Navigating the portal

This section covers how to login to and logout of the portal, how to navigate the platform based on your assigned user roles, and how Organisation Administrators can manage their organization’s details and users.

Login & Logout Procedures

Logout

The Logout button is accessible at the bottom left corner of your main navigation menu. When you hover over the menu and click logout, confirm your choice when prompted.

Navigating the Portal

The portal features a dynamic, collapsible navigation bar. When you hover your cursor over the left side of the screen, the navigation menu will expand and overlap the page content.

The menu options you see are strictly determined by the Application Types and Roles assigned to your account. The menu is divided into two main categories: Applications and Administration.

1. Applications

The items visible under the Applications category depend on your specific applicant role:

For Health Product Application (HPA) Roles:

My Applications: Shows all active applications currently being processed across their different states.
Draft Applications: Contains all draft applications not yet submitted to SAHPRA, allowing you to easily continue building your application. Once an application passes the payment upload step, it moves to “My Applications”.
Legacy Applications: Contains all Legacy applications imported to your organisation profile. Unvalidated/uncleaned imported applications will be listed here with a “Legacy Draft” status before moving to My Applications.
Search Applications: Used to search for any application by a linked proprietary name, the legacy application number, or the newly assigned application ID.
Application Summaries: View and generate summaries for your applications.
Change Requests: View and create change requests for applications.
Portal Approved Products: Contains any applications with approved products.

For Clinical Trials Roles:

My Applications: Shows all active clinical trial applications currently being processed.
Draft Applications: Contains all unsubmitted draft clinical trial applications.
Application Queries: Displays any queries received from SAHPRA regarding any of your clinical trial applications.

For Section 21 Roles:

My Applications: Shows all active Section 21 applications currently being processed.
Draft Applications: Contains all unsubmitted draft Section 21 applications.

2. Administration

This category is exclusively available to Organisation Administrators.

Organisation Management: Allows administrators to view and update the primary Organisation Details.
FTP Credentials: This option will only appear if the Organisation Administrator also has an HPA Role. It allows the administrator to set and manage their FTP credentials for secure file transfers.

Organisation Management (Administrator Access)

As an Organisation Administrator, selecting Organisation Management under the Administration menu will open your primary dashboard for managing your organization’s presence on the portal.

Organisation Details

The main Organisation Management page displays your current organization details.

Change the needed information on the page if necessary. Once you are satisfied with your changes, click Save Changes. A popup will appear to confirm your changes have been successfully applied.

User Management

Within the Organisation Management page, click the Manage Users button to open the user management interface. This displays a table of all users currently linked to your organization.

Managing Existing Users: Click the Action ellipse (three dots) next to a user’s name to perform certain actions on their porfile. As an administrator, you can Edit User, Manage Role, Send Message, or Disable User. Disabled users will be blocked from logging in, but they are not permanently deleted and can be Enabled again at any time.

Inviting a New User: To add someone to your organization, click the Invite User button. A popup will appear where you can configure the new user’s access:
- Email Address: Enter the new user’s email address.
- Role Selection: Choose whether the user will be an Organisation Administrator (full management access) or an Organisation Employee (standard access).
- Application Types: It is important to select all applicable application type roles (e.g., HPA, Clinical Trial, S21). This directly determines what types of applications this specific user will be able to access, process, and manage on the portal.
- Once you click “Invite”, the user will receive an email to complete their account setup.
- Their status will display as “Pending Invite” on your dashboard until they finish the process.

Note: When inviting a user who already has an existing individual profile on the portal, that user will be migrated to your organization automatically. No further action is required from the individual being migrated.

Subdivisions Management

Also located within the Organisation Management page is the Manage Divisions button. Clicking this allows you to add, edit, or remove structural subdivisions within your organization to help organize your applications and staff.

FTP Credentials

If you have an HPA role, you will see a separate FTP Credentials page under the Administration navigation menu.

Note: FTP details must be set on this page before attempting to create applications that require eCTD uploads to the SAHPRA FTP Server. The system will warn you that an upload could not be verified if your FTP details are missing when you try to Confirm FTP Upload on a sequence.

Profile & Notifications

Your profile can be accessed via the profile icon in the top right corner, where personal account details can be managed and updated.

Profile

Notifications can be accessed by clicking the bell icon in the top right. Selecting “View All Notifications” will display a full history of your alerts.

Notifications Dropdown

Notifications Page

Password Management

If you need to reset your password, click the reset link on the main login page. You will be prompted to enter your registered email address. If an account exists for that address, a password reset email will be delivered with instructions to complete the process.

API Manufacturer Information

The API manufacturer information section can be filled in by searching the applicable INN (either partially or in full) and clicking the magnifying glass icon. Please allow a few moments for the search to return results, then select the correct INN from the list provided. For Fixed Dose Combinations (FDCs), please enter each INN on a new line in alphabetical order.
If the search does not produce a result, a checkbox labelled Override will be displayed. If the required INN or manufacturer cannot be found in the lookup, you may check this box to enable manual entry.

This will unlock the text fields and allow you to enter the required information directly, including selecting the Number Type from a dropdown menu.

Note: If Entity Owned is selected as the Number Type, the Number field will be hidden as it is not required.