SAHPRA implements a new and improved online submission portal for Section 21 applications

19 March 2021

SAHPRA has implemented a new and improved online submission portal for Section 21 applications (Category A Medicines). This has been in development over the past few months. The new submission portal will improve the communication timelines between SAHPRA and applicants.

It also allows the end user to:

  • 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.

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

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

  1. Named patient applications – first time application
  2. Bulk stock applications – first time application
  3. 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.
  4. 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.

You are encouraged to register on the system a substantial time in advance of submitting an application so that the registration doesn’t delay the application submission.

Visit online portal