Online submission portal for Section 21 applications

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About

The portal has been in development over the past few months. The new submission portal will improve the communication timelines between SAHPRA and applicants. The app also allows the end user to perform the following tasks:

Create a user account, manage the user account.

Submit an application (applications submitted cannot be edited).

Receive feedback and notifications via email.

Track the status of your application.

How is the portal accessible?

The portal must only be accessed via the e-services tab on SAHPRA’s homepage.

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Portal Categories

There are four categories of Section 21 applications that can be submitted through the portal:

  • Named patient applications – first time application
  • Bulk stock applications – first time application

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  • You are requested to submit/resubmit the re-authorisation application as a new application. The re-authorisation portal will be closed for further applications. We apologise for the inconvenience.

Unregistered Ivermectin Products

Approved under the “IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME”

    Product Manufacturing site Imported by
    Alice™ Square Pharmaceuticals (Bangladesh) Forrester Pharma (Pty)/Lamar International
    Parakil™ Incepta Pharmaceuticals Ltd (Bangladesh) RX Medicals (Pty) Ltd.
    Parakil™ Incepta Pharmaceuticals Ltd (Bangladesh) Trinity Pharma (Pty) Ltd
    Invermectin tablets USP Ingenus Pharmaceuticals NJ, LCC (New Jersey) RX Medicals (Pty) Ltd.
    Stromectol™ MSD (Kenya,US, France) Equity Pharmaceuticals
    Ivermectin Kwality Pharmaceutical (India) Equity Pharmaceuticals
    Ivermex EUROPEENNE DE PHARMACOTECHNIE - EUROPHARTECH rue Henri Matisse, 63370 Lempdes ,France Haempharma (Pty) Ltd

Contacts