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22 Mar 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:
- Named patient applications – first time application
- Bulk stock applications – first time application
- 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.
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.