Training Manual Update Logs

Set HPA Approval

Overview

  • This section guides you through the process of setting an approval for a Health Product Application (HPA), as well as Variations and Renewals.

  • Once a submission reaches a Approved state, the strengths of the application that are approved must be set on the system to generate registration numbers and return the information to the applicant.

Approving an application – New Application

Step 1: Access the Applications Dashboard

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

Applications Dashboard

Step 2: Select Application

  1. Locate the Application you wish to set approval for

  2. Click the View button next to the located Application.

View Application
  1. An application overview will appear.

Step 3: Set Approval

  1. Navigate to the Submissions tab

Select Application Type
  1. Click Set Approval.

Step 4: Fill in final proprietary names

  1. Once clicking on this button for a new application a popup will appear allowing the administrative user can select the strengths which are approved. The details that must be entered for each approved strength is the Approved Proprietary name and The Registration Date.

  2. When satisfied the checkbox must be selected for these strengths and the “Approve” button can be clicked to complete approval.

Select HPA Type

Select HPA Type
  1. A registration number will automatically be assigned to each strength that is approved. The application will be sent back to the applicant to complete additional information. The applicant will also receive a notification to action their final registration payment.

Approving variations and renewals

  • Once on the Overview page for an application on a submission level, a button will be available labelled Set Approval once a submission is deemed approved. Once clicking on this button for a variation or renewal application, a popup will appear allowing the administrative user to simply select the Approve button to complete the application. The applicant will be notified of the approval.