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South Africa (SAHPRA) Guidance on How to Submit Variation Applications

The purpose of this document is to inform applicants on how to submit variations to the South African Health Products Regulatory Authority (SAHPRA) for Category A and C medicines as well as what to expect during the variation evaluation process.

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

The purpose of the Digital Variations Portal is two-fold:

  • Facilitate the submission and processing of Type I variation applications

  • Provide an electronic database of implemented variations for use by Port Health, without the need for industry to wait for amended registration certificates

For variations submitted in eCTD format for the first time, applicants will be required to include a baseline as part of the dossier. For variations submitted in eSubmission format, applicants may opt to include a baseline where relevant and practical.

Type I eSubmission variation applications and eSubmission response submissions should be submitted via the Digital Variations Portal (DVP). The DVP is not applicable to the Biological medicines & veterinary medicines.

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

Click the LINK for more detailed information on the BAU (Business As Usual ) VARIATIONS COMMUNICATION


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