FAQs – Section 21 Application

What are the contact details of the Section 21(Category A Medicines for Human Use) unit?

NameEmail addressTelephone numberCellphone number
Section 21 enquiriessection21@sahpra.org.zaN/AN/A
Vivian Mashiane
vivian.mashiane@sahpra.org.za+27 12 015 5494N/A
Mmabatho Tefummabatho.tefu@sahpra.org.za+27 12 501 0347N/A
Duduzile Rapodile
duduzile.rapodile@sahpra.org.za27 12 501 0450+27 82 688 9952
Ebenezer Minlah
ebenezer.minlah@sahpra.org.za+27 12 501 0342+27 66 287 3312
Manager: Dr Shyamli Munbodhshyamli.munbodh@sahpra.org.za+27 12 501 3041+27 72 134 4546

How do I apply for Section 21(Category A Medicines for Human Use) authorisation?

SAHPRA has implemented a submission portal in order to address Section 21 applications for Category A Medicines for Human Use only. Applicants can access the submission portal for authorizations 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 App_Notification@sahpra.org.za. Also monitor the junk mail and spam folder for the correspondence.

Who can I contact regarding a Section 21 application to for a natural supplement / herbal medicine/complementary medicine?

Kaizer Thembo

Tel: 012 501 0408
kaizer.thembo@sahpra.org.za

 

PEM: Complementary Unit Licensing

admin@sahpracm.org.za

Who can I contact regarding a Section 21 application to for a veterinary medicine?

Alice Sigobodhla

Cell: 079 400 5796
Tel: 012 501 0426
alice.sigobodhla@sahpra.org.za

Who can I contact regarding a Section 21 application to for a medical device?

Matlapeng Shabalala

Tel: 012 015 5426
Cell: 071 302 0409
Matlapeng.Shabalala@sahpra.org.za

Which contact details for the Section 21(Category A Medicines for Human Use) unit are now non-operational and must not be used?

Any contact detail not appearing in the aforementioned hyperlink should not be used. In addition, the Section 21(Category A Medicines for Human Use) unit no longer uses fax lines as a means of communication.

What is the Section 21 application fee?

The current fee is R350. The latest fee can be obtained by referring to the Section on FEES the on the SAHPRA website.

What are the banking details?

Refer to the Fees Gazette

What do I write as beneficiary reference when doing payment for a Section 21(Category A Medicines for Human Use) application?

It is best to use the cell phone number of the person who will know the most about the application as beneficiary reference. This will allow ease of enquiry if the payment is audited.

Once I have made a payment for a Section 21(Category A Medicines for Human Use) application, where do I send the Proof Of Payment to?

  • Attach the proof of payment to the online application.
  • If you submitted the application without a proof of payment, you will receive a “More information for [Applicant’s name] is requested!” from App_Notifications@sahpra.org.za in the applicant’s email inbox. It will contain a hyperlink. It will contain a hyperlink [Click here to resubmit]. Once you click on the hyperlink, the attachment of the proof of payment (and any further documents) will be enabled. You will also be able to add explanatory text. When this is submitted, it is processed by the Section 21 unit.
  • It is important to monitor the applicants email inbox. Also monitor the junk mail and spam folder for the correspondence.

What is the turnaround time for a Section 21 application for Category A medicines for human use?

The turnaround time is 3 working days. There are in fact, cases, where this turnaround time, might be prolonged i.e. substances, unfamiliar medication which requires extensive research to be done by the evaluators or further information is requested from applicants.

What do I do if the details on a Section 21 approval letter need to be changed?

It might be the case that certain details on a valid (six month) approval need to be amended, including but not limited to, changing the treating practitioner, change of 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. However, if the approval is no longer valid (six months have elapsed since approval), the applicant must submit an application with recent proof of payment details.

What do I do when a SAHPRA-registered medicine is out of stock?

Obtain an out of stock letter from the supplier and attach to the online application.

How long is a Section 21 authorisation valid?

It is valid for a maximum of 6 (six) months unless otherwise stated.

Who can apply for a Section 21?

A Healthcare Professional (HCP) must apply.

Can a patient apply for a Section 21 on their own?

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

If a Medical Practitioner is the patient, can they apply for a section 21 on their own?

No, a Medical Practitioner other than the one who is a patient must apply for a section 21 authorisation.

Can I hand deliver or email my application?

No hand deliveries or emailed applications will be accepted.

SAHPRA has implemented a submission portal in order to process Section 21 applications for Category A Medicines for Human Use only. Applicants can access the submission portal for authorizations in the main menu: E-SERVICES > Section 21 Applications.

Where can I get information on what medicine is registered by SAHPRA?

As per the following hyperlink: Registered health products

What is the function of Section 21 Unit?

The Section 21 Unit (Category A Medicines for Human Use) of the South African Health Products Authority (SAHPRA) processes and evaluates applications from applicants (treating practitioners) for access to unregistered medication within South Africa (SA). The applicant establishes whether there is a need for a certain medicine; if the Category A medicine for human use is unregistered within South Africa, the applicant will submit a Section 21 application (Category A Medicines for Human Use).

How can I obtain and authorisation for unregistered medicines or consignments brought into SA from abroad?

It must be noted that it is irregular for an individual to seek authorisation for the release of unregistered medicines after these have been detained by SARS (Customs). It is advised that you obtain all necessary authorisations prior to the unregistered medicine being sent to SA.

If you are a foreign national who requires the medication from your home country, please email your request to Mokgadi.fafudi@sahpra.org.za together with a copy of the script and the biodata page of your passport requesting an authorisation.

If your doctor has prescribed the unregistered medicine, your doctor must submit a Section 21 application as per the procedure highlighted earlier in the FAQs.

How can I apply for a Section 21 authorisation for an unregistered medicine to be used in a public health emergency?

Refer to the PHE guideline

Please note that an authorisation does not guarantee that your unregistered product will be procured.

How do I get an authorisation for a donation of medicines?

Refer to the Donations guideline

What is an unmet clinical need?

Identification of unmet medical need:

  • A medical condition whose treatment is not satisfactorily addressed by currently available treatment modalities, or
  • No treatment exists, or
  • Reduced adverse effects, or
  • Improved compliance.

How will I receive an outcome to my application?

  1. Login to your account. Check the status of your application.
  2. If your application has been finalised, i.e. approved or rejected, the outcome letter will be sent to the applicant’s registered email address. The email will be received from app_notifications@sahpra.org.za. Also check the junk mail/spam folder for your email. If the applicant has not received the email, the applicant must send an email request (from the email address that they registered their account with) to section21@sahpra.org.za for the outcome letter to be re-sent.
  3. If your application is pending, the notification will be sent to the applicant’s email address. The subject will contain the wording “More information for [Applicant’s name] is requested!”.

The email will be received from app_notifications@sahpra.org.za. Also check the junk mail/spam folder for your email.

Click on the hyperlink illustrated above in the body of the email. Then attach the requested documents or type in a response in the textbox.

If the applicant has not received the pending notification email, the applicant must send an email request (from the email address that they registered their account with) to section21@sahpra.org.za for the pending notification email to be re-sent.