Online submission portal for Section 21 applications

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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  • Named-patient reauthorisations – The system will not allow you to submit a reauthorisation unless an approved application exists under your profile as an applicant. It is for this reason that all reauthorisation requests be submitted as a first time applications so that a reauthorisation can be submitted when it is required.
  • Bulk stock reauthorisations – The system will not allow you to submit a reauthorisation unless an approved application exists under your profile as an applicant. It is for this reason that all reauthorisation requests be submitted as a first time applications so that a reauthorisation can be submitted when it is required.

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