SAHPRA Engagement Portal – Type II Pilot Variation Applications: Submission Window and Fee Processing Clarification

The South African Health Products Regulatory Authority (SAHPRA) refers to Type II variation applications submitted under the Type II Pilot Programme and acknowledges the challenges experienced by certain applicants in finalising payment due to the different pricing calculation method applied through the Portal, as per previous communication shared with Industry. As indicated in the previous communications, the interpretation of the calculation module has been aligned with the industry’s interpretation, and the development changes have been requested from the Development team.