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Introduction

Welcome to the SAHPRA Portal User Guide

This guide provides step-by-step instructions for using the South African Health Products Regulatory Authority (SAHPRA) Engagement portal.

Purpose of This Manual

The SAHPRA Engagement Portal https://portal.sahpra.org.za/ is an online platform designed to facilitate interactions between applicants and the South African Health Products Regulatory Authority (SAHPRA). This portal enables users to submit and track applications, manage their profiles, and ensure compliance with regulatory requirements.

This manual provides step-by-step guidance on how to effectively use the portal, including navigation, user account management, and submission of applications.

Key Learning Objectives

By the end of this training, users will be able to:

  • Navigate the SAHPRA Engagement Portal efficiently.
  • Manage user profiles, including login, logout, and password resets.
  • Understand the process of submitting and tracking applications.

User Role Breakdown

To ensure secure and relevant access, the SAHPRA portal uses a role-based system. User permissions are determined by their base account type and any specific application roles assigned to them.

Account Types

  • Individual: Designed for independent applicants who are not affiliated with a registered organization. These users can independently submit, amend, and track the progress of their own applications.
  • Employee: Granted to users acting on behalf of an organization. This role provides access to the organization’s data and applications, with specific capabilities determined by the application roles they are assigned.
  • Organisation Administrator: Includes all standard Employee permissions, plus the administrative authority to view and update the organization’s profile and manage its affiliated users.

Application-Specific Roles

  • HPA - Applicant: Grants full access to initiate and manage Health Product Applications (HPA), including all related navigation menus and functions.
  • S21 - Applicant: Grants full access to initiate and manage Section 21 Applications, including all related navigation menus and functions.
  • Clinical Trial - Applicant: Grants full access to initiate and manage Clinical Trial Applications, including all related navigation menus and functions.

System Requirements

The SAHPRA portal works best with:

  • Modern web browsers (Chrome, Firefox, Edge, Safari)
  • JavaScript enabled
  • PDF viewer for application documents