such applications as defined above be re-compiled in line with the new regulatory requirements as published on the SAHPRA website and re-submitted for evaluation from 1st August 2019.

 BAU variation applications should be re-classified, consolidated and also re-compiled in line with the relevant regulatory requirements published on the SAHPRA website.

 BAU variation applications should be submitted in eSubmission or eCTD format only. If a BAU variation application is in eCTD format, and the original application was not in eCTD format, a baseline submission is required.

For more information, contact Mr T Sehloho (Head of BAU Processes) on 012 842 7589 or Tohlang.sehloho@sahpra.org.za

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