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)

Health Product Applications

  • Optimized 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. Refer to the complete HPA guide for details.
  • Enhanced the Renewals flow and adjusted pricing to align with SAHPRA guidelines
  • Resolved an issue where removing an INN from a draft application would remove all added INNs from the application as well.

Section 21 Applications

  • Added a Weekly option when indicating the “Dosage Interval” selection when creating a Section 21 Application
  • When indicating “No Concomitant disease?”, those fields will no longer be required.
Version 1.5.1 (2025-07-08)

Section 21 Applications

  • Enhanced the Outcome Report functionality for both Named Patient and Multi Patient applications
  • Resolved an issue where the Address indicated on section C would prevent users from proceeding with the application
  • Organizational users can now access all Section 21 Applications submitted by any user within the same organisation

Health Product Applications

  • Updated the pricing structure of HPA Variations to correctly charge document fees for the applicable variation codes selected
Version 1.5.2 (2025-07-11)

Section 21 Applications

  • Enhanced the Intended Patient Pack Selling Price field for improved readability

Health Product Applications

  • Optimized the MetaSync integration with the SAHPRA portal
Version 1.5.3 (2025-07-15)

Health Product Applications

  • Optimized FTP and trigger file creation
  • Implemented an Application Summary Admin dashboard for generating application summaries for individual applications or all applications. For detailed instructions, see the dashboard guide.
  • Resolved an issue with application summary generation, as well as mismatching data added to the summary
Version 1.5.4 (2025-07-18)

Health Product Applications

  • Adjusted the Renewal pricing structure to align with SAHPRA updated guidelines
Version 1.5.5 (2025-07-28)

Health Product Applications

  • The variation creation screen will now display all your applications, removing the previous automatic filtering. It is now the user’s responsibility to select only those applications that are eligible for the variation.
  • Enhanced the application selection process when initiating a variation for an application.
  • Added the ability for users to enter application numbers for duplicate strengths on baseline applications.
  • Enhanced the application summary PDF to display more accurate and legible information.
  • Enhanced the View Documents screen to clearly indicate which documents are associated with specific sequences.
Version 1.5.6 (2025-08-04)

Health Product Applications

  • Enhanced the HPA application registration process to align with SAHPRA guidelines
  • Implemented a tool to better manage MetaSync integration and data misalignment between DocuBridge and the SAHPRA portal caused by legacy and inaccurate data capturing
  • Added the Update Application functionality to the Search Applications page, mirroring its availability on the Application Management Dashboard.
  • Updated the Variation Summary generation to align with SAHPRA guidelines
  • Implemented a popup prompt for users to specify the Original submission type for the application. Important: This feature applies only to Baseline Applications. A baseline application requires an indicator of the application type for functional purposes, and users must provide the Original submission type that the baseline application was created for.
Version 1.5.7 (2025-08-07)

General

  • Implemented a feature to send Email notifications to all registered users on the portal
Version 1.5.8 (2025-08-08)

Health Product Applications

  • Updated the Health Checker to move any application to a Legacy State if data on the application is missing.
Version 1.5.9 (2025-08-13)

Health Product Applications

  • Updated the Transfer of Applicancy functionality and adjusted pricing to align with SAHPRA guidelines
  • Updated Renewal response fees to align with SAHPRA guidelines
Version 1.5.10 (2025-08-21)

Health Product Applications

  • Added new consolidated Variation Codes (Quality Biological Codes) to the dropdown menu when creating a Variation
  • Updated the pricing structure for Variations to align with SAHPRA guidelines. For more information please visit Communication to Stakeholders - Variation Pricing
  • Added the Delink Application variation to the SAHPRA portal. Refer to the Delinking variation guide for details.
  • Enhanced the Sales Order reference to be unique for each type of payment submitted.
Version 1.4.0 (2025-06-09)

Section 21 Applications

  • Users can now access 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.
  • Updated the Reauthorisation process to align with SAHPRA guidelines.

Health Product Applications

  • Added a New Variation button to the application Overview page, allowing applicants to create a variation directly from the application.
  • Enhanced the Variations flow 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.
  • Resolved 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

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

General

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

Section 21 Applications

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

Health Product Applications

  • Resolved 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.

Health Product Applications

  • Updated pricing for CEP and CPQ to not count as an additional API as per SAHPRA guidelines
  • Added the ability to generate a PDF Summary 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, users will be warned if they attempt to leave the page before completing all required information needed to save a draft application. Important: Complete all required 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

  • Added a Checklist for both Multiple Patient and Named Patient applications
  • Revised the pricing structure for Section 21 Multi-Patient applications. 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.
  • Enhanced the Dosage Unit field to support the use of decimal points (e.g., 0.5 mg) without causing application errors.

Health Product Applications

  • Added a new left-hand navigation tab titled Export Applications. 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. Users are encouraged to utilize 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.

  • Enhanced the Indication field to be 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.

  • Enhanced the Strength fields to 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
  • Added the ability for users to indicate whether or not an application for a Named Patient includes a Concomitant Disease
  • Enhanced all Strength fields to support decimal values

Health Product Applications

  • Enhanced the Number field to display properly for entering your required priority number when applying for a Priority HPA Application
  • Adjusted the payment infrastructure for priority HPA applications
  • Enhanced all Strength fields to support decimal values
Version 1.2.3 (2025-05-16)

Health Product Applications

  • Resolved an issue where a payment is still requested after submitting a payment on a sequence
  • Enhanced dose combination functionality to 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 enhancements
  • 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

  • Made several fields in both Named Patient and Multi-Patient Section 21 applications 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.
  • Expanded the Site Authorized list to include previously missing entries. This field is no longer required for submission.
  • Updated the ICD-11 code list to include missing codes and support overrides for public health applications and emergency use cases.
  • Resolved several issues where application fields were not saving and where proof of payment documents failed to save when disputed and re-uploaded.

Health Product Applications

  • Enabled Master and Duplicate Assignment functionality 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. For persistent issues, contact support at portal.support@sahpra.org.za with the relevant sequence details. 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.