|Name||Email address||Telephone number||Cellphone number|
|Section 21 firstname.lastname@example.org||N/A||N/A|
|Vivian Mashianeemail@example.com||+27 12 015 5494||N/A|
|Mmabatho Tefufirstname.lastname@example.org||+27 12 501 0347||N/A|
|Duduzile Rapodileemail@example.com||27 12 501 0450||+27 82 688 9952|
|Ebenezer Minlahfirstname.lastname@example.org||+27 12 501 0342||+27 66 287 3312|
|Manager: Dr Shyamli Munbodhemail@example.com||+27 12 501 3041||+27 72 134 4546|
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.
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.
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.
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.
|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 However, if the approval is no longer valid (six months have elapsed since approval), the applicant must submit an application with recent proof of payment details.|
Obtain an out of stock letter from the supplier and attach to the online application.
It is valid for a maximum of 6 (six) months unless otherwise stated.
A Healthcare Professional (HCP) must apply.
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.
No, a Medical Practitioner other than the one who is a patient must apply for a section 21 authorisation.
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.
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).
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.firstname.lastname@example.org 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.
Identification of unmet medical need:
The email will be received from email@example.com. 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 firstname.lastname@example.org for the pending notification email to be re-sent.