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SAPHRA (ECTD & Human Medicines Unit): Variation Communication Guideline

South African Health Products Regulatory Authority (SAHPRA) on 30 September 2022, released updated guidance on " Business As Usual (BAU) Variations Communication".

SAHPRA has adopted the European Union (EU) variation classification guideline, with the full details (including the associated exceptions) published in the Variations Addendum for Human and Veterinary Medicines [2.08].

The purpose of this guidance is to inform applicants on how to submit variations for Category A and C medicines to the SAHPRA as well as what to expect during the review of variation applications.

Type I eSubmission variation applications and eSubmission response submissions should be submitted via the Digital Variations Portal (DVP). Type I eCTD, eCTD response submissions and all Type II variation applications should be submitted via the File Transfer Protocol (FTP).

Applicants can submit "z" code variations to SAHPRA for unforeseen changes not accounted for in the EMA guidelines. Any codes that have not been detailed in the SAHPRA variations addendum should be submitted as a "z" code.

Applicants are to submit "z" code variation requests to the relevant technical unit (Unit Manager & Variations email addresses) and the relevant unit will inform the applicant within 5 working days of the correct application classification and the application fee required, via email.

“z” code submissions cannot be made without obtaining and/or receiving confirmation from SAHPRA.

Click this LINK to know more about SAPHRA's Variations Communication guideline.


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