19 November 2020

The Backlog Clearance Team has been made aware of a miscommunication in our Newsletter dated August 2020 and we would like to clarify the matter. It relates to the submission of Type I & II variation applications and states that Type I variations should not be submitted with Type II via the FTP server, but via the Digital Variations Portal (DVP).

Where only Type I variations are to be submitted, submission is via the DVP. Where Type I and Type II variations are both included in a single submission, these applications should be submitted via the FTP server, as the variations are in many cases interlinked and cannot be separated. However,

applicants should remember that such Type I variations are not implementable until the entire variation application (including the Type II variations) is approved by SAHPRA.

Lastly, kindly note that all Backlog Type I variations were finalized during the soft launch in December 2019. All Type I variation applications that were not submitted and processed during the soft launch must be submitted as new variation applications to BAU, accompanied by the applicable fee. Of late, SAHPRA has seen Backlog Type I variations being submitted on the portal, where applicants have missed the resubmission window. These applications have been rejected and applicants are required to submit these variations as new variation applications. Only responses to previous recommendations, where Type II variations have been reclassified as Type I variations, will be handled without the requirement of a new variation submission

How do I report?
Please complete the online COVI-Vig form. This form can be accessed by clicking on ONLINE
SERVICES on the SAHPRA website homepage,, then navigate to COVI-Vig

All-related enquiries and correspondence must be sent to

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