Training Manual Update Logs

Change Request

This section guides you through the process of creating a Change Request for a Health Product Application (HPA).

Prerequisites

Things to take note of:

  1. You will need the Application ID of the application you are creating a Change Request for.
  2. You can click on the Save Draft button and return to the change request later.
  3. You can click on the Submit button to submit the change request for review. Please note that once you submit the change request, you will not be able to edit it.
  4. This will not change the application on the portal or DocuBridge, it will only submit the changes for review. The changes will then be applied to the application on the portal and DocuBridge after the change request has been reviewed.

Create a Change Request

  • Determine the Application ID of the application you are creating a Change Request for. You will only be able to create a Change Request by searching for the Application ID of the application you are creating a Change Request for, and not by searching for the Application Number or Proprietary Name.

Step 1: Access the Change Request Dashboard

After logging in to the SAHPRA portal, you will be directed to the Applications Dashboard.

Navigate to the Change Request dashboard by clicking on the Change Request button in the right navigation menu.

Applications Dashboard

Step 2: Create a Change Request

  1. Type the Application ID of the application you are creating a Change Request for into the search bar.

  2. Click on the Search button.

  3. Basic information about the application will be displayed.

Search Application
  1. Click on the Create Draft From Application button.

Create Draft From Application
  1. A new change request will be created and the application will be listed on the dashboard.

Step 3: Edit the draft change request

  1. The draft change request can be edited by clicking on the Edit button next to the draft change request.

  2. The application will then load populated with the information from the application currently saved to the application on the portal.

Edit Draft Change Request

  1. This feature allows you to:

    • Make changes to the general information about the application Edit General Information
    • Add, remove or update submissions Edit Submissions
    • Add, remove or update sequences Edit Sequences
  • Add, remove or update strengths Edit Strengths
  1. You can also make comments on the change request by clicking on the Show Comments button on the top right of the page. These comments will be visible to all reviewers of the change request.

Show Comments

Step 4: Submit the change request

  1. If you are not satisfied with the changes you have made, you can click on the Save Draft button to save the change request as a draft. You can return to the change request later and continue editing it.

  2. If you are satisfied with the changes you have made, you can click on the Submit button to submit the change request for review.

Submit Change Request