FAQs – Section 21 Application

• The applicant can follow the following link: https://portal.sahpra.org.za/user-manual/_site/index.html, or
• Once logged in to the application dashboard, the applicant must click on the question mark located at top right corner of the application dashboard, or
• Click on the question mark on the log in page (portal.sahpra.org.za).

• https://www.sahpra.org.za/event/engagement-portal-emergency-webinar-to-address-the-section-21-portal-issues/
• https://www.sahpra.org.za/event/industry-awareness-webinar-introduction-to-the-new-s21-portal/

If your application has been finalised, i.e. approved or rejected, a notification email will be sent to the applicant’s registered email address from notifications@sahpra.org.za. Once your application has been rejected or approved, the Signed Outcome Letter will reside in the Application Documents section of the application. Simply find the application under your Application Manager and click on the Overview option under the Actions available on the right-hand side of the application. The Signed Outcome Letter will be available under the Application Documents tab.

If the applicant has not received a notification email, the applicant must send an email request (from the email address used to register their profile) to section21@sahpra.org.za for the outcome letter to be re-sent.

To find the query comments, you select the Application Manager after-which the application was searched using the application ID. Once on the application, you click on the drop-down arrow under the Action tab to select Overview. Select Review Comments to view the query comments. To respond to the query comments, select the relevant tab to respond to query.

An application can be submitted through the  submission portal.  This portal only processes Section 21 applications for Category A Medicines for Human Use. Applicants can access the submission portal for authorisations in the main menu: E-Services > Section 21 Applications Once the application is submitted, you are required to monitor the applicant’s email inbox for a response from the email address:  notifications@sahpra.org.za. Also, monitor the junk mail and spam folder for the correspondence.

The current fee is R400 (effective 13 February 2025). The latest fee can be obtained by referring to the Section on FEES the on the SAHPRA website.

Tip: Consult the latest fees schedule on SAHPRA’s website if you are not sure.

Do not make any payments on an application until you have proceeded with the application process wherein you will receive an Application ID/Order Number on an invoice. The beneficiary reference must be the application ID or order number that appears on the invoice that is generated at the end of the creation of the application.

1. Payment while completing the application

• After completing Section D of the application, applicants should then attach their proof of payment by selecting EFT as the payment method. Upload your proof of payment by clicking the upload button and selecting your file, then
• Click “Submit Proof” to submit your payment proof.

2. Payment after receiving payment disputed notification

After receiving an email stating that your payment was disputed for your application, you can submit a new proof of payment for that application.

Navigate to the Applications Dashboard and then:

• Locate your application you wish to submit a new proof of payment for.
• Click on the Action button to the right of the application and

Select Make Payment

• Upload and Submit your new proof of payment.
• You may be required to request for a refund of the incorrect payment.
• Refund process as per the SAHPRA PAYMENT GUIDELINE.

2.1 Refund request by an applicant

For SAHPRA to process your refund, you are required to provide the following information:

• Letter from the company explaining the reason for the refund request
• Proof of payment (A letter from the bank is not acceptable)
• Valid Tax Clearance Certificate
• Banking details
• Cipro Certificates and ID copies of directors [CK]

or

2.2 Refund request by an individual

For SAHPRA to process your refund, you are required to provide the following information:

• An affidavit or letter stating the reason for refund request
• Certified copy of ID
• Proof of payment
• Banking details

Please note these when requesting a refund: Email refund applications to finance@sahpra.org.za and copy the relevant unit processing the application.

Subject line: Marked “application for refund”

Queries

3. Payment after receiving payment awaiting notification

If you submitted the application without a proof of payment, you would receive a “Payment  Awaiting” notification.

Currently, the credit card payment option has not been implemented as yet.

The Section 21 Unit aims to evaluate and make a decision on an application within three (3) working days of receipt of the application by the Section 21 Unit via the online system.

What does my status “In Review” mean?

• An “Application status” indicates the progress and current stage of an application. “In Review” indicates that the application is currently being evaluated.

• A “Queried application” means an application has specific questions that need to be addressed and documents that need to be attached before it can be fully processed.

It might be the case that certain details on a valid approval need to be amended, including but not limited to, changing the treating practitioner or change of an importing company. In this case, please resubmit your application on the online portal with the amended details. The reason for re-submitting must be clearly mentioned in the re-submitted application. The applicant may request for a refund from the Finance Unit (finance@sahpra.org.za). However, if the approval is no longer valid (where six months have elapsed since approval), the applicant must submit an application with recent proof of payment details.

The prescribing medical practitioner must apply.

No, a treating Medical Practitioner, who takes full clinical responsibility (for monitoring safety, efficacy and quality of the unregistered medicine), must complete an online application.