Navigating the portal

This section covers how to login to the portal and logout of the portal, as well as navigating the portal.

Login & Logout Procedures

Logout

The Logout button is accessible at the bottom left of your main navigation once logged in. Confirm that you want to logout when it prompt you to logout

Navigating the Portal

The Applications tab (Containing Applications Manager and Draft Applications) shows all applications currently in processing in their different states.
The Draft Applications sub-tab contains all draft applications not yet submitted to SAHPRA to easily continue building your application. Once the application has passed the payment upload step, it will move to the Applications Manager.
The Legacy Applications sub-tab contains all the Legacy applications imported to your organisation profile. All applications imported that are not validated/cleaned will be listed here with a status of “Legacy Draft” beforew moving to the Application Manager tab.
The Search Applications sub-tab can be used to search any application by a proprietary name linked to the application, the legacy application number, and the newly assigned application ID.
The Approved Products tab will have any applications with approved applications/ products located in the tab.
The Organisation Management tab (Only applicable to Organisation Administrators) allows the user to see and edit their Organisation Details, manage and invite users that are part of the organisation under User Management and management of the organisation Sub Divisions.

Note: FTP details must be set under your Organisation Details before attempting to create applications that require eCTD uploads to the SAHPRA FTP Server. The system will warn that a upload could not be verified if the FTP details are not filled in when trying to “Confirm FTP Upload” on a sequence.
Your profile can be accessed via the profile icon in the top right where personal account details can be managed and changed.

Profile

Notifications can be accessed via the bell icon in the top right when clicked on. When clicking on “View All Notifications” a full history of notifications will be shown.

Password Management

If you wish to reset your password there is a link on the main login page to reset your password. Once selected an email address is required to send a password reset email. If the account exists, the email will be delivered and the process can be followed to reset your password.

API manufacturer Information

The API manufacturer Information section can be filled in by searching the applicable INN (either partially or in full) and clicking on 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 did 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 and is not required to be completed.