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Short answer: A Section 21 application is how a doctor in South Africa gets permission to use a medicine that is not registered here. The treating practitioner applies, not the patient. You apply online at portal.sahpra.org.za under E-Services → Section 21 Applications. The fee is R400 (the amount published by SAHPRA as effective 13 February 2025). SAHPRA aims to decide within three working days of receiving the application.
This page covers the practical parts the guideline does not put up front: who may sign, what the fee actually buys, how to pay so your application is not held up, what happens after you submit, and how to fix an approval that has the wrong details on it.
What Section 21 actually is
Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) lets the South African Health Products Regulatory Authority (SAHPRA) authorise the sale or use of a medicine that has not been registered in South Africa. The procedural detail sits in regulation 29 of the General Regulations.
People often call these “Section 21 drugs”. That is slightly misleading. There is no fixed list of Section 21 medicines. Any unregistered medicine can become a Section 21 medicine for one named patient if a practitioner makes the case for it. The authorisation attaches to the patient and the prescriber, not to the product in general.
Typical situations where it is used:
- A medicine is registered elsewhere in the world but has never been registered in South Africa.
- A registered medicine is out of stock nationally and an unregistered equivalent must be imported.
- A patient needs a treatment for a rare condition where no registered option exists.
- Emergency or early access during a public health event. SAHPRA used Section 21 this way for COVID-19 vaccines before full registration.
The three streams — and why most people only need Category A
The word “category” causes a lot of confusion, because people expect a Category A, B and C. That is not how it works.
| Stream | What it covers | Where it is handled |
|---|---|---|
| Category A — Medicines for Human Use | Unregistered medicines prescribed for a named human patient | The Section 21 Unit, through the online submission portal |
| Veterinary medicines | Unregistered medicines for animals | A separate procedure — not the Category A portal |
| Complementary medicines | Unregistered complementary medicines | A separate procedure with its own application form |
SAHPRA states that the application procedures for the veterinary and complementary streams differ vastly from Category A. If you are a clinician treating a human patient, Category A is your route, and the online portal is built for it. If you are applying for the other two streams, do not use the Category A portal — get the correct form from SAHPRA’s forms library first.
Who is allowed to apply
The applicant must be the prescribing medical practitioner. A patient cannot apply for themselves, and a family member cannot apply on the patient’s behalf.
This is not an administrative preference. The practitioner who applies takes on clinical responsibility for monitoring the safety, efficacy and quality of an unregistered product in that patient. That is the trade SAHPRA is making: it waives registration, and a named clinician accepts accountability for the outcome.
In practice this means a pharmacist, a hospital procurement officer or a patient advocacy group can prepare the paperwork, but a practitioner has to be the named applicant.
What it costs
| Item | Amount | Source and date |
|---|---|---|
| Section 21 application (Category A, medicines for human use) | R400 | Fee published by SAHPRA as effective 13 February 2025 |
| All other SAHPRA fee categories | Varies | Set out in SAHPRA’s Payment Guideline, which is revised periodically |
Two things worth knowing about the fee:
- It is per application, not per patient per year. If the same patient needs a further authorisation later, that is a new application and a new fee.
- Fees change. The R400 figure carries an effective date for a reason. SAHPRA revises its Payment Guideline periodically, so check the current Payment Guideline on the SAHPRA site before you pay, especially if you are reading this well after early 2025.
The R400 is the Section 21 application fee only. It is not the same as the cost of registering a medicine, and it is not the same as the “SAHPRA certificate” fees people ask about — those are licensing and registration fees on a different scale entirely.
How to apply, step by step
- Create an account on the engagement portal at
portal.sahpra.org.za. This is the same portal used for several other SAHPRA services, so you may already have credentials. - Go to E-Services, then Section 21 Applications. The Section 21 submission portal handles Category A medicines for human use only.
- Complete the application form online. You will be asked to establish clinical need — why this patient requires a medicine that is not registered in South Africa, and why registered alternatives are not suitable.
- Attach your supporting documents. What is needed depends on the case, but commonly includes culture or laboratory reports supporting the clinical need, and the patient’s informed consent.
- Pay by EFT and upload proof of payment in Section D of the application. This is the step that most often delays an application.
- Submit and wait for the outcome notification.
The payment detail that holds applications up
When you make the EFT, the beneficiary reference must match the Application ID or Order Number generated on your invoice. If you use the patient’s name, your practice name, or an old reference, SAHPRA’s finance system cannot match your payment to your application, and the application sits unprocessed while everyone waits.
Generate the invoice first, copy the reference exactly, then pay.
How long it takes
SAHPRA’s stated target is that the Section 21 Unit will evaluate and decide on an application within three working days of receipt.
Read “of receipt” carefully. The clock starts when SAHPRA has a complete application, which includes matched proof of payment. An application submitted on Friday with an unmatched EFT reference is not a three-working-day application. Most of the delay people experience in Section 21 is on the payment-matching step, not the clinical evaluation.
Three working days is a target, not a guarantee, and complex cases can take longer.
What happens after you submit
- Notification emails come from [email protected]. Add this to your safe-senders list — these mails land in spam folders often enough to be worth pre-empting.
- The signed outcome letter appears in the portal under the Overview tab, in the Application Documents section. The email tells you a decision exists; the portal holds the document you actually need.
- Download and keep the signed letter. It is the evidence of authorisation for the pharmacy, the importer and your own records.
Fixing an approval with the wrong details
If an authorisation is issued with incorrect details, SAHPRA does not edit the existing approval. You resubmit the application with the amended information and clearly state the reason for the change.
Because a resubmission is a new application, a fee question arises. Where a fee has been paid in error or twice, a refund request goes to [email protected]. Handle the clinical resubmission and the finance request as two separate threads — the Section 21 Unit does not process refunds.
General Section 21 queries go to [email protected].
Questions people actually ask
What is the application fee for SAHPRA Section 21?
R400, as published by SAHPRA with an effective date of 13 February 2025. Confirm against the current Payment Guideline before paying, as fees are revised periodically.
How long does SAHPRA Section 21 approval take?
The Section 21 Unit aims to decide within three working days of receiving a complete application. Incomplete applications and unmatched payment references are the usual reasons this slips.
What are “Section 21 drugs”?
There is no standing list. A Section 21 medicine is any unregistered medicine that SAHPRA has authorised for a named patient on a practitioner’s application. The same product may be authorised for one patient and not another.
Can a patient apply for themselves?
No. The prescribing medical practitioner must be the applicant and accepts responsibility for monitoring safety and efficacy.
How much does it cost to get a SAHPRA certificate?
This is a different question from Section 21. Licensing, registration and certificate fees are separate categories in SAHPRA’s Payment Guideline and are substantially higher than the R400 Section 21 application fee.
How long is a Section 21 authorisation valid, and how much may I import?
Validity periods and permitted quantities are set out in SAHPRA’s guideline document rather than on its web pages, and they vary by case. The governing document is SAHPGL-CEM-S21-02, Version 6, dated 30 October 2025. Download the current version from SAHPRA’s site and confirm the limits that apply to your application — we have not reproduced figures here that we could not verify against the published document.
Is Section 21 the same as a clinical trial authorisation?
No, and mixing them up is a common and costly error. Section 21 gives one named patient access to an unregistered medicine as treatment. Research use runs through a different pathway entirely — see our guide to SAHPRA’s clinical trial and bioequivalence authorisation process. If you are giving an unregistered product to participants to generate data, that is a trial, not Section 21.
Before you start
Have these ready and the application is straightforward:
- A named prescribing practitioner willing to be the applicant
- The clinical justification, with supporting reports
- Patient informed consent
- Portal credentials for
portal.sahpra.org.za - The invoice reference, copied exactly, ready for the EFT
Regulatory fees and turnaround targets change. Every figure on this page carries the date it was published so you can see how current it is, but confirm the fee and the guideline version on SAHPRA’s own site before you submit.
Working across more than one African regulator? Our guide to the African Medicines Agency and multi-country trials covers how these national pathways are being harmonised.
