Training Manual Update Logs

Release Notes

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

Version 1.5.0 (2025-06-30)

HPA Applications

  • Improved performance with lazy loading implemented on the search applications page when creating a variation.
  • Added the ability to indicate multiple pack sizes per strength when registering an application. This is indicated here
  • Improved the Renewals flow and pricing to align with SAHPRA guidelines
  • Fixed an issue where removing an INN from a draft application would remove all added INN’s from the application as well.

Section 21

  • Added a Weekly option when indicating the “Dosage Interval” selection when creating an s21 Application
  • When indicating “No Concomitant disease?”, those fields will no longer be required.
Version 1.5.1 (2025-07-08)

Section 21

  • Improved the Outcome Report functionality for both Named Patient and Multi Patient applications
  • Fixed an issue where the Address indicated on section C would prevent users from proceeding with the application
  • Users linked to an organisation can now view all S21 Applications made by any other user within the same organisation

HPA Applications

  • Updated the pricing structure of HPA Variations to correctly charge document fees for the applicable variation codes selected
Version 1.4.0 (2025-06-09)

Section 21 Applications

  • You can now view all Proof of Payments made for an application.
  • For Multiple Patient applications, a new upload field has been added beneath the Amount of Patients to be treated to provide justification for the indicated number of patients.
  • The Reauthorisation process has been updated to align with SAHPRA guidelines.

HPA Applications

  • A New Variation button has been added to the application Overview page, allowing applicants to create a variation directly from the application.
  • The Variations flow has been updated to improve performance and application selection, as well as reducing confusion around optional information.
  • Pricing for Variations is now calculated per selected application number, in line with SAHPRA guidelines.
  • The Document fee for variation applications will now be charged with the initial submission.
  • Updated pricing for Clone and Replica variations to align with SAHPRA guidelines.
  • For legacy variations that did not require variation codes, you no longer need to enter a code when updating the legacy application/information.
  • Fixed an issue where the trigger file failed if an entity-owned INN did not have an APIMF.
  • Updated various sequence types that should not have a price, to align with SAHPRA guidelines.

General

  • Fixed an issue where various document links expired
  • Optimised the Application Management Dashboard to load applications faster
  • Optimised the Draft Applications Dashboard to load applications faster
  • Optimised the Legacy Applications Dashboard to load applications faster
  • Updated various text information for better clarity
Version 1.4.1 (2025-06-18)

General

  • All lookup lists are now displayed in alphabetical order.
  • Improved performance with lazy loading implemented on the search applications page.

Section 21

  • Fixed dropdown fields that were incorrectly accepting text input instead of defined options.

HPA

  • Fixed issue where approved strengths were not displaying when initiating a registration payment.
  • Introduced new variation form that allows submission without codes and supports conditional information entry based on variation type.
Version 1.3.0 (2025-05-22)

Section 21 Applications

  • Comments provided to applicants regarding an application will now be included in the outcome report
  • The reason for rejection will be included on the Application Outcome Report if your application has been rejected.

HPA Applications

  • Pricing for CEP and CPQ have been updated to not count as an additional API as per SAHPRA guidelines
  • A PDF Summary can now be generated for any application with all the information of the application. This can be done on the Overview page of the application
  • When Creating a New Application, you will be warned if you try to leave the page before all the required information is filled in needed to save a draft application. Note, Please fill in all information on the first page of a new application and proceed to the strengths screen if you wish to save a draft application.
Version 1.3.1 (2025-05-29)
  • Updated Training documentation
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 according to intended patients to be treated.
  • The Dosage Unit field now supports the use of decimal points (e.g., 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 decimal points (e.g., 0.5 mg) without causing application errors.

Version 1.2.1 (2025-05-12)
  • Updated Training documentation
Version 1.2.2 (2025-05-13)

Section 21 Applications

  • Adjusted payments for updated pricing when selecting certain reasons for: Reason for not using SAHPRA-Registered medicine
  • Users can now indicate whether or not an application for a Named Patient includes a Concomitant Disease
  • Users can now add decimals to all Strengths

HPA Applications

  • The Number field will now display properly to enter your required priority number when applying for a Priority HPA Application
  • Adjusted the payment infrastructure for priority HPA applications
  • Users can now add decimals to all Strengths
Version 1.2.3 (2025-05-16)

HPA Applications

  • Fixed an issue where a payment is still requested after submitting a payment on a sequence
  • Fixed dose combination can now be indicated and added directly to each strength. Enter your Strength as e.g. 50/20/10 — highest schedule to lowest schedule in alphabetical order per schedule of listed API/INN

General

  • Various performance and stability improvements
  • When inviting a user with an existing individual profile on the portal, the user will now be migrated to your organisation. No action is required from the individual that is being migrated.
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.
Version 1.0.0 (2025-04-01)

Initial release of the SAHPRA Engagement Portal with core functionality.

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. You can submit feedback directly through the portal’s feedback form or email portal.support@sahpra.org.za.