Release Notes

This page tracks all significant changes made to the SAHPRA Engagement Portal.

Version 1.2.0 (2025-05-10)

Section 21 Applications

  • A Checklist has been added for both Multiple Patient and Named Patient applications
  • The pricing structure for Section 21 Multi-Patient applications has been revised. When the applicable reason is selected—as agreed upon in discussions with industry stakeholders—the total fee will now be R400 per application, regardless of the number of patients. All other Multi-Patient applications will continue to be charged at R400 per indicated patient.
  • The Dosage Unit field now supports the use of both commas and decimal points (e.g., 0,5 mg or 0.5 mg) without causing application errors.

HPA Applications

  • A new left-hand navigation tab titled Export Applications has been added. This allows applicants to update missing or incomplete information on existing applications, including indications, strength data, application numbers, and duplicate or master relationships.

    Upon accessing this tab, organisations will see a list of their existing applications on the portal, with an option to Export the application data for review and correction. We encourage users to make use of this functionality to rectify legacy data discrepancies.

    Important Note: Sequences created on the portal with incorrect pricing due to missing data may be deleted directly from the exported spreadsheet. However, new sequences or submissions that were not part of the original legacy application must not be added to the export sheet. Instead, please use the standard process on the portal to create new sequences, variations, or submissions. The Export/Import feature can be used multiple times if the imported data does not appear correct on first attempt.

  • The Indication field has been enhanced and is based on ICD-11 codes, making selection more intuitive and aligned with international standards. It now supports multiple selections, allowing users to assign more than one indication per application.

  • The Strength fields also now support the use of both commas and decimal points (e.g., 0,5 mg or 0.5 mg) without causing application errors.

Version 1.1.0 (2025-04-30)

Section 21 Applications

  • Several fields in both Named Patient and Multi-Patient Section 21 applications are now optional, simplifying the application process. A detailed guide outlining the updated field requirements is available in the OVERVIEW section of the Section 21 Training Manual.
  • The Site Authorized list has been expanded to include previously missing entries. This field is no longer required for submission.
  • Updates to the ICD-11 code list have been made to include missing codes and support overrides for public health applications and emergency use cases.
  • Several fixes have been implemented to resolve issues where application fields were not saving and where proof of payment documents failed to save when disputed and re-uploaded.

HPA Applications

  • Master and Duplicate Assignment functionality is now enabled for applications still in the Legacy State. Applications requiring duplicate master allocations for strengths no longer available in Legacy will be handled on a case-by-case basis. Please contact portal.support@sahpra.org.za if this applies to your application.
  • All HPA applications in the draft Legacy State must now specify a Submission Type and any variation codes used before continuing. Applications that are no longer in draft will be frozen, and users will be prompted to complete the missing information upon access.
  • Please review all Submission Types and variation codes carefully and reassign them where necessary to ensure accuracy.
  • Applicants are also encouraged to check whether sequences that previously experienced issues with payment invoice generation now generate correctly. If issues persist, please email the relevant sequence details to portal.support@sahpra.org.za. This is necessary to enable removal of the affected sequences and allow continuation of responses.

How to Stay Updated

  • Check this page regularly for the latest portal updates
  • Contact SAHPRA support for specific update inquiries

Reporting Issues

If you notice any issues with the portal or have suggestions for improvements, please contact SAHPRA support through the appropriate channels.